Safety and efficacy of fixed-dose combination rilpivirine-tenofovir-emtricitabine (RPV/TDF/FTC) in treatment-experienced patients infected with HIV-1

Purpose of the study : Rilpivirine (RPV) is a new non-nucleoside reverse transcriptase inhibitor (NNRTI) which has shown non-inferiority to efavirenz (EFV) in terms of efficacy and safety profiles. The vast majority of clinical data has been performed in the treatment naive population and has not been studied in depth in treatment-experienced patients. We sought to explore the safety and efficacy of RPV/TDF/FTC in treatment-experienced patients attending our clinics. Methods: HIV-infected individuals commenced on RPV/TDF/FTC from December 2011 to June 2012 were retrospectively identified from a patient database. Patient demographics were extracted. Biochemical, virological and immunological parameters were collated. At baseline, 1 month and 3 month time points the following laboratory results were compared using the Kruskal-Wallis test: CD4 count, HIV viral load, amino transferase (ALT), cholesterol, triglyceride and HDL/cholesterol ratio. Summary of results: Sixty-five patients (4 female) were identified. Median age was 38 years (range: 25-73). Fifty-six patients were treatment experienced (2 re-start); 39 on NNRTI-based (33 on EFV), 10 on PI-based and 4 on other regimens. 9 patients were naive to treatment. The reasons for switch are illustrated in Fig. 1. Fifty-four patients had HIV-RNA-1 <40 copies/mL at the time of switch and all remained undetectable at 3 months. At baseline, the median CD4 count was 555 cells/mm 3 (range: 209-1586) in the switch group, which increased significantly to 638 cells/mm 3 (p<0.005) 3 months after switch. Switch to RPV/TDF/FTC had a favorable effect on lipid profile. At baseline the median cholesterol, triglyceride and HDL/cholesterol ratio levels were 4.8 mmol/L, 1.78 mmol/L and 4.37 respectively. At 1 month post-switch this decreased to 4.5 mmol/L, 1.65 mmol/L and 4.24 and at 3 months post-switch decreased to 4.1 mmol/L, 1.44 mmol/L and 4.04. Median HIV-RNA-1 in treatment-naive patients (n=9) at baseline was 50298 copies/mL, at 1 month four patients had HIV-RNA-1 <40 copies/mL and at 3 months eight patients had HIV-RNA-1 <40 copies/mL. RPV/TDF/FTC had no favourable effect on lipid profile in treatment-naive group and had no effect on ALT levels in either the switch or the treatment-naive group. Conclusion: In this cohort, RPV/TDF/FTC has been shown to have a safe virological efficacy and safety profile as a switch therapy for patients suppressed on their current standard of care and are experiencing adverse events. (Published: 11 November 2012) Citation: Abstracts of the Eleventh International Congress on Drug Therapy in HIV Infection Cevik M et al. Journal of the International AIDS Society 2012, 15 (Suppl 4):18291 http://www.jiasociety.org/index.php/jias/article/view/18291 | http://dx.doi.org/10.7448/IAS.15.6.18291