Combined therapy with saquinavir, ritonavir and stavudine in moderately to severely immunosuppressed HIV-infected protease inhibitor-naive patients

Battegay, M.; Vernazza, P. L.; Bernasconi, Enos; Flepp, Markus; Sendi, Pedram; Erb, P.; Malinverni, R.; Jaccard, Christophe; Morgenthaler, S.; Bedoucha, V.; Hirschel, Bernard

doi:10.1046/j.1468-1293.2001.00047.x

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Title		Combined therapy with saquinavir, ritonavir and stavudine in moderately to severely immunosuppressed HIV-infected protease inhibitor-naive patients
Authors		Battegay, M. Vernazza, P. L. Bernasconi, Enos Flepp, Markus Sendi, Pedram Erb, P. Malinverni, R. Jaccard, Christophe Morgenthaler, S. Bedoucha, V. Hirschel, Bernard show all authors [1 - 11]
Published in		HIV medicine. 2001, vol. 2, no. 1, p. 35-42
Abstract		OBJECTIVE: To assess the short-term and long-term effect of a combination of saquinavir, ritonavir and stavudine in moderately to severely immunosuppressed protease inhibitor-naive patients. DESIGN: Prospective open-label multicentre study. PATIENTS AND METHODS: A total of 64 protease inhibitor-naive and stavudine-naive HIV-infected patients with a CD4 count of < 250 cells/microL and > 10 000 HIV-1 RNA copies/mL received saquinavir hard-gelatin capsules, ritonavir and stavudine. Full (drop in viraemia of > 2 log10 and/or < 500 copies/mL) and partial responders (drop to between 500 and 5000 viraemia copies/mL) at week 9 (end of phase I) entered the second phase (additional 12-month period). RESULTS: Fifty-six patients completed phase I, 45 (70%) full responders and nine (14%) partial responders by intent-to-treat analysis. Thirty-nine patients completed phase II, 33 (52%) full responders and two (3%) partial responders. Six patients had < 50 HIV-1 RNA copies/mL at week 9, and 20 (31%) patients at month 12 of phase II. Mean CD4 cell counts increased significantly in the 56 patients from 89 to 184 cells/microL after 9 weeks and from 100 to 292 cells/microL in the 39 patients treated for another 12 months. Higher baseline viraemia and lower baseline CD4 cell counts were not associated with an unfavourable virological response at week 9 and month 12 of phase II. HIV DNA in peripheral blood monocytes decreased substantially (- 1.5 log10) but was detectable in all except one patient at the end of phase II. CONCLUSION: In protease- and stavudine-naive HIV-infected patients with moderate to severe immunosuppression, saquinavir in combination with ritonavir and stavudine caused a substantial long-term decrease in plasma viral load in approximately half the participants and a substantial increase in CD4 cell counts.
Keywords		Adolescent — Adult — Aged — Cohort Studies — Drug Administration Schedule — Drug Therapy, Combination — Female — HIV Infections/ drug therapy — HIV Protease Inhibitors/administration & dosage/ therapeutic use — Humans — Immunocompromised Host — Male — Middle Aged — Prospective Studies — Reverse Transcriptase Inhibitors/administration & dosage/ therapeutic use — Ritonavir/administration & dosage/ therapeutic use — Saquinavir/administration & dosage/ therapeutic use — Stavudine/administration & dosage/ therapeutic use — Switzerland — Treatment Outcome — Viral Load
Identifiers		DOI: 10.1046/j.1468-1293.2001.00047.x PMID: 11737374
Full text		Article - Limited access to UNIGE
Structures		Faculté de médecine / Section de médecine clinique / Département de médecine
Citation (ISO format)		BATTEGAY, M. et al. Combined therapy with saquinavir, ritonavir and stavudine in moderately to severely immunosuppressed HIV-infected protease inhibitor-naive patients. In: HIV medicine, 2001, vol. 2, n° 1, p. 35-42. doi: 10.1046/j.1468-1293.2001.00047.x https://archive-ouverte.unige.ch/unige:7096