Efficacy of combination therapy with indinavir (IDV) in HIV patients naive to and experienced with saqinavir (SQV) and nucleoside reverse transcriptase inhibitors (NRTI).
Annu Conf Australas Soc HIV Med. 1997 Nov 13-16;9:131 (poster no. P31). Unique Identifier : AIDSLINE MED/98095213 Chuah J; Whiteman D; Gold Coast Sexual Health Clinic, Miami, Queensland.
Abstract:
OBJECTIVE: Opinions differ as to the extent previous experience with one protease inhibitor (PI) will select resistance to and affect subsequent therapy with a different PI. This study compared the viral load reduction, proportion of patients achieving viral load below detection (BD) level and changes in CD4 counts in 44 HIV patients with previous SQV (n = 12) exposure, various NRTI experienced (NRTI+)(n = 17) and NRTI naive NRTI-) (n = 15) treatment background with combination therapy, involving two NRTI and IDV. METHODS: Prospective study of HIV seropositive patients presented to a regional sexual health clinic from September 96 were enrolled in the study after counselling and informed consent. Viral load (Amplicor, Roche) and CD4 count were performed at base line, prior to commencement of triple therapy with two NRTI and IDV and at 1, 3, 6, 9, 12, 15, 18, 21 and 24 months subsequently. Patients were followed at 1 to 3 monthly intervals for clinical progression, adverse reactions, compliance and treatment supply. Viral load was recorded as BD when < 200 copies/ml (Amplicor, Roche). Treatment failure was defined as failure to achieve > or = 0.75 log reduction in viral load by 3 months and patients were then changed to other combinations with at least two new agents. This is an interim report on 44 patients enrolled between Sept 96 and June 97. RESULTS: At baseline, the median viral load (VL) = 5.03 log copies/ml, median CD4 were 180 cells/cmm; median duration of therapy was 6.0 months. Median HIV viral load reduction was 4.98 log, median CD4 increases were 130.0 cell/cmm with 65.9% (29/44) patients achieving and maintaining BD level in viral load (VL) and 9.1% failing treatment. Baseline median VL in patients with SAQ vs NRTI+ vs NRTI- were 4.8 vs 5.0 vs 5.5 log; CD4 were 185 vs 180 vs 160 cell/cmm; median duration of therapy was 6.5 vs 9.0 vs 5.0 months; median viral load reduction were 2.1 vs 2.5 vs 2.7 log. BD proportion were 58.3% vs 70.6% vs 66.7%, while median CD4 increases were 40 vs 140 vs 155 cells/cmm (p = 0.007). There were 11 (25%) adverse events reported: Haematuria/calculi = 4 (9.1%), Nausea/vomiting = 1 (2.3%), and 6 other events consisting of transient epigastric discomfort, hair loss, peripheral neuropathy PN). Only one patient with PN ceased treatment temporarily, the others continued without interruption of triple therapy. CONCLUSIONS: Triple combination therapy with two NRTI and IDV is well tolerated, potent and effective in achieving significant HIV viral load reduction and immune recovery in HIV patients. However, previous exposure to another PI (SAQ) may reduce the efficacy of the combination therapy with two NRTI and IDV, as reflected in reduced immune recovery in this study to date.
Keywords: *Anti-HIV Agents/THERAPEUTIC USE *HIV Protease Inhibitors/THERAPEUTIC USE *Indinavir/THERAPEUTIC USE *Saquinavir/THERAPEUTIC USE 980430
M9840150
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