Combined therapy with saquinavir, ritonavir and stavudine in moderately to severely immunosuppressed HIV‐infected protease inhibitor‐naive patients

Battegay, Manuel; Vernazza, Pietro; Bernasconi, Enos; Flepp, Markus; Sendi, Parham; P, Erb; Malinverni, Raffaele; Jaccard, C.; Morgenthaler, S.; Bédoucha, Véronique; Hirschel, Bernard

doi:10.1046/j.1468-1293.2001.00047.x

Cited by 2 publications

(1 citation statement)

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“…Several studies have demonstrated that the combination of RTV plus SQV reduces plasma HIV‐1 viral load to a similar extent to that of a single PI‐based regimen [4–9]. These studies, however, either did not use control groups, reported only 24 weeks follow‐up data, or compared different dosing or intensification regimens of RTV plus SQV.…”

Section: Introductionmentioning

confidence: 99%

Ritonavir plus saquinavir versus single protease inhibitor therapy in protease inhibitor‐naive HIV‐infected patients: the Swiss HIV Cohort Study

et al. 2002

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ObjectivesTo compare the response to ritonavir (RTV) plus saquinavir (SQV) with single protease inhibitor (PI) therapies among PI-naive HIV-1 infected individuals. MethodsResponse to treatment was analysed according to the intent-to-treat principle in a prospective observational cohort study of 177 patients who between May 1995 and March 2000 started a double PI therapy with RTV and SQV (nonboosting dosages) plus at least one nucleoside reverse transcriptase inhibitor (NRTI) and 2214 patients with a single PI therapy plus two NRTIs. We used survival analysis and Cox's proportional hazard regression methods. The primary endpoint was the time to a plasma viral load of <400 copies/mL. Secondary endpoints were taken as a gain in the CD4 count of >100 cells/mL, and change of initial PI for any reason. ResultsBaseline characteristics in both treatment groups were balanced. Median follow-up in both groups was 10.4 months. Time to an HIV-1 viral load of <400 copies/mL and an increase in the CD4 count of >100 Â 10 6 cells/L was shorter for RTV plus SQV compared with single PI regimens (log rank test for each endpoint P <0.05). The adjusted hazard ratios of RTV plus SQV compared with single PI regimens were 1.21 (95% con®dence interval 0.99±1.47) for achieving an HIV-1 viral load of <400 copies/mL, 1.12 (0.88±1.42) for an increase in the CD4 count of >100 cells/mL, and 0.90 (0.73±1.11) for change of ®rst PI regimen. ConclusionsTreatment with RTV plus SQV compared with single PI regimens appeared to give similar results for virological or immunological response.Keywords: antiretroviral therapy, HIV infections, prospective cohort study, protease inhibitors IntroductionThe introduction of potent antiretroviral therapy has lead to a dramatic reduction in HIV-related morbidity and mortality [1±3]. Generally, a potent antiretroviral therapy consists of one protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitors (NNRTI) combined with at least two nucleoside reverse transcriptase inhibitors (NRTI). Pharmacokinetic studies have shown that ritonavir (RTV) may boost serum levels of other PIs such as saquinavir (SQV) and indinavir (IDV), and has lead to the introduction of dual PI therapies. ORIGINAL RESEARCHSeveral studies have demonstrated that the combination of RTV plus SQV reduces plasma HIV-1 viral load to a similar extent to that of a single PI-based regimen [4±9]. These studies, however, either did not use control groups, reported only 24 weeks follow-up data, or compared different dosing or intensi®cation regimens of RTV plus SQV. There is very little evidence from controlled trials in PI-naive patients comparing the dual PI therapy of RTV plus SQV with single PI regimens. In one randomized controlled trial, the dual combination of RTV plus SQV showed superior short-term antiretroviral activity when compared with single protease regimen with either IDV or RTV [10]. However, the limited number of included patients and the short follow-up period limit the generalizability of these study ®ndings.The goal of ...

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Section: Introductionmentioning

confidence: 99%

Ritonavir plus saquinavir versus single protease inhibitor therapy in protease inhibitor‐naive HIV‐infected patients: the Swiss HIV Cohort Study

et al. 2002

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Antiretroviral treatment monitoring with an improved HIV‐1 p24 antigen test: an inexpensive alternative to tests for viral RNA

Schüpbach

Böni

Flepp

et al. 2001

Journal of Medical Virology

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Monitoring of viral RNA has become indispensable for the management of HIV-1 infection, but is expensive. This study investigated whether a highly improved test for p24 antigen could serve as an alternative. Thirty-four patients enrolled during 1997 into two treatment studies were tested prospectively for viral RNA by the Roche HIV-1 Monitor and for p24 antigen using signal-amplification-boosted ELISA of heat-denatured plasma. P24 antigen was detectable in 75.8% of 178 samples and HIV RNA in 73.9% of 138 samples. The half-life of p24 antigen in the first phase of effective treatment was 1.6 +/-.4 days (RNA, 1.7 +/-.8). An apparent second, slower decay phase had a half-life of 42 +/- 16 days. Treatment failure occurred in 14 patients. Secondary treatment failures with RNA rebounds from undetectable levels to < or = 10(3) copies/ml in two patients with an undetectable viral load and 10(3) HIV RNA copies/ml, respectively, at baseline were not detected by p24 antigen but carried a low risk for secondary resistance mutations. The other 12 failures were on average detected 29 days earlier by p24 antigen than by RNA (P =.0204), owing to slightly more frequent testing for p24 than for RNA (2.7 vs. 2.4 tests). Average costs for p24 antigen testing up to a failure were only 20.5% of those for RNA (P <.0001). These results indicate that heat-denatured, amplification-boosted p24 antigen measurement can be used as a simple and inexpensive alternative to HIV RNA testing for monitoring treatment.

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Combined therapy with saquinavir, ritonavir and stavudine in moderately to severely immunosuppressed HIV‐infected protease inhibitor‐naive patients

Cited by 2 publications

References 29 publications

Ritonavir plus saquinavir versus single protease inhibitor therapy in protease inhibitor‐naive HIV‐infected patients: the Swiss HIV Cohort Study

Ritonavir plus saquinavir versus single protease inhibitor therapy in protease inhibitor‐naive HIV‐infected patients: the Swiss HIV Cohort Study

Antiretroviral treatment monitoring with an improved HIV‐1 p24 antigen test: an inexpensive alternative to tests for viral RNA

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