A randomized trial comparing initial HAART regimens of nelfinavir/nevirapine and ritonavir/saquinavir in combination with two nucleoside reverse transcriptase inhibitors.

Department of Infectious Diseases, Hvidovre University Hospital, Hvidovre, Denmark.
Antiviral therapy (Impact Factor: 3.07). 12/2003; 8(6):595-602.
Source: PubMed

ABSTRACT A triple-class HAART regimen may be associated with a better virological effect than conventional regimens, but may also lead to toxicity and more profound resistance.
Randomized, controlled, open-label trial of 233 protease inhibitor- and non-nucleoside reverse transcriptase inhibitor-naive HIV-infected patients allocated to a regimen of nelfinavir and nevirapine (1250/200 mg twice daily; n = 118) or ritonavir and saquinavir (400/400 mg twice daily; n = 115), both in combination with two nucleoside reverse transcriptase inhibitors. The primary end-point was HIV RNA < or = 20 copies/ml after 48 weeks (missing value = failure). Patients remained under follow-up also in case of switch from the randomized therapy.
At baseline, the median CD4 cell counts were 126 (range: 0-942) (nelfinavir/nevirapine) and 150 (0-642) (ritonavir/saquinavir) cells/mm3, and HIV RNA measurements 5.0 copies/ml (1.3-6.4) in both groups. A total of 102 (86%) and 101 (88%) were antiretroviral-naive. 44% discontinued randomized therapy; P = 0.13. Of these, 80 and 73% switched therapy due to adverse events; P = 0.99. At week 48, 69 and 56%, respectively, had a HIV RNA < or = 20 copies/ml; P = 0.037.
A regimen of nelfinavir/nevirapine had a favourable virological effect and tolerability over a 48-week period compared with ritonavir/saquinavir, when administered in combination with two nucleoside reverse transcriptase inhibitors. However, more extensive follow-up is required to determine the long-term consequences of triple class HAART regimens, including the development of broad drug resistance.

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    ABSTRACT: Background We assessed whether quadruple or triple-class therapy for the initial treatment of HIV-1 infection provides a virological benefit over standard triple therapy in patients with a very high plasma viraemia.Design National observational HIV cohort in the Netherlands.Methods Inclusion criteria were age ≥18 years, treatment-naïve, plasma viral load (pVL) ≥500.000 copies/ml and initiation of quadruple or triple therapy between 2001-2011. Time to viral suppression, defined as pVL <50 c/ml, was compared between the two groups using Kaplan-Meier plots and multivariate Cox regression analysis.Results 675 patients were included: 125 (19%) initiated quadruple and 550 (81%) triple therapy. Median pVL was 5.9 (IQR 5.8-6.1) log(10) c/ml in both groups (P=0.49). 22 (18%) patients on quadruple and 63 (12%) on triple therapy interrupted the treatment regimen because of drug-related toxicity (P=0.06). Median time to viral suppression was 5.8 (IQR 4.6-7.9) and 6.0 (4.0-9.4) months in the patients on quadruple and triple therapy (log rank, P=0.42). In the adjusted Cox analysis, quadruple therapy was not associated with time to viral suppression (HR 1.07 (95% CI 0.86-1.33), P=0.53). Similar results were seen when comparing triple- versus dual-class therapy (n=72 vs. n=601, respectively).Conclusions Initial quadruple or triple-class therapy was equally effective as standard triple therapy in the suppression of HIV-1 in treatment-naïve patients with very high viraemia and did not result in a faster pVL decline, but did expose patients to additional toxicity.
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