Effectiveness, Safety, and Patient-reported Outcomes of Emtricitabine/tenofovir Alafenamide-based Regimens for the Treatment of HIV-1 Infection: Final 24-month Results from the Prospective German TAFNES Cohort Study

Overview

Journal HIV Med

Publisher Wiley

Specialty Infectious Diseases

Date 2024 Oct 30

PMID 39476488

Authors

Christoph Stephan

Christoph D Spinner

Ansgar Rieke

Stefan Christensen

Stefan Mauss

Sandra Schreiber

Boris Albuquerque

Marion Heinzkill

Heribert Ramroth

Hans-Jurgen Stellbrink

Affiliations

Soon will be listed here.

Abstract

Background: Tenofovir alafenamide (TAF) was introduced in the European Union in 2015 as a novel prodrug of tenofovir showing similar efficacy in clinical trials and a more favorable safety profile than tenofovir disoproxil fumarate (TDF). The German TAFNES cohort study (2016-2019) was conducted to generate real-world evidence.

Methods: Treatment-naïve (TN) and treatment-experienced (TE) people with HIV (PWH) receiving elvitegravir/cobicistat/emtricitabine/TAF (E/C/F/TAF), rilpivirine/F/TAF (R/F/TAF) or F/TAF + 3rd agent were included. Month (M) 24 outcomes included virologic effectiveness (HIV RNA <50 copies/mL), treatment persistence, adverse drug reactions (ADRs) and patient-reported outcomes, using the HIV Symptom Index (HIV-SI), 36-Item Short Form Health Survey (SF-36) and HIV Treatment Satisfaction (HIVTSQ) questionnaires.

Results: The study included 767 PWH (92% men, median age 46 years; 301 TN, 466 TE; E/C/F/TAF [n = 318], R/F/TAF [n = 192], F/TAF + 3rd agent [n = 257]). Among TN, 35% had late HIV diagnosis (CD4 < 350/μL and/or AIDS). Of TE, 95% were on suppressive antiretroviral therapy (ART) before switching. D:A:D (Data Collection on Adverse Effects of Anti-HIV Drugs) 5-year risks for chronic kidney disease were high for about 1 in 10 TN and 4 in 10 TE. Overall treatment persistence at M24 was 81% (E/C/F/TAF: 88%; R/F/TAF: 86%; F/TAF + 3rd agent: 70%, with ART simplification of multiple-tablet regimens in 13%). M24 viral suppression (missing = excluded) was 96% (479/501). Discontinuations due to virologic failure or ADRs were rare, 2% (12/767) and 4% (30/767), respectively. HIV-SI and SF-36 summary scores improved in TN; HIVTSQ change scores showed an improvement in treatment satisfaction in TE.

Conclusion: Real-world data confirmed a favorable safety profile and high virologic effectiveness with high treatment satisfaction on F/TAF-based ART.

Citing Articles

Effectiveness, safety, and patient-reported outcomes of emtricitabine/tenofovir alafenamide-based regimens for the treatment of HIV-1 infection: Final 24-month results from the prospective German TAFNES cohort study.

Stephan C, Spinner C, Rieke A, Christensen S, Mauss S, Schreiber S HIV Med. 2024; 26(2):239-251.

PMID: 39476488 PMC: 11786613. DOI: 10.1111/hiv.13728.

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