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Epzicom (Abacavir Sulfate / Lamivudine) - Summary

 
 



Boxed Warning section

WARNINGS

EPZICOM contains 2 nucleoside analogues (abacavir sulfate and lamivudine) and is intended only for patients whose regimen would otherwise include these 2 components.

Hypersensitivity Reactions: Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir sulfate, a component of EPZICOM. 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 EPZICOM 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 EPZICOM if hypersensitivity cannot be ruled out, even when other diagnoses are possible.

Following a hypersensitivity reaction to abacavir, NEVER restart EPZICOM or any other abacavir-containing product because more severe symptoms can occur within hours and may include life-threatening hypotension and death.

Reintroduction of EPZICOM 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).

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, 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 human immunodeficiency virus (HIV-1) and have discontinued lamivudine, which is one component of EPZICOM. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue EPZICOM and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted (see WARNINGS).

 

 

EPZICOM SUMMARY

EPZICOM Tablets contain the following 2 synthetic nucleoside analogues: abacavir sulfate (ZIAGEN®, also a component of TRIZIVIR®) and lamivudine (also known as EPIVIR® or 3TC) with inhibitory activity against HIV-1. EPZICOM Tablets are for oral administration.

EPZICOM (ABACAVIR) is indicated for the following:

  • EPZICOM is one of multiple products containing abacavir. Before starting EPZICOM, review medical history for prior exposure to any abacavir-containing product in order to avoid reintroduction in a patient with a history of hypersensitivity to abacavir.
  • In one controlled study (CNA30021), more patients taking ZIAGEN 600 mg once daily had severe hypersensitivity reactions compared with patients taking ZIAGEN 300 mg twice daily.
  • As part of a triple-drug regimen, EPZICOM Tablets are recommended for use with antiretroviral agents from different pharmacological classes and not with other nucleoside/nucleotide reverse transcriptase inhibitors.
  • See WARNINGS, ADVERSE REACTIONS, and Description of Clinical Studies.

     

    CNA30021 was an international, multi-center, double-blind, controlled study in which 770 HIV-1-infected, therapy-naive adults were randomized and received either ZIAGEN 600 mg once daily or ZIAGEN 300 mg twice daily, both in combination with EPIVIR 300 mg once daily and efavirenz 600 mg once daily. The double-blind treatment duration was at least 48 weeks. Study participants had a mean age of 37 years, were: male (81%), Caucasian (54%), black (27%), and American Hispanic (15%). The median baseline CD4+ cell count was 262 cells/mm3 (range: 21 to 918 cells/mm3) and the median baseline plasma HIV-1 RNA was 4.89 log10 copies/mL (range: 2.60 to 6.99 log10 copies/mL).

    The outcomes of randomized treatment are provided in Table 3.

    Table 3. Outcomes of Randomized Treatment Through Week 48 (CNA30021)
    Outcome

    ZIAGEN 600 mg q.d.

    plus EPIVIR plus

    Efavirenz

    (n = 384)

    ZIAGEN 300 mg b.i.d.

    plus EPIVIR plus

    Efavirenz

    (n = 386)

    Responder* 64% (71%) 65% (72%)
    Virologic failure† 11% (5%) 11% (5%)
    Discontinued due to adverse reactions 13% 11%
    Discontinued due to other reasons‡ 11% 13%
    * Patients achieved and maintained confirmed HIV-1 RNA <50 copies/mL (<400 copies/mL) through Week 48 (Roche AMPLICOR Ultrasensitive HIV-1 MONITOR® standard test version 1.0).
    † Includes viral rebound, failure to achieve confirmed <50 copies/mL (<400 copies/mL) by Week 48, and insufficient viral load response.
    ‡ Includes consent withdrawn, lost to follow-up, protocol violations, clinical progression, and other.

    After 48 weeks of therapy, the median CD4+ cell count increases from baseline were 188 cells/mm3 in the group receiving ZIAGEN 600 mg once daily and 200 cells/mm3 in the group receiving ZIAGEN 300 mg twice daily. Through Week 48, 6 subjects (2%) in the group receiving ZIAGEN 600 mg once daily (4 CDC classification C events and 2 deaths) and 10 subjects (3%) in the group receiving ZIAGEN 300 mg twice daily (7 CDC classification C events and 3 deaths) experienced clinical disease progression. None of the deaths were attributed to study medications.

     


    See all Epzicom indications & dosage >>

    NEWS HIGHLIGHTS

    Media Articles Related to Epzicom (Abacavir / Lamivudine)

    Targeting semen proteins to prevent HIV infection
    Source: HIV / AIDS News From Medical News Today [2015.08.18]
    Researchers describe two approaches they say could prevent HIV infection by targeting proteins in semen called amyloid fibrils that boost transmission of the virus.

    'Molecular tweezer' targets HIV and prevents semen from promoting infection
    Source: Flu / Cold / SARS News From Medical News Today [2015.08.18]
    Compound shaped like a tweezer could prove more effective at preventing HIV infection -- and with less side effects -- than other microbicides in developmentAn unprecedented potential "molecular...

    Kicking latent HIV: New strategies to reactivate reservoirs of latent infection
    Source: HIV / AIDS News From Medical News Today [2015.07.31]
    In cells with latent HIV infection, the virus is dormant, and such cells are therefore not attacked by the immune system or by standard antiretroviral therapy.

    more news >>

    Published Studies Related to Epzicom (Abacavir / Lamivudine)

    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.

    Abacavir does not affect circulating levels of inflammatory or coagulopathic biomarkers in suppressed HIV: a randomized clinical trial. [2010.11.13]
    OBJECTIVE: The Simplification of antiretroviral therapy with Tenofovir-Emtricitabine or Abacavir-Lamivudine trial (STEAL) study randomized HIV participants to switch existing nucleoside reverse transcriptase inhibitors (NRTI) to either abacavir/lamivudine (ABC/3TC; n = 179) or tenofovir/emtricitabine (TDF/FTC; n = 178). An increased risk in cardiovascular disease (CVD) was reported (hazard ratio 7.7, P = 0.048) in ABC/3TC recipients compared with TDF/FTC in the STEAL study. The impact of ABC/3TC treatment on a range of CVD and inflammatory biomarkers was explored... CONCLUSION: A thorough examination of selected biomarkers associated with cardiovascular morbidity and mortality did not reveal associations with the use of ABC/3TC relative to use of TDF/FTC.

    Comparison of changes in bone density and turnover with abacavir-lamivudine versus tenofovir-emtricitabine in HIV-infected adults: 48-week results from the ASSERT study. [2010.10.15]
    BACKGROUND: Abacavir-lamivudine and tenofovir DF-emtricitabine fixed-dose combinations are commonly used as first-line antiretroviral therapies. However, few studies have comprehensively compared their relative safety profiles... CONCLUSIONS: This study demonstrated the impact of first-line treatment regimens on bone. Greater increases in bone turnover and decreases in BMD were observed in subjects treated with tenofovir-emtricitabine than were observed in subjects treated with abacavir-lamivudine.

    Randomized comparison of renal effects, efficacy, and safety with once-daily abacavir/lamivudine versus tenofovir/emtricitabine, administered with efavirenz, in antiretroviral-naive, HIV-1-infected adults: 48-week results from the ASSERT study. [2010.09.01]
    BACKGROUND: Abacavir/lamivudine and tenofovir/emtricitabine fixed-dose combinations are commonly used first-line antiretroviral therapies, yet few studies have comprehensively compared their safety profiles... CONCLUSIONS: The study showed no difference in estimated glomerular filtration rate between the arms, however, increases in markers of tubular dysfunction were observed in the tenofovir/emtricitabine arm, the long-term consequence of which is unclear. A significant difference in efficacy favoring tenofovir/emtricitabine was observed.

    Randomized comparison of renal effects, efficacy, and safety with once-daily abacavir/lamivudine versus tenofovir/emtricitabine, administered with efavirenz, in antiretroviral-naive, HIV-1-infected adults: 48-week results from the ASSERT study. [2010.09]
    BACKGROUND: Abacavir/lamivudine and tenofovir/emtricitabine fixed-dose combinations are commonly used first-line antiretroviral therapies, yet few studies have comprehensively compared their safety profiles... CONCLUSIONS: The study showed no difference in estimated glomerular filtration rate between the arms, however, increases in markers of tubular dysfunction were observed in the tenofovir/emtricitabine arm, the long-term consequence of which is unclear. A significant difference in efficacy favoring tenofovir/emtricitabine was observed.

    more studies >>

    Clinical Trials Related to Epzicom (Abacavir / Lamivudine)

    Comparison of Epzicom and Truvada for the Initial Once Daily HIV Treatment [Recruiting]
    A non-inferiority randomized control trial in treatment nave HIV patients to compare virologic effect of two backbone regimens with Epzicom (lamivudine and abacavir) and Truvada (emtricitabine and tenofovir). Both arms are treated with fixed combination of ritonavir boosted atazanavir as key drugs.

    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).

    Pharmacokinetic Study Of EPZICOM Tablet [Completed]
    This study was designed to explore the drug levels in the blood in Japanese HIV-infected patients taking EPZICOM tablet at least for 2 weeks prior to administration of the study drug. Pharmacokinetics after administration of EPZICOM tablet will be investigated in a total of 8 subjects.

    Pilot Study With Isentress (Raltegravir) and Epzicom (Abacavir/Lamivudine) in Treatment Naive HIV-Infected Subjects [Recruiting]
    To evaluate the efficacy and safety of Raltegravir and Epzicom over 48 weeks in ART-naive HIV-infected subjects.

    Artery Elasticity After Switch From Epzicom to Truvada [Recruiting]
    Recent research as suggested that use of the HIV medication abacavir (Ziagen, or co-formulated with lamivudine as Epzicom) may increase risk for heart disease, though findings from multiple studies have been inconsistent. This pilot study will examine vascular function, a marker of heart disease risk, among patients taking abacavir as part of their HIV medications and are then randomized to: 1) switch to tenofovir, another HIV medication, or 2) continue to take abacavir.

    more trials >>

    Reports of Suspected Epzicom (Abacavir / Lamivudine) Side Effects

    Maternal Exposure During Pregnancy (25)Foetal Exposure During Pregnancy (21)Stillbirth (17)Immune Reconstitution Syndrome (10)Nausea (9)Renal Failure Acute (8)Anaemia (8)Regurgitation (7)Pyrexia (7)Tracheomalacia (7)more >>


    Page last updated: 2015-08-18

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