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Truvada (Emtricitabine / Tenofovir Disoproxil Fumarate) - Summary

 

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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).

 

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.

TRUVADA NEWS HIGHLIGHTS

Media Articles Related to Truvada (Emtricitabine / Tenofovir Disoproxil)

HIV Infection From Injection Drug Use Is Growing Global Problem
Source: MedPage Today Infectious Disease [2008.09.23]

HIV Infection Rate for Young Black Men 'Alarming:' CDC
Source: MedicineNet Human Immunodeficiency Virus (HIV, AIDS) Specialty [2008.09.12]

Scientists Spot New Twist in HIV Infection
Source: MedicineNet Sexually Transmitted Diseases (STDs In Men) Specialty [2008.09.05]

Herpes Suppression May Not Prevent HIV Infection
Source: MedicineNet Genital Herpes In Women Specialty [2008.06.20]

HIV's Genetic 'Flight Plan' Filed
Source: MedPageToday.com - medical news plus CME for physicians [2008.10.02]

more>>

Published Studies Related to Truvada (Emtricitabine / Tenofovir Disoproxil)

Bioequivalence of efavirenz/emtricitabine/tenofovir disoproxil fumarate single-tablet regimen. [2007.10.01]

Pharmacokinetics of emtricitabine, tenofovir, and GS-9137 following coadministration of emtricitabine/tenofovir disoproxil fumarate and ritonavir-boosted GS-9137. [2007.07.01]

Steady-state pharmacokinetics of emtricitabine and tenofovir disoproxil fumarate administered alone and in combination in healthy volunteers. [2007.06]

Efavirenz/emtricitabine/tenofovir disoproxil fumarate fixed-dose combination: first-line therapy for all? [2007.02]

Tenofovir disoproxil fumarate-emtricitabine coformulation for once-daily dual NRTI backbone. [2006.08]

more>>

Clinical Trials Related to Truvada (Emtricitabine / Tenofovir Disoproxil)

Boosted Atazanavir and Truvada Given Once-Daily - BATON Study [Completed]

Combination of Efavirenz and Truvada - COMET Study [Completed]

FEM-PrEP (TruvadaŽ): Study to Assess the Role of TruvadaŽ in Preventing HIV Acquisition in Women [Not yet recruiting]

TOTEM: Switch From Other Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to Once Daily Truvada [Active, not recruiting]

RECOMB: Peripheral Body Fat Distribution After Switching From AZT Containing Backbone to Truvada [Active, not recruiting]

more>>

Page last updated: 2008-10-02

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