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11th International AIDS Conference

Vancouver, British Columbia — July 7-12, 1996

Improved survival and decreased progression of HIV in patients treated with saquinavir (Invirase, SQV) plus HIVID (zalcitabine, ddC).

Int Conf AIDS 1996 Jul 7-12; 11:29 (abstract no. LB.B.6033)
Lalezari J, Haubrich R, Burger HU, Beattie D, Donatacci L, Salgo MP; Mt. Zion Hospital of UCSF, San Francisco, CA. Fax: (415) 476-3622. E-mail: miklos.salgo@roche.com.

OBJECTIVE: To compare the safety, tolerability and efficacy of SQV plus ddC, compared to ddC or SQV alone.

METHODS: In this double-blind, multicentre, phase II/III study, HIV infected patients with a CD4 lymphocyte count of 50-300 cells/mm³, and greater than or equal to 16 weeks of prior ZDV therapy, were randomized to receive ddC 0.75 mg q8h, SQV 600 mg q8h, or SQV 600 mg + ddC 0.75 mg q8h.

RESULTS: The patients in the intent to treat analysis (N=940) were balanced across the treatment arms with respect to sex, age, race, baseline viral load (median 5.1-5.2 log copies/ml), baseline CD4 count (median 160-180 cells/mm³, and reason for discontinuing prior ZDV. Duration on initial treatment was shorter for patients on ddC, but follow-up was similar for all arms (median 73-74 weeks). (Table: see text) For both time to first AIDS-defining event or death, and for survival alone, there were statistically significant benefits of combination SQV + ddC over ddC. There were no significant differences in the comparisons of SQV to ddC. (Table: see text) A prior analysis of surrogate markers and safety in the first 423 patients out to week 48 established the safety profile of SQV, which was well tolerated alone and in combination. A full safety report from this study will be completed later in the year.

CONCLUSIONS: Clinical progression to first AIDS defining event or death, and survival alone, were prolonged in the SQV + ddC group compared to those on ddC alone.

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