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Combined therapy with saquinavir, ritonavir and stavudine in moderately to severely immunosuppressed HIV‐infected protease inhibitor‐naive patients
Author(s) -
Battegay M,
Vernazza Pl,
Bernasconi E,
Flepp M,
Sendi P,
Erb P,
Malinverni R,
Jaccard C,
Morgenthaler S,
Bedoucha V,
Hirschel B
Publication year - 2001
Publication title -
hiv medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 79
eISSN - 1468-1293
pISSN - 1464-2662
DOI - 10.1046/j.1468-1293.2001.00047.x
Subject(s) - saquinavir , stavudine , medicine , ritonavir , protease inhibitor (pharmacology) , indinavir , gastroenterology , viral load , prospective cohort study , virology , immunology , human immunodeficiency virus (hiv) , antiretroviral therapy
1Basel Centre for HIV Research, Outpatient Department of Internal Medicine, University Hospital Basel,2Department of Internal Medicine, Cantonal Hospital St Gallen,3Department of Internal Medicine, Regional Hospital Lugano,4Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich,5Basel Centre for HIV Research, Institute for Medical Microbiology, University Basel,6Division of Infectious Diseases, University Hospital Bern,7Division of Infectious Diseases, University Hospital Lausanne,8Roche Pharma AG, Reinach, and9Division of Infectious Diseases, University Hospital Geneva, SwitzerlandObjective 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/μL and > 10 000 HIV‐1 RNA copies/mL received saquinavir hard‐gelatin capsules, ritonavir and stavudine. Full (drop in viraemia of > 2 log 10 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/μL after 9 weeks and from 100 to 292 cells/μL 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 log 10 ) 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.