RAFFI F, BONNET B, ESNAULT JL, FERRE V, PERRE P, ALLAVENA C, RELIQUET V, LEAUTEZ S; Interscience Conference on Antimicrobial Agents and Chemotherapy.

Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 1999 Sep 26-29; 39: 532 (abstract no. 2198).

CISIH, HIV Res. Unit, Nantes, FRANCE.

OBJECTIVE: To investigate whether substituting a PI with a NNRTI could maintain virological suppression via a more convenient, simpler and well tolerated regimen. DESIGN: A prospective, observational pilot study.METHODS: Eligible patients (pts) had to be NNRTI-naive, on a PI-containing regimen for > 1 year, with plasma viral load (pVL) < 400 copies/ml for > 6 months (M) and increased CD4 cell count under HAART. PI was replaced by an od NNRTI, with continuation of the same 2 NRTIs. Monthly follow-up included hematology, biochemical tests, CD4, pVL (ultrasensitive assay with a detection limit of 80 copies/ml), reversion of lipodystrophy syndrome. Failure was defined as a detectable pVL after switch.RESULTS: Forty-six pts (36 male, 10 female, 15 with prior AIDS diagnosis), were included because of digestive intolerance to PI (n=9), lipodystrophy (n=11), adherence problems (n=5), renal colic (n=3), and/or wish to simplify regimen (n=24). At the time of switch, mean time with undetectable pVL on the PI-regimen was 17.7 M, mean CD4 cell count was 478/mm3, NRTIs were ZDV/ 3TC in 28, d4T/3TC in 11, d4T/ddI in 6, ZDV/ddI in 1. NNRTI was od nevirapine (400 mg/d) in 40, and od efavirenz (600 mg/d) in 6 pts. Two pts were excluded from analysis: one because of prior NNRTI experience and one who had a detectable pVL at switch. After a mean follow-up of 19 weeks (median 20 weeks, range 4-43, >24 weeks in 15/44), pVL remained < 80 copies/ml in 38/44 pts (probability of event-free survival: 90% at M2, 84% at M6). The 6 failures occurred at M1 (n=1), M2 (n=3) or M3 (n=2); all were low-grade (pVL range: 95-1,400 copies/mL); and 5/6 pts experienced an intercurrent infection in the preceeding weeks. Failure was associated with history of antiretroviral therapy (ART) prior to the successfull PI-regimen (6/6 vs 19/38 in non-failing pts, p<0.05), and total pre vious ART (p<0.05), but not with duration of undetectable pVL before switch, prior AIDS diagnosis, lowest CD4 count in pt's history or CD4 count as switch.CONCLUSION: NNRTI switch strategy is effective in pts with undetectable pVL following an initial first-line PI-regimen.

Publication Types:

• Meeting Abstracts

Keywords:

• AIDS Vaccines
• Acquired Immunodeficiency Syndrome
• Antiretroviral Therapy, Highly Active
• CD4 Lymphocyte Count
• Clinical Protocols
• Didanosine
• Female
• HIV Infections
• HIV Seropositivity
• Humans
• Lamivudine
• Longitudinal Studies
• Male
• Nevirapine
• Oxazines
• Stavudine
• Viral Load
• Zidovudine
• efavirenz
• organization & administration

Other ID:

• GWAIDS0008412

UI: 102245909

From Meeting Abstracts