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A randomized clinical trial comparing ritonavir-boosted lopinavir versus maraviroc each with tenofovir plus emtricitabine for post-exposure prophylaxis for HIV infection.
J Antimicrob Chemother. 2016 07; 71(7):1982-6.JA

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 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.

CONCLUSIONS

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.

Authors+Show Affiliations

Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain.Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain.Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain.Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain.Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain.Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain.Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain.Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain.Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain.Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain.Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain.Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain fgarcia@clinic.ub.es.No affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26994091

Citation

Leal, Lorna, et al. "A Randomized Clinical Trial Comparing Ritonavir-boosted Lopinavir Versus Maraviroc Each With Tenofovir Plus Emtricitabine for Post-exposure Prophylaxis for HIV Infection." The Journal of Antimicrobial Chemotherapy, vol. 71, no. 7, 2016, pp. 1982-6.
Leal L, León A, Torres B, et al. A randomized clinical trial comparing ritonavir-boosted lopinavir versus maraviroc each with tenofovir plus emtricitabine for post-exposure prophylaxis for HIV infection. J Antimicrob Chemother. 2016;71(7):1982-6.
Leal, L., León, A., Torres, B., Inciarte, A., Lucero, C., Mallolas, J., Laguno, M., Martínez-Rebollar, M., González-Cordón, A., Manzardo, C., Rojas, J., Pich, J., Arnaiz, J. A., Gatell, J. M., & García, F. (2016). A randomized clinical trial comparing ritonavir-boosted lopinavir versus maraviroc each with tenofovir plus emtricitabine for post-exposure prophylaxis for HIV infection. The Journal of Antimicrobial Chemotherapy, 71(7), 1982-6. https://doi.org/10.1093/jac/dkw048
Leal L, et al. A Randomized Clinical Trial Comparing Ritonavir-boosted Lopinavir Versus Maraviroc Each With Tenofovir Plus Emtricitabine for Post-exposure Prophylaxis for HIV Infection. J Antimicrob Chemother. 2016;71(7):1982-6. PubMed PMID: 26994091.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized clinical trial comparing ritonavir-boosted lopinavir versus maraviroc each with tenofovir plus emtricitabine for post-exposure prophylaxis for HIV infection. AU - Leal,Lorna, AU - León,Agathe, AU - Torres,Berta, AU - Inciarte,Alexy, AU - Lucero,Constanza, AU - Mallolas,Josep, AU - Laguno,Montserrat, AU - Martínez-Rebollar,María, AU - González-Cordón,Ana, AU - Manzardo,Christian, AU - Rojas,Jhon, AU - Pich,Judit, AU - Arnaiz,Joan A, AU - Gatell,Josep M, AU - García,Felipe, AU - ,, Y1 - 2016/03/18/ PY - 2015/09/29/received PY - 2016/02/04/accepted PY - 2016/3/20/entrez PY - 2016/3/20/pubmed PY - 2017/8/23/medline SP - 1982 EP - 6 JF - The Journal of antimicrobial chemotherapy JO - J Antimicrob Chemother VL - 71 IS - 7 N2 - 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 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. CONCLUSIONS: 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. SN - 1460-2091 UR - https://www.unboundmedicine.com/medline/citation/26994091/A_randomized_clinical_trial_comparing_ritonavir_boosted_lopinavir_versus_maraviroc_each_with_tenofovir_plus_emtricitabine_for_post_exposure_prophylaxis_for_HIV_infection_ L2 - https://academic.oup.com/jac/article-lookup/doi/10.1093/jac/dkw048 DB - PRIME DP - Unbound Medicine ER -