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].
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VIREAD SUMMARY
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:
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There are no study results demonstrating the effect of VIREAD on clinical progression of HIV-1.
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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).
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NEWS HIGHLIGHTS
Published Studies Related to Viread (Tenofovir Disoproxil)
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.
A randomized trial of two-drug versus three-drug tenofovir-containing maintenance regimens in virologically controlled HIV-1 patients. [2009.07]
OBJECTIVES: To assess simplified maintenance regimens containing dual antiretroviral drugs in patients with controlled human immunodeficiency virus type 1 infection... CONCLUSIONS: The non-inferiority of the two-drug versus the three-drug regimen was not demonstrated. Lipid parameters improved after switching from twice-daily highly active antiretroviral therapy (HAART) to once-daily tenofovir-based HAART.
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.
Viral dynamics of hepatitis B virus DNA in human immunodeficiency virus-1-hepatitis B virus coinfected individuals: similar effectiveness of lamivudine, tenofovir, or combination therapy. [2009.04]
CONCLUSION: HBV viral dynamic parameters are similar following anti-HBV NRTI monotherapy and dual combination therapy in the setting of HIV-1-HBV coinfection. HIV-1 coinfection has minimal effect on HBV viral dynamics, even in the setting of advanced HIV-1-related immunosuppression.
Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B. [2008.12.04]
BACKGROUND: Tenofovir disoproxil fumarate (DF) is a nucleotide analogue and a potent inhibitor of human immunodeficiency virus type 1 reverse transcriptase and hepatitis B virus (HBV) polymerase... CONCLUSIONS: Among patients with chronic HBV infection, tenofovir DF at a daily dose of 300 mg had superior antiviral efficacy with a similar safety profile as compared with adefovir dipivoxil at a daily dose of 10 mg through week 48. (ClinicalTrials.gov numbers, NCT00116805 and NCT00117676.) 2008 Massachusetts Medical Society
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]
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.
Study Comparing Tenofovir Disoproxil Fumarate (TDF), Emtricitabine/TDF, & Entecavir in the Treatment of Chronic HBV in Subjects w/Decompensated Liver Disease. [Active, not recruiting]
The study is designed to evaluate and compare the safety and tolerability of tenofovir
disoproxil fumarate (DF), emtricitabine/tenofovir DF, and entecavir in the treatment of
hepatitis B patients with decompensated liver disease.
A Study to Compare Tenofovir Versus Hepsera (Adefovir) for the Treatment of HBeAg Negative Chronic Hepatitis B [Active, not recruiting]
This study is designed to evaluate the safety and antiviral activity of tenofovir disoproxil
fumarate (DF) compared to Hepsera for the treatment of HBeAg negative chronic hepatitis B.
Patients will either receive tenofovir or the approved hepatitis B therapy, Hepsera.
A Study to Compare Tenofovir Versus Hepsera (Adefovir) for the Treatment of Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B [Active, not recruiting]
This study is designed to evaluate the safety and antiviral activity of tenofovir compared to
Hepsera for the treatment of HBeAg positive chronic hepatitis B. Patients will either receive
tenofovir or the approved hepatitis B therapy, Hepsera.
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Page last updated: 2009-10-20
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