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)
FDA OKs HIV 'Quad' Pill Source: MedPage Today Product Alert [2012.08.28] WASHINGTON -- The FDA has approved Stribild, the four-drug combination of elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate, for once-daily treatment of HIV in adults who have never received HIV treatment.
Synthetic Agents Related To Active Ingredient In Marijuana Weaken HIV Infection Source: HIV / AIDS News From Medical News Today [2013.05.04] HIV, the virus that causes AIDS, is notorious for hiding within certain types of cells, where it reproduces at a slowed rate and eventually gives rise to chronic inflammation, despite drug therapy...
Baby "Cured" of HIV Infection Source: MedicineNet Human Immunodeficiency Virus (HIV, AIDS) Specialty [2013.04.03] Title: Baby "Cured" of HIV Infection Category: Doctor's & Expert's views on Symptoms Created: 4/3/2013 6:12:00 PM Last Editorial Review: 4/3/2013 6:12:53 PM
Everyone Aged 15 To 65 Should Receive HIV Testing, New Guidelines Say Source: HIV / AIDS News From Medical News Today [2013.04.30] Clinicians are now recommended to screen all patients aged 15 to 65, and other teens or older adults who are at an elevated risk for HIV infection, according to new guidelines released today. The guidelines were part of the final recommendation statement on screening for HIV by the U.S...
Latest HIV Vaccine Fails In The US, Government Stops Study Source: HIV / AIDS News From Medical News Today [2013.04.26] A study testing the latest experimental HIV vaccine has been stopped after an independent review board found that it did not prevent HIV infection and did not decrease the amount of HIV in the blood. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced that they will stop giving doses of this experimental vaccine...
Published Studies Related to Emtriva (Emtricitabine)
Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial. [2011.07.16] BACKGROUND: Efavirenz with tenofovir-disoproxil-fumarate and emtricitabine is a preferred antiretroviral regimen for treatment-naive patients infected with HIV-1. Rilpivirine, a new non-nucleoside reverse transcriptase inhibitor, has shown similar antiviral efficacy to efavirenz in a phase 2b trial with two nucleoside/nucleotide reverse transcriptase inhibitors. We aimed to assess the efficacy, safety, and tolerability of rilpivirine versus efavirenz, each combined with tenofovir-disoproxil-fumarate and emtricitabine... INTERPRETATION: Rilpivirine showed non-inferior efficacy compared with efavirenz, with a higher virological-failure rate, but a more favourable safety and tolerability profile. FUNDING: Tibotec. Copyright (c) 2011 Elsevier Ltd. All rights reserved.
Peripheral and central fat changes in subjects randomized to abacavir-lamivudine or tenofovir-emtricitabine with atazanavir-ritonavir or efavirenz: ACTG Study A5224s. [2011.07.15] BACKGROUND: We compare the effect of 4 different antiretroviral regimens on limb and visceral fat... CONCLUSIONS: ABC-3TC- and TDF-FTC-based regimens increased limb and visceral fat at week 96, with a similar prevalence of lipoatrophy. Compared to the EFV group, subjects assigned to ATV-r had a trend towards higher mean percentage increase in VAT. CLINICAL TRIALS REGISTRATION: NCT00118898.
Lipid profiles for nevirapine vs. atazanavir/ritonavir, both combined with tenofovir disoproxil fumarate and emtricitabine over 48 weeks, in treatment-naive HIV-1-infected patients (the ARTEN study). [2011.07] OBJECTIVES: Dyslipidaemic effects of antiretrovirals (ARVs) may contribute to increased cardiovascular risk (CR) in HIV-1-infected patients. The ARTEN (atazanavir/ritonavir on a background of tenofovir and emtricitabine vs. nevirapine on the same background, in naive HIV-1-infected patients) study compared prospectively ritonavir-boosted atazanavir (ATZ/r) 300 mg/100 mg once daily (qd) with immediate release nevirapine (NVP) 200 mg twice daily or 400 mg qd, each combined with fixed-dose tenofovir 300 mg/emtricitabine 200 mg qd in 569 ARV-naive HIV-1-infected patients. Lipid profiles and CR from baseline to week 48 are reported... CONCLUSIONS: In ARV-naive patients with low CR at the outset, NVP showed a potentially less atherogenic lipid profile compared with ATZ/r. (c) 2011 British HIV Association.
Bone mineral density and fractures in antiretroviral-naive persons randomized to receive abacavir-lamivudine or tenofovir disoproxil fumarate-emtricitabine along with efavirenz or atazanavir-ritonavir: Aids Clinical Trials Group A5224s, a substudy of ACTG A5202. [2011.06.15] BACKGROUND: Long-term effects of abacavir (ABC)-lamivudine (3TC), compared with tenofovir (TDF)-emtricitabine (FTC) with efavirenz (EFV) or atazanavir plus ritonavir (ATV/r), on bone mineral density (BMD) have not been analyzed... CONCLUSIONS: Compared with ABC-3TC, TDF-FTC-treated participants had significantly greater decreases in spine and hip BMD, whereas ATV/r led to more significant losses in spine, but not hip, BMD than EFV. Clinical Trials Registration. NCT00118898.
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.
Clinical Trials Related to Emtriva (Emtricitabine)
An Open-Label Study of Emtricitabine in Combination With Other Antiretroviral Agents in HIV Infected Pediatric Subjects [Completed]
Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV 1 Infected Patients [Not yet recruiting]
Phase 3B Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Women [Recruiting]
To evaluate the efficacy of a regimen containing
elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus ritonavir-boosted
atazanavir plus emtricitabine/tenofovir disoproxil fumarate in HIV-1 infected,
antiretroviral treatment-naïve adult women as determined by the achievement of HIV 1 RNA <50
copies/mL at Week 48
Safety and Efficacy of Darunavir/Cobicistat/Emtricitabine/GS-7340 Single Tablet Regimen Versus Cobicistat-boosted Darunavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in HIV-1 Infected, Antiretroviral Treatment Naive Adults [Recruiting]
A 96 Week Study to Compare Tenofovir Versus Tenofovir Plus Emtricitabine for the Treatment of Chronic Hepatitis B [Active, not recruiting]
Reports of Suspected Emtriva (Emtricitabine) Side Effects
Stillbirth (8),
PRE-Eclampsia (8),
Maternal Exposure During Pregnancy (5),
Immune Reconstitution Syndrome (4),
Renal Tubular Disorder (3),
Condition Aggravated (3),
Anaemia (2),
Abdominal Pain (1),
Agitation (1),
Confusional State (1), more >>
|
|
|
|
Page last updated: 2013-05-04
|