WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT EXACERBATION OF HEPATITIS B
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 and Precautions].
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 coinfected with HBV and HIV-1. 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 for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue EMTRIVA. If appropriate, initiation of anti-hepatitis B therapy may be warranted [See Warnings and Precautions].
|
| |
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.
|
NEWS HIGHLIGHTSMedia Articles Related to Emtriva (Emtricitabine)
IDSA: Obesity Slows Immune Recovery in HIV Infection (CME/CE, with video)
Source: MedPage Today Infectious Disease [2009.11.03]
PHILADELPHIA (MedPage Today) -- The immune systems of HIV patients who are obese don't respond to antiretroviral therapy as well as do those of people of normal weight, a researcher said here.
HIV Infections, Deaths Declining In Caribbean, Senior Official Says
Source: Sexual Health / STDs News From Medical News Today [2009.10.28]
Ahead of the regional Pan Caribbean Partnership Against HIV/AIDS (PANCAP) meeting, a senior official announced that the number of new HIV infections in the region has fallen since last year, Agence France-Presse reports.
New Epidemic Of Sexually Transmitted Hepatitis C Infection In HIV-infected Men In NYC
Source: HIV / AIDS News From Medical News Today [2009.10.31]
Researchers in New York City are reporting their work uncovering a new epidemic of hepatitis C virus (HCV) infection among men-who-have-sex-with-men (MSM) who have HIV infection. These authors have previously reported unusually rapid fibrosis progression due to new HCV in MSM who have HIV infection and now expand on their findings, demonstrating that sexual transmission rather than injection drug use is the route of infection.
Published Studies Related to Emtriva (Emtricitabine)
A randomized comparative trial of continued zidovudine/lamivudine or replacement with tenofovir disoproxil fumarate/emtricitabine in efavirenz-treated HIV-1-infected individuals. [2009.08.15]
BACKGROUND: Long-term antiretroviral therapy dramatically reduces HIV-related morbidity and mortality but is also associated with metabolic and morphological changes and requires high levels of adherence... CONCLUSIONS: Switching from zidovudine/lamivudine to tenofovir disoproxil fumarate/emtricitabine in persons on efavirenz therapy maintains virological control, establishes a once-daily regimen, results in improvements in hemoglobin and key lipid parameters, and preserves and restores limb fat relative to continuation of zidovudine/lamivudine.
Randomized, double-blind, placebo-matched, multicenter trial of abacavir/lamivudine or tenofovir/emtricitabine with lopinavir/ritonavir for initial HIV treatment. [2009.07.31]
BACKGROUND: Abacavir sulfate/lamivudine (ABC/3TC) and tenofovir DF/emtricitabine (TDF/FTC) are widely used nucleoside reverse transcriptase inhibitors for initial HIV-1 treatment. This is the first completed, randomized clinical trial to directly compare the efficacy, safety, and tolerability of these agents, each in combination with lopinavir/ritonavir in antiretroviral-naive patients... CONCLUSION: Both ABC/3TC and TDF/FTC provided comparable antiviral efficacy, safety, and tolerability when each was combined with lopinavir/ritonavir in treatment-naive patients.
A simplification trial switching from nucleoside reverse transcriptase inhibitors to once-daily fixed-dose abacavir/lamivudine or tenofovir/emtricitabine in HIV-1-infected patients with virological suppression. [2009.07.01]
BACKGROUND: Data comparing abacavir/lamivudine versus tenofovir/emtricitabine in antiretroviral-naive patients are controversial. We compared 48-week efficacy and safety of these combinations as substitutes of nucleosides in patients with virological suppression... CONCLUSIONS: In HIV-1-infected patients with virological suppression, abacavir/lamivudine did not meet the noninferiority outcome for treatment efficacy compared with tenofovir/emtricitabine.
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.
Once-daily atazanavir/ritonavir versus twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 48 week efficacy and safety results of the CASTLE study. [2008.08.23]
BACKGROUND: Atazanavir/ritonavir is as effective as lopinavir/ritonavir, with a more favourable lipid profile and less gastrointestinal toxicity, in treatment-experienced HIV-1-infected patients. We compared these two combinations directly in treatment-naive patients... INTERPRETATION: In treatment-naive patients, atazanavir/ritonavir once-daily demonstrated similar antiviral efficacy to lopinavir/ritonavir twice-daily, with less gastrointestinal toxicity but with a higher rate of hyperbilirubinaemia.
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) Versus Emtricitabine/Tenofovir DF Fixed-Dose in Subjects Resistant to Lamivudine [Recruiting]
This study will evaluate the effectiveness, safety, and tolerability of tenofovir DF versus
emtricitabine plus tenofovir DF combination treatment in subjects with lamivudine
resistance.
Tenofovir Disoproxil Fumarate (DF)/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects [Active, not recruiting]
The purpose of this study is to assess two regimens in antiretroviral-naive subjects.
|
|
|
|
Page last updated: 2009-11-03
|
