SUSTIVA (efavirenz) in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection. This indication is based on two clinical trials of at least one year duration that demonstrated prolonged suppression of HIV RNA.

Study 006, a randomized, open-label trial, compared SUSTIVA (600 mg once daily) + zidovudine (ZDV, 300 mg q12h) + lamivudine (LAM, 150 mg q12h) or SUSTIVA (600 mg once daily) + indinavir (IDV, 1000 mg q8h) with indinavir (800 mg q8h) + zidovudine (300 mg q12h) + lamivudine (150 mg q12h). Twelve hundred sixty-six patients (mean age 36.5 years [range 18-81], 60% Caucasian, 83% male) were enrolled. All patients were efavirenz-, lamivudine-, NNRTI-, and PI-naïve at study entry. The median baseline CD4+ cell count was 320 cells/mm³ and the median baseline HIV-1 RNA level was 4.8 log10 copies/mL. Treatment outcomes with standard assay (assay limit 400 copies/mL) through 48 and 168 weeks are shown in Table 3. Plasma HIV RNA levels were quantified with standard (assay limit 400 copies/mL) and ultrasensitive (assay limit 50 copies/mL) versions of the AMPLICOR HIV-1 MONITOR ^Ò; assay. During the study, version 1.5 of the assay was introduced in Europe to enhance detection of non clade B virus.

^aPatients achieved and maintained confirmed HIV-1 RNA <400 copies/mL through Week 48 or Week 168.
^bIncludes patients who rebounded, patients who were on study at Week 48 and failed to achieve confirmed HIV-1 RNA <400 copies/mL at time of discontinuation, and patients who discontinued due to lack of efficacy.
^cIncludes consent withdrawn, lost to follow-up, noncompliance, never treated, missing data, protocol violation, death, and other reasons. Patients with HIV-1 RNA levels <400 copies/mL who chose not to continue in the voluntary extension phases of the study were censored at date of last dose of study medication.

For patients treated with SUSTIVA + zidovudine + lamivudine, SUSTIVA + indinavir, or indinavir + zidovudine + lamivudine, the percentage of responders with HIV-1 RNA <50 copies/mL was 65%, 50%, and 45%, respectively, through 48 weeks, and 43%, 31%, and 23%, respectively, through 168 weeks. A Kaplan-Meier analysis of time to loss of virologic response (HIV RNA <400 copies/mL) suggests that both the trends of virologic response and differences in response continue through 4 years.

ACTG 364 is a randomized, double-blind, placebo-controlled, 48-week study in NRTI experienced patients who had completed two prior ACTG studies. One-hundred ninety six patients (mean age 41 years [range 18-76], 74% Caucasian, 88% male) received NRTIs in combination with SUSTIVA (efavirenz) (600 mg once daily), or nelfinavir (NFV, 750 mg TID), or SUSTIVA (600 mg once daily) + nelfinavir in a randomized, double-blinded manner. The mean baseline CD4+ cell count was 389 cells/mm³ and mean baseline HIV-1 RNA level was 8130 copies/mL. Upon entry into the study, all patients were assigned a new open-label NRTI regimen, which was dependent on their previous NRTI treatment experience. There was no significant difference in the mean CD4+ cell count among treatment groups; the overall mean increase was approximately 100 cells at 48 weeks among patients who continued on study regimens. Treatment outcomes are shown in Table 4. Plasma HIV RNA levels were quantified with the AMPLICOR HIV-1 MONITOR^Ò; assay using a lower limit of quantification of 500 copies/mL.

* For some patients, Week 56 data were used to confirm the status at Week 48.
^a Subjects achieved virologic response (two consecutive viral loads <500 copies/mL) and maintained it through Week 48.
^b Includes viral rebound and failure to achieve confirmed <500 copies/mL by Week 48.
^c See ADVERSE REACTIONS for a safety profile of these regimens.
^d Includes loss to follow-up, consent withdrawn, noncompliance.

A Kaplan-Meier analysis of time to treatment failure through 72 weeks demonstrates a longer duration of virologic suppression (HIV RNA <500 copies/mL) in the SUSTIVA containing treatment arms.

Adults

The recommended dosage of SUSTIVA is 600 mg orally, once daily, in combination with a protease inhibitor and/or nucleoside analogue reverse transcriptase inhibitors (NRTIs). It is recommended that SUSTIVA be taken on an empty stomach, preferably at bedtime. The increased efavirenz concentrations observed following administration of SUSTIVA with food may lead to an increase in frequency of adverse events (see CLINICAL PHARMACOLOGY: Effect of Food on Oral Absorption). Dosing at bedtime may improve the tolerability of nervous system symptoms (see WARNINGS: Nervous System Symptoms, PRECAUTIONS: Information for Patients, and ADVERSE REACTIONS).

Concomitant Antiretroviral Therapy: SUSTIVA must be given in combination with other antiretroviral medications (see CLINICAL PHARMACOLOGY: Drug Interactions and PRECAUTIONS: Drug Interactions and INDICATIONS AND USAGE).

It is recommended that SUSTIVA be taken on an empty stomach, preferably at bedtime. Table 10 describes the recommended dose of SUSTIVA for pediatric patients 3 years of age or older and weighing between 10 and 40 kg. The recommended dosage of SUSTIVA for pediatric patients weighing greater than 40 kg is 600 mg, once daily.

Capsules

SUSTIVA ^Ò; capsules are available as follows:

Capsules 200 mg are gold color, reverse printed with "SUSTIVA" on the body and imprinted "200 mg" on the cap.

Bottles of 90 NDC 0056-0474-92

Capsules 100 mg are white, reverse printed with "SUSTIVA" on the body and imprinted "100 mg" on the cap.

Bottles of 30 NDC 0056-0473-30

Capsules 50 mg are gold color and white, printed with "SUSTIVA" on the gold color cap and reverse printed "50 mg" on the white body.

Bottles of 30 NDC 0056-0470-30

SUSTIVA tablets are available as follows:

Tablets 600 mg are yellow, capsular-shaped, film-coated tablets, with "SUSTIVA" printed on both sides.

Bottles of 30 NDC 0056-0510-30

SUSTIVA capsules and SUSTIVA tablets should be stored at 25^°; C (77^°; F); excursions permitted to 15^°;-30^°; C (59^°;-86^°; F) [see USP Controlled Room Temperature].

Distributed by: Bristol-Myers Squibb Company, Princeton, NJ 08543 USA
SUSTIVA ^Ò; is a registered trademark of Bristol-Myers Squibb Pharma Company.
Other brands listed are the trademarks of their respective owners and are not trademarks of Bristol-Myers Squibb Company.
ÒBristol-Myers Squibb Company 2005
Printed in USA, 51-022486-05 1178226A3 Revised February 2005

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