Short duration pan‐genotypic therapy with glecaprevir‐pibrentasvir for six weeks among people with recent HCV infection
File(s)Martinello_et_al-2019-Hepatology.pdf (11.93 MB)
Accepted version
Author(s)
Type
Journal Article
Abstract
Among treatment‐naïve individuals with chronic HCV infection and without cirrhosis, glecaprevir‐pibrentasvir for eight weeks is recommended. The aim of this analysis was to evaluate the efficacy of glecaprevir‐pibrentasvir for six weeks in people with acute and recent HCV infection. In this open‐label single‐arm multicentre international pilot study, adults with recent HCV (duration of infection <12 months) received glecaprevir‐pibrentasvir 300mg‐120mg daily for six weeks. Primary infection was defined by first positive anti‐HCV antibody and/or HCV RNA within six months of enrolment and either acute clinical hepatitis within the past 12 months (symptomatic seroconversion illness or ALT>10xULN) or anti‐HCV antibody seroconversion within 18 months. Reinfection was defined as new positive HCV RNA within six months of enrolment and evidence of prior spontaneous or treatment‐induced clearance. The primary endpoint was sustained virologic response at 12 weeks post‐treatment (SVR12). Thirty men (median age 43 years, 90% men‐who‐have‐sex‐with‐men) received treatment, of whom 77% (n=23) were HIV‐positive, 47% (n=14) had ever injected drugs, and 13% (n=4) had HCV reinfection. The majority had HCV genotype 1 (83%, n=25), followed by genotype 4 (10%, n=3) and genotype 3 (7%, n=2). At baseline, median estimated duration of infection was 29 weeks (range 13, 52) and median HCV RNA was 6.2 log10 IU/mL (range 0.9, 7.7). SVR12 in the intention‐to‐treat and per‐protocol populations was achieved in 90% (27/30) and 96% (27/28), respectively. There was one case of relapse and two cases of non‐virological failure (death, n=1; loss to follow up, n=1). No treatment‐related serious adverse events were seen.
Date Issued
2020-07-01
Date Acceptance
2019-10-01
Citation
Hepatology, 2020, 72 (1), pp.7-18
ISSN
0270-9139
Publisher
Wiley
Start Page
7
End Page
18
Journal / Book Title
Hepatology
Volume
72
Issue
1
Copyright Statement
© 2019 by the American Association for the Study of Liver Diseases. This is the accepted version of the following article: Martinello, M. , Orkin, C. , Cooke, G. , Bhagani, S. , Gane, E. , Kulasegaram, R. , Shaw, D. , Tu, E. , Petoumenos, K. , Marks, P. , Grebely, J. , Dore, G. J., Nelson, M. and Matthews, G. V. (2019), Short duration pan‐genotypic therapy with glecaprevir‐pibrentasvir for six weeks among people with recent HCV infection. Hepatology. Accepted Author Manuscript, which has been published in final form at https://doi.org/10.1002/hep.31003
Sponsor
Medical Research Council (MRC)
National Institute for Health Research
Medecins Sans Frontieres (MSF)
National Institute for Health Research
Identifier
https://aasldpubs.onlinelibrary.wiley.com/doi/abs/10.1002/hep.31003
Grant Number
MR/K01532X/1
EME/14/02/17
PO 0501154372
RP-2016-07-012
Subjects
1101 Medical Biochemistry and Metabolomics
1103 Clinical Sciences
1107 Immunology
Gastroenterology & Hepatology
Publication Status
Published
Article Number
hep.31003
Date Publish Online
2019-10-24