Efficacy and safety of switching double‐boosted protease inhibitors to boosted darunavir in HIV‐infected patients with virologic suppression

Purpose of the study Switching to ritonavir‐boosted darunavir (DRV/r) in patients treated with double ritonavir‐boosted protease inhibitors (PI/r) may result in better tolerability, less pill burden, better lipid profile and a lower cost, while maintaining virologic efficacy. Methods Multicentre, concurrent cohort observational study. HIV‐infected adults with HIV RNA <50 copies/mL for at least the previous 12 months on a double PI/r‐based therapy were offered to switch to DRV/r (DRV group) or to continue on the same regimen (control group). Visits (including blood tests, adherence and side effects assessment) were performed every 3 months, with a follow‐up of at least one year. Descriptive values are described as n (%) or median (interquartile range). Changes from baseline in quantitative variables have been calculated with the Wilcoxon Signed Ranks Test and comparisons between groups have been performed with the Mann‐Whitney test, using SPSS 20.0 statistical package. Summary of results 65 patients were included (35 DRV group and 30 control group); median age was 46 (40–49) years, 76% were male. At baseline, double‐boosted PI regimens were lopinavir‐atazanavir/r 24%, lopinavir‐saquinavir/r 46%, lopinavir‐fosamprenavir/r 8%, atazanavir‐saquinavir/r 18% and others 4%. There were no significant differences between groups in baseline characteristics, except for patients who switched to DRV had a higher number of prior antiretroviral regimens [6 (3–8) vs 2 (1–4), p=.002]. Of the patients who switched to DRV/r, 46% received DRV/r once‐daily and 54% twice‐daily. After 48 weeks, one patient in each arm had virologic failure and one patient in the DRV arm stopped treatment due to side effects (depressive syndrome); there were no episodes of rash or clinical hepatitis. Efficacy (HIV RNA <50 copies/mL) was similar in the DRV and control groups by intention‐to‐treat analysis (94 vs. 97%, p=NS). There were no significant differences in laboratory parameters between treatment groups except for a decrease in total bilirrubin in patients who switched to DRV/r (−0.69 vs +0.28 mg/dL, p=.028). Treatment switch represented a median saving of 157 (32–264) euros per patient per month. Conclusions Switching from a double‐boosted PI regimen to DRV maintains virologic efficacy, with good tolerability and a lower cost.