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First‐line ritonavir/indinavir 100/800 mg twice daily plus nucleoside reverse transcriptase inhibitors in a German multicentre study: 48‐week results
Author(s) -
Voigt E,
Wickesberg A,
Wasmuth JC,
Gute P,
Locher L,
Salzberger B,
Wöhrmann A,
Adam A,
Weitner L,
Rockstroh JK
Publication year - 2002
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.1468-1293.2002.00123.x
Subject(s) - indinavir , ritonavir , medicine , regimen , viral load , gastroenterology , reverse transcriptase inhibitor , nucleoside reverse transcriptase inhibitor , pharmacology , virology , human immunodeficiency virus (hiv) , antiretroviral therapy
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 log 10 copies/mL (range 2.0–4.60 log 10 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.