AEGiS-08CROI: Successful substitution of protease inhibitors with efavirenz (EFV) in patients with undetectable viral loads--a prospective, randomized, multicenter, open-label study (DMP 049).

8th Conference on Retroviruses and Opportunistic Infections

Chicago, IL - February 4 - 8, 2001

Successful substitution of protease inhibitors with efavirenz (EFV) in patients with undetectable viral loads--a prospective, randomized, multicenter, open-label study (DMP 049)

Conf Retroviruses Opportunistic Infect 2001 Feb 4-8; 8:49 (abstract no. 20)

S. Becker¹, A. Rachlis², J. Gill³, E. Dejesus⁴, G. Pierone⁵, L. Kirkland⁶, S. Koosian⁷, D. Farina⁸, D. Labriola⁸, N. Ruiz⁸, L. Bessen⁸, and S. Villano⁸
¹Pacific Horizon Med. Group, San Francisco, CA; ²Sunnybrook and Women's Coll. Hlth. Sci. Ctr., Toronto, ON; ³Southern Alberta HIV Clin., Calgary; ⁴IDC Res. Initiative, Altamonte Springs, FL; ⁵Treasure Coast Infectious Disease Consultants, Vero Beach, FL; ⁶The Burnside Clin., Columbia, SC; ⁷Oceanview Internal Med., Long Beach, CA; and ⁸DuPont Pharmaceuticals Co., Wilmington, DE.

BACKGROUND: Simple, potent antiretroviral (ARV) regimens that enhance adherence and are well tolerated are needed.

METHODS: Prospective, randomized, multicenter, open-label, 48-week study comparing the duration of viral load (VL) suppression of a continued PI + 2 NRTIs regimen to an EFV substitution regimen. Patients (pts) who had achieved VL ≤ 50 copies/mL (cpm) were randomized (2: 1) to substitute the PI(s) with EFV 600 mg QD or to continue with their existing PI regimen; NRTIs were maintained. Virologic failure was defined as a confirmed VL >50 cpm. Except where noted, differences between groups were assessed using a Chi-square test.

RESULTS: 346 pts randomized (mean age 41 yrs; 90% male; mean duration of PI treatment 21 months [92% had received PIs ≥ 6 months]; mean baseline CD4 count 574 cells/mm³). Outcome by week 24 for 322 patients treated: (EFV substitution [n = 217] vs. continued PI(s) [n = 105]): discontinued from study (any reason), 15 (6.9%) vs. 13 (12.4%), p>0.05; met criteria for virologic failure, 6 (3.0%) vs. 9 (10.2%), p=0.011(Kaplan-Meier estimates of % failing at 24 weeks); viral suppression maintained (observed), 188/199 (95%) vs. 83/90 (92.2%), p>0.05; viral suppression maintained (ITT: NC=F), 187/210 (89.0%) vs. 80/99 (81.0%), p<0.05; mean change in CD4 count, +34 vs. +64, p>0.05 (ANOVA); adherence (pts with missed doses on multiple visits), 21% vs. 38%, p=0.002.

CONCLUSIONS: EFV substitution of a PI, in a suppressive PI-containing regimen, successfully maintains ARV suppression (VL ≤ 50 cpm), results in continued increases in CD4 counts, and is associated with improved adherence. This strategy may allow for improved long-term treatment success.

2001-02-04
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Copyright © 2001 - Foundation for Retrovirology and Human Health. Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Foundation for Retrovirology and Human Health. Licensed (AIDSLINE) from National Library of Medicine.