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Emtriva (Emtricitabine) - 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).

EMTRIVA IS NOT APPROVED FOR THE TREATMENT OF CHRONIC HEPATITIS B VIRUS (HBV) INFECTION AND THE SAFETY AND EFFICACY OF EMTRIVA HAVE NOT BEEN ESTABLISHED IN PATIENTS CO-INFECTED WITH HBV AND HIV. SEVERE ACUTE EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN PATIENTS WHO HAVE DISCONTINUED EMTRIVA. HEPATIC FUNCTION SHOULD BE MONITORED CLOSELY WITH BOTH CLINICAL AND LABORATORY FOLLOW-UP AT LEAST SEVERAL MONTHS IN PATIENTS WHO DISCONTINUE EMTRIVA AND ARE CO-INFECTED WITH HIV AND HBV. IF APPROPRIATE, INITIATION OF ANTI-HEPATITIS B THERAPY MAY BE WARRANTED (SEE WARNINGS).

 

EMTRIVA SUMMARY

EMTRIVA is the brand name of emtricitabine, a synthetic nucleoside analogue with activity against human immunodeficiency virus type 1 (HIV-1) reverse transcriptase.

EMTRIVA is indicated, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults.

EMTRIVA NEWS HIGHLIGHTS

Media Articles Related to Emtriva (Emtricitabine)

HIV Infection Rate for Young Black Men 'Alarming:' CDC
Source: MedicineNet Mens Health Specialty [2008.09.12]

Scientists Spot New Twist in HIV Infection
Source: MedicineNet Sexually Transmitted Diseases (STDs In Women) 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: MedPage Today Infectious Disease [2008.10.02]

more>>

Published Studies Related to Emtriva (Emtricitabine)

Impact of switching virologically suppressed, HIV-1-infected patients from twice-daily fixed-dose zidovudine/lamivudine to once-daily fixed-dose tenofovir disoproxil fumarate/emtricitabine. [2008.03]

Single-dose tenofovir and emtricitabine for reduction of viral resistance to non-nucleoside reverse transcriptase inhibitor drugs in women given intrapartum nevirapine for perinatal HIV prevention: an open-label randomised trial. [2007.11.17]

Baseline genotype as a predictor of virological failure to emtricitabine or stavudine in combination with didanosine and efavirenz. [2007.08]

Pharmacokinetic evaluation of emtricitabine in combination with other nucleoside antivirals in healthy volunteers. [2007.07]

Tenofovir disoproxil fumarate, emtricitabine, and efavirenz versus fixed-dose zidovudine/lamivudine and efavirenz in antiretroviral-naive patients: virologic, immunologic, and morphologic changes--a 96-week analysis. [2006.12.15]

more>>

Clinical Trials Related to Emtriva (Emtricitabine)

An Open-Label Study of Emtricitabine in Combination With Other Antiretroviral Agents in HIV Infected Pediatric Subjects [Completed]

A 96 Week Study to Compare Tenofovir Versus Tenofovir Plus Emtricitabine for the Treatment of Chronic Hepatitis B [Active, not recruiting]

Tenofovir DF (Disoproxil Fumarate) in Combination With Emtricitabine in HIV-1 Patients [Completed]

Tenofovir Disoproxil Fumarate (DF)/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects [Active, not recruiting]

The Safety and Effectiveness of 524W91 [Completed]

more>>

Page last updated: 2008-10-02

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