Ritonavir plus saquinavir versus single protease inhibitor therapy in protease inhibitor‐naive HIV‐infected patients: the Swiss HIV Cohort Study

• Published in: HIV medicine Vol. 3; no. 4; pp. 247 - 253
• Main Authors: Bucher, HC, Bichsel, M, Taffé, P, Furrer, H, Telenti, A, Hirschel, B, Weber, R, Bernasconi, E, Vernazza, P, Minder, C, Battegay, M
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Science Ltd 01.10.2002
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; antiretroviral therapy; CD4 Lymphocyte Count; Cohort Studies; Drug Therapy, Combination; Female; Follow-Up Studies; HIV infections; HIV Infections - drug therapy; HIV Protease Inhibitors - administration & dosage; Humans; Male; Middle Aged; prospective cohort study; Prospective Studies; protease inhibitors; Reverse Transcriptase Inhibitors - administration & dosage; Ritonavir - administration & dosage; RNA, Viral - blood; Saquinavir - administration & dosage; Viral Load
• ISSN: 1464-2662; 1468-1293
• DOI: 10.1046/j.1468-1293.2002.00113.x

Objectives To compare the response to ritonavir (RTV) plus saquinavir (SQV) with single protease inhibitor (PI) therapies among PI‐naive HIV‐1 infected individuals. Methods Response to treatment was analysed according to the intent‐to‐treat principle in a prospective observational cohort study of 177 patients who between May 1995 and March 2000 started a double PI therapy with RTV and SQV (nonboosting dosages) plus at least one nucleoside reverse transcriptase inhibitor (NRTI) and 2214 patients with a single PI therapy plus two NRTIs. We used survival analysis and Cox's proportional hazard regression methods. The primary endpoint was the time to a plasma viral load of < 400 copies/mL. Secondary endpoints were taken as a gain in the CD4 count of >100 cells/μL, and change of initial PI for any reason. Results Baseline characteristics in both treatment groups were balanced. Median follow‐up in both groups was 10.4 months. Time to an HIV‐1 viral load of < 400 copies/mL and an increase in the CD4 count of >100 × 106 cells/L was shorter for RTV plus SQV compared with single PI regimens (log rank test for each endpoint P < 0.05). The adjusted hazard ratios of RTV plus SQV compared with single PI regimens were 1.21 (95% confidence interval 0.99–1.47) for achieving an HIV‐1 viral load of < 400 copies/mL, 1.12 (0.88–1.42) for an increase in the CD4 count of > 100 cells/μL, and 0.90 (0.73–1.11) for change of first PI regimen. Conclusions Treatment with RTV plus SQV compared with single PI regimens appeared to give similar results for virological or immunological response.