WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS, POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B, and RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD, a component of TRUVADA, in combination with other antiretrovirals [See Warnings and Precautions].
TRUVADA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of TRUVADA have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued TRUVADA. Therefore, hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are infected with HBV and discontinue TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted [See Warnings and Precautions].
TRUVADA used for a PrEP indication must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and periodically (at least every 3 months) during use. Drug-resistant HIV-1 variants have been identified with use of TRUVADA for a PrEP indication following undetected acute HIV-1 infection. Do not initiate TRUVADA for a PrEP indication if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed [See Warnings and Precautions].
TRUVADA tablets are fixed dose combination tablets containing emtricitabine and tenofovir disoproxil fumarate. EMTRIVA is the brand name for emtricitabine, a synthetic nucleoside analog of cytidine. Tenofovir disoproxil fumarate (tenofovir DF) is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Both emtricitabine and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase.
Treatment of HIV-1 Infection
TRUVADA®, a combination of EMTRIVA® and VIREAD®, is indicated in combination with other antiretroviral agents (such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.
The following points should be considered when initiating therapy with TRUVADA for the treatment of HIV-1 infection:
- It is not recommended that TRUVADA be used as a component of a triple nucleoside regimen.
- TRUVADA should not be coadministered with ATRIPLA®, COMPLERA®, EMTRIVA, VIREAD or lamivudine-containing products [See Warnings and Precautions].
- In treatment experienced patients, the use of TRUVADA should be guided by laboratory testing and treatment history [See Microbiology].
TRUVADA is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. This indication is based on clinical trials in men who have sex with men (MSM) at high risk for HIV-1 infection and in heterosexual serodiscordant couples [See Clinical Studies (14.2, 14.3) ].
When considering TRUVADA for pre-exposure prophylaxis the following factors may help to identify individuals at high risk:
has partner(s) known to be HIV-1 infected, or
engages in sexual activity within a high prevalence area or social network and one or more of the following:
inconsistent or no condom use
diagnosis of sexually transmitted infections
exchange of sex for commodities (such as money, food, shelter, or drugs)
use of illicit drugs or alcohol dependence
- partner(s) of unknown HIV-1 status with any of the factors listed above
When prescribing TRUVADA for pre-exposure prophylaxis, healthcare providers must:
prescribe TRUVADA as part of a comprehensive prevention strategy because TRUVADA is not always effective in preventing the acquisition of HIV-1 infection [See Warnings and Precautions];
counsel all uninfected individuals to strictly adhere to the recommended TRUVADA dosing schedule because the effectiveness of TRUVADA in reducing the risk of acquiring HIV-1 was strongly correlated with adherence as demonstrated by measurable drug levels in clinical trials [See Warnings and Precautions];
confirm a negative HIV-1 test immediately prior to initiating TRUVADA for a PrEP indication. If clinical symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected, delay starting PrEP for at least one month and reconfirm HIV-1 status or use a test approved by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection. [See Warnings and Precautions]; and
screen for HIV-1 infection at least once every 3 months while taking TRUVADA for PrEP.
Media Articles Related to Truvada (Emtricitabine / Tenofovir Disoproxil)
FDA approves diagnostic test to differentiate between types of HIV infection
Source: HIV / AIDS News From Medical News Today [2015.07.24]
The U.S. Food and Drug Administration has approved the Bio-Rad BioPlex 2200 HIV Ag-Ab assay, the first FDA-approved diagnostic that differentiates between HIV-1 antibodies, HIV-2 antibodies, and...
Kicking latent HIV: New strategies to reactivate reservoirs of latent infection
Source: HIV / AIDS News From Medical News Today [2015.07.31]
In cells with latent HIV infection, the virus is dormant, and such cells are therefore not attacked by the immune system or by standard antiretroviral therapy.
Cash Incentives Fail to Prevent HIV in Impoverished Girls
Source: Medscape Public Health & Prevention Headlines [2015.07.28]
Paying girls to attend high school did not reduce the incidence of HIV infection in a disappointing South African study.
Medscape Medical News
Study finds PrEP use feasible among high-risk groups in US community settings
Source: HIV / AIDS News From Medical News Today [2015.07.22]
A majority of men who have sex with men (MSM) and transgender women (TGW) at high risk for HIV infection took anti-HIV medication for pre-exposure prophylaxis (PrEP), most of the time, in a...
HPTN 052 demonstrates sustained benefit of early antiretroviral therapy
Source: HIV / AIDS News From Medical News Today [2015.07.21]
Antiretroviral therapy (ART) for HIV infection provides lasting protection against the sexual transmission of the virus from infected men and women to their HIV-uninfected sexual partners...
Published Studies Related to Truvada (Emtricitabine / Tenofovir Disoproxil)
A randomized double-blind comparison of coformulated
elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus
efavirenz/emtricitabine/tenofovir disoproxil fumarate for initial treatment of
HIV-1 infection: analysis of week 96 results. 
We report week 96 results from a phase 3 trial of
elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate
(EVG/COBI/FTC/TDF, n = 348) vs efavirenz/emtricitabine/tenofovir disoproxil
fumarate (EFV/FTC/TDF, n = 352). At week 48, EVG/COBI/FTC/TDF was noninferior to
EFV/FTC/TDF (88% vs 84%, difference +3.6%, 95% confidence interval: -1.6% to
Beliefs about antiretroviral therapy, treatment adherence and quality of life in a 48-week randomised study of continuation of zidovudine/lamivudine or switch to tenofovir DF/emtricitabine, each with efavirenz. [2011.06]
Adherence may be facilitated by reducing perceptual and practical barriers to antiretroviral therapy (ART). Practical barriers include the complexity of daily dosing, while perceptual barriers include perceptions of the need for treatment and concerns about adverse effects... Switching from CBV to TVD may improve patient reported outcomes including slightly better adherence, a greater reduction in concerns about adverse effects and less treatment intrusiveness.
Randomized, phase 2 evaluation of two single-tablet regimens elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate for the initial treatment of HIV infection. [2011.03.27]
OBJECTIVE: To assess the safety and efficacy of two, single-tablet regimens for the initial treatment of HIV infection. DESIGN: Phase 2, randomized, double-blind, double-dummy, multicenter, active-controlled study... CONCLUSION: Once-daily EVG/COBI/FTC/TDF achieved and maintained a high rate of virologic suppression with fewer central nervous system and psychiatric adverse events compared to a current standard-of-care regimen of EFV/FTC/TDF.
Concomitant administration of BILR 355/r with emtricitabine/tenofovir disoproxil fumarate increases exposure to emtricitabine and tenofovir: a randomized, open-label, prospective study. [2011.03]
The objective of this study was to evaluate the pharmacokinetic interaction of ritonavir-boosted BILR 355 (BILR 355/r) with emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF). This was an open-label, prospective study... There was no evidence of increased risk of TFV or FTC toxicity upon co-administration of FTC/TDF with BILR 355/r.
Patient-reported outcomes in virologically suppressed, HIV-1-Infected subjects after switching to a simplified, single-tablet regimen of efavirenz, emtricitabine, and tenofovir DF. [2010.02]
A randomized, open-label, multicenter study was conducted to evaluate the therapeutic switch to a single-tablet formulation of efavirenz/emtricitabine/tenofovir DF (EFV/FTC/TDF) among virologically suppressed, HIV-1-infected subjects. Eligible subjects on stable antiretroviral therapy (ART) with HIV-1 RNA less than 200 copies per milliliter for 3 months or more were stratified by prior protease inhibitor (PI)- or non-nucleoside reverse transcriptase inhibitor (NNRTI)-based therapy and randomized (2:1) to EFV/FTC/TDF or to stay on their baseline regimen (SBR)...
Clinical Trials Related to Truvada (Emtricitabine / Tenofovir Disoproxil)
FEM-PrEP (Truvada«): Study to Assess the Role of Truvada« in Preventing HIV Acquisition in Women [Recruiting]
This Phase III, double-blind, randomized, placebo-controlled trial will enroll an estimated
3900 HIV-negative women from 7 sites in 5 countries (Kenya, Malawi, Tanzania,South
Africa,Zambia and Zimbabwe). The study's purpose is to investigate the safety and
effectiveness of a once-daily Truvada┬« pill (compared with placebo) in preventing HIV among
HIV-uninfected women at risk of becoming infected through sexual intercourse.
The study population includes HIV-antibody-negative women between the ages of 18-35 who are
at risk of HIV acquisition through sexual intercourse. Each participant will be randomized
to take either a daily single oral tablet of Truvada┬«, which is a fixed-dose combination of
emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg), or an identical
placebo. All participants will receive risk reduction counseling and condoms. Women must be
using a study-approved effective non-barrier contraceptive method at the time of enrollment
and will be asked to do so for the whole period they are on study drug. They will receive
contraceptive counseling throughout the study. Any diagnosed, treatable sexually transmitted
infection will be treated free of charge.
Study duration is approximately 37-40 months at each site; participant screening and
enrollment is anticipated to take approximately 12-16 months. After enrollment, each
participant will be followed every four weeks for 52 weeks on study drug. All participants
will be followed for an additional four weeks after study drug has been stopped.
Participants at risk for hepatitis B virus (HBV) flare will be followed every four weeks
for at least 12 weeks after stopping study product. Participants who acquire HIV infection
during the study will stop taking the study drug at the time of HIV diagnosis, will be
followed for 52 weeks post diagnosis and will be referred for care and treatment.
Participants who become pregnant will stop taking the study drug but will continue follow-up
visits. After the study, incidence rates of HIV infection will be compared between the two
groups (active drug and placebo) using the intent-to-treat principle.
Boosted Atazanavir and Truvada Given Once-Daily - BATON Study [Completed]
To determine the safety and efficacy of a simple, once-daily antiretroviral (ARV) regimen
consisting of a fixed-dose combination tablet containing Truvada combined with atazanavir
boosted with ritonavir in treatment naive patients.
Raltegravir vs. Atazanavir in Combination With Truvada´┐Ż for the Treatment of Antiretroviral na´┐Żve HIV Infected Patients [Recruiting]
This is a pilot that will evaluate two regimens for treating HIV infected patients that
haven't been on treatment before. HIV/AIDS patients may have an increased risk of
myocardial infarction and antiretroviral therapy used may contribute to this. We will
evaluate virological, immunological and cardiovascular effects of two HIV treatment
A Dose-Ranging Study to Compare MK-1439 Plus TRUVADA´┐Ż Versus Efavirenz Plus TRUVADA´┐Ż in Human Immunodeficiency Virus (HIV)-1 Infected Participants (MK-1439-007 AM9) [Recruiting]
Part 1 - Dose-Ranging. Part 1 will evaluate the (1) safety and tolerability and (2) efficacy
(antiretroviral activity) of 4 doses of MK-1439 compared with efavirenz, when each is given
in combination with TRUVADA« for at least 24 weeks in approximately 200 participants. A
single dose of MK-1439 will be selected for further study after all participants complete
the Week 24 visit in Part 1. Participants receiving any dose of MK-1439 in Part 1 will be
switched to the selected MK-1439 dose and continue in the study for up to 96 weeks.
Part 2 - Selected Dose. Part 2 will be initiated after the MK-1439 dose has been selected as
indicated above for Part 1. Approximately 120 additional participants will be randomized in
1: 1 ratio to the selected dose of MK-1439 or efavirenz, each in combination with TRUVADA┬«
for 96 weeks of blinded treatment. Part 2 will evaluate the safety of the selected dose
compared with efavirenz, particularly with regard to central nervous system adverse events
The hypothesis tested in this study is that MK-1439 at the final dose selected is superior
to efavirenz, each given in combination with TRUVADA┬«, as measured by the proportion of
participants with CNS events by Week 8. If superiority is established at Week 8, the same
hypothesis will be tested for Week 24.
Truvada Plus Raltegravir for Nonoccupational Post-exposure Prophylaxis (nPEP) [Recruiting]
This study will evaluate the safety and tolerability of the combination of truvada and
raltegravir given for 28 days for the prevention of HIV infection.
Reports of Suspected Truvada (Emtricitabine / Tenofovir Disoproxil) Side Effects
Foetal Exposure During Pregnancy (139),
Maternal Exposure During Pregnancy (70),
Abortion Spontaneous (63),
Renal Failure Acute (47),
Abortion Induced (33),
Patent Ductus Arteriosus (24),
Premature Baby (23), more >>
Page last updated: 2015-07-31