BRETT-SMITH HM, REYNOLDS L, BESSEN L, RUTKIEWICZ V; Interscience Conference on Antimicrobial Agents and Chemotherapy (43rd: 2003: Chicago, Ill.).

Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2003 Sep 14-17; 43: abstract no. H-843.

Bristol-Myers Squibb, Wallingford, CT.

BACKGROUND: Stavudine (d4T) XR/PRC provides equivalent 24 hour exposure to d4T IR, but has 1/2 the peak and 2-3 fold higher trough plasma levels. Week (wk) 48 efficacy and safety data demonstrated comparability, but the differing pharmacokinetics could result in clinically relevant differences in outcomes with longer dosing. METHODS: This analysis integrates results from two randomized, double-blind (through 1 year), studies of treatment-naive patients comparing XR/PRC versus IR, each with lamivudine (3TC) and efavirenz (EFV). At 1 year, subjects could elect to rollover into a common long-term dosing study. Efficacy is not censored for successful 1 year completers who did not rollover. Safety data are cumulative from start of therapy through on-going dosing as of March 2003. RESULTS: Median baseline values: HIV RNA 4.8 log[10] c/mL and CD4 277 cells/mm3. Median time on treatment: 115 wks. The most common regimen-related adverse events (AE) were dizziness, peripheral neurologic symptoms (PNS)* and rash. [table: see text]. CONCLUSIONS: Overall two-year efficacy and safety for Stavudine XR/PRC are comparable to IR, with trends which favor XR for safety events of interest.

Publication Types:

• Meeting Abstracts

Keywords:

• Anti-HIV Agents
• CD4-Positive T-Lymphocytes
• China
• HIV
• HIV Infections
• HIV Protease Inhibitors
• Humans
• Lamivudine
• Longitudinal Studies
• Oxazines
• Research
• Stavudine
• efavirenz
• methods

Other ID:

• GWAIDS0024962

UI: 102264586

From Meeting Abstracts