WARNING: HEMATOLOGIC TOXICITY, MYOPATHY, LACTIC ACIDOSIS, EXACERBATIONS OF HEPATITIS B
Zidovudine, one of the 2 active ingredients in COMBIVIR®, has been associated with hematologic toxicity including neutropenia and anemia, particularly in patients with advanced HIV-1 disease [see Warnings and Precautions].
Prolonged use of zidovudine has been associated with symptomatic myopathy [see Warnings and Precautions].
Lactic acidosis and hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including lamivudine, zidovudine, and other antiretrovirals. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur [see Warnings and Precautions].
Acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and HIV-1 and have discontinued lamivudine, which is one component of COMBIVIR. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue COMBIVIR and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions].
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COMBIVIR SUMMARY
COMBIVIR Tablets are combination tablets containing lamivudine and zidovudine. Lamivudine (EPIVIR®, 3TC®) and zidovudine (RETROVIR®, azidothymidine, AZT, or ZDV) are synthetic nucleoside analogues with activity against human immunodeficiency virus (HIV).
COMBIVIR in combination with other antiretroviral agents is indicated for the treatment of HIV infection.
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NEWS HIGHLIGHTS
Published Studies Related to Combivir (Lamivudine / Zidovudine)
A randomized, controlled trial of initial anti-retroviral therapy with abacavir/lamivudine/zidovudine twice-daily compared to atazanavir once-daily with lamivudine/zidovudine twice-daily in HIV-infected patients over 48 weeks (ESS100327, the ACTION Study). [2009.04.09]
CONCLUSION: ABC/3TC/ZDV demonstrated comparable virologic efficacy to ATV+3TC/ZDV in this population over 48 weeks. In those with a baseline VL >/= 100,000 c/mL, subjects in the ATV+3TC/ZDV showed better virologic efficacy. Both regimens offer benefits in select therapy-naive subjects. TRIAL REGISTRATION: [Clinical Trials Identifier, NCT00082394].
Virologic failure in first-line human immunodeficiency virus therapy with a CCR5 entry inhibitor, aplaviroc, plus a fixed-dose combination of lamivudine-zidovudine: nucleoside reverse transcriptase inhibitor resistance regardless of envelope tropism. [2009.03]
The CCR102881 (ASCENT) study evaluated the antiviral activity of the novel CCR5 entry inhibitor aplaviroc plus a fixed-dose combination of lamivudine-zidovudine (Combivir) in drug-naive human immunodeficiency virus type 1-infected subjects with only CCR5-tropic virus detected in plasma... The acquisition of the M184V mutation is the primary characteristic of virologic failure in first-line therapy with aplaviroc plus lamivudine-zidovudine, regardless of the envelope tropism.
Phase II study of vicriviroc versus efavirenz (both with zidovudine/lamivudine) in treatment-naive subjects with HIV-1 infection. [2008.10.15]
BACKGROUND: Vicriviroc (VCV) is a CCR5 antagonist with nanomolar activity against human immunodeficiency virus (HIV) replication in vitro and in vivo. We report the results of a phase II dose-finding study of VCV plus dual nucleoside reverse-transcriptase inhibitors (NRTIs) in the treatment-naive HIV-1-infected subjects... CONCLUSIONS: VCV administered with dual NRTIs in treatment-naive subjects with HIV-1 infection had increased rates of virologic failure, compared with efavirenz plus dual NRTIs. No treatment-limiting toxicity was observed. Study of higher doses of VCV as part of combination therapy is warranted.
A prospective, 96-week study of the impact of Trizivir, Combivir/nelfinavir, and lamivudine/stavudine/nelfinavir on lipids, metabolic parameters and efficacy in antiretroviral-naive patients: effect of sex and ethnicity. [2006.03]
OBJECTIVES: To compare the lipid and metabolic effects, efficacy, and safety of twice-daily regimens of Trizivir (abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg triple nucleoside tablet; TZV), Combivir (lamivudine 150 mg/zidovudine 300 mg combination tablet; COM)+nelfinavir (NFV), and stavudine (d4 T)+lamivudine (3TC)+NFV. STUDY DESIGN: An international, phase 4, open-label, parallel-group, 34-centre study was conducted in 254 non-diabetic, antiretroviral-naive, HIV-infected out-patients with an HIV-1 RNA level of >1000 HIV-1 RNA copies/mL and < or =200,000 copies/mL and a CD4 cell count of >50 cells/microL... CONCLUSIONS: Over 96 weeks, TZV twice daily has significantly less effect on LDL cholesterol than COM/NFV or d4T/3TC/NFV twice daily, especially in women and black patients, and is associated with similar virological and CD4 responses.
Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV. [2006.01.19]
BACKGROUND: Durable suppression of replication of the human immunodeficiency virus (HIV) depends on the use of potent, well-tolerated antiretroviral regimens to which patients can easily adhere... CONCLUSIONS: Through week 48, the combination of tenofovir DF and emtricitabine plus efavirenz fulfilled the criteria for noninferiority to a fixed dose of zidovudine and lamivudine plus efavirenz and proved superior in terms of virologic suppression, CD4 response, and adverse events resulting in discontinuation of the study drugs. (ClinicalTrials.gov number, NCT00112047.) Copyright 2006 Massachusetts Medical Society.
Clinical Trials Related to Combivir (Lamivudine / Zidovudine)
GW873140 In Combination With Combivir In HIV Infected Subjects [Terminated]
This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in
combination with Combivir in HIV infected, untreated subjects.
Study to Explore Safety And Tolerability of Fosamprenavir With or Without Ritonavir in Combination With TRIZIVIR or COMBIVIR [Completed]
Antiretroviral Therapy (ART) naive subjects will be enrolled in this clinical research study
to test the safety and tolerability of fosamprenavir with or without ritonavir in combination
TRIZIVIR and COMBIVIR. Subjects will receive 24 weeks of therapy.
A Study Comparing The Safety, Tolerability and Efficacy of Trizivir VS Combivir & Atazanavir In Subjects With HIV [Completed]
The aim of this study was to assess whether TRIZIVIR, administered twice-daily was as safe,
tolerable and efficacious as a combination of the drugs COMBIVIR administered twice-daily and
atazanavir administered once daily. Over the course of 48 weeks, various parameters that
measure safety, tolerability and efficacy of the investigational drugs were measured and
compared.
Seronegatives and Metabolic Abnormalities Protocol 2 (SAMA002): Study to Compare the Effect of Kaletra and Combivir® in HIV-Negative Healthy Subjects [Active, not recruiting]
This is a randomised study of the effect of treatment with Combivir (zidovudine [AZT] and
lamivudine [3TC]) and Kaletra (lopinavir [LPVr]), alone and in combination, on the
development of abnormalities in lipid and glucose metabolism in HIV negative healthy
subjects.
Study of Combivir for Patients With Primary Biliary Cirrhosis [Completed]
This is a proof of principal study to determine whether combination anti-viral therapy with
Combivir impacts on hepatic biochemistry in patients with primary biliary cirrhosis
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Page last updated: 2009-10-20
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