This visit was
for an STI

The next could be for HIV

Help protect patients at risk for HIV with TRUVADA FOR PrEP®

Approved to significantly reduce the risk of sexually acquired HIV-1 in individuals at risk, in combination with safer sex practices.1,2

TRUVADA FOR PrEP is one tablet taken once daily as part of a comprehensive prevention plan.1

HIV-1–negative status must be confirmed immediately prior to initiating TRUVADA FOR PrEP and at least every 3 months thereafter.

See how STIs can affect HIV risk >>
CDC and WHO recommended to help reduce the risk of HIV in combination with safer sex practices for individuals at risk3,4

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • TRUVADA FOR PrEP must only be prescribed to individuals confirmed to be HIV‑negative immediately prior to initiation and at least every 3 months during use. Drug-resistant HIV‑1 variants have been identified with use of TRUVADA FOR PrEP following undetected acute HIV‑1 infection. Do not initiate if signs or symptoms of acute HIV‑1 infection are present unless HIV‑negative status is confirmed
  • Severe acute exacerbations of hepatitis B have been reported in HBV‑infected patients who discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HBV after discontinuing TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted

See more Important Safety Information below Indication.

INDICATION

TRUVADA FOR PrEP (pre-exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35 kg) who are at risk for HIV, when used in combination with safer sex practices. HIV-negative status must be confirmed immediately prior to initiation.

  • If clinical symptoms of acute HIV-1 infection are present and recent exposures (<1 month) are suspected, delay initiation for at least 1 month until HIV-negative status is reconfirmed. Alternatively, confirm HIV-negative status with a test cleared by the FDA to aid in the diagnosis of acute HIV‑1 infection

Individuals at risk for sexually acquired HIV‑1 may include those:

  • With HIV‑1 infected partner(s), or
  • Who engage in sexual activity in a high prevalence area or social network and have additional risk factors, such as: inconsistent or no condom use, diagnosis of sexually transmitted infections (STIs), exchange of sex for commodities, use of illicit drugs or alcohol dependence, incarceration, or sexual partners of unknown HIV status with any of these risk factors

Please see full Prescribing Information for TRUVADA FOR PrEP, including BOXED WARNING.

See how STIs can affect HIV risk >>

Proactive
HIV Prevention

INDICATION

TRUVADA FOR PrEP® (pre-exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV‑1 in adults and adolescents (≥35 kg) who are at risk for HIV, when used in combination with safer sex practices. HIV‑negative status must be confirmed immediately prior to initiation.

HELP PROACTIVELY PREVENT HIV WITH TRUVADA FOR PrEP—ONE TABLET, ONCE DAILY1

Approved to significantly reduce the risk of sexually acquired HIV-1 in individuals at risk, in combination with safer sex practices1,2

  • One tablet, once daily
  • Taken with or without food
emtricitabine
(FTC) 200 mg + tenofovir disoproxil
fumarate (TDF) 300 mg

IMPORTANT SAFETY INFORMATION (cont'd)

Contraindications

  • TRUVADA FOR PrEP is contraindicated in individuals with unknown or positive HIV status

U.S. AND GLOBAL HEALTH GUIDELINES RECOMMEND TRUVADA FOR PrEP IN COMBINATION WITH SAFER SEX PRACTICES TO HELP REDUCE THE RISK OF SEXUALLY ACQUIRED HIV‑1 IN INDIVIDUALS AT RISK3-7

CDC
Centers for Disease Control and Prevention
WHO
World Health
Organization
ACOG
The American College of Obstetricians and Gynecologists
IAS-USA
International Antiviral Society–USA
ACHA
American College Health Association

All of these organizations:

  • Provide criteria for determining a person's risk of HIV infection and for TRUVADA FOR PrEP use
  • Include TRUVADA FOR PrEP as a prevention option for HIV‑1–negative individuals at risk for HIV infection
  • Emphasize the importance of counseling on adherence and comprehensive HIV risk reduction
  • Recommend confirming HIV‑1–negative status prior to starting PrEP
  • Recommend that ongoing use of TRUVADA FOR PrEP be guided by regular risk assessment

Health guidelines recommend TRUVADA FOR PrEP and emphasize the importance of counseling on adherence and HIV‑1 risk reduction strategies.

National HIV/AIDS Strategy (NHAS) recommends TRUVADA FOR PrEP in combination with safer sex practices for HIV prevention8

A goal of the NHAS is to expand efforts to prevent HIV infection using a combination of effective, evidence-based approaches.
These include:

  • HIV testing
  • PrEP (pre-exposure prophylaxis) and PEP (post-exposure prophylaxis) in combination with behavioral interventions that support engagement in care and adherence to treatment
  • TasP (treatment as prevention) in HIV-positive individuals. Adhering to HIV treatment and maintaining an undetectable viral load can help reduce the transmission of HIV to others
  • Correct and consistent condom use
  • Access to sterile needles and syringes

The NHAS recommends TRUVADA FOR PrEP in combination with behavioral interventions that support engagement in care and adherence to treatment.8


IMPORTANT SAFETY INFORMATION (cont'd)

Warnings and precautions: Comprehensive risk reduction strategies

  • Reduce HIV‑1 risk: TRUVADA FOR PrEP is not always effective in preventing HIV‑1. Use only as part of a comprehensive prevention strategy that includes safer sex practices, regular testing for HIV‑1 and other STIs, and counseling on reducing sexual risk behaviors
  • Reduce potential for drug resistance: TRUVADA FOR PrEP should only be used in individuals confirmed to be HIV-negative immediately prior to initiation, at least every 3 months while taking TRUVADA, and upon an STI diagnosis. HIV‑1 resistance substitutions may emerge in individuals with undetected HIV‑1 infection who are taking only TRUVADA. TRUVADA alone is not a complete regimen for treating HIV‑1
    • HIV antibody tests may not detect acute HIV infection. If recent exposures are suspected or symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash), delay initiating (≥1 month) or discontinue use and confirm HIV-negative status with a test approved by the FDA for the diagnosis of acute HIV infection
    • If a screening test indicates possible HIV-1 infection, convert the HIV-1 PrEP regimen to an HIV treatment regimen until HIV-negative status is confirmed
  • Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule, as efficacy is strongly correlated with adherence. Some individuals, such as adolescents, may benefit from more frequent visits and counseling

IN AN ANALYSIS OF REAL-WORLD DATA,

TRUVADA FOR PrEP UPTAKE WAS SIGNIFICANTLY ASSOCIATED WITH A REDUCTION IN NEW HIV DIAGNOSES9,10

The study modeled the impact of TRUVADA FOR PrEP on the number of annual HIV diagnoses in the U.S. from 2012-2016. The effect of TRUVADA FOR PrEP independent from the effect of treatment as prevention (TasP) was also evaluated using available viral suppression data (averaged from 2012-2015).


First Analysis: Evaluated association between TRUVADA FOR PrEP uptake and HIV diagnoses.

  • Determined estimated annual percent change (EAPC) in HIV diagnoses and in TRUVADA FOR PrEP use from 2012-2016 in 50 states and the District of Columbia
  • Grouped the states into quintiles according to TRUVADA FOR PrEP use in populations at risk for HIV from 2012-2016, from highest to lowest use
  • Calculated average EAPC and 95% CIs for HIV diagnoses by quintile

Repeat Analysis: Examined whether the association of TRUVADA FOR PrEP uptake and HIV diagnoses changes when controlling for viral suppression levels.

  • In a subset of states (n=39) with available data (≥1 year of complete lab reporting, averaging available years from 2012-2014), HIV viral suppression rates among people living with HIV at the end of the calendar year were used for each state for 2012-2015

Study Limitations: The analyses are ecological and don't imply a causal association between TRUVADA FOR PrEP use and HIV diagnoses. HIV diagnoses and TRUVADA FOR PrEP use may be underreported. The calculation of the number of people at risk for HIV in this analysis was based on 2015 data and applied to all analytic years. The relative contributions of TRUVADA FOR PrEP vs viral suppression (TasP) to the declining trend in HIV diagnoses cannot be determined. Measures of changing risk behaviors or HIV testing behaviors were not included in the study design.


Data sources (2012-2016) included National HIV Surveillance System for annual number of HIV diagnoses (2012-2016) and viral suppression rates (2012-2015); U.S. Census Bureau for HIV diagnosis rates in the general U.S. population; a U.S. national prescription database representing more than 83% of all prescriptions dispensed by commercial U.S. pharmacies for estimating TRUVADA FOR PrEP use during a calendar year, and a validated algorithm was used to exclude FTC/TDF use for non-PrEP reasons (access to data on TRUVADA FOR PrEP was provided by AIDSVu.org); and a CDC estimation method for the number of people per state with a TRUVADA FOR PrEP indication.


Disclaimer: Two authors are employees of Gilead Sciences, Inc. and participated in the study design.

In a Retrospective Analysis of Real-World Data, TRUVADA FOR PrEP Use Impacted HIV Diagnosis RatesEstimated Annual Percent Change (EAPC) in HIV Diagnoses of Persons ≥13 Years of Age for U.S. States Grouped Into Quintiles of TRUVADA FOR PrEP Use 2012-2016*

In this analysis of real-world data over a 5-year period, states in the high-use quintile for TRUVADA FOR PrEP had the greatest reduction in HIV diagnoses, independent of viral suppression rates on aggregate‡§

*Persons indicated for TRUVADA FOR PrEP from 2012-2016.

†Highest TRUVADA FOR PrEP use quintile = mean 110/1000 prescriptions/people with TRUVADA FOR PrEP indication.

Lowest TRUVADA FOR PrEP use quintile = mean 33/1000 prescriptions/people with TRUVADA FOR PrEP indication.

‡In the 39 states for which there are viral suppression data, averaged for available years from 2012-2015.

§Data shown for quintiles are trends and do not represent the EAPC for each individual state.


IMPORTANT SAFETY INFORMATION (cont'd)

Warnings and precautions

  • New onset or worsening renal impairment: Cases of acute renal impairment and Fanconi syndrome have been reported with the use of tenofovir disoproxil fumarate (TDF). TRUVADA is not recommended in individuals with estimated creatinine clearance (CrCl) <60 mL/min. Avoid concurrent or recent use with a nephrotoxic agent. Acute renal failure has been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients. Monitor renal function in all patients – See Dosage and Administration section
  • Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia associated with proximal renal tubulopathy, have been reported with the use of TDF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss
  • Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations
  • Drug interactions: See Drug Interactions section. Consider the potential for drug interactions prior to and during use of TRUVADA and monitor for adverse reactions

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • TRUVADA FOR PrEP must only be prescribed to individuals confirmed to be HIV‑negative immediately prior to initiation and at least every 3 months during use. Drug-resistant HIV‑1 variants have been identified with use of TRUVADA FOR PrEP following undetected acute HIV‑1 infection. Do not initiate if signs or symptoms of acute HIV‑1 infection are present unless HIV‑negative status is confirmed
  • Severe acute exacerbations of hepatitis B have been reported in HBV‑infected patients who discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HBV after discontinuing TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted

Contraindications

  • TRUVADA FOR PrEP is contraindicated in individuals with unknown or positive HIV status

Warnings and precautions: Comprehensive risk reduction strategies

  • Reduce HIV‑1 risk: TRUVADA FOR PrEP is not always effective in preventing HIV‑1. Use only as part of a comprehensive prevention strategy that includes safer sex practices, regular testing for HIV‑1 and other STIs, and counseling on reducing sexual risk behaviors
  • Reduce potential for drug resistance: TRUVADA FOR PrEP should only be used in individuals confirmed to be HIV-negative immediately prior to initiation, at least every 3 months while taking TRUVADA, and upon an STI diagnosis. HIV‑1 resistance substitutions may emerge in individuals with undetected HIV‑1 infection who are taking only TRUVADA. TRUVADA alone is not a complete regimen for treating HIV‑1
    • HIV antibody tests may not detect acute HIV infection. If recent exposures are suspected or symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash), delay initiating (≥1 month) or discontinue use and confirm HIV-negative status with a test approved by the FDA for the diagnosis of acute HIV infection
    • If a screening test indicates possible HIV-1 infection, convert the HIV-1 PrEP regimen to an HIV treatment regimen until HIV-negative status is confirmed
  • Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule, as efficacy is strongly correlated with adherence. Some individuals, such as adolescents, may benefit from more frequent visits and counseling

Warnings and precautions

  • New onset or worsening renal impairment: Cases of acute renal impairment and Fanconi syndrome have been reported with the use of tenofovir disoproxil fumarate (TDF). TRUVADA is not recommended in individuals with estimated creatinine clearance (CrCl) <60 mL/min. Avoid concurrent or recent use with a nephrotoxic agent. Acute renal failure has been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients. Monitor renal function in all patients – See Dosage and Administration section
  • Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia associated with proximal renal tubulopathy, have been reported with the use of TDF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss
  • Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations
  • Drug interactions: See Drug Interactions section. Consider the potential for drug interactions prior to and during use of TRUVADA and monitor for adverse reactions

Adverse reactions

  • Common adverse reactions (>2% and more frequently than placebo) of TRUVADA FOR PrEP in clinical trials were headache, abdominal pain, and weight loss

Drug interactions

  • Prescribing information: Consult the full Prescribing Information for TRUVADA for more information, warnings, and potentially significant drug interactions, including clinical comments
  • Hepatitis C antivirals: Coadministration with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir increases TDF exposure; monitor for adverse reactions
  • Drugs affecting renal function: Coadministration of TRUVADA with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine and/or tenofovir

Pregnancy and lactation

  • Pregnancy: An Antiretroviral Pregnancy Registry (APR) has been established. Available data from observational studies and the APR show no increase in the rate of major birth defects for TRUVADA compared with a US reference population. Consider HIV prevention methods, including TRUVADA FOR PrEP in women due to the potential increased risk of HIV-1 infection during pregnancy and mother to child transmission during acute HIV-1 infection
  • Lactation: Emtricitabine and tenofovir have been detected in human milk. Evaluate the benefits and risks of TRUVADA FOR PrEP in breastfeeding women, including the risk of HIV-1 acquisition due to nonadherence, and subsequent mother to child transmission. Health benefits of breastfeeding should be considered along with potential adverse effects of TRUVADA on the child, which are unknown

Dosage and administration

  • Dosage: One tablet once daily with or without food
  • HIV screening: Test for HIV-1 infection prior to initiating and at least every 3 months during treatment
  • HBV screening: Test for HBV infection prior to or when initiating treatment
  • Renal impairment and monitoring: Not recommended in individuals with CrCl <60 mL/min. In all patients, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein on a clinically appropriate schedule. In patients with chronic kidney disease, also assess serum phosphorus

Risk & Patient
Identification

INDICATION

TRUVADA FOR PrEP® (pre-exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV‑1 in adults and adolescents (≥35 kg) who are at risk for HIV, when used in combination with safer sex practices. HIV‑negative status must be confirmed immediately prior to initiation.

THE RISK OF GETTING HIV PERSISTS TODAY FOR BOTH MEN AND WOMEN

1.1 million individuals are estimated to be at elevated risk for sexually acquired HIV in the U.S., with ~40,000 diagnoses annually11,12

Learn more about lifetime risk of HIV infection in the U.S. by selecting a risk level OR interacting with the map below.

LIFETIME RISK OF HIV
DIAGNOSIS BY STATE13

Highest
STATERISK*
DC1 in 13
MD1 in 49
GA1 in 51
FL1 in 54
LA1 in 56
NY1 in 69
TX1 in 81
STATERISK*
NJ1 in 84
MS1 in 85
SC1 in 86
NC1 in 93
DE1 in 96
AL1 in 97
  
High
STATERISK*
NV1 in 98
IL1 in 101
CA1 in 102
TN1 in 103
PA1 in 115
VA1 in 115
MA1 in 121
STATERISK*
AZ1 in 138
CT1 in 139
RI1 in 143
OH1 in 150
MO1 in 155
AR1 in 159
  
Low
STATERISK*
MI1 in 167
OK1 in 168
KY1 in 173
IN1 in 183
WA1 in 185
CO1 in 191
NM1 in 196
STATERISK*
HI1 in 202
OR1 in 214
MN1 in 216
KS1 in 262
NE1 in 264
  
  
Lowest
STATERISK*
WV1 in 302
WI1 in 307
IA1 in 342
UT1 in 366
ME1 in 373
AK1 in 384
SD1 in 402
STATERISK*
NH1 in 411
WY1 in 481
VT1 in 527
ID1 in 547
MT1 in 578
ND1 in 670
  
West
STATERISK*
NV1 in 98
CA1 in 102
WA1 in 185
CO1 in 191
HI1 in 202
OR1 in 214
UT1 in 366
STATERISK*
AK1 in 384
WY1 in 481
ID1 in 547
MT1 in 578
  
  
  
  
  
Northeast
STATERISK*
DC1 in 13
MD1 in 49
NY1 in 69
NJ1 in 84
DE1 in 96
PA1 in 115
MA1 in 121
STATERISK*
CT1 in 139
RI1 in 143
ME1 in 373
NH1 in 411
VT1 in 527
  
  
Southeast
STATERISK*
GA1 in 51
FL1 in 54
LA1 in 56
MS1 in 85
SC1 in 86
NC1 in 93
AL1 in 97
STATERISK*
TN1 in 103
VA1 in 115
AR1 in 159
KY1 in 173
WV1 in 302
  
  
Southwest
STATERISK*
TX1 in 81
AZ1 in 138
OK1 in 168
NM1 in 196
  
  
  
  
  
Midwest
STATERISK*
IL1 in 101
OH1 in 150
MO1 in 155
MI1 in 167
IN1 in 183
MN1 in 216
KS1 in 262
STATERISK*
NE1 in 264
WI1 in 307
IA1 in 342
SD1 in 402
ND1 in 670
  
  
 

Overall, 1 in 99 Americans will be diagnosed with HIV in their lifetime.13

*Chances of an individual being diagnosed with HIV during their lifetime.

HIV RISK CAN AFFECT SEXUALLY ACTIVE INDIVIDUALS OF ALL GENDERS, ETHNICITIES, AGES, AND SEXUAL ORIENTATIONS


Age
HIV diagnosis
  • Young adults continue to be the group at highest risk12

Ethnicity
Lifetime risk of HIV diagnosis*
     Men14      Women14
Overall 1 in 68 1 in 253
African American 1 in 22 1 in 54
Hispanic 1 in 51 1 in 256
Native Hawaiian/
Pacific Islander		 1 in 95 1 in 432
Caucasian 1 in 140 1 in 941
Asian 1 in 176 1 in 943

Women
Current risk of HIV diagnosis

70% OF HETEROSEXUALS AT RISK OF SEXUALLY ACQUIRED HIV ARE WOMEN11†

  • Women who live in areas of high prevalence of HIV may not be aware of the risk15
  • 1 in 5 people diagnosed with HIV is a woman12

†Approximately 258,000 heterosexuals are at risk of HIV.


MSM
Lifetime risk of HIV diagnosis*
African American
1 in 2
Hispanic
1 in 4
Caucasian
1 in 11
  • Among MSM, African Americans and Hispanics are at the highest lifetime risk for HIV infection13
  • Receptive partners of anal sex are 13 times more likely to become infected with HIV than insertive partners16
  • MSM are 83 times more likely to become infected with HIV than heterosexual men17

Transgender
HIV prevalence and risk

~1.4 million Americans identify as transgender18

  • ~22% of transgender women in the U.S. are HIV positive19
    • Among transgender women, HIV prevalence is ~34 times greater than among cisgender adults19
    • 72% of transgender women perceive themselves to be at low or no HIV risk20
  • 69% of transgender men report condomless sex with cisgender men21
  • 89% of transgender individuals believe that it is important for their healthcare provider to know their gender identity22

*Chances of an individual being diagnosed with HIV during their lifetime.

MSM=men who have sex with men.

STIs CAN BE A RED FLAG FOR HIV RISK3,23

Behaviors that can result in an STI can also increase the risk of HIV. These may include sex:



Without a condom

With partner(s)
of unknown status

While under the influence
of drugs or alcohol


CDC guidelines recommend considering TRUVADA FOR PrEP in combination with safer sex practices for HIV-negative individuals who are at risk for HIV3


A record high of 2.3 million new cases of syphilis, gonorrhea, and chlamydia combined were diagnosed and reported in 201724



SYPHILIS ↑ 76% (2017 vs 2013
in the U.S.)25
Genital ulcers are associated with
5x
increased risk of becoming HIV+26
Among women, syphilis is associated with
20x
increased risk of becoming HIV+27
Among men with syphilis
~20%
became HIV+ within 10 years28

GONORRHEA ↑ 67% (2017 vs 2013
in the U.S.)25
A history of 2 prior rectal gonorrhea infections is associated with
8x
increased risk of becoming HIV+29
Among MSM with a history of rectal gonorrhea or chlamydia
1 in 15
become HIV+ within 1 year30
Among women with a history of gonorrhea, there was
6x
increased risk of HIV diagnoses27

CHLAMYDIA ↑ 22% (2017 vs 2013
in the U.S.)31
A history of 2 prior rectal chlamydia infections is associated with
8x
increased risk of becoming HIV+29
Among women, chlamydia is associated with
2x
increased risk of becoming HIV+27
Among MSM with a history of rectal gonorrhea or chlamydia
1 in 15
become HIV+ within 1 year30


Many STIs are asymptomatic. Comprehensive STI screening is recommended, including at all sites of exposure.32,33

  • It is estimated that 95% of gonorrhea infections among MSM would be missed by screening the urethra only32
  • 86% of rectal chlamydia and 84% of rectal gonorrhea infections are asymptomatic34

51% of people newly diagnosed with HIV had an STI history that included chlamydia, gonorrhea, or syphilis in a real-world study (n=214)35


IMPORTANT SAFETY INFORMATION (cont'd)

Warnings and precautions

  • New onset or worsening renal impairment: Cases of acute renal impairment and Fanconi syndrome have been reported with the use of tenofovir disoproxil fumarate (TDF). TRUVADA is not recommended in individuals with estimated creatinine clearance (CrCl) <60 mL/min. Avoid concurrent or recent use with a nephrotoxic agent. Acute renal failure has been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients. Monitor renal function in all patients – See Dosage and Administration section

CDC=Centers for Disease Control and Prevention.

ROUTINE PATIENT VISITS CAN FREQUENTLY BE MISSED OPPORTUNITIES TO HELP PREVENT HIV INFECTIONS36

In a real-world study, many of those newly diagnosed with HIV had a chance to work with a healthcare provider to prevent HIV prior to their diagnoses

Nearly

2 out of 3

2 out of 3

patients newly diagnosed with HIV had visited a healthcare facility at least once prior to diagnosis

(n=504/785)


Patients had a mean of

7

healthcare visits
before an HIV diagnosis

IMPORTANT SAFETY INFORMATION (cont'd)

Warnings and precautions (cont'd)

  • Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia associated with proximal renal tubulopathy, have been reported with the use of TDF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss
  • Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations
  • Drug interactions: See Drug Interactions section. Consider the potential for drug interactions prior to and during use of TRUVADA and monitor for adverse reactions

BE THE CATALYST TO SPARK A CONVERSATION ABOUT HIV RISK AND PREVENTION

Only 23% and 47% of sexually active men and women, respectively, report receiving a sexual risk assessment, despite visiting a healthcare provider in the past year37


Uncover HIV risk by starting a dialogue with patients about:


STI history

"Have you or your partner(s) ever had an STI?"38

HIV testing habits

"Do you tend to get tested for HIV regularly, or just when you think you may have been exposed?"39

Sexual relationships

"Are your sexual partner(s) new or long-term? Are you and your partner(s) in an open relationship?"38


IMPORTANT SAFETY INFORMATION (cont'd)

Adverse reactions

  • Common adverse reactions (>2% and more frequently than placebo) of TRUVADA FOR PrEP in clinical trials were headache, abdominal pain, and weight loss

ONLY 18% OF PATIENTS AT RISK FOR HIV ARE CURRENTLY PRESCRIBED TRUVADA FOR PrEP40*

Factors that help to identify appropriate candidates for TRUVADA FOR PrEP may include1:


Having partner(s) who are HIV+
OR
Engaging in sexual activity within a high-prevalence area or social network and having an HIV risk factor such as:

Diagnosis of sexually transmitted infections

Use of illicit drugs or alcohol dependence

Inconsistent or no condom use

Partner(s) of
unknown HIV-1 status

Incarceration


Exchange of sex for commodities

TRUVADA FOR PrEP (pre-exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV‑1 in adults and adolescents (≥35 kg) who are at risk for HIV, when used in combination with safer sex practices. HIV‑negative status must be confirmed immediately prior to initiation.



When prescribing TRUVADA FOR PrEP, consider the following1:

TRUVADA FOR PrEP should only be prescribed to individuals who are confirmed to be HIV-1 negative immediately prior to initial use and who do not have signs or symptoms consistent with acute HIV infection.

While using TRUVADA FOR PrEP, HIV-1 screening tests should be repeated at least every 3 months, and upon diagnosis of any STIs.

Individuals must strictly adhere to the dosing schedule because the effectiveness of TRUVADA FOR PrEP is strongly correlated with adherence.

TRUVADA FOR PrEP must only be prescribed as part of a comprehensive prevention strategy because TRUVADA is not always effective in preventing HIV-1 infection.


*Number of persons prescribed TRUVADA FOR PrEP divided by the number of people estimated to be indicated for pre-exposure prophylaxis.


IMPORTANT SAFETY INFORMATION (cont'd)

Drug interactions

  • Prescribing information: Consult the full Prescribing Information for TRUVADA for more information, warnings, and potentially significant drug interactions, including clinical comments
  • Hepatitis C antivirals: Coadministration with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir increases TDF exposure; monitor for adverse reactions
  • Drugs affecting renal function: Coadministration of TRUVADA with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine and/or tenofovir

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • TRUVADA FOR PrEP must only be prescribed to individuals confirmed to be HIV‑negative immediately prior to initiation and at least every 3 months during use. Drug-resistant HIV‑1 variants have been identified with use of TRUVADA FOR PrEP following undetected acute HIV‑1 infection. Do not initiate if signs or symptoms of acute HIV‑1 infection are present unless HIV‑negative status is confirmed
  • Severe acute exacerbations of hepatitis B have been reported in HBV‑infected patients who discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HBV after discontinuing TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted

Contraindications

  • TRUVADA FOR PrEP is contraindicated in individuals with unknown or positive HIV status

Warnings and precautions: Comprehensive risk reduction strategies

  • Reduce HIV‑1 risk: TRUVADA FOR PrEP is not always effective in preventing HIV‑1. Use only as part of a comprehensive prevention strategy that includes safer sex practices, regular testing for HIV‑1 and other STIs, and counseling on reducing sexual risk behaviors
  • Reduce potential for drug resistance: TRUVADA FOR PrEP should only be used in individuals confirmed to be HIV-negative immediately prior to initiation, at least every 3 months while taking TRUVADA, and upon an STI diagnosis. HIV‑1 resistance substitutions may emerge in individuals with undetected HIV‑1 infection who are taking only TRUVADA. TRUVADA alone is not a complete regimen for treating HIV‑1
    • HIV antibody tests may not detect acute HIV infection. If recent exposures are suspected or symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash), delay initiating (≥1 month) or discontinue use and confirm HIV-negative status with a test approved by the FDA for the diagnosis of acute HIV infection
    • If a screening test indicates possible HIV-1 infection, convert the HIV-1 PrEP regimen to an HIV treatment regimen until HIV-negative status is confirmed
  • Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule, as efficacy is strongly correlated with adherence. Some individuals, such as adolescents, may benefit from more frequent visits and counseling

Warnings and precautions

  • New onset or worsening renal impairment: Cases of acute renal impairment and Fanconi syndrome have been reported with the use of tenofovir disoproxil fumarate (TDF). TRUVADA is not recommended in individuals with estimated creatinine clearance (CrCl) <60 mL/min. Avoid concurrent or recent use with a nephrotoxic agent. Acute renal failure has been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients. Monitor renal function in all patients – See Dosage and Administration section
  • Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia associated with proximal renal tubulopathy, have been reported with the use of TDF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss
  • Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations
  • Drug interactions: See Drug Interactions section. Consider the potential for drug interactions prior to and during use of TRUVADA and monitor for adverse reactions

Adverse reactions

  • Common adverse reactions (>2% and more frequently than placebo) of TRUVADA FOR PrEP in clinical trials were headache, abdominal pain, and weight loss

Drug interactions

  • Prescribing information: Consult the full Prescribing Information for TRUVADA for more information, warnings, and potentially significant drug interactions, including clinical comments
  • Hepatitis C antivirals: Coadministration with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir increases TDF exposure; monitor for adverse reactions
  • Drugs affecting renal function: Coadministration of TRUVADA with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine and/or tenofovir

Pregnancy and lactation

  • Pregnancy: An Antiretroviral Pregnancy Registry (APR) has been established. Available data from observational studies and the APR show no increase in the rate of major birth defects for TRUVADA compared with a US reference population. Consider HIV prevention methods, including TRUVADA FOR PrEP in women due to the potential increased risk of HIV-1 infection during pregnancy and mother to child transmission during acute HIV-1 infection
  • Lactation: Emtricitabine and tenofovir have been detected in human milk. Evaluate the benefits and risks of TRUVADA FOR PrEP in breastfeeding women, including the risk of HIV-1 acquisition due to nonadherence, and subsequent mother to child transmission. Health benefits of breastfeeding should be considered along with potential adverse effects of TRUVADA on the child, which are unknown

Dosage and administration

  • Dosage: One tablet once daily with or without food
  • HIV screening: Test for HIV-1 infection prior to initiating and at least every 3 months during treatment
  • HBV screening: Test for HBV infection prior to or when initiating treatment
  • Renal impairment and monitoring: Not recommended in individuals with CrCl <60 mL/min. In all patients, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein on a clinically appropriate schedule. In patients with chronic kidney disease, also assess serum phosphorus

Efficacy &
Resistance

INDICATION

TRUVADA FOR PrEP® (pre-exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV‑1 in adults and adolescents (≥35 kg) who are at risk for HIV, when used in combination with safer sex practices. HIV‑negative status must be confirmed immediately prior to initiation.

TRUVADA FOR PrEP® CLINICAL TRIAL DESIGNS

Partners PrEP1,2

Randomized, double-blind, placebo-controlled efficacy and safety study in adults1,2

*TDF alone is not approved to reduce the
risk of sexually acquired HIV-1.


Primary endpoint: Seroconversion of HIV-negative partner2

Study population2

  • Serodiscordant heterosexual couples (both men and women enrolled)
  • ≥18 years old
  • HIV-1–positive partner ineligible for ART

Baseline characteristics of uninfected partners1

  • Mean age of subjects: 33-34 years
  • Gender: 61%-64% male across study groups

Participants received1,2

  • Safer sex counseling
  • Evaluation of adherence
  • HIV-1 monitoring and care
  • Condoms
  • STI testing and treatment
  • Monthly HIV-1 testing

Duration2

July 2008, with data collected through July 2011

  • Cohort followed for 7830 person-years for the assessment of HIV-1 incidence accrued (median, 23 months; interquartile range, 16-28; range, 1-36)

Location1,2

Kenya, Uganda

iPrEx1,41

Randomized, double-blind, placebo-controlled efficacy and safety study in adults1,41

Primary endpoint: Seroconversion of HIV-negative partner1

Study population1,41

  • HIV-1–seronegative men or transgender women who have sex with men
  • ≥18 years old
  • High risk for HIV-1 acquisition

Baseline characteristics of uninfected partners1

  • Mean age of subjects: 27 years
  • Race/ethnicity:
    • 72% Hispanic/Latino
    • 18% White
    • 9% Black
    • 5% Asian

Participants received1

  • Monthly HIV-1 testing
  • Risk reduction counseling
  • Condoms
  • Management of STIs

Duration1,41

July 2007, with data collected through May 2010

  • Cohort followed for 4237 person-years

Location41

Peru, Ecuador, South Africa, Brazil, Thailand, and the U.S. (Boston, San Francisco)


IMPORTANT SAFETY INFORMATION (cont'd)

Pregnancy and lactation

  • Pregnancy: An Antiretroviral Pregnancy Registry (APR) has been established. Available data from observational studies and the APR show no increase in the rate of major birth defects for TRUVADA compared with a US reference population. Consider HIV prevention methods, including TRUVADA FOR PrEP in women due to the potential increased risk of HIV-1 infection during pregnancy and mother to child transmission during acute HIV-1 infection
  • Lactation: Emtricitabine and tenofovir have been detected in human milk. Evaluate the benefits and risks of TRUVADA FOR PrEP in breastfeeding women, including the risk of HIV-1 acquisition due to nonadherence, and subsequent mother to child transmission. Health benefits of breastfeeding should be considered along with potential adverse effects of TRUVADA on the child, which are unknown

ART=antiretroviral therapy; TDF=tenofovir disoproxil fumarate.

PROVEN REDUCTION IN HIV‑1 ACQUISITION IN UNINFECTED INDIVIDUALS TAKING TRUVADA FOR PrEP1

Across all trial participants

Partners PrEP Trial

HIV-1 seroconversion was observed in1,2:

  • 13 out of 1576 subjects in the TRUVADA group
  • 52 out of 1578 subjects in the placebo group
iPrEx Trial

HIV-1 seroconversion was observed in1:

  • 48 out of 1251 subjects in the TRUVADA group
  • 83 out of 1248 subjects in the placebo group

In participants with detectable drug levels†

Partners PrEP Trial

(post-hoc analysis)

Among TRUVADA users who became infected with HIV-1, 9 out of 12 did not have detectable drug levels.42

iPrEx Trial

(post-hoc analysis)

Among TRUVADA users who became infected with HIV-1, 31 out of 34 did not have detectable drug levels.41

†These results were based on a post-hoc case control study of detectable plasma and intracellular drug levels in about 10% of subjects. Risk reduction appeared to be the greatest in subjects with detectable intracellular tenofovir levels.1,2,41

Efficacy was strongly correlated with adherence1


IMPORTANT SAFETY INFORMATION (cont'd)

Dosage and administration

  • Dosage: One tablet once daily with or without food
  • HIV screening: Test for HIV-1 infection prior to initiating and at least every 3 months during treatment
  • HBV screening: Test for HBV infection prior to or when initiating treatment
  • Renal impairment and monitoring: Not recommended in individuals with CrCl <60 mL/min. In all patients, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein on a clinically appropriate schedule. In patients with chronic kidney disease, also assess serum phosphorus

CI=confidence interval.

NO CASES OF DRUG RESISTANCE WERE OBSERVED AMONG INDIVIDUALS WHO WERE HIV-1 NEGATIVE AT BASELINE1

To minimize the risk of resistance, TRUVADA FOR PrEP should only be prescribed to individuals confirmed to be HIV-1 negative

Of the individuals who became infected with HIV-1 after initiating TRUVADA FOR PrEP, no cases of resistance to the components of TRUVADA were identified at the time of HIV-1 seroconversion in two pivotal trials.1,41,42


Individuals Who Became HIV Positive During the Study

      HIV+
(Subjects, n)		   HIV+ WITH
RESISTANCE
(Subjects, n)
Partners PrEP Trial   PLACEBO 51 ➝ 0
  TRUVADA 12 ➝ 0
iPrEx Trial   PLACEBO 83 ➝ 0
  TRUVADA 48 ➝ 0



Of the individuals who had unrecognized/acute HIV-1 infection at the time of TRUVADA FOR PrEP initiation, resistance to the components of TRUVADA was observed in two pivotal trials.1,2,41


Individuals With Unrecognized/Acute HIV Infection at Baseline

      HIV+
(Subjects, n)		   HIV+ WITH
RESISTANCE
(Subjects, n)
Partners PrEP Trial   PLACEBO 6 ➝ 0 
  TRUVADA 3 ➝ 1‡
iPrEx Trial   PLACEBO 8 ➝ 1‡
  TRUVADA 2 ➝ 2‡
    ‡M184V/I.      


  • While using TRUVADA FOR PrEP, HIV-1 screening tests should be repeated at least every 3 months, and upon diagnosis of any STIs. Individuals should be counseled to adhere to the recommended TRUVADA dosing schedule. Some individuals, such as adolescents, may benefit from more frequent visits and counseling1
  • TRUVADA FOR PrEP should only be prescribed to individuals who are confirmed to be HIV-1 negative immediately prior to initial use and who do not have signs or symptoms consistent with acute HIV infection1

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • TRUVADA FOR PrEP must only be prescribed to individuals confirmed to be HIV‑negative immediately prior to initiation and at least every 3 months during use. Drug-resistant HIV‑1 variants have been identified with use of TRUVADA FOR PrEP following undetected acute HIV‑1 infection. Do not initiate if signs or symptoms of acute HIV‑1 infection are present unless HIV‑negative status is confirmed
  • Severe acute exacerbations of hepatitis B have been reported in HBV‑infected patients who discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HBV after discontinuing TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • TRUVADA FOR PrEP must only be prescribed to individuals confirmed to be HIV‑negative immediately prior to initiation and at least every 3 months during use. Drug-resistant HIV‑1 variants have been identified with use of TRUVADA FOR PrEP following undetected acute HIV‑1 infection. Do not initiate if signs or symptoms of acute HIV‑1 infection are present unless HIV‑negative status is confirmed
  • Severe acute exacerbations of hepatitis B have been reported in HBV‑infected patients who discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HBV after discontinuing TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted

Contraindications

  • TRUVADA FOR PrEP is contraindicated in individuals with unknown or positive HIV status

Warnings and precautions: Comprehensive risk reduction strategies

  • Reduce HIV‑1 risk: TRUVADA FOR PrEP is not always effective in preventing HIV‑1. Use only as part of a comprehensive prevention strategy that includes safer sex practices, regular testing for HIV‑1 and other STIs, and counseling on reducing sexual risk behaviors
  • Reduce potential for drug resistance: TRUVADA FOR PrEP should only be used in individuals confirmed to be HIV-negative immediately prior to initiation, at least every 3 months while taking TRUVADA, and upon an STI diagnosis. HIV‑1 resistance substitutions may emerge in individuals with undetected HIV‑1 infection who are taking only TRUVADA. TRUVADA alone is not a complete regimen for treating HIV‑1
    • HIV antibody tests may not detect acute HIV infection. If recent exposures are suspected or symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash), delay initiating (≥1 month) or discontinue use and confirm HIV-negative status with a test approved by the FDA for the diagnosis of acute HIV infection
    • If a screening test indicates possible HIV-1 infection, convert the HIV-1 PrEP regimen to an HIV treatment regimen until HIV-negative status is confirmed
  • Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule, as efficacy is strongly correlated with adherence. Some individuals, such as adolescents, may benefit from more frequent visits and counseling

Warnings and precautions

  • New onset or worsening renal impairment: Cases of acute renal impairment and Fanconi syndrome have been reported with the use of tenofovir disoproxil fumarate (TDF). TRUVADA is not recommended in individuals with estimated creatinine clearance (CrCl) <60 mL/min. Avoid concurrent or recent use with a nephrotoxic agent. Acute renal failure has been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients. Monitor renal function in all patients – See Dosage and Administration section
  • Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia associated with proximal renal tubulopathy, have been reported with the use of TDF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss
  • Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations
  • Drug interactions: See Drug Interactions section. Consider the potential for drug interactions prior to and during use of TRUVADA and monitor for adverse reactions

Safety &
Tolerability

INDICATION

TRUVADA FOR PrEP® (pre-exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV‑1 in adults and adolescents (≥35 kg) who are at risk for HIV, when used in combination with safer sex practices. HIV‑negative status must be confirmed immediately prior to initiation.

Contraindications & Drug Interactions Adverse Events Discontinuations & Lab Abnormalities Warnings & Precautions Dosage & Administration

CONTRAINDICATIONS AND DRUG INTERACTIONS

Contraindications

  • TRUVADA FOR PrEP is contraindicated in individuals with unknown or positive HIV status

Drug interactions

  • Prescribing information: Consult the full Prescribing Information for TRUVADA for more information, warnings, and potentially significant drug interactions, including clinical comments
  • Hepatitis C antivirals: Coadministration with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir increases TDF exposure; monitor for adverse reactions
  • Drugs affecting renal function: Coadministration of TRUVADA with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine and/or tenofovir

COMMON ADVERSE EVENTS WITH TRUVADA FOR PrEP WERE COMPARABLE TO PLACEBO IN TWO PIVOTAL TRIALS1*

iPrEx

Selected Adverse Events (All Grades) Reported in ≥2% in Any Treatment Group and Greater Than Placebo1

    TRUVADA Placebo  
    (n=1251) (n=1248)  
 
 
Headache   7% 6%  
 
 
Abdominal pain   4% 2%  
 
 
Weight decreased   3% 2%  
 

Partners PrEP

  • The frequency of adverse events in the TRUVADA treatment group was generally either less than or the same as in the placebo group

*Adherence in the TRUVADA arms of these two pivotal trials varied across participants.

DISCONTINUATION RATES DUE TO ADVERSE EVENTS WITH TRUVADA FOR PrEP WERE COMPARABLE TO PLACEBO2,40,41

Partners PrEP Trial2,40

PLACEBO
0.1%
(1/1584)
TDF-
CONTAINING
0.1%
(2/1579)

iPrEx Trial41

PLACEBO
6%
(72/1248)
TRUVADA
6%
(79/1251)

Renal and hepatic discontinuations due to adverse events

Partners PrEP Trial1 TDF-Containing Arms
(Subjects, n)		 Placebo
(Subjects, n)
 
Discontinuations due to an increase in serum creatinine 6 0
iPrEx Trial1 TRUVADA
(Subjects, n)		 Placebo
(Subjects, n)
 
Discontinuations due to an increase in serum creatinine 1 0
 
 
Discontinuations due to low serum phosphorus 1 0


TDF=tenofovir disoproxil fumarate.



Impact on renal and hepatic function with TRUVADA FOR PrEP

Laboratory Abnormalities (Highest Toxicity Grade
Reported for Each Subject) in Pivotal Trials1

Grade 2-4† Partners PrEP Trial iPrEx Trial
 
  TRUVADA
(n=1579)		 Placebo
(n=1584)		 TRUVADA
(n=1251)		 Placebo
(n=1248)
 
 
Creatinine (>1.4 x ULN) <1% <1% <1% <1%
 
 
Phosphorus (<2.0 mg/dL) 9% 9% 10% 8%
 
 
AST (>2.6 x ULN) <1% <1% 5% 5%
 
 
ALT (>2.6 x ULN) <1% <1% 7% 7%
 
 
Hemoglobin (<9.4 mg/dL) 2% 2% 1% 2%
 
 
Neutrophils (<750/mm3) 5% 3% <1% <1%
 

†Grading is per Division of AIDS (DAIDS) criteria.


ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal.


Renal impairment and monitoring

  • Not recommended in individuals with CrCl <60 mL/min
    • In all patients, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein on a clinically appropriate schedule
    • In patients with chronic kidney disease, also assess serum phosphorus

DECREASES IN BONE MINERAL DENSITY (BMD) WERE OBSERVED WITH TRUVADA FOR PrEP AND RETURNED TOWARD BASELINE AFTER DISCONTINUATION IN THE iPrEx TRIAL1

  iPrEx Trial1 Partners PrEP Trial1
 
  TRUVADA Placebo TRUVADA Placebo
 
 
Subjects who lost at least 5% of BMD at the spine during treatment 13% 6% — —
 
 
Bone fractures 1.7% 1.4% 0.8% 0.6%
 

iPrEx Trial1

  • No correlation between BMD and fractures was noted

Partners PrEP Trial1

  • No BMD evaluations were performed
  • Similar fracture rates between treatment and placebo groups

ATN1131

In a 48-week, single-arm, open-label safety study examining TRUVADA FOR PrEP among 67 adolescent (15-18 years of age) MSM‡:

  • Median BMD increased from baseline to Week 48 by 2.58% for lumbar spine and 0.72% for total body
    • 1 subject had significant (≥4%) total body BMD loss at Week 24
  • Median changes from baseline BMD Z-scores were 0.0 for lumbar spine and –0.2 for total body at Week 48
    • 3 subjects showed a worsening (change from > –2 to ≤ –2) from baseline in their lumbar spine or total body BMD Z-scores at Week 24 or 48

‡Interpretation of these data may be limited due to low rate of adherence by Week 48.

MSM=men who have sex with men.


Warnings and precautions: Bone mineral density

  • Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia associated with proximal renal tubulopathy, have been reported with the use of TDF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss

WARNINGS AND PRECAUTIONS

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • TRUVADA FOR PrEP must only be prescribed to individuals confirmed to be HIV‑negative immediately prior to initiation and at least every 3 months during use. Drug-resistant HIV‑1 variants have been identified with use of TRUVADA FOR PrEP following undetected acute HIV‑1 infection. Do not initiate if signs or symptoms of acute HIV‑1 infection are present unless HIV‑negative status is confirmed
  • Severe acute exacerbations of hepatitis B have been reported in HBV‑infected patients who discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HBV after discontinuing TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted

Warnings and precautions: Comprehensive risk reduction strategies

  • Reduce HIV‑1 risk: TRUVADA FOR PrEP is not always effective in preventing HIV‑1. Use only as part of a comprehensive prevention strategy that includes safer sex practices, regular testing for HIV‑1 and other STIs, and counseling on reducing sexual risk behaviors
  • Reduce potential for drug resistance: TRUVADA FOR PrEP should only be used in individuals confirmed to be HIV-negative immediately prior to initiation, at least every 3 months while taking TRUVADA, and upon an STI diagnosis. HIV‑1 resistance substitutions may emerge in individuals with undetected HIV‑1 infection who are taking only TRUVADA. TRUVADA alone is not a complete regimen for treating HIV‑1
    • HIV antibody tests may not detect acute HIV infection. If recent exposures are suspected or symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash), delay initiating (≥1 month) or discontinue use and confirm HIV-negative status with a test approved by the FDA for the diagnosis of acute HIV infection
    • If a screening test indicates possible HIV-1 infection, convert the HIV-1 PrEP regimen to an HIV treatment regimen until HIV-negative status is confirmed
  • Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule, as efficacy is strongly correlated with adherence. Some individuals, such as adolescents, may benefit from more frequent visits and counseling

Warnings and precautions

  • New onset or worsening renal impairment: Cases of acute renal impairment and Fanconi syndrome have been reported with the use of tenofovir disoproxil fumarate (TDF). TRUVADA is not recommended in individuals with estimated creatinine clearance (CrCl) <60 mL/min. Avoid concurrent or recent use with a nephrotoxic agent. Acute renal failure has been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients. Monitor renal function in all patients – See Dosage and Administration section
  • Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia associated with proximal renal tubulopathy, have been reported with the use of TDF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss
  • Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations
  • Drug interactions: See Drug Interactions section. Consider the potential for drug interactions prior to and during use of TRUVADA and monitor for adverse reactions

Pregnancy and lactation

  • Pregnancy: An Antiretroviral Pregnancy Registry (APR) has been established. Available data from observational studies and the APR show no increase in the rate of major birth defects for TRUVADA compared with a US reference population. Consider HIV prevention methods, including TRUVADA FOR PrEP in women due to the potential increased risk of HIV-1 infection during pregnancy and mother to child transmission during acute HIV-1 infection
  • Lactation: Emtricitabine and tenofovir have been detected in human milk. Evaluate the benefits and risks of TRUVADA FOR PrEP in breastfeeding women, including the risk of HIV-1 acquisition due to nonadherence, and subsequent mother to child transmission. Health benefits of breastfeeding should be considered along with potential adverse effects of TRUVADA on the child, which are unknown

TRUVADA FOR PrEP DOSAGE AND ADMINISTRATION

Dosage and administration

  • Dosage: One tablet once daily with or without food
  • HIV screening: Test for HIV-1 infection prior to initiating and at least every 3 months during treatment
  • HBV screening: Test for HBV infection prior to or when initiating treatment
  • Renal impairment and monitoring: Not recommended in individuals with CrCl <60 mL/min. In all patients, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein on a clinically appropriate schedule. In patients with chronic kidney disease, also assess serum phosphorus
  • One tablet, once daily
  • Taken with or without food
emtricitabine
(FTC) 200 mg + tenofovir disoproxil
fumarate (TDF) 300 mg

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • TRUVADA FOR PrEP must only be prescribed to individuals confirmed to be HIV‑negative immediately prior to initiation and at least every 3 months during use. Drug-resistant HIV‑1 variants have been identified with use of TRUVADA FOR PrEP following undetected acute HIV‑1 infection. Do not initiate if signs or symptoms of acute HIV‑1 infection are present unless HIV‑negative status is confirmed
  • Severe acute exacerbations of hepatitis B have been reported in HBV‑infected patients who discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HBV after discontinuing TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted

Contraindications

  • TRUVADA FOR PrEP is contraindicated in individuals with unknown or positive HIV status

Warnings and precautions: Comprehensive risk reduction strategies

  • Reduce HIV‑1 risk: TRUVADA FOR PrEP is not always effective in preventing HIV‑1. Use only as part of a comprehensive prevention strategy that includes safer sex practices, regular testing for HIV‑1 and other STIs, and counseling on reducing sexual risk behaviors
  • Reduce potential for drug resistance: TRUVADA FOR PrEP should only be used in individuals confirmed to be HIV-negative immediately prior to initiation, at least every 3 months while taking TRUVADA, and upon an STI diagnosis. HIV‑1 resistance substitutions may emerge in individuals with undetected HIV‑1 infection who are taking only TRUVADA. TRUVADA alone is not a complete regimen for treating HIV‑1
    • HIV antibody tests may not detect acute HIV infection. If recent exposures are suspected or symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash), delay initiating (≥1 month) or discontinue use and confirm HIV-negative status with a test approved by the FDA for the diagnosis of acute HIV infection
    • If a screening test indicates possible HIV-1 infection, convert the HIV-1 PrEP regimen to an HIV treatment regimen until HIV-negative status is confirmed
  • Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule, as efficacy is strongly correlated with adherence. Some individuals, such as adolescents, may benefit from more frequent visits and counseling

Warnings and precautions

  • New onset or worsening renal impairment: Cases of acute renal impairment and Fanconi syndrome have been reported with the use of tenofovir disoproxil fumarate (TDF). TRUVADA is not recommended in individuals with estimated creatinine clearance (CrCl) <60 mL/min. Avoid concurrent or recent use with a nephrotoxic agent. Acute renal failure has been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients. Monitor renal function in all patients – See Dosage and Administration section
  • Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia associated with proximal renal tubulopathy, have been reported with the use of TDF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss
  • Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations
  • Drug interactions: See Drug Interactions section. Consider the potential for drug interactions prior to and during use of TRUVADA and monitor for adverse reactions

Adverse reactions

  • Common adverse reactions (>2% and more frequently than placebo) of TRUVADA FOR PrEP in clinical trials were headache, abdominal pain, and weight loss

Drug interactions

  • Prescribing information: Consult the full Prescribing Information for TRUVADA for more information, warnings, and potentially significant drug interactions, including clinical comments
  • Hepatitis C antivirals: Coadministration with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir increases TDF exposure; monitor for adverse reactions
  • Drugs affecting renal function: Coadministration of TRUVADA with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine and/or tenofovir

Pregnancy and lactation

  • Pregnancy: An Antiretroviral Pregnancy Registry (APR) has been established. Available data from observational studies and the APR show no increase in the rate of major birth defects for TRUVADA compared with a US reference population. Consider HIV prevention methods, including TRUVADA FOR PrEP in women due to the potential increased risk of HIV-1 infection during pregnancy and mother to child transmission during acute HIV-1 infection
  • Lactation: Emtricitabine and tenofovir have been detected in human milk. Evaluate the benefits and risks of TRUVADA FOR PrEP in breastfeeding women, including the risk of HIV-1 acquisition due to nonadherence, and subsequent mother to child transmission. Health benefits of breastfeeding should be considered along with potential adverse effects of TRUVADA on the child, which are unknown

Dosage and administration

  • Dosage: One tablet once daily with or without food
  • HIV screening: Test for HIV-1 infection prior to initiating and at least every 3 months during treatment
  • HBV screening: Test for HBV infection prior to or when initiating treatment
  • Renal impairment and monitoring: Not recommended in individuals with CrCl <60 mL/min. In all patients, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein on a clinically appropriate schedule. In patients with chronic kidney disease, also assess serum phosphorus

Implementing
TRUVADA FOR PrEP

INDICATION

TRUVADA FOR PrEP® (pre-exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV‑1 in adults and adolescents (≥35 kg) who are at risk for HIV, when used in combination with safer sex practices. HIV‑negative status must be confirmed immediately prior to initiation.

IMPLEMENTING TRUVADA FOR PrEP FITS WITHIN THE PARADIGM OF PREVENTIVE HEALTH IN PRIMARY CARE

Here's a brief overview of what you need to do prior to initiating TRUVADA FOR PrEP:

Screen for HIV and HBV1

  • TRUVADA FOR PrEP must only be prescribed to HIV-1–negative individuals
  • Drug-resistant HIV-1 variants have been identified with use of TRUVADA FOR PrEP following undetected acute HIV-1 infection
  • If signs or symptoms of acute HIV-1 infection are present and recent exposures (<1 month) are suspected, delay initiation of TRUVADA FOR PrEP for at least 1 month and reconfirm HIV-1–negative status
  • If screening or symptoms consistent with acute HIV-1 infection indicate an individual may have become HIV positive while taking TRUVADA FOR PrEP, convert the HIV-1 PrEP regimen to an HIV treatment regimen until HIV-negative status is confirmed
  • Test and monitor for chronic HBV, and if negative, consider vaccination

Counsel individuals on the importance of daily dosing1

  • Individuals should strictly adhere to the recommended TRUVADA dosing schedule
  • The effectiveness of TRUVADA in reducing the risk of acquiring HIV-1 is strongly correlated with adherence
  • Some individuals, such as adolescents, may benefit from more frequent visits and counseling

Confirm estimated CrCl is ≥60 mL/min1

  • Not recommended in individuals with CrCl <60 mL/min
  • In all patients, assess serum creatinine, estimated CrCl, urine glucose, and urine protein on a clinically appropriate schedule
  • Reassess potential risks and benefits of using TRUVADA FOR PrEP if a decrease in CrCl is observed during use
  • In patients with chronic kidney disease, also assess serum phosphorus

TRUVADA FOR PrEP is part of guideline-recommended care. Prescribe to appropriate patients as part of a comprehensive prevention strategy involving condoms, safer sex practices, and knowledge of partner(s)' HIV-1 status.1,3

For pregnant women and those of reproductive age1:

Conduct pregnancy testing prior to initiating TRUVADA FOR PrEP

Consider HIV prevention methods, including TRUVADA FOR PrEP, due to the potential increased risk of HIV-1 infection during pregnancy, and mother to child transmission during acute HIV-1 infection

Providers are encouraged to register women taking TRUVADA FOR PrEP during pregnancy in an Antiretroviral Pregnancy Registry to monitor fetal outcomes (1-800-258-4263)


CrCl=creatinine clearance; HBV=hepatitis B virus.



IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • TRUVADA FOR PrEP must only be prescribed to individuals confirmed to be HIV‑negative immediately prior to initiation and at least every 3 months during use. Drug-resistant HIV‑1 variants have been identified with use of TRUVADA FOR PrEP following undetected acute HIV‑1 infection. Do not initiate if signs or symptoms of acute HIV‑1 infection are present unless HIV‑negative status is confirmed
  • Severe acute exacerbations of hepatitis B have been reported in HBV‑infected patients who discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HBV after discontinuing TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • TRUVADA FOR PrEP must only be prescribed to individuals confirmed to be HIV‑negative immediately prior to initiation and at least every 3 months during use. Drug-resistant HIV‑1 variants have been identified with use of TRUVADA FOR PrEP following undetected acute HIV‑1 infection. Do not initiate if signs or symptoms of acute HIV‑1 infection are present unless HIV‑negative status is confirmed
  • Severe acute exacerbations of hepatitis B have been reported in HBV‑infected patients who discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HBV after discontinuing TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted

Contraindications

  • TRUVADA FOR PrEP is contraindicated in individuals with unknown or positive HIV status

Warnings and precautions: Comprehensive risk reduction strategies

  • Reduce HIV‑1 risk: TRUVADA FOR PrEP is not always effective in preventing HIV‑1. Use only as part of a comprehensive prevention strategy that includes safer sex practices, regular testing for HIV‑1 and other STIs, and counseling on reducing sexual risk behaviors
  • Reduce potential for drug resistance: TRUVADA FOR PrEP should only be used in individuals confirmed to be HIV-negative immediately prior to initiation, at least every 3 months while taking TRUVADA, and upon an STI diagnosis. HIV‑1 resistance substitutions may emerge in individuals with undetected HIV‑1 infection who are taking only TRUVADA. TRUVADA alone is not a complete regimen for treating HIV‑1
    • HIV antibody tests may not detect acute HIV infection. If recent exposures are suspected or symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash), delay initiating (≥1 month) or discontinue use and confirm HIV-negative status with a test approved by the FDA for the diagnosis of acute HIV infection
    • If a screening test indicates possible HIV-1 infection, convert the HIV-1 PrEP regimen to an HIV treatment regimen until HIV-negative status is confirmed
  • Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule, as efficacy is strongly correlated with adherence. Some individuals, such as adolescents, may benefit from more frequent visits and counseling

Warnings and precautions

  • New onset or worsening renal impairment: Cases of acute renal impairment and Fanconi syndrome have been reported with the use of tenofovir disoproxil fumarate (TDF). TRUVADA is not recommended in individuals with estimated creatinine clearance (CrCl) <60 mL/min. Avoid concurrent or recent use with a nephrotoxic agent. Acute renal failure has been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients. Monitor renal function in all patients – See Dosage and Administration section
  • Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia associated with proximal renal tubulopathy, have been reported with the use of TDF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss
  • Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations
  • Drug interactions: See Drug Interactions section. Consider the potential for drug interactions prior to and during use of TRUVADA and monitor for adverse reactions

Adverse reactions

  • Common adverse reactions (>2% and more frequently than placebo) of TRUVADA FOR PrEP in clinical trials were headache, abdominal pain, and weight loss

Drug interactions

  • Prescribing information: Consult the full Prescribing Information for TRUVADA for more information, warnings, and potentially significant drug interactions, including clinical comments
  • Hepatitis C antivirals: Coadministration with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir increases TDF exposure; monitor for adverse reactions
  • Drugs affecting renal function: Coadministration of TRUVADA with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine and/or tenofovir

Access &
Resources

INDICATION

TRUVADA FOR PrEP® (pre-exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV‑1 in adults and adolescents (≥35 kg) who are at risk for HIV, when used in combination with safer sex practices. HIV‑negative status must be confirmed immediately prior to initiation.

ELIGIBLE PATIENTS MAY PAY AS LITTLE AS A $0 CO-PAY*

The Gilead Advancing Access® program is committed to helping eligible patients afford their Gilead medication whether they are insured, uninsured, or underinsured

  • Insurance Support: provides help with coverage and benefits investigations, prior authorizations, and navigating alternative coverage options
  • Financial Support: connects patients to appropriate financial assistance, including co-pay support, alternative funding information, and the Medication Assistance Program

The co-pay coupon now covers up to $7200 per year with no monthly limit for eligible patients.
Advancing Access

*Co-pay support is available for commercially insured eligible patients only. Subject to change; for full terms and conditions, visit www.gileadadvancingaccess.com/copay-coupon-card. This is not health insurance. Only accepted at participating pharmacies.


Enroll patients at:
GileadAdvancingAccess.com/hcp    OR   
1-800-226-2056
Monday-Friday | 9 AM to 8 PM ET

REGISTER FOR UPDATES

Want to stay up-to-date on TRUVADA FOR PrEP and HIV prevention? Register and we'll send updates as new information becomes available.

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PrEP PROVIDER DIRECTORY

If your patients need assistance finding an HCP in their area who can prescribe TRUVADA FOR PrEP, direct them to preplocator.org

This tool is not owned or maintained by Gilead Sciences, Inc. Gilead Sciences, Inc. is not responsible for the content of the PrEP Provider Locator or how it is used. The PrEP Provider Locator was developed by researchers from Emory University's Rollins School of Public Health with funding from MAC AIDS Fund.


Find a healthcare provider near you

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Gilead is committed to keeping healthcare providers and patients informed on HIV prevention.

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TRUVADA FOR PrEP RISK EVALUATION AND MITIGATION STRATEGY (REMS)

Information about the REMS program for TRUVADA FOR PrEP:

  • TRUVADA FOR PrEP—in combination with safer sex practices—can help reduce the risk of sexually acquired HIV-1 infection as part of a comprehensive HIV-1 prevention strategy for individuals at risk. TRUVADA FOR PrEP does not replace existing prophylaxis strategies
  • REMS is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks
  • To help ensure TRUVADA FOR PrEP is prescribed and taken safely, Gilead has worked with the FDA to develop materials for the REMS program to educate and inform healthcare providers and uninfected individuals at risk for acquiring HIV‑1

The goals of the REMS for TRUVADA FOR PrEP are to inform and educate prescribers and uninfected individuals at risk for acquiring HIV-1 infection about:

  • The importance of strict adherence to the recommended dosing regimen
  • The importance of regular monitoring of HIV-1 serostatus and discontinuing TRUVADA FOR PrEP if seroconversion has occurred, to reduce the risk of development of resistant HIV‑1 variants
  • The fact that TRUVADA FOR PrEP must be considered as only part of a comprehensive strategy to reduce the risk of HIV-1 infection and that other preventive measures should also be used


For further information and to download REMS materials, visit:
REMS


Do you also see patients who are HIV positive?
Learn more about an HIV treatment option

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • TRUVADA FOR PrEP must only be prescribed to individuals confirmed to be HIV‑negative immediately prior to initiation and at least every 3 months during use. Drug-resistant HIV‑1 variants have been identified with use of TRUVADA FOR PrEP following undetected acute HIV‑1 infection. Do not initiate if signs or symptoms of acute HIV‑1 infection are present unless HIV‑negative status is confirmed
  • Severe acute exacerbations of hepatitis B have been reported in HBV‑infected patients who discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HBV after discontinuing TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted

Contraindications

  • TRUVADA FOR PrEP is contraindicated in individuals with unknown or positive HIV status

Warnings and precautions: Comprehensive risk reduction strategies

  • Reduce HIV‑1 risk: TRUVADA FOR PrEP is not always effective in preventing HIV‑1. Use only as part of a comprehensive prevention strategy that includes safer sex practices, regular testing for HIV‑1 and other STIs, and counseling on reducing sexual risk behaviors
  • Reduce potential for drug resistance: TRUVADA FOR PrEP should only be used in individuals confirmed to be HIV-negative immediately prior to initiation, at least every 3 months while taking TRUVADA, and upon an STI diagnosis. HIV‑1 resistance substitutions may emerge in individuals with undetected HIV‑1 infection who are taking only TRUVADA. TRUVADA alone is not a complete regimen for treating HIV‑1
    • HIV antibody tests may not detect acute HIV infection. If recent exposures are suspected or symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash), delay initiating (≥1 month) or discontinue use and confirm HIV-negative status with a test approved by the FDA for the diagnosis of acute HIV infection
    • If a screening test indicates possible HIV-1 infection, convert the HIV-1 PrEP regimen to an HIV treatment regimen until HIV-negative status is confirmed
  • Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule, as efficacy is strongly correlated with adherence. Some individuals, such as adolescents, may benefit from more frequent visits and counseling

Warnings and precautions

  • New onset or worsening renal impairment: Cases of acute renal impairment and Fanconi syndrome have been reported with the use of tenofovir disoproxil fumarate (TDF). TRUVADA is not recommended in individuals with estimated creatinine clearance (CrCl) <60 mL/min. Avoid concurrent or recent use with a nephrotoxic agent. Acute renal failure has been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients. Monitor renal function in all patients – See Dosage and Administration section
  • Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia associated with proximal renal tubulopathy, have been reported with the use of TDF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss
  • Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations
  • Drug interactions: See Drug Interactions section. Consider the potential for drug interactions prior to and during use of TRUVADA and monitor for adverse reactions

Adverse reactions

  • Common adverse reactions (>2% and more frequently than placebo) of TRUVADA FOR PrEP in clinical trials were headache, abdominal pain, and weight loss

Drug interactions

  • Prescribing information: Consult the full Prescribing Information for TRUVADA for more information, warnings, and potentially significant drug interactions, including clinical comments
  • Hepatitis C antivirals: Coadministration with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir increases TDF exposure; monitor for adverse reactions
  • Drugs affecting renal function: Coadministration of TRUVADA with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine and/or tenofovir

Pregnancy and lactation

  • Pregnancy: An Antiretroviral Pregnancy Registry (APR) has been established. Available data from observational studies and the APR show no increase in the rate of major birth defects for TRUVADA compared with a US reference population. Consider HIV prevention methods, including TRUVADA FOR PrEP in women due to the potential increased risk of HIV-1 infection during pregnancy and mother to child transmission during acute HIV-1 infection
  • Lactation: Emtricitabine and tenofovir have been detected in human milk. Evaluate the benefits and risks of TRUVADA FOR PrEP in breastfeeding women, including the risk of HIV-1 acquisition due to nonadherence, and subsequent mother to child transmission. Health benefits of breastfeeding should be considered along with potential adverse effects of TRUVADA on the child, which are unknown

IMPORTANT SAFETY INFORMATION

INDICATION

TRUVADA FOR PrEP (pre-exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35 kg) who are at risk for HIV, when used in combination with safer sex practices. HIV-negative status must be confirmed immediately prior to initiation.

  • If clinical symptoms of acute HIV-1 infection are present and recent exposures (<1 month) are suspected, delay initiation for at least 1 month until HIV-negative status is reconfirmed. Alternatively, confirm HIV-negative status with a test cleared by the FDA to aid in the diagnosis of acute HIV‑1 infection

Individuals at risk for sexually acquired HIV‑1 may include those:

  • With HIV‑1 infected partner(s), or
  • Who engage in sexual activity in a high prevalence area or social network and have additional risk factors, such as: inconsistent or no condom use, diagnosis of sexually transmitted infections (STIs), exchange of sex for commodities, use of illicit drugs or alcohol dependence, incarceration, or sexual partners of unknown HIV status with any of these risk factors

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • TRUVADA FOR PrEP must only be prescribed to individuals confirmed to be HIV‑negative immediately prior to initiation and at least every 3 months during use. Drug-resistant HIV‑1 variants have been identified with use of TRUVADA FOR PrEP following undetected acute HIV‑1 infection. Do not initiate if signs or symptoms of acute HIV‑1 infection are present unless HIV‑negative status is confirmed
  • Severe acute exacerbations of hepatitis B have been reported in HBV‑infected patients who discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HBV after discontinuing TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted

Contraindications

  • TRUVADA FOR PrEP is contraindicated in individuals with unknown or positive HIV status

Warnings and precautions: Comprehensive risk reduction strategies

  • Reduce HIV‑1 risk: TRUVADA FOR PrEP is not always effective in preventing HIV‑1. Use only as part of a comprehensive prevention strategy that includes safer sex practices, regular testing for HIV‑1 and other STIs, and counseling on reducing sexual risk behaviors
  • Reduce potential for drug resistance: TRUVADA FOR PrEP should only be used in individuals confirmed to be HIV-negative immediately prior to initiation, at least every 3 months while taking TRUVADA, and upon an STI diagnosis. HIV‑1 resistance substitutions may emerge in individuals with undetected HIV‑1 infection who are taking only TRUVADA. TRUVADA alone is not a complete regimen for treating HIV‑1
    • HIV antibody tests may not detect acute HIV infection. If recent exposures are suspected or symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash), delay initiating (≥1 month) or discontinue use and confirm HIV-negative status with a test approved by the FDA for the diagnosis of acute HIV infection
    • If a screening test indicates possible HIV-1 infection, convert the HIV-1 PrEP regimen to an HIV treatment regimen until HIV-negative status is confirmed
  • Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule, as efficacy is strongly correlated with adherence. Some individuals, such as adolescents, may benefit from more frequent visits and counseling

Warnings and precautions

  • New onset or worsening renal impairment: Cases of acute renal impairment and Fanconi syndrome have been reported with the use of tenofovir disoproxil fumarate (TDF). TRUVADA is not recommended in individuals with estimated creatinine clearance (CrCl) <60 mL/min. Avoid concurrent or recent use with a nephrotoxic agent. Acute renal failure has been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients. Monitor renal function in all patients – See Dosage and Administration section
  • Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia associated with proximal renal tubulopathy, have been reported with the use of TDF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss
  • Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations
  • Drug interactions: See Drug Interactions section. Consider the potential for drug interactions prior to and during use of TRUVADA and monitor for adverse reactions

Adverse reactions

  • Common adverse reactions (>2% and more frequently than placebo) of TRUVADA FOR PrEP in clinical trials were headache, abdominal pain, and weight loss

Drug interactions

  • Prescribing information: Consult the full Prescribing Information for TRUVADA for more information, warnings, and potentially significant drug interactions, including clinical comments
  • Hepatitis C antivirals: Coadministration with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir increases TDF exposure; monitor for adverse reactions
  • Drugs affecting renal function: Coadministration of TRUVADA with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine and/or tenofovir

Pregnancy and lactation

  • Pregnancy: An Antiretroviral Pregnancy Registry (APR) has been established. Available data from observational studies and the APR show no increase in the rate of major birth defects for TRUVADA compared with a US reference population. Consider HIV prevention methods, including TRUVADA FOR PrEP in women due to the potential increased risk of HIV-1 infection during pregnancy and mother to child transmission during acute HIV-1 infection
  • Lactation: Emtricitabine and tenofovir have been detected in human milk. Evaluate the benefits and risks of TRUVADA FOR PrEP in breastfeeding women, including the risk of HIV-1 acquisition due to nonadherence, and subsequent mother to child transmission. Health benefits of breastfeeding should be considered along with potential adverse effects of TRUVADA on the child, which are unknown

Dosage and administration

  • Dosage: One tablet once daily with or without food
  • HIV screening: Test for HIV-1 infection prior to initiating and at least every 3 months during treatment
  • HBV screening: Test for HBV infection prior to or when initiating treatment
  • Renal impairment and monitoring: Not recommended in individuals with CrCl <60 mL/min. In all patients, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein on a clinically appropriate schedule. In patients with chronic kidney disease, also assess serum phosphorus

Please click here to view full Prescribing Information for TRUVADA FOR PrEP, including BOXED WARNING.


References: 1. TRUVADA [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2018. 2. Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367(5):399-410. 3. Centers for Disease Control and Prevention. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2017 Update: A Clinical Practice Guideline. http://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf. Published March 2018. Accessed February 20, 2019. 4. World Health Organization. Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection: Recommendations for a Public Health Approach. 2nd ed. http://www.who.int/hiv/pub/arv/arv-2016/en. Published June 2016. Accessed February 20, 2019. 5. The American College of Obstetricians and Gynecologists Committee on Gynecologic Practice. Committee Opinion No 595: Preexposure prophylaxis for the prevention of human immunodeficiency virus. Obstet Gynecol. 2014;123(5):1133-1136. 6. Saag MS, Benson CA, Gandhi RT, et al. Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2018 recommendations of the International Antiviral Society-USA Panel. JAMA. 2018;320(4):379-396. 7. American College Health Association. ACHA Guidelines: HIV Pre-exposure Prophylaxis. https://www.acha.org/documents/resources/guidelines/ACHA_HIV_PrEP_Guidelines_Jan2019.pdf. Published January 2019. Accessed February 20, 2019. 8. White House Office of National AIDS Policy. National HIV/AIDS Strategy for the United States: Updated to 2020. https://files.hiv.gov/s3fs-public/nhas-update.pdf. Published July 2015. Accessed February 20, 2019. 9. Sullivan PS, Smith DK, Mera-Giler R, et al. The impact of pre-exposure prophylaxis with FTC/TDF on HIV diagnoses, 2012-2016, United States. Presented at: 22nd International AIDS Conference; July 23-27, 2018; Amsterdam, the Netherlands. Poster LBPEC036. 10. Sullivan PS, Smith DK, Mera-Giler R, et al. The impact of pre-exposure prophylaxis with TDF/FTC on HIV diagnoses, 2012-2016, United States. https://programme.aids2018.org/Abstract/Print/?abstractid=13004. Accessed February 20, 2019. 11. Smith DK. Race/ethnicity, blacks have highest number needing PrEP in the United States, 2015. Presented at: 25th Annual Conference on Retroviruses and Opportunistic Infections; March 4-7, 2018; Boston, MA. http://www.croiwebcasts.org/console/player/37188?mediaType=slideVideo&&crd_fl=1&ssmsrq=1532629430968&ctms=5000&csmsrq=1130. Accessed February 20, 2019. 12. Centers for Disease Control and Prevention. HIV Surveillance Report, 2017; vol 29. https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2017-vol-29.pdf. Published November 2017. Accessed February 20, 2019. 13. Centers for Disease Control and Prevention. Lifetime risk of HIV diagnosis in the United States. https://www.justfacts.com/document/lifetime_risk_hiv.pdf. Published February 2016. Accessed February 20, 2019. 14. Hess KL, Hu X, Lansky A, Mermin J, Hall HI. Lifetime risk of a diagnosis of HIV infection in the United States. Ann Epidemiol. 2017;27(4):238-243. 15. Nunn A, Zaller N, Cornwall A, et al. Low perceived risk and high HIV prevalence among a predominantly African American population participating in Philadelphia's rapid HIV testing program. AIDS Patient Care STDS. 2011;25(4):229-235. 16. Centers for Disease Control and Prevention. Anal sex and HIV risk. https://www.cdc.gov/hiv/risk/analsex.html. Reviewed November 13, 2018. Accessed February 20, 2019. 17. Centers for Disease Control and Prevention. 2016 Conference on Retroviruses and Opportunistic Infections. https://www.cdc.gov/nchhstp/newsroom/2016/croi-2016.html. Published February 24, 2016. Accessed February 20, 2019. 18. Flores AR, Herman JL, Gates GJ, Brown TNT. How Many Adults Identify as Transgender in the United States? Los Angeles, CA: The Williams Institute; 2016. https://williamsinstitute.law.ucla.edu/wp-content/uploads/How-Many-Adults-Identify-as-Transgender-in-the-United-States.pdf. Accessed February 20, 2019. 19. Clark H, Babu AS, Wiewel EW, Opoku J, Crepaz N. Diagnosed HIV infection in transgender adults and adolescents: results from the National HIV Surveillance System, 2009–2014. AIDS Behav. 2017;21(9):2774-2783. 20. Herbst JH, Jacobs ED, Finlayson TJ, et al. Estimating HIV prevalence and risk behaviors of transgender persons in the United States: a systematic review. AIDS Behav. 2008;12(1):1-17. 21. Reisner SL, Murchison GR. A global research synthesis of HIV and STI biobehavioural risks in female-to-male transgender adults. Glob Public Health. 2016;11(7-8):866-887. 22. Maragh-Bass AC, Torain M, Adler R, et al. Is it okay to ask: transgender patient perspectives on sexual orientation and gender identity collection in healthcare. Acad Emerg Med. 2017;24(6):655-667. 23. Centers for Disease Control and Prevention. STDs and HIV. https://www.cdc.gov/std/hiv/STD-HIV-FS-July-10-2017.pdf. Published July 2017. Accessed February 20, 2019. 24. Centers for Disease Control and Prevention. Reported STDs in the United States, 2017. https://www.cdc.gov/nchhstp/newsroom/docs/factsheets/std-trends-508.pdf. Published September 2018. Accessed February 20, 2019. 25. Centers for Disease Control and Prevention. The U.S. is experiencing steep, sustained increases in sexually transmitted diseases. https://www.cdc.gov/nchhstp/newsroom/docs/2018/infographic_Experiencing-Steep-Sustained-Increases-in-STD.pdf. Accessed February 20, 2019. 26. Boily MC, Baggaley RF, Wang L, et al. Heterosexual risk of HIV-1 infection per sexual act: a systematic review and meta-analysis of observational studies. Lancet Infect Dis. 2009;9(2):118-129. 27. Peterman TA, Newman DR, Maddox L, Schmitt K, Shiver S. Risk for HIV following a diagnosis of syphilis, gonorrhea or chlamydia: 328,456 women in Florida, 2000-2011. Int J STD AIDS. 2015;26(2):113-119. 28. Peterman TA, Newman DR, Maddox L, Schmitt K, Shiver S. High risk for HIV following syphilis diagnosis among men in Florida, 2000-2011. Public Health Rep. 2014;129(2):164-169. 29. Bernstein KT, Marcus JL, Nieri G, Philip SS, Klausner JD. Rectal gonorrhea and chlamydia reinfection is associated with increased risk of HIV seroconversion. J Acquir Immune Defic Syndr. 2010;53(4):537-543. 30. Pathela P, Braunstein SL, Blank S, Schillinger JA. HIV incidence among men with and those without sexually transmitted rectal infections: estimates from matching against an HIV case registry. Clin Infect Dis. 2013;57(8):1203-1209. 31. Centers for Disease Control and Prevention. Sexually transmitted disease surveillance 2017. https://www.cdc.gov/std/stats17/default.htm. Reviewed October 15, 2018. Accessed February 20, 2019. 32. Marcus JL, Bernstein KT, Kohn RP, Liska S, Philip SS. Infections missed by urethral-only screening for chlamydia or gonorrhea detection among men who have sex with men. Sex Transm Dis. 2011;38(10):922-924. 33. Centers for Disease Control and Prevention. Screening recommendations and considerations referenced in the 2015 STD treatment guidelines and original sources. https://www.cdc.gov/std/tg2015/screening-recs-2015tg-revised2016.pdf. Accessed March 5, 2019. 34. Kent CK, Chaw JK, Wong W, et al. Prevalence of rectal, urethral, and pharyngeal chlamydia and gonorrhea detected in 2 clinical settings among men who have sex with men: San Francisco, California, 2003. Clin Infect Dis. 2005;41(1):67-74. 35. Truong HM, Pipkin S, O'Keefe KJ, et al. Recent infection, sexually transmitted infections, and transmission clusters frequently observed among persons newly diagnosed with HIV in San Francisco. J Acquir Immune Defic Syndr. 2015;69(5):606-609. 36. Okoye S, Chang MH, Weissman S, Dufffus W. Missed opportunities to initiate pre-exposure prophylaxis in South Carolina—2013-2016. Abstract 884. Open Forum Infect Dis. 2017;4(suppl 1):S16. doi:10.1093/ofid/ofx162.040. 37. Copen CE. Receipt of a sexual risk assessment from a doctor or medical care provider in the past year among women and men aged 15–44 with recent sexual activity. Natl Health Stat Report. 2018;(110):1-12. 38. Centers for Disease Control and Prevention. A guide to taking a sexual history. CDC publication: 99-8445. https://www.cdc.gov/std/treatment/sexualhistory.pdf. Accessed February 20, 2019. 39. Centers for Disease Control and Prevention. Vital signs: HIV testing. https://www.cdc.gov/vitalsigns/hiv-testing/infographic.html. Reviewed November 28, 2017. Accessed February 20, 2019. 40. Data on file. Gilead Sciences, Inc. 2016. 41. Grant RM, Lama JR, Anderson PL, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010;363(27):2587-2599. 42. Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women [supplementary appendix]. N Engl J Med. 2012;367(5):399-410. http://www.nejm.org/doi/suppl/10.1056/NEJMoa1108524/suppl_file/nejmoa1108524_appendix.pdf.

Tap for Important Safety Information, including BOXED WARNING on the risk of drug resistance with TRUVADA FOR PrEP in undiagnosed early HIV‑1 infection and post-treatment acute exacerbation of hepatitis B.

This information is intended for U.S. healthcare professionals.

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