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Durable HIV Suppression and Tolerability with Efavirenz (EFV) + Indinavir (IDV): Results at 132 Weeks (Study 003-Cohort IV) S. RIDDLER*1, J. KAHN2, G. MARTIN3, G. DRUSANO4, E. GODOFSKY5, D. HAVLIR6, L. M. PLOUGHMAN7, D. J. MANION7, N. M. RUIZ7, and Study 003 Team.
1Univ. of Pittsburgh, PA; 2San Francisco Gen. Hosp., CA; 3Natl. Naval Med. Ctr., Bethesda, MD; 4Albany Med. Coll., NY; 5Bach and Godofsky, Bradenton, FL; 6Univ. of California Treatment Ctr., San Diego; and 7DuPont Pharmaceuticals Co., Wilmington, DE
Background: EFV, in combination with PIs or NRTIs, has demonstrated significant, durable clinical efficacy in suppressing viral loads.
Methods: Multicenter, randomized, double-blind study conducted in 101 asymptomatic or mildly symptomatic patients. 59 patients were randomized to EFV (200 mg/day) + IDV (800/1000 mg/day) and 42 patients to IDV (800/1000 mg/day) alone. At week 12, d4T and EFV were added to the IDV alone arm and at week 36, the dose of EFV was increased to 600 mg/day, in both treatment arms.
Baseline Characteristics: 86% male; mean age 38.5 (+ 8.0) years; mean HIV-1 RNA: 5.06 (+ 0.55) log10 copies/mL; mean CD4 count: 283 + 118 cells/mm3. Methods of analysis: observed data (OBS); intent-to-treat: noncompleter=failure (NC=F).
Results at week 132: HIV-RNA <400 Copies/mL: OBS-EFV+IDV 90.5% (38/42), IDV 70.8% (17/24);NC=F-EFV+IDV 65.5% (38/58), IDV 40.5% (17/42). No statistical comparisons were made after week 12 due to the addition of EFV to the monotherapy arm. Similar results were seen in patients with baseline viral loads >100,000 copies/mL. Mean change in CD4 cell counts at 120 weeks were 374.8 (+ 36.1) cells/mm3 and 266.3 (+ 36.1) cells/mm3, respectively, for the EFV+IDV and IDV+ d4T+EFV arms. The most frequently reported treatment-related adverse events among all patients receiving EFV (n=93) were diarrhea and nausea.
Conclusions: EFV, with a PI or a PI + NRTI combination, demonstrates durable suppression of HIV-RNA, with CD4 cell recovery and maintenance over an extended period. EFV is well tolerated with few discontinuations due to adverse events.
Key Words: Durability, Efavirenz, ProteaseInhibitors
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