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).
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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.
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EPIVIR NEWS HIGHLIGHTS Media Articles Related to Epivir (Lamivudine)
lamivudine and zidovudine, Combivir
Source: MedicineNet abacavir Specialty [2005.09.26]
Title: lamivudine and zidovudine, Combivir
Category: Medications
Created: 11/8/2000 8:14:00 PM
Last Editorial Review: 9/26/2005
Published Studies Related to Epivir (Lamivudine)
A randomized study of adefovir dipivoxil in place of HBIG in combination with lamivudine as post-liver transplantation hepatitis B prophylaxis. [2008.11]
CONCLUSION: Compared with combination HBIG plus lamivudine [generic for Epivir] prophylaxis, combination adefovir plus lamivudine provides equivalent protection against recurrent HBV infection but with better tolerability and less cost.
Steady-state pharmacokinetic comparison of generic and branded formulations of stavudine, lamivudine and nevirapine in HIV-infected Ugandan adults. [2008.11]
BACKGROUND: We aimed to compare the steady-state pharmacokinetic parameters and tolerability of Triomune 40 (stavudine 40 mg, lamivudine [generic for Epivir] 150 mg and nevirapine 200 mg) and branded formulations of these drugs in HIV-infected Ugandans... CONCLUSIONS: Pharmacokinetic profiles of generic and branded drugs were similar. Differences particularly with regard to stavudine were demonstrated. Surveillance of the quality of generic antiretroviral drugs in the target populations is needed. Capacity building for pharmacokinetic research in resource-limited settings is a priority.
Phase II study of vicriviroc versus efavirenz (both with zidovudine/lamivudine) in treatment-naive subjects with HIV-1 infection. [2008.10.15]
BACKGROUND: Vicriviroc (VCV) is a CCR5 antagonist with nanomolar activity against human immunodeficiency virus (HIV) replication in vitro and in vivo. We report the results of a phase II dose-finding study of VCV plus dual nucleoside reverse-transcriptase inhibitors (NRTIs) in the treatment-naive HIV-1-infected subjects... CONCLUSIONS: VCV administered with dual NRTIs in treatment-naive subjects with HIV-1 infection had increased rates of virologic failure, compared with efavirenz plus dual NRTIs. No treatment-limiting toxicity was observed. Study of higher doses of VCV as part of combination therapy is warranted.
Didanosine, lamivudine, and efavirenz versus zidovudine, lamivudine, and efavirenz for the initial treatment of HIV type 1 infection: final analysis (48 weeks) of a prospective, randomized, noninferiority clinical trial, GESIDA 3903. [2008.10.15]
BACKGROUND: The combination of didanosine, lamivudine [generic for Epivir], and efavirenz (ddI/3TC/EFV) for the initial treatment of human immunodeficiency virus type 1 (HIV-1) infection has been insufficiently analyzed in clinical trials... CONCLUSIONS: At week 48, ddI/3TC/EFV administered once per day with food did not have results inferior to those of COM/EFV treatment. A statistically significantly higher proportion of patients in the COM/EFV arm than in the ddI/3TC/EFV arm discontinued therapy because of adverse events, mainly because of hematological toxicity. CLINICAL TRIALS REGISTRATION: NCT00256828.
Efficacy and safety of entecavir for chronic HBV in HIV/HBV coinfected patients receiving lamivudine as part of antiretroviral therapy. [2008.09.12]
BACKGROUND: Prolonged use of lamivudine [generic for Epivir] in patients coinfected with HIV and hepatitis B virus (HBV) leads to an increasing risk of lamivudine resistance in both diseases. We investigated the addition of entecavir, a potent inhibitor of HBV polymerase, to lamivudine-containing highly active antiretroviral therapy (HAART) in patients who experienced rebound in HBV viremia while maintaining suppression of plasma HIV RNA less than 400 copies/ml... CONCLUSION: In this study, entecavir was associated with rapid, clinically significant reductions in HBV DNA, with maintenance of HIV viremia suppression, in HIV/HBV coinfected patients with HBV viremia while on lamivudine treatment.
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]
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).
Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine [Active, not recruiting]
Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown
to be active in vitro against a wide range of clinical isolates (including those resistant to
existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy
for 10 days reduced HIV-1 viral load by up to 1. 6 log, consistent with currently available
agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at
300 mg twice daily. No significant effects were seen on the QTc interval. The goal of this
study is to compare the safety and efficacy of maraviroc (UK-427,857) versus efavirenz, when
each are combined with two other antiretroviral agents, in patients who are previously naive
to antiretroviral therapy. This study will involve approximately 200 centers from around the
world to achieve a total randomized subject population of 1071 subjects. Patients will be
randomly assigned to one of three groups: maraviroc (UK-427,857) 300 mg once daily added to
zidovudine/lamivudine (300 mg/150 mg twice daily), Maraviroc (UK-427,857) 300 mg twice daily
added to zidovudine/lamivudine (300 mg/150 mg twice daily) or efavirenz (600 mg once daily)
added to zidovudine/lamivudine (300 mg/150 mg twice daily). The study will enroll over
approximately an 18 month period (5 months Phase 2b run-in, 13 months Phase 3) with 96 weeks
of treatment. This may be extended for an additional 3 years depending on the results at 96
weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24,
32, 40, 48, 60, 72, 84 and 96. Blood samples will also be taken at study entry, weeks 2, 4,
8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Additionally, blood samples will be drawn
twice, at least 30 minutes apart, at weeks 2 and 48 for maraviroc (UK-427,857)
pharmacokinetic analysis. As part of this clinical study a blood sample will be taken for
non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram
at study entry, weeks 24, 48 and 96. A computerized tomography (CT) scan will also be
performed, at selected centers, at study entry and week 96. Patients will be asked to
complete a symptom distress questionnaire at study entry, weeks 12, 24, 48 and 96.
Induction/Simplification With Atazanavir + Ritonavir + Abacavir/Lamivudine Fixed-Dose Combination In HIV-1 Infection [Active, not recruiting]
This study was designed to test the efficacy, safety, tolerability and durability of the
antiviral response between atazanavir (ATV) + ritonavir (RTV) + abacavir/lamivudine(ABC/3TC)
each administered once daily (QD) for 36 weeks followed by randomization to either a
simplification regimen of ATV or continuation of ATV+RTV for an additional 48 weeks, each in
combination with ABC/3TC in antiretroviral (ART)-naive, HIV-1 infected, HLA-B*5701 negative
subjects.
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]
To compare the proportion of patients in the 2 zidovudine (ZDV)-containing arms who have a
plasma HIV RNA concentration below the limit of detection (defined as 500 copies/ml or less)
at Weeks 20 and 24 [AS PER AMENDMENT 8/24/98: HIV RNA concentration below the limit of
detection is now defined as 200 copies/ml or less]. To compare the safety and tolerability of
the different treatment regimens. To compare the decrease in plasma HIV-1 RNA and the change
in CD4 count from baseline to the average of Weeks 20 and 24 [AS PER AMENDMENT 12/19/97: and
to the average of Weeks 44 and 48; AS PER AMENDMENT 8/24/98: and the average of Weeks 88 and
96] in the 2 ZDV-containing arms. To study the emergence of resistance to ZDV, lamivudine
(3TC), stavudine (d4T), delavirdine (DLV), and indinavir (IDV) in treated patients. To
correlate the antiviral and immunologic activity and emergence of drug resistance with
pharmacologic parameters of study drugs. To delineate the pharmacokinetic interactions of IDV
and DLV. [AS PER AMENDMENT 12/19/97: To delineate the possible development of cellular
resistance to nucleoside analogs and the consequences of switching nucleoside study drugs on
intracellular phosphorylation.] To document rates and patterns of adherence over the course
of the study, from day of randomization through 48 weeks. [AS PER AMENDMENT 8/24/98: To
define long-term durability of the virologic activity of the different treatment regimens, as
defined by the proportion of patients with plasma HIV-1 RNA levels that remains below the
limit of detection. To define long-term tolerability of the different treatment regimens.]
Although a change in reverse transcriptase (RT) inhibitors is recommended when adding or
changing protease inhibitors in a treatment regimen, the choice of available RT inhibitors is
often limited by prior exposure, toxicity, or pharmacologic interaction with the protease
inhibitors. This study addresses the question of whether to continue 3TC or substitute the
nonnucleoside reverse transcriptase inhibitor (NNRTI) DLV when adding IDV to therapy for
patients previously treated with ddI or d4T plus 3TC who have greater than 500 copies/ml of
plasma HIV-1 RNA. Although the activity of DLV as monotherapy or in combination with
nucleoside reverse transcriptase inhibitors is of limited duration due to rapid emergence of
resistance, it is possible that DLV will contribute significantly to the activity of 3-drug
regimens that include a new RT inhibitor plus a protease inhibitor.
3TC (Lamivudine; GR109714X) Open-Label Program [Completed]
To make lamivudine (3TC) available to patients with progressive, symptomatic HIV disease who
cannot participate in a controlled clinical trial and who are refractory or unable to
tolerate other therapies. To collect data pertaining to the safety of 3TC at two dose levels.
To evaluate the effect of 3TC on markers of hepatitis B in co-infected patients at five to
ten selected sites.
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Page last updated: 2009-02-07
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