Combivir (Lamivudine / Zidovudine) - Indications and Dosage

INDICATIONS AND USAGE

COMBIVIR is indicated in combination with other antiretrovirals for the treatment of HIV-1 infection.

Clinical Studies

COMBIVIR

There have been no clinical trials conducted with COMBIVIR. See CLINICAL PHARMACOLOGY for information about bioequivalence. One COMBIVIR Tablet given twice daily is an alternative regimen to EPIVIR Tablets 150 mg twice daily plus RETROVIR 600 mg per day in divided doses.

Lamivudine Plus Zidovudine

The NUCB3007 (CAESAR) study was conducted using EPIVIR 150-mg Tablets (150 mg twice daily) and RETROVIR 100-mg Capsules (2 x 100 mg 3 times daily). CAESAR was a multi-center, double-blind, placebo-controlled study comparing continued current therapy [zidovudine alone (62% of patients) or zidovudine with didanosine or zalcitabine (38% of patients)] to the addition of EPIVIR or EPIVIR plus an investigational non-nucleoside reverse transcriptase inhibitor, randomized 1:2:1. A total of 1,816 HIV-infected adults with 25 to 250 (median 122) CD4 cells/mm³ at baseline were enrolled: median age was 36 years, 87% were male, 84% were nucleoside-experienced, and 16% were therapy-naive. The median duration on study was 12 months. Results are summarized in Table 3.

Table 3. Number of Patients (%) With At Least 1 HIV Disease-Progression Event or Death

Endpoint	Current Therapy (n = 460)	EPIVIR plusCurrent Therapy (n = 896)	EPIVIR plus a NNRTI* plus Current Therapy (n = 460)
HIV progression or death	90 (19.6%)	86 (9.6%)	41 (8.9%)
Death	27 (5.9%)	23 (2.6%)	14 (3.0%)

* An investigational non-nucleoside reverse transcriptase inhibitor not approved in the United States.

DOSAGE AND ADMINISTRATION

The recommended oral dose of COMBIVIR for adults and adolescents (at least 12 years of age) is 1 tablet (containing 150 mg of lamivudine and 300 mg of zidovudine) twice daily.

Dose Adjustment

Because it is a fixed-dose combination, COMBIVIR should not be prescribed for patients requiring dosage adjustment such as those with reduced renal function (creatinine clearance <50 mL/min), patients with hepatic impairment, or patients experiencing dose-limiting adverse events.

HOW SUPPLIED

COMBIVIR Tablets, containing 150 mg lamivudine and 300 mg zidovudine, are white, film-coated, modified-capsule-shaped tablets engraved with “GXFC3” on one side. They are available as follows:

60 Tablets/Bottle (NDC 0173-0595-00)

Store between 2° and 30°C (36° and 86°F).

Unit Dose Pack of 120 (NDC 0173-0595-02)

Store between 2° and 30°C (36° and 86°F).

GlaxoSmithKline

Research Triangle Park, NC 27709

Lamivudine is manufactured under agreement from

Shire Pharmaceuticals Group plc

Basingstoke, UK

©2006, GlaxoSmithKline. All rights reserved.

October 2006 RL-2315