Johnson M; Conference on Retroviruses and Opportunistic Infections.
Program Abstr 6th Conf Retrovir Oppor Infect Conf Retrovir Oppor Infect 6th 1999 Chic Ill. 1999 Jan 31-Feb 4; 6th: 140 (abstract no. 389).
Royal Free Hospital, London, UK.
Objective: To determine whether HIV-infected patients with high baseline viral load or previous antiretroviral experience benefit from quadruple therapy with 2 protease inhibitors (PIs), SQV-SGC and NFV, compared with triple therapy with a single PI. Methods: 157 PI-naive adults with HIV RNA >/= 10 000 copies/ml were randomized to (A) SQV-SGC 1200mg tid + 2 nucleoside reverse transcriptase inhibitors (NRTIs) (n=26), (B) NFV 750mg tid +2NRTIs (n=26), (C) SQV-SGC 800mg tid +NFV 750mg tid +2NRTIs (n=51) or (D) SQV-SGC 800mg tid +NFV 750mg tid (n=54). Crossovers were allowed for virological failure after 16 weeks. Results: Patients were 54% treatment naive, with mean baseline HIV RNA 4.8 log10 copies/ml. After 48 weeks of therapy, the proportions < 50 copies/ml (UltraSensitive) in arms A-D were 42%, 42%, 51%, 35% (all patients), 50%, 57%, 48%, 37% (naive) and 33%, 25%, 54%, 33% (experienced), using an ITT approach. Response to triple therapy was considerably lower in patients with baseline viral load > 4.8 log10 copies/ml (43% < 50 copies/ml for high baseline viral load vs 57% low); the difference was smaller for quadruple therapy (63% high vs 67% low). In the 5, 9, 4, 18 patients in arms A-D who met the protocol-defined conditions of virological relapse, time to relapse was significantly longer in arm C (median 50-56 days in arms A, B, D; too few relapsers to calculate in arm C) (p=0.005). 22 patients with virological failure intensifying to arm C had a mean HIV RNA decrease of 0.97 log10 copies/ml, with 41% < 400 copies/ml and 24% < 50 copies/ml 12 weeks after switching (n=17). Conclusions: Quadruple therapy with 2 PIs has benefits compared with triple therapy in treatment-experienced patients and in those with high baseline viral load.
Publication Types:
Keywords:
- Acquired Immunodeficiency Syndrome
- Adult
- Antiretroviral Therapy, Highly Active
- Capsules
- Drug Therapy, Combination
- Gelatin
- HIV Infections
- Humans
- Nelfinavir
- Reverse Transcriptase Inhibitors
- Saquinavir
- Viral Load
- drug therapy
- therapy
Other ID:
UI: 102195158
From Meeting Abstracts