A randomized clinical trial comparing ritonavir-boosted lopinavir versus maraviroc each with tenofovir plus emtricitabine for post-exposure prophylaxis for HIV infection

Abstract

Objectives: The objective of this study was to assess post-exposure prophylaxis (PEP) non-completion at day 28, comparing ritonavir-boosted lopinavir versus maraviroc, both with tenofovir disoproxil/emtricitabine as the backbone. Methods: We conducted a prospective, open, randomized clinical trial. Individuals attending the emergency room because of potential sexual exposure to HIV and who met criteria for receiving PEP were randomized to one of two groups: tenofovir disoproxil/emtricitabine (245/200 mg) once daily plus either ritonavir-boosted lopinavir (400/100 mg) or maraviroc (300 mg) twice daily. Five follow-up visits were scheduled for days 1, 10, 28, 90 and 180. The primary endpoint was PEP non-completion at day 28. Secondary endpoints were adherence, adverse events and rate of seroconversions. This study was registered in ClinicalTrials.gov: NCT01533272. Results: One-hundred-and-seventeen individuals were randomized to receive ritonavir-boosted lopinavir and 120 to maraviroc (n=237). PEP non-completion at day 28 was 38% (n=89), with significant differences between arms [ritonavir-boosted lopinavir 44% (n=51) versus maraviroc 32% (n=38), P=0.05]. We performed a modified ITT analysis including only those patients who attended on day 1 (n=182). PEP noncompletion in this subgroup was also significantly higher in the ritonavir-boosted lopinavir arm (27% versus 13%, P=0.004). The proportion of patients with low adherence was similar between arms (52% versus 47%, P=0.56). Adverse events were reported by 111 patients and were significantly more common in the ritonavir- boosted lopinavir arm (72% versus 51%, P=0.003). No seroconversions were observed during the study. Conclusions: PEP non-completion and adverse eventswere both significantly higher in patients allocated to ritonavir- boosted lopinavir. These data suggest that maraviroc is a well-tolerated antiretroviral that can be used in this setting.