1015. Gastrointestinal (GI) Adverse Events With Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Through Week 96: An AMBER Post Hoc Analysis

ABSTRACT: Abstract

Background

Ritonavir boosted protease inhibitors have been associated with GI intolerance. A post hoc analysis was conducted to assess the GI profile of D/C/F/TAF in treatment naïve patients.

Methods

The phase 3 AMBER trial (ClinicalTrials.gov: NCT02431247) enrolled treatment naïve patients randomized 1:1 to receive once daily D/C/F/TAF 800/150/200/10 mg or D/C + F/tenofovir disoproxil fumarate (TDF). This post hoc analysis evaluated the incidence, prevalence and duration of GI adverse events of interest (AEOIs) through Wk 96. Related GI AEOIs were defined as diarrhea, nausea, abdominal pain and flatulence (by preferred term using MedDRAv21) deemed very likely, probable, or possibly related to study drug by the investigator. Incidence and prevalence were examined

SUBMITTER: Dunn K 

PROVIDER: S-EPMC7776806 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature