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].
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ZIAGEN SUMMARY
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.
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NEWS HIGHLIGHTSMedia Articles Related to Ziagen (Abacavir)
IDSA: Obesity Slows Immune Recovery in HIV Infection (CME/CE, with video)
Source: MedPage Today Infectious Disease [2009.11.03]
PHILADELPHIA (MedPage Today) -- The immune systems of HIV patients who are obese don't respond to antiretroviral therapy as well as do those of people of normal weight, a researcher said here.
HIV Infections, Deaths Declining In Caribbean, Senior Official Says
Source: Sexual Health / STDs News From Medical News Today [2009.10.28]
Ahead of the regional Pan Caribbean Partnership Against HIV/AIDS (PANCAP) meeting, a senior official announced that the number of new HIV infections in the region has fallen since last year, Agence France-Presse reports.
New Epidemic Of Sexually Transmitted Hepatitis C Infection In HIV-infected Men In NYC
Source: HIV / AIDS News From Medical News Today [2009.10.31]
Researchers in New York City are reporting their work uncovering a new epidemic of hepatitis C virus (HCV) infection among men-who-have-sex-with-men (MSM) who have HIV infection. These authors have previously reported unusually rapid fibrosis progression due to new HCV in MSM who have HIV infection and now expand on their findings, demonstrating that sexual transmission rather than injection drug use is the route of infection.
Published Studies Related to Ziagen (Abacavir)
Randomized, double-blind, placebo-matched, multicenter trial of abacavir/lamivudine or tenofovir/emtricitabine with lopinavir/ritonavir for initial HIV treatment. [2009.07.31]
BACKGROUND: Abacavir sulfate/lamivudine (ABC/3TC) and tenofovir DF/emtricitabine (TDF/FTC) are widely used nucleoside reverse transcriptase inhibitors for initial HIV-1 treatment. This is the first completed, randomized clinical trial to directly compare the efficacy, safety, and tolerability of these agents, each in combination with lopinavir/ritonavir in antiretroviral-naive patients... CONCLUSION: Both ABC/3TC and TDF/FTC provided comparable antiviral efficacy, safety, and tolerability when each was combined with lopinavir/ritonavir in treatment-naive patients.
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 simplification trial switching from nucleoside reverse transcriptase inhibitors to once-daily fixed-dose abacavir/lamivudine or tenofovir/emtricitabine in HIV-1-infected patients with virological suppression. [2009.07.01]
BACKGROUND: Data comparing abacavir/lamivudine versus tenofovir/emtricitabine in antiretroviral-naive patients are controversial. We compared 48-week efficacy and safety of these combinations as substitutes of nucleosides in patients with virological suppression... CONCLUSIONS: In HIV-1-infected patients with virological suppression, abacavir/lamivudine did not meet the noninferiority outcome for treatment efficacy compared with tenofovir/emtricitabine.
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].
Comparison of once-daily fosamprenavir boosted with either 100 or 200 mg of ritonavir, in combination with abacavir/lamivudine: 96-week results from COL100758. [2009.04]
The long-term efficacy of once-daily (qd) fosamprenavir (FPV) 1400 mg boosted by ritonavir 100 mg (FPV/r100) has not been evaluated previously. A 96-week open-label, randomized, multicenter study compared the efficacy/safety of FPV/r100 with FPV 1400 mg boosted by ritonavir 200 mg qd (FPV/r200), plus abacavir/lamivudine 600 mg/300 mg qd, in antiretroviral-naive, HIV-infected patients with viral load (VL)> or =1000 copies/ml...
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
(APV)/ritonavir (RTV).
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
therapy.
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Page last updated: 2009-11-03
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