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A study to evaluate the efficacy, safety and tolerability of co-administered lopinavir/ritonavir (LPVr) and nevirapine (NVP) in HIV-infected adults

Purpose of the study

The persisting concern of mitochondrial toxicity and the potential development of cardio-metabolic toxicity from nucleoside analogues has prompted clinicians to consider alternative treatment strategies. Here we investigate the efficacy, safety and tolerability of a nucleoside-sparing regimen consisting of nevirapine and boosted lopinavir in 'The NRTI-sparing Study'.

Methods

In this prospective, 48-week, two-centre study, 40 patients were recruited to receive lopinavir/ritonavir (LPV/r) soft gel capsules (SGC) (533/133 mg BID) plus nevirapine (NVP) (200 mg BID). Once HIV-RNA was <50 copies/ml, patients were allowed to switch to the new LPV/r tablet formulation (400/100 mg BID); this was not considered a switch in the analyses. Fasting lipids, CD4 count, and HIV-1 RNA were performed on days 1, 4 and 7 and weeks 2, 4, 12, 24, 36 and 48. Analyses were intention-to-treat (ITT; switch & missing = failure) and on treatment.

Summary of results

Patients were predominantly male (85%) and Caucasian (65%) with a median (range) age of 37 years (23, 69). The one non-ART-naïve patient had received NRTI monotherapy previously. At baseline the median (range) CD4 count and HIV viral load (VL) were 201 cells/mm3 (8, 614) and 5 log copies/ml (3.5, 6), respectively. At 24 and 48 weeks (ITT), 26 patients (65%; 95% CI 46–77) and 20 patients (50%; 95% CI 32–64) achieved HIV-RNA<50 copies/ml, respectively. These values rose to 26/31 (84%; CI 65–94) and 20/25 (79%) in an on treatment (OT) analysis (missing = excluded). At 48 weeks, in an OT analysis, median (range) CD4 change was +155 (-3, +534) cells/mm3 and the median (IQR) change from baseline in total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides was +0.7 (+0.1, +1.8), +0.4 (-0.3, +0.8), +0.3 (+0.1, +0.5) and +0.6 (+0.2, +1.4), respectively. Fifteen patients switched to the LPV/r tablet formulation. Two patients developed AIDS-defining illnesses and discontinued the study drugs; two died (unrelated to study drug); two developed a rash (one Stevens-Johnson syndrome), and one developed NNRTI resistance. Overall, 15 individuals discontinued treatment. The median (range) time to discontinuation was 24 weeks (2, 43).

Conclusion

In this predominantly antiretroviral-naïve cohort, at 48 weeks 79% of the patients remaining on the NRTI-sparing regimen had HIV-RNA <50 copies/ml. These figures are comparable with previously reported figures in similar treatment strategies.

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Open Access This article is published under license to BioMed Central Ltd. This is an Open Access article is distributed under the terms of the Creative Commons Attribution 2.0 International License (https://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Mahungu, T., Else, L., Smith, C. et al. A study to evaluate the efficacy, safety and tolerability of co-administered lopinavir/ritonavir (LPVr) and nevirapine (NVP) in HIV-infected adults. JIAS 11, P6 (2008). https://doi.org/10.1186/1758-2652-11-S1-P6

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  • DOI: https://doi.org/10.1186/1758-2652-11-S1-P6

Keywords

  • Nevirapine
  • Nucleoside Analogue
  • Tablet Formulation
  • Lopinavir
  • Mitochondrial Toxicity