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Clinical pharmacy and clinical trials (including case series)
Virological response at 24 weeks and safety of darunavir/ritonavir in HIV infected patients
  1. B. Lopez Centeno,
  2. M. Polanco Paz,
  3. P. Sanmartin Fenollera,
  4. M. Perez Encinas
  1. 1Hospital Universitario Fundación Alcorcón Hospital Pharmacy Madrid, Spain

Abstract

Background Use evaluation in clinical practice of darunavir boosted with ritonavir(DRV/r) in HIV patients.

Purpose Study the effectiveness and safety of DRV/r at 24 weeks (24Ws).

Materials and methods Retrospective observational study of series of HIV patients treated with DRV/r between January-2008 and September-2011. The changes in viral load (VL) and CD4 cell counts were evaluated in patients at baseline and at 24Ws. Also, safety and tolerability. End points: i)Primary effectiveness: % patients with VL<50 copies/ml at 24Ws, in patients with virologic failure(VF) or VL<50 initially; ii)Security: discontinuation rate due to intolerance or toxicity. Secondary effectiveness end points: i)Increased CD4 at 24w; ii)Security: hepatotoxicity(criteria: ALT/AST concentrations(U/L)>5N(55/41) in HCV/HBV non-coinfected and >3.5 baseline in coinfected). Data analysis using descriptive statistics

CPC070 table 1

At time of analysis 28/30 patients completed 24Ws of therapy.

Results Most common DRV/r-based regimens: 27.3% PI/r, 54.5% PI/r+2NRTIs in VL<50 group and 35.3% PI/r+RAL+NNRTIs, 29.4% PI/r in VF group. 39.3% HCV/HBV coinfected(Child-Pugh A 90.9% and B 9.1%), none antihepatitis treatment, median ALT=125(IQR: 48-170)/AST=113(IQR: 55-136). Non-coinfected, median ALT=20(IQR: 12-24)/AST=20(IQR: 17.5-24.5). Two patients 18.2%(95% CI:2.3-51.7) with VL>50(94/113 copies/ml respectively) in VL<50 group, while 47%(95% CI:23-72.2) in VF group achieved undetectable VL. Median CD4 variation in VL<50 group was -16cell/mm3(95% CI: -88-102) and in VF group was 50 cell/mm3(95% CI: 33-179). 6.6%(n=30) patients discontinued treatment (abdominal pain/constipation and hypersensitivity). No episodes of hepatotoxicity.

Conclusions This study, performed in a small group of patients in routine clinical care, showed that, at 24Ws, the regimens of rescue which contain DRV/r, achieve similar rates of virological suppression than those observed in the clinical trials. During the study, DRV/r was well tolerated and safe in HIV non-coinfected and coinfected patients with mild and moderate hepatic impairment.

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