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

• Published in: Journal of antimicrobial chemotherapy 2016-07, Vol.71 (7), p.1982-1986
• Main Authors: Leal, Lorna, León, Agathe, Torres, Berta, Inciarte, Alexy, Lucero, Constanza, Mallolas, Josep, Laguno, Montserrat, Martínez-Rebollar, María, González-Cordón, Ana, Manzardo, Christian, Rojas, Jhon, Pich, Judit, Arnaiz, Joan A, Gatell, Josep M, García, Felipe
• Format: Article
• Language: English
• Subjects: Adult; Anti-HIV Agents - administration & dosage; Anti-HIV Agents - adverse effects; Antiretroviral drugs; Chemoprevention - adverse effects; Chemoprevention - methods; Clinical trials; Comparative analysis; Drug-Related Side Effects and Adverse Reactions - epidemiology; Female; HIV; HIV Infections - prevention & control; Human immunodeficiency virus; Humans; Male; Medication Adherence; Post-Exposure Prophylaxis - methods; Prospective Studies; Risk assessment
• ISSN: 0305-7453; 1460-2091
• DOI: 10.1093/jac/dkw048

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. 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. 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 non-completion 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. PEP non-completion and adverse events were 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.