WARNINGS
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).
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TRUVADA SUMMARY
TRUVADA®
(emtricitabine and tenofovir disoproxil fumarate)
Tablets
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.
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NEWS HIGHLIGHTS
Published Studies Related to Truvada (Emtricitabine / Tenofovir Disoproxil)
Simplification of antiretroviral therapy to a single-tablet regimen consisting of efavirenz, emtricitabine, and tenofovir disoproxil fumarate versus unmodified antiretroviral therapy in virologically suppressed HIV-1-infected patients. [2009.06.01]
OBJECTIVE: To evaluate a simplification strategy for HIV-1-infected patients virologically suppressed on antiretroviral therapy (ART) by switching to a single-tablet regimen consisting of efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF). DESIGN:: Prospective, randomized, controlled, open-label, multicenter study... CONCLUSION: Simplification to EFV/FTC/TDF maintained high and comparable rates of virologic suppression vs. SBR through 48 weeks.
Bioequivalence of efavirenz/emtricitabine/tenofovir disoproxil fumarate single-tablet regimen. [2007.10.01]
OBJECTIVE: Efavirenz (EFV; 600 mg), emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg) are preferred agents for treatment of HIV-1 infection in adults. This study evaluated the pharmacokinetics (PK) and bioequivalence of an investigational coformulation of EFV/FTC/TDF (test) single-tablet regimen compared with the commercially available individual dosage forms (EFV+FTC+TDF; reference treatment) in healthy subjects... CONCLUSIONS: The coformulation of EFV/FTC/TDF is bioequivalent to administration of its individual components.
Pharmacokinetics of emtricitabine, tenofovir, and GS-9137 following coadministration of emtricitabine/tenofovir disoproxil fumarate and ritonavir-boosted GS-9137. [2007.07.01]
OBJECTIVES: To evaluate the potential for clinically relevant drug-drug interaction between emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) and the ritonavir-boosted HIV integrase inhibitor GS-9137 (GS-9137/r)... CONCLUSION: There is no clinically relevant drug-drug interaction between FTC/TDF and GS-9137/r on their coadministration.
Steady-state pharmacokinetics of emtricitabine and tenofovir disoproxil fumarate administered alone and in combination in healthy volunteers. [2007.06]
The approved antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate, were considered good candidates for a fixed-dose combination product that could be administered as a single pill once daily (qd), thereby simplifying existing treatment regimens and promoting patient adherence.Steady-state pharmacokinetic parameters (AUC(tau), C(max), and C(min)) of emtricitabine and tenofovir (as tenofovir disoproxil fumarate) in combination were essentially equivalent versus each drug alone, providing a pharmacokinetic rationale for combining these products in emtricitabine/tenofovir disoproxil fumarate fixed-dose tablets.
Switch from a ZDV/3TC-based regimen to a completely once daily (QD) regimen of emtricitabine/tenofovir DF fixed dose combination plus a third QD agent (SONETT). [2009.05.14]
OBJECTIVES: To assess the efficacy and safety of a treatment switch from a twice-daily (BID) regimen containing zidovudine (ZDV) and lamivudine (3TC) plus a third agent to a once daily (QD) regimen containing the fixed-dose combination of tenofovir DF/emtri?citabine (TDF/FTC, Truvada) plus a divergent third QD agent in HIV-1 infected patients... CONCLUSIONS: Results from this study support switching from a ZDV/3TC-containing HAART regimen to a completely QD regimen of TDF/FTC plus a third agent. Virologic and immunologic control are maintained, with apparent benefits in haemoglobin.
Clinical Trials Related to Truvada (Emtricitabine / Tenofovir Disoproxil)
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.
Combination of Efavirenz and Truvada - COMET Study [Completed]
To characterize the risks (safety and tolerability), effectiveness (continued viral load
suppression and CD4 changes), and benefits (safety, tolerability, adherence, general
satisfaction with the treatment regimen and QoL), of switching from a Combivir (BID) /
efavirenz (QD) regimen to an all QD regimen of Truvada/efavirenz.
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
and Zambia). 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.
Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve 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
regimens.
TOTEM: Switch From Other Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to Once Daily Truvada [Active, not recruiting]
This study looks at lipid changes in HIV infected patients when they are switched from
existing HIV treatment to a treatment containing Truvada.
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Page last updated: 2009-10-20
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