LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGS ALONE OR IN COMBINATION WITH OTHER ANTIRETROVIRALS (SEE WARNINGS).
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. SEVERE ACUTE EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN PATIENTS WHO HAVE DISCONTINUED EMTRIVA or VIREAD, THE COMPONENTS OF TRUVADA. HEPATIC FUNCTION SHOULD BE MONITORED CLOSELY WITH BOTH CLINICAL AND LABORATORY FOLLOW-UP FOR AT LEAST SEVERAL MONTHS IN PATIENTS WHO ARE COINFECTED WITH HIV AND HBV AND DISCONTINUE TRUVADA. IF APPROPRIATE, INITIATION OF ANTI-HEPATITIS B THERAPY MAY BE WARRANTED (SEE WARNINGS).
(emtricitabine and tenofovir disoproxil fumarate)
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 (VIREAD, also known as 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.
TRUVADA 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. Safety and efficacy studies using TRUVADA Tablets or using EMTRIVA and VIREAD in combination are ongoing.
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: 2014-11-30