TRIZIVIR contains 3 nucleoside analogues (abacavir sulfate, lamivudine, and zidovudine) and is intended only for patients whose regimen would otherwise include these 3 components.
Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir sulfate, a component of TRIZIVIR. Hypersensitivity to abacavir is a multi-organ clinical syndrome usually characterized by a sign or symptom in 2 or more of the following groups: (1) fever, (2) rash, (3) gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain), (4) constitutional (including generalized malaise, fatigue, or achiness), and (5) respiratory (including dyspnea, cough, or pharyngitis). Discontinue TRIZIVIR as soon as a hypersensitivity reaction is suspected.
Patients who carry the HLA-B*5701 allele are at high risk for experiencing a hypersensitivity reaction to abacavir. Prior to initiating therapy with abacavir, screening for the HLA-B*5701 allele is recommended; this approach has been found to decrease the risk of hypersensitivity reaction. Screening is also recommended prior to reinitiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir. HLA-B*5701-negative patients may develop a suspected hypersensitivity reaction to abacavir; however, this occurs significantly less frequently than in HLA-B*5701-positive patients.
Regardless of HLA-B*5701 status, permanently discontinue TRIZIVIR if hypersensitivity cannot be ruled out, even when other diagnoses are possible.
Following a hypersensitivity reaction to abacavir, NEVER restart TRIZIVIR or any other abacavir-containing product because more severe symptoms can occur within hours and may include life-threatening hypotension and death.
Reintroduction of TRIZIVIR or any other abacavir-containing product, even in patients who have no identified history or unrecognized symptoms of hypersensitivity to abacavir therapy, can result in serious or fatal hypersensitivity reactions. Such reactions can occur within hours (see WARNINGS and PRECAUTIONS: Information for Patients).
Zidovudine has been associated with hematologic toxicity including neutropenia and severe anemia, particularly in patients with advanced Human Immunodeficiency Virus (HIV-1) disease (see WARNINGS). Prolonged use of zidovudine has been associated with symptomatic myopathy.
Lactic Acidosis and Severe Hepatomegaly:
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including abacavir, lamivudine, zidovudine, and other antiretrovirals (see WARNINGS).
Exacerbations of Hepatitis B:
Severe 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 TRIZIVIR. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue TRIZIVIR and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted (see WARNINGS).
TRIZIVIR: TRIZIVIR Tablets contain the following 3 synthetic nucleoside analogues: abacavir sulfate (ZIAGEN), lamivudine (also known as EPIVIR® or 3TC), and zidovudine (also known as RETROVIR® , azidothymidine, or ZDV) with inhibitory activity against human immunodeficiency virus (HIV).
TRIZIVIR is indicated alone or in combination with other antiretroviral agents for the treatment of HIV-1 infection. The indication for TRIZIVIR is based on 2 controlled trials with abacavir of 16 and 48 weeks in duration that evaluated suppression of HIV RNA and changes in CD4 cell count. At present, there are no results from controlled trials evaluating the effect of abacavir on clinical progression of HIV. There are limited data on the use of this triple-combination regimen in patients with higher viral load levels (>100,000 copies/mL) at baseline (see Description of Clinical Studies for ZIAGEN).
TRIZIVIR: There have been no clinical trials conducted with TRIZIVIR (see CLINICAL PHARMACOLOGY for information about bioequivalence of TRIZIVIR).
Published Studies Related to Trizivir (Abacavir / Lamivudine / Zidovudine)
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.
A combination drug of abacavir-lamivudine-zidovudine (Trizivir) for treating HIV infection and AIDS. [2009.07.08]
CONCLUSIONS: Our findings indicate that Trizivir remains a viable option for initiating antiretroviral therapy, especially in HIV-infected patients with pre-existing hyperlipidaemia and those who do not tolerate ritonavir.
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].
Induction therapy with trizivir plus efavirenz or lopinavir/ritonavir followed by trizivir alone in naive HIV-1-infected adults. [2008.01.30]
BACKGROUND: Induction-maintenance strategies were associated with a low response rate. We compared the virological response with two different induction regimens with trizivir plus efavirenz or lopinavir/ritonavir... CONCLUSION: Trizivir plus either efavirenz or lopinavir/ritonavir followed by maintenance with trizivir achieved a low but similar response at 72 weeks, with a high incidence of adverse events leading to drug discontinuation during the induction phase in both arms. The study showed a trend towards an increased virological failure rate in the efavirenz arm during the maintenance phase.
Clinical Trials Related to Trizivir (Abacavir / Lamivudine / Zidovudine)
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
Immuno-Virological Efficacy of Combination With Trizivir +Tenofovir in Multiresistant HIV Patients [Terminated]
To evaluate whether the combined therapy of two nucleosides plus one nucleotide (Trizivir +
TDF) manages to keep CD4 lymphocytes stable in patients with HIV infection on antiretroviral
treatment that present virological failure and multiple resistance to antiretrovirals.
Study To Evaluate Long Term Maintenance With TRIZIVIR After Boosted Protease Inhibitor (PI) Or Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) In HIV-1 Infected Adults [Completed]
The current goal of antiretroviral therapy is to use a potent regimen that will suppress
plasma viral load and maintain this suppression as long as possible. However, for most
patients treated with such potent regimen, several problems can limit their long term
effectiveness and contribute to incomplete viral suppression. These problems include poor
tolerability, metabolic toxic effects. In order to avoid common problems as toxicity it might
be interested to simplify treatment with fewer toxicity, lower pill burden. In this study
we will evaluate the safety and efficacy of a simplification treatment with TRIZIVIR in long
term after a Boosted PI or NNRTI containing regimen as first line therapy.
FREE Study: Efficacy and Toxicity of Trizivir [Recruiting]
Antiretroviral na´ve patients with <350 xE6/l CD4 cells and a HIV-viral load of > 30. 000
cop/ml are started on combivir « and Kaletra «. When patients have reached an undetectable
viral load of< 50 cop/ml on two consecutive occasions at least at week 12, but no later than
week 24, they are randomised in either continuation with Combivir/Kaletra or switch to
Trizivir « twice daily one pill during 96 weeks. All patients randomised in the
combivir/Kaletra arm are eligible to switch to Trizivir at any post randomisation visit when
they reach predefined switch criteria for elevated levels of fasting glucose or lipids.
Reports of Suspected Trizivir (Abacavir / Lamivudine / Zidovudine) Side Effects
Abortion Induced (7),
Foetal Exposure During Pregnancy (6),
Maternal Exposure During Pregnancy (5),
Tricuspid Valve Disease (2),
Tricuspid Valve Incompetence (2),
Cerebral Ventricle Dilatation (2),
Congenital Cardiovascular Anomaly (2),
Right Atrial Dilatation (2),
Congenital Anomaly (2), more >>
Page last updated: 2010-10-05