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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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