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].
|
| |
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.
|
|
NEWS HIGHLIGHTS
Published Studies Related to Combivir (Lamivudine / Zidovudine)
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.
Abacavir/lamivudine/zidovudine maintenance after standard induction in antiretroviral therapy-naive patients: FREE randomized trial interim results. [2010.06]
Maintenance with a triple nucleoside reverse transcriptase Inhibitor (NRTI) regimen after successful induction with a dual NRTI/protease inhibitor (PI) combination may be advantageous, because of low pill burden, favorable lipids, and less drug interactions... Patients on successful standard ART can be safely switched to a NRTI-only regimen, at least for the tested time period.
Early versus delayed fixed dose combination abacavir/lamivudine/zidovudine in patients with HIV and tuberculosis in Tanzania. [2009.12]
Fixed dose combination abacavir/lamivudine/zidovudine (ABC/3TC/ZDV) among HIV-1 and tuberculosis (TB)-coinfected patients was evaluated and outcomes between early vs. delayed initiation were compared... Rates of virologic suppression were similar between early and delayed treatment strategies with triple nucleoside regimens when substitutions were allowed.
Development of HIV-1 drug resistance through 144 weeks in antiretroviral-naive subjects on emtricitabine, tenofovir disoproxil fumarate, and efavirenz compared with lamivudine/zidovudine and efavirenz in study GS-01-934. [2009.10.01]
Study 934 was an open-label, randomized Phase III study of emtricitabine + tenofovir DF + efavirenz (FTC + TDF + EFV) compared with lamivudine + zidovudine + efavirenz (3TC + ZDV + EFV) in antiretroviral therapy-naive HIV-1 infected subjects... Baseline NNRTI-R was significantly associated with virologic failure in both groups (P < 0.001).
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].
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.
Combivir And Maraviroc In Antiretroviral Naive Subjects In Russia [Recruiting]
One hundred subjects in Russia will be treated with a combination of Combivir (zidovudine
and lamivudine) and maraviroc as their first line HIV therapy. The aim is to assess the
efficacy and safety of this combination in a Russian population of patients.
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.
Reports of Suspected Combivir (Lamivudine / Zidovudine) Side Effects
Foetal Exposure During Pregnancy (173),
Maternal Exposure During Pregnancy (105),
Premature Baby (68),
Abortion Spontaneous (65),
Stillbirth (33),
Anaemia (28),
Atrial Septal Defect (25),
Foetal Growth Restriction (24),
Talipes (23),
Single Umbilical Artery (18), more >>
|
|
|
|
Page last updated: 2011-12-09
|
