Please use this identifier to cite or link to this item: https://repository.monashhealth.org/monashhealthjspui/handle/1/35904
Title: Retreatment with elbasvir, grazoprevir, sofosbuvir +/- ribavirin is effective for GT3 and GT1/4/6 HCV infection after relapse.
Authors: Pianko S. ;Doyle J.;Stoove M.;Hellard M.;Iser D.;Thompson A.;Sievert W. ;Papaluca T.;Sinclair M.;Gow P.;Arachchi N.;Cameron K.;Bowden S.;O'Keefe J.
Institution: (Papaluca, Iser, Thompson) St Vincent's Hospital and the University of Melbourne, Fitzroy, VIC, Australia (Sinclair, Gow) The Austin Hospital, Melbourne, VIC, Australia (Pianko, Sievert) Monash Health and Monash University, Melbourne, VIC, Australia (Arachchi, Cameron) Western Health, Melbourne, VIC, Australia (Bowden, O'Keefe) Victorian Infectious Disease Reference Laboratory, Melbourne, VIC, Australia (Doyle) Department of Infectious Diseases, The Alfred and Monash University, Melbourne, VIC, Australia (Doyle, Stoove, Hellard) Burnet Institute, Melbourne, VIC, Australia
Issue Date: 15-Dec-2019
Copyright year: 2019
Publisher: Blackwell Publishing Ltd
Place of publication: United Kingdom
Publication information: Liver International. 39 (12) (pp 2285-2290), 2019. Date of Publication: 01 Dec 2019.
Journal: Liver International
Abstract: Introduction: Despite highly effective direct-acting antiviral (DAA) therapies for chronic hepatitis C virus (HCV) infection, some patients experience virological relapse. Salvage regimens should include multiple agents to suppress emergence of resistance-associated substitutions (RAS) and minimise treatment failure. The combination of sofosbuvir (SOF) and elbasvir/grazoprevir (ELB/GZR) +/-ribavirin (RBV) is an effective retreatment strategy for HCV genotype (GT)1 and 4 infection. We hypothesised that SOF and ELB/GZR (+/-RBV) would also be an effective salvage regimen for DAA-experienced GT3 patients. Method(s): We evaluated the efficacy and safety of SOF/ELB/GZR +/- RBV in DAA-experienced participants with chronic HCV infection who had prior relapse. Participants were treated at four hospitals between December 2016 and March 2018 for either 12- or 16-weeks. The primary endpoint was sustained virological response at week 12 post-treatment (SVR12) using intention-to-treat analysis. Result(s): There were 40 participants included in the analysis. The mean age was 53 years, 53% had GT3, 33% had GT1 infection and 63% had cirrhosis. Fifty-eight percent were treated for 12 weeks, 42% were treated for 16 weeks and 90% received RBV. The SVR12 rate was 98% overall, 100% in non-GT3 participants and 95% in GT3 participants. One GT3 cirrhotic participant relapsed. ELB/GZR was stopped at week 6 in one GT3 cirrhotic participant who switched to SOF/velpatasvir/RBV for a further 12 weeks and achieved SVR12. RBV dose reduction was required in two participants. Treatment was otherwise well tolerated. Discussion(s): The combination of SOF/ELB/GZR +/- RBV is effective and safe for difficult-to-cure patients who relapse after first-line DAA, including those with cirrhosis and GT3 infection.Copyright © 2019 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
DOI: http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1111/liv.14201
PubMed URL: 31355968 [http://www.ncbi.nlm.nih.gov/pubmed/?term=31355968]
ISSN: 1478-3223
URI: https://repository.monashhealth.org/monashhealthjspui/handle/1/35904
Type: Article
Subjects: adult
Hepatitis C virus genotype 1
Hepatitis C virus genotype 4
Hepatitis C virus genotype 6
human
insomnia/si [Side Effect]
intention to treat analysis
liver cirrhosis
male
rash/si [Side Effect]
headache/si [Side Effect]
retreatment
sustained virologic response
treatment duration
treatment outcome
*relapse
*hepatitis C/dt [Drug Therapy]
article
clinical article
drug dose reduction
drug efficacy
drug safety
drug tolerability
drug withdrawal
fatigue/si [Side Effect]
female
gastrointestinal symptom/si [Side Effect]
*elbasvir plus grazoprevir/ae [Adverse Drug Reaction]
*elbasvir plus grazoprevir/cb [Drug Combination]
*elbasvir plus grazoprevir/dt [Drug Therapy]
nonstructural protein 5A/ec [Endogenous Compound]
*ribavirin/ae [Adverse Drug Reaction]
*ribavirin/cb [Drug Combination]
*ribavirin/dt [Drug Therapy]
*sofosbuvir/ae [Adverse Drug Reaction]
*sofosbuvir/cb [Drug Combination]
*sofosbuvir/dt [Drug Therapy]
sofosbuvir plus velpatasvir/cb [Drug Combination]
sofosbuvir plus velpatasvir/dt [Drug Therapy]
adverse event
*antiviral therapy
*hepatitis C / *drug therapy
adult
adverse event
*antiviral therapy
Article
clinical article
drug dose reduction
drug efficacy
drug safety
drug tolerability
drug withdrawal
fatigue / side effect
female
gastrointestinal symptom / side effect
headache / side effect
Hepatitis C virus genotype 1
Hepatitis C virus genotype 4
Hepatitis C virus genotype 6
human
insomnia / side effect
intention to treat analysis
liver cirrhosis
male
rash / side effect
*relapse
retreatment
sustained virologic response
treatment duration
treatment outcome
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