First‐line ritonavir/indinavir 100/800 mg twice daily plus nucleoside reverse transcriptase inhibitors in a German multicentre study: 48‐week results

• Published in: HIV medicine Vol. 3; no. 4; pp. 277 - 282
• Main Authors: Voigt, E, Wickesberg, A, Wasmuth, J‐C, Gute, P, Locher, L, Salzberger, B, Wöhrmann, A, Adam, A, Weitner, L, Rockstroh, JK
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Science Ltd 01.10.2002
• Subjects: Adult; antiretroviral therapy; Antiretroviral Therapy, Highly Active - adverse effects; boosted protease inhibitor regimen; CD4 Lymphocyte Count; Drug Therapy, Combination; Female; first line treatment; Follow-Up Studies; Germany; HIV Infections - drug therapy; HIV Infections - immunology; HIV Infections - virology; HIV Protease Inhibitors - administration & dosage; HIV Protease Inhibitors - adverse effects; Humans; indinavir; Indinavir - administration & dosage; Indinavir - adverse effects; Male; Middle Aged; Prospective Studies; protease inhibitor combination; Reverse Transcriptase Inhibitors - administration & dosage; Reverse Transcriptase Inhibitors - adverse effects; ritonavir; Ritonavir - administration & dosage; Ritonavir - adverse effects; RNA, Viral - blood; Treatment Outcome; Viral Load; Germany
• ISSN: 1464-2662; 1468-1293
• DOI: 10.1046/j.1468-1293.2002.00123.x

Objectives To evaluate safety and efficacy of the protease inhibitor combination ritonavir/indinavir 100/800 mg twice daily plus 2–3 nucleoside reverse transcriptase inhibitors (NRTI) in antiretroviral‐naive patients. Methods Within this open‐label, uncontrolled multicentre trial, antiretroviral‐naive patients (n = 57) with median baseline HIV‐RNA of 308 000 copies/mL (range 170–3.01 million copies/mL) and median CD4 cell count of 50 cells/μL (range 0–853 cells/μL) were started on 2–3 NRTIs plus ritonavir/indinavir 100/800 mg twice daily. CD4 cell counts and HIV‐RNA were determined at weeks 0, 4, 8, 12, 16, 20, 24 and 48. Statistical analysis was performed on treatment as well as intent‐to‐treat. Results Viral load decreased by a median of 3.79 log10 copies/mL (range 2.0–4.60 log10 copies/mL) until week 48. At week 48, 23/57 (40%, intent‐to‐treat) patients showed a viral load ≤ 80 copies/mL. In parallel, median CD4 cell counts increased by a median of 149 cells/μL (range −60–420 cells/μL). Median triglycerides and cholesterol increased from baseline 160 mg/dL (range 33–364 mg/dL) to 218 mg/dL (range 110–527 mg/dL) at week 48 and from 166 mg/dL (range 63–262 mg/dL) to 233 mg/dL (range 95–359 mg/dL), respectively. Twenty‐seven of fifty‐seven patients (47%) discontinued study medication, 19 (33%) due to nephrolithiasis. Two patients changed their antiretroviral regimen after failing virologically. Conclusion Ritonavir/indinavir 100/800 mg twice daily appears to be effective up to 48 weeks despite high baseline viraemia and low CD4 cell count in antiretroviral‐naive patients. However, discontinuation due to adverse events, especially nephrotoxicity, is frequent and limits treatment duration. Therefore, extra hydration appears inevitable with this combination.