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Epivir (Lamivudine) - Summary

 

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WARNING

LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION, INCLUDING LAMIVUDINE AND OTHER ANTIRETROVIRALS (SEE WARNINGS).

EPIVIR TABLETS AND ORAL SOLUTION (USED TO TREAT HUMAN IMMUNODEFICIENCY VIRUS [HIV] INFECTION) CONTAIN A HIGHER DOSE OF THE ACTIVE INGREDIENT (LAMIVUDINE) THAN EPIVIR-HBV ® TABLETS AND ORAL SOLUTION (USED TO TREAT CHRONIC HEPATITIS B). PATIENTS WITH HIV INFECTION SHOULD RECEIVE ONLY DOSING FORMS APPROPRIATE FOR TREATMENT OF HIV (SEE WARNINGS AND PRECAUTIONS).

SEVERE ACUTE EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN PATIENTS WHO ARE CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HIV AND HAVE DISCONTINUED EPIVIR. HEPATIC FUNCTION SHOULD BE MONITORED CLOSELY WITH BOTH CLINICAL AND LABORATORY FOLLOW-UP FOR AT LEAST SEVERAL MONTHS IN PATIENTS WHO DISCONTINUE EPIVIR AND ARE CO-INFECTED WITH HIV AND HBV. IF APPROPRIATE, INITIATION OF ANTI-HEPATITIS B THERAPY MAY BE WARRANTED (SEE WARNINGS).

 

EPIVIR SUMMARY

EPIVIR® Tablets
(lamivudine tablets)
EPIVIR® Oral Solution
(lamivudine oral solution)

EPIVIR (also known as 3TC) is a brand name for lamivudine, a synthetic nucleoside analogue with activity against human immunodeficiency virus-1 (HIV-1) and hepatitis B virus (HBV). The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2',3'-dideoxy, 3'-thiacytidine.

EPIVIR in combination with other antiretroviral agents is indicated for the treatment of HIV infection.

EPIVIR NEWS HIGHLIGHTS

Media Articles Related to Epivir (Lamivudine)

lamivudine and zidovudine, Combivir
Source: MedicineNet abacavir Specialty [2005.09.26]

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Published Studies Related to Epivir (Lamivudine)

Clinical Trial: Randomized controlled trial of zidovudine and lamivudine for patients with primary biliary cirrhosis stabilized on ursodiol. [2008.07.09]

Efficacy and safety of entecavir in lamivudine-refractory patients with chronic hepatitis B: Randomized controlled trial in Japanese patients. [2008.06.12]

Absence of HIV-1 shedding in male genital tract after 1 year of first-line lopinavir/ritonavir alone or in combination with zidovudine/lamivudine. [2008.06]

Long-term subcutaneous tissue changes among antiretroviral-naive persons initiating stavudine, zidovudine, or abacavir with lamivudine. [2008.05.01]

Treatment of chronic delta hepatitis with lamivudine vs lamivudine + interferon vs interferon. [2008.04]

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Clinical Trials Related to Epivir (Lamivudine)

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]

Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine [Active, not recruiting]

Induction/Simplification With Atazanavir + Ritonavir + Abacavir/Lamivudine Fixed-Dose Combination In HIV-1 Infection [Active, not recruiting]

Virologic and Immunologic Activity of Continued Lamivudine (3TC) Vs Delavirdine (DLV) in Combination With Indinavir (IDV) and Zidovudine (ZDV) or Stavudine (d4T) in 3TC-Experienced Subjects [Completed]

3TC (Lamivudine; GR109714X) Open-Label Program [Completed]

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Page last updated: 2008-08-10

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