Glecaprevir-pibrentasvir for 4 weeks among people with recent HCV infection: The TARGET3D study.

Background & Aims

Short duration treatment may aid HCV elimination among key populations. This study evaluated the efficacy of glecaprevir-pibrentasvir for 4 weeks among people with recent HCV infection.

Methods

In this single-arm multicentre international trial, adults with recent HCV (duration of infection <12 months) received glecaprevir-pibrentasvir 300 mg-120 mg daily for 4 weeks. Primary infection was defined as a first positive anti-HCV antibody and/or HCV RNA measurement within 6 months of enrolment and either acute clinical hepatitis within 12 months (symptomatic illness or alanine aminotransferase >10x the upper limit of normal) or antibody seroconversion within 18 months. Reinfection was defined as new positive HCV RNA within 6 months and prior clearance (spontaneous or treatment). The primary endpoint was sustained virological response at 12 weeks post-treatment (SVR12) in the intention-to-treat (ITT) and per-protocol (PP) populations.

Results

Twenty-three participants (96% men, 70% HIV, 57% ever injected drugs) received treatment, of whom 74% had genotype 1a infection and 35% recent reinfection. At baseline, median duration of infection was 17 weeks (IQR 11-29) and HCV RNA was 5.8 log

Conclusion

While most achieved SVR, the efficacy of a 4-week regimen of glecaprevir-pibrentasvir was lower than observed with longer treatment durations (≥6 weeks) among people with recent HCV.

Trial Registration

Clinicaltrials.gov Identifier: NCT02634008.

Impact and implications

Short duration treatment may aid HCV elimination among key populations. This investigator-initiated single-arm multicentre international pilot trial demonstrated that efficacy of glecaprevir-pibrentasvir for 4 weeks among people with recent HCV infection was sub-optimal (SVR12 78% ITT, 82% PP). Baseline HCV RNA appeared to impact response, with higher efficacy among participants with lower baseline HCV RNA (≤6 log

Informations de copyright

© 2023 The Authors.

Déclaration de conflit d'intérêts

MM: No conflict. SB: Participated in advisory boards and is on the speaker’s bureau for AbbVie and Gilead. DS: No conflict. CO: Honoraria for advisory boards, lecture fees and travel scholarships from MSD, Janssen, Gilead, ViiV and AbbVie, and research grant funding from all the above. GC: Consultant/advisor for and has received grant funding from Gilead and MSD. EG: Participated in the advisory boards and also in speakers’ bureau for Gilead Sciences Inc, Janssen and AbbVie. DI: No conflict. AU: No conflict. RK: No conflict. CS: No conflict. ET: No conflict. JG: Consultant/advisor and has received research grants from AbbVie, bioLytical, Camurus, Cepheid, Gilead Sciences, Hologic, and Indivior. GJD: Advisory board member and has received honoraria from Merck, Gilead, and AbbVie, has received research grant funding from Merck, Gilead, and AbbVie, and travel sponsorship from Merck, Gilead, and AbbVie. MN: Advisory board payments, speaker payments and research funding from AbbVie, Bristol Myers Squibb, Gilead, and MSD. GVM: Research funding, advisory board payments and speaker payments from Gilead, AbbVie, and ViiV and research funding and speaker payments from Janssen. Please refer to the accompanying ICMJE disclosure forms for further details.