WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT EXACERBATION OF HEPATITIS
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD, in combination with other antiretrovirals [See Warnings and Precautions].
Severe acute exacerbations of hepatitis have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including VIREAD. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including VIREAD. If appropriate, resumption of anti-hepatitis B therapy may be warranted [See Warnings and Precautions].
VIREAD is the brand name for tenofovir disoproxil fumarate (a prodrug of tenofovir) which is a fumaric acid salt of bis -isopropoxycarbonyloxymethyl ester derivative of tenofovir. In vivo tenofovir disoproxil fumarate is converted to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase.
VIREAD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on analyses of plasma HIV-1 RNA levels and CD4 cell counts in controlled studies of VIREAD in treatment-na[iuml ]ve adults and in treatment-experienced adults.
Additional important information regarding the use of VIREAD for the treatment of HIV-1 infection:
There are no study results demonstrating the effect of VIREAD on clinical progression of HIV-1.
The use of VIREAD should be considered for treating adult patients with HIV-1 strains that are expected to be susceptible to tenofovir as assessed by laboratory testing or treatment history (see Description of Clinical Studies).
Media Articles Related to Viread (Tenofovir Disoproxil)
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.
Published Studies Related to Viread (Tenofovir Disoproxil)
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.
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.
Randomized, phase 2 evaluation of two single-tablet regimens elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate for the initial treatment of HIV infection. [2011.03.27]
OBJECTIVE: To assess the safety and efficacy of two, single-tablet regimens for the initial treatment of HIV infection. DESIGN: Phase 2, randomized, double-blind, double-dummy, multicenter, active-controlled study... CONCLUSION: Once-daily EVG/COBI/FTC/TDF achieved and maintained a high rate of virologic suppression with fewer central nervous system and psychiatric adverse events compared to a current standard-of-care regimen of EFV/FTC/TDF.
No resistance to tenofovir disoproxil fumarate detected after up to 144 weeks of therapy in patients monoinfected with chronic hepatitis B virus. [2011.03]
CONCLUSION: No nucleoside-naive or nucleoside-experienced patient developed HBV pol/RT mutations associated with TDF resistance after up to 144 weeks of exposure to TDF monotherapy. Copyright (c) 2010 American Association for the Study of Liver Diseases.
Clinical Trials Related to Viread (Tenofovir Disoproxil)
A 96 Week Study to Compare Tenofovir Versus Tenofovir Plus Emtricitabine for the Treatment of Chronic Hepatitis B [Active, not recruiting]
Safety and Effectiveness of Tenofovir 1% Gel, Tenofovir Disproxil Fumarate, and Emtricitabine/Tenofovir Disoproxil Fumarate Tablets in Preventing HIV in Women [Recruiting]
A new approach to HIV prevention currently being studied includes the use of microbicides,
substances that kill microbes. Tenofovir disoproxil fumarate (TDF) and
emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) are oral, FDA-approved, anti-HIV
drugs, and tenofovir gel is an experimental microbicide. The purpose of this study is to
determine the safety and effectiveness of daily tenofovir 1% gel compared to a vaginal
placebo gel, and the safety and effectiveness of oral TDF and oral FTC/TDF compared to an
oral placebo in preventing HIV infection among women at risk for sexually transmitted
Kaletra and Viread in Antiretroviral Na├»ve Patients [Recruiting]
Once daily antiretroviral therapy with Viread (tenofovir DF, 300mg) plus Kaletra (LPV/r,
800mg/200mg) will be effective in suppressing and maintaining suppression of HIV RNA to <50
copies/ml in antiretroviral na´ve patients through 48 weeks of therapy.
Metabolic Impact Assessment of Tenofovir Disoproxil Fumarate on Non-HIV-1 Infected Healthy Adult Male Volunteers [Completed]
Metabolic changes commonly occur in HIV therapy. The purpose of this study is to assess the
impact on insulin sensitivity from the administration of tenofovir disoproxil fumarate 300 mg
compared with placebo in non-HIV-1 infected healthy adult males. Additionally, endothelial
function, adipocytokines and lipids will be monitored.
A Phase 1b Study Assessing GS-7340 in Treatment-Naive Adults With Chronic Hepatitis B [Recruiting]
Reports of Suspected Viread (Tenofovir Disoproxil) Side Effects
Renal Failure Acute (19),
Viral Load Increased (16),
Renal Failure (15),
Lactic Acidosis (14),
Fanconi Syndrome (13),
Maternal Exposure During Pregnancy (13),
Renal Impairment (12),
Drug Ineffective (10),
Abortion Spontaneous (9),
Death (9), more >>
Page last updated: 2012-08-28