AEGiS-13IAC: Successful substitution of protease inhibitors with SUSTIVA (Efavirenz) in patients with undetectable plasma HIV-1 RNA levels -Results of a prospective, randomized, multicenter, open-label study (DMP 266-027).

13th International AIDS Conference

Durban, South Africa - July 9-July 14, 2000

Successful substitution of protease inhibitors with SUSTIVA (Efavirenz) in patients with undetectable plasma HIV-1 RNA levels -Results of a prospective, randomized, multicenter, open-label study (DMP 266-027).

Int Conf AIDS 2000 Jul 9-14; 13:43 (abstract no.. LbPeB7044)

Katlama C
Groupe Hospitalier Pitie-Salpetriere, Services des Maladies Infectieuses et Tropicales, Paris, France.

BACKGROUND: Simple, potent anti-retroviral (ARV) regimens that enhance adherence and are well tolerated are needed. Substitution of complicated ARV regimens with efavirenz (EFV)-based therapy may provide these benefits.

METHODS: Randomized, multicenter, open-label study. Patients receiving a regimen containing PI(s) + NRTIs with plasma HIV-1 RNA levels <50 copies/mL were enrolled. Patients were randomized to substitute the PI(s) with EFV 600 mg QD or to continue with the existing PI regimen (NRTIs were maintained). Enrollment to a third arm (EFV + PI[s]) was discontinued because of poor acceptance by patients and providers. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >=50 copies/mL.

RESULTS: 165 patients were randomized (mean age 40 years; 89% male; median duration of PI treatment 23 months [range 2-59 months], median baseline CD4 count 479 cells/mm³). Outcome by Week 24 was as follows: (Table: see text)

CONCLUSIONS: EFV substitution of a PI, in a suppressive PI-containing regimen, successfully maintains full anti-retroviral control (plasma HIV-1 RNA levels <50 copies/mL) and continued increases in CD4 counts.

Keywords: AEGIS, Oxazines, CD4 Lymphocyte Count, Protease Inhibitors, HIV Protease Inhibitors, efavirenz, Male, Human, AIDS
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