WARNING: RISK OF HYPERSENSITIVITY REACTIONS, LACTIC ACIDOSIS, AND SEVERE HEPATOMEGALY
Serious and sometimes fatal hypersensitivity reactions have been associated with ZIAGEN (abacavir sulfate).
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 ZIAGEN 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 ZIAGEN if hypersensitivity cannot be ruled out, even when other diagnoses are possible.
Following a hypersensitivity reaction to abacavir, NEVER restart ZIAGEN or any other abacavir-containing product because more severe symptoms can occur within hours and may include life-threatening hypotension and death.
Reintroduction of ZIAGEN 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].
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including ZIAGEN and other antiretrovirals [see Warnings and Precautions].
ZIAGEN is the brand name for abacavir sulfate, a synthetic carbocyclic nucleoside analogue with inhibitory activity against HIV. The chemical name of abacavir sulfate is
( S,cis) -4-[2-amino-6-(cyclopropylamino)-9 H -purin-9-yl]-2-cyclopentene-1-methanol sulfate (salt) (2:1). Abacavir sulfate is the enantiomer with 1S, 4R absolute configuration on the cyclopentene ring.
ZIAGEN Tablets and Oral Solution, in combination with other antiretroviral agents, are indicated for the treatment of HIV-1 infection.
Published Studies Related to Ziagen (Abacavir)
Comparative effectiveness of continuing a virologically effective first-line boosted protease inhibitor combination or of switching to a three-drug regimen containing either efavirenz, nevirapine or abacavir. [2011.08]
OBJECTIVES: To compare virological effectiveness in patients who continued on a virologically successful first-line boosted protease inhibitor (PI)-containing combination antiretroviral therapy (cART) regimen or who switched to a PI-free cART including efavirenz, nevirapine or abacavir... CONCLUSIONS: Switching from a virologically successful first-line boosted PI-containing cART regimen to a non-nucleoside reverse transcriptase inhibitor-containing cART regimen containing either efavirenz or nevirapine is virologically safe, while switching to abacavir-containing cART should be avoided.
Peripheral and central fat changes in subjects randomized to abacavir-lamivudine or tenofovir-emtricitabine with atazanavir-ritonavir or efavirenz: ACTG Study A5224s. [2011.07.15]
BACKGROUND: We compare the effect of 4 different antiretroviral regimens on limb and visceral fat... CONCLUSIONS: ABC-3TC- and TDF-FTC-based regimens increased limb and visceral fat at week 96, with a similar prevalence of lipoatrophy. Compared to the EFV group, subjects assigned to ATV-r had a trend towards higher mean percentage increase in VAT. CLINICAL TRIALS REGISTRATION: NCT00118898.
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.
Low incidence of abacavir hypersensitivity reaction among African children initiating antiretroviral therapy. [2011.06]
Hypersensitivity reactions are reported in approximately 5% of adults receiving abacavir, but there are few published data in children. Among 1150 African children receiving antiretroviral therapy in a randomized trial, suspected hypersensitivity reactions to abacavir were rare (0.3%; 95% CI, 0.01-0.9).
No risk of myocardial infarction associated with initial antiretroviral treatment containing abacavir: short and long-term results from ACTG A5001/ALLRT. [2011.04.01]
BACKGROUND: Observational and retrospective clinical trial cohorts have reported conflicting results for the association of abacavir use with risk of myocardial infarction (MI), possibly related to issues that may bias estimation of treatment effects, such as time-varying confounders, informative dropout, and cohort loss due to competing events... CONCLUSION: We find no evidence to suggest that initial ART containing abacavir increases MI risk over short-term and long-term periods in this population with relatively low MI risk. Traditional CVD risk factors should be the main focus in assessing CVD risk in individuals with human immunodeficiency virus infection. (c) The Author 2011. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved.
Clinical Trials Related to Ziagen (Abacavir)
Effectiveness and Safety of Epivir/Ziagen/Zerit (3TC/ABC/d4T) Versus Epivir/Ziagen/Sustiva (3TC/ABC/EFV) Versus Epivir/Ziagen/Agenerase/Norvir (3TC/ABC/APV/RTV) in HIV Patients Who Have Never Received Treatment [Active, not recruiting]
The purpose of this study is to see how effective and safe it is to give 1 of the 3 following
treatments to patients who may not have received anti-HIV treatment: 1) lamivudine
(3TC)/abacavir (ABC)/stavudine (d4T); 2) 3TC/ABC/efavirenz (EFV); or 3) 3TC/ABC/amprenavir
A Study of the Safety and Effectiveness of Combination Anti-HIV Therapy in HIV-Infected Adults [Completed]
Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir) [Active, not recruiting]
The purpose of this study is to look at the safety and effectiveness of a pill called
Trizivir that is a combination of three anti-HIV drugs (zidovudine, lamivudine, and
abacavir). Zidovudine and lamivudine are often given combined in one pill (Combivir). In this
study, Trizivir will be compared to Combivir plus abacavir.
Four-Drug Combination Therapy With Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients [Active, not recruiting]
The purpose of this study is to see if the multidrug combination of zidovudine (ZDV),
lamivudine (3TC), 1592U89 (abacavir [ABC]), and 141W94 (amprenavir [APV]) is a safe and
effective treatment for HIV-infected patients and if there is a reduction of active HIV in
blood and other tissues.
HIV infection is a life-changing illness and new HIV treatments must be tested. This study
will test if a 4-drug combination will reduce HIV virus activity in blood and other tissues
and if it is safe and well tolerated. Doctors also want to know if the multidrug combination
is able to decrease viral activity over a long time period.
KALETRA Or LEXIVA With Ritonavir Combined With EPIVIR And Abacavir In Naive Subjects Over 48 Weeks [Completed]
This study will compare the ability of fosamprenavir 700 mg with ritonavir 100 mg twice a
day or lopinavir 400 mg with ritonavir 100 mg twice a day both combined with a fixed dose
combination tablet of abacavir 600 mg and lamivudine 300 mg once a day to suppress virus
levels of HIV to less than 400 copies/mL of blood. In addition we will study the safety and
tolerability of these compounds over the 48 week study period in patients naive to anti-HIV
Reports of Suspected Ziagen (Abacavir) Side Effects
Abortion Spontaneous (13),
Renal Failure Acute (12),
Maternal Exposure During Pregnancy (10),
Renal Tubular Disorder (7),
Foetal Exposure During Pregnancy (6),
Coronary Artery Occlusion (6), more >>
Page last updated: 2011-12-09