Rilpivirine use in the Swiss HIV cohort study: a prospective cohort study

Delphine Sculier,For The Swiss Hiv Cohort Study ,Angèle Gayet-Ageron,Jan Fehr,Enos Bernasconi,Manuel Battegay,Patrick Schmid,Matthias Cavassini,Cedric Hirzel,Alexandra Calmy

doi:10.1186/s12879-017-2579-2

Abstract

BackgroundRilpivirine is safe and effective in HIV-naïve patients with low baseline HIV-RNA or in switch strategy. It offers the advantages of few drug-drug interactions and a favourable toxicity profile. We aimed to determine the reasons for prescribing the rilpivirine (RPV)/tenofovir disoproxil (TDF)/emtricitabine (FTC) co-formulation within the Swiss HIV Cohort Study and to assess its effectiveness and safety over a 24 months period.MethodsAll individuals enrolled in the Swiss HIV Cohort Study who initiated a RPV/TDF/FTC co-formulation between April 2013 and March 2014 were included. Primary outcomes were the HIV-RNA viral load (copies/mL) and CD4 cell count (cells/mm3) at 6, 12 and 24 months. Reasons for a switch to RPV/TDF/FTC were evaluated through a standardized questionnaire. We also assessed discontinuation and reasons for discontinuation of RPV/TDF/FTC until October 30, 2015.ResultsOf 644 individuals who started the RPV/TDF/FTC co-formulation, only 7.5% were treatment-naïve. At 24 months, viral suppression (HIV-RNA <50 copies/mL) was achieved in 100% and 96.7% of cART-naïve and cART-experienced patients respectively. The switch to RPV was mainly done for simplification (44.6%) and to overcome central nervous system toxicity symptoms due to efavirenz (24%). Six months after switch, 74.8% of patients reported an improvement of psycho-neurological symptoms with continued improvement at 12 months for almost 80%. However, one quarter of patients reported a discontinuation of RPV/TDF/FTC on October 30, 2015 after a median time of 18.4 months. Reasons for discontinuation included physician decision (5.3%) and side-effects (3.9%) mainly related to the central nervous system and to renal toxicity.ConclusionThe RPV/TDF/FTC co-formulation was safe and effective throughout 24 months of follow-up but barely prescribed for HIV-naïve patients. Despite excellent virological suppression among both treatment-naïve and -experienced patients, we observed a high rate of treatment discontinuation.

Highlights

Rilpivirine is safe and effective in Human immunodeficiency virus (HIV)-naïve patients with low baseline HIV-RNA or in switch strategy
Our experience suggested that the RPV/TDF/FTC co-formulation was used among virologically suppressed combined antiretroviral treatment (cART)-experienced patients in a switch strategy, either to reduce adverse events due to the current regimen or for treatment simplification
75% of all HIV infected patients on cART in Switzerland are followed within the Swiss HIV Cohort Study (SHCS) network [21]

Summary

Introduction

Rilpivirine is safe and effective in HIV-naïve patients with low baseline HIV-RNA or in switch strategy. We aimed to determine the reasons for prescribing the rilpivirine (RPV)/tenofovir disoproxil (TDF)/emtricitabine (FTC) co-formulation within the Swiss HIV Cohort Study and to assess its effectiveness and safety over a 24 months period. The combination of rilpivirine (RPV), tenofovir disoproxil (TDF) and emtricitabine (FTC) has demonstrated noninferior efficacy in randomized controlled trials compared to efavirenz (EFV)-based regimens among HIV-infected, treatment-naïve patients with a baseline viral load of less than 105 copies/mL [1,2,3,4]. Our experience suggested that the RPV/TDF/FTC co-formulation was used among virologically suppressed cART-experienced patients in a switch strategy, either to reduce adverse events due to the current regimen or for treatment simplification. We assessed its effectiveness and safety at 6 (M6), 12 (M12) and 24 months (M24) post-initiation under routine clinical conditions

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