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Title: Efficacy and Safety of Sofosbuvir/Velpatasvir/Voxilaprevir for Hepatitis C Virus (HCV) NS5A-Inhibitor Experienced Patients With Difficult to Cure Characteristics.
Austin Authors: Papaluca, Timothy ;Roberts, Stuart K;Strasser, Simone I;Stuart, Katherine A;Farrell, Geoffrey;MacQuillan, Gerry;Dore, Gregory J;Wade, Amanda J;George, Jacob;Hazeldine, Simon;O'Beirne, James;Wigg, Alan;Fisher, Leslie;McGarity, Bruce;Sawhney, Rohit;Sinclair, Marie ;Thomas, James;Valiozis, Ivan;Weltman, Martin;Wilson, Mark;Woodward, Aidan;Ahlenstiel, Golo;Haque, Mazhar;Levy, Miriam;Prewett, Emily;Sievert, William;Sood, Siddharth ;Tse, Edmund;Valaydon, Zina;Bowden, Scott;Douglas, Mark;New, Kate;O'Keefe, Jacinta;Hellard, Margaret;Doyle, Joseph;Stoove, Mark;Thompson, Alexander J
Affiliation: Medical School, University of Western Australia, Nedlands, Western Australia, Australia
Royal Prince Alfred Hospital, New South Wales, Australia
University of Sydney, New South Wales, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Princess Alexandra Hospital, Queensland, Australia
Canberra Hospital, Australian Capital Territory, Australia
Kirby Institute, UNSW Sydney, New South Wales, Australia
St Vincent's Hospital Sydney, New South Wales, Australia
University Hospital Geelong, Victoria, Australia
Burnet Institute, Victoria, Australia
Fiona Stanley Hospital, Western Australia, Australia
Sunshine Coast University Hospital, Queensland, Australia
University of Sunshine Coast, Queensland, Australia
Nepean Hospital, New South Wales, Australia
Monash University, Victoria, Australia
Flinders Medical Centre, South Australia, Australia
University of Melbourne, Victoria, Australia
Bendigo Health, Victoria, Australia
Bathurst Base Hospital, New South Wales, Australia
Eastern Health, Victoria, Australia
Austin Health
Prince Charles Hospital, Queensland, Australia
University of Queensland, St Lucia, Queensland, Australia
Wollongong Hospital, New South Wales, Australia
Royal Hobart Hospital, Tasmania, Australia
Mater Hospital Brisbane, QueenslandAustralia
Blacktown Mount Druitt Hospital, New South Wales, Australia
Liverpool Hospital, New South Wales, Australia
Deakin University, Victoria, Australia
Monash Health, Victoria, Australia
Royal Melbourne Hospital, Victoria, Australia
Royal Adelaide Hospital, South Australia, Australia
Western Health, Victoria, Australia
Victorian Infectious Diseases Reference Laboratory, Victoria, Australia
Westmead Hospital, New South Wales, Australia
Westmead Institute for Medical Research, University of Sydney, New South Wales, Australia
St Vincent's Hospital Melbourne, Victoria, Australia
Alfred Hospital Melbourne, Victoria, Australia
Issue Date: 2-Nov-2021
Publication information: Clinical Infectious Diseases 2021; 73(9): e3288-e3295
Abstract: In clinical trials, hepatitis C virus (HCV) salvage treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) achieved an SVR12 rate of >95% in NS5A-experienced participants. Lower SVR12 rates have been reported in real-world studies, particularly for genotype (GT)3 infection and cirrhosis. We determined the efficacy and safety of SOF/VEL/VOX in a large real-world cohort. We assessed the efficacy of salvage SOF/VEL/VOX for HCV infection in NS5A-inhibitor experienced participants with cirrhosis and portal hypertension, prior liver transplantation (LT) or severe extra-hepatic manifestations. SOF/VEL/VOX was available via an early access program. The primary outcome was SVR12. Secondary outcome was frequency of adverse events (AE). Ninety-seven participants were included. Median age was 58, 82% were male, 78% had cirrhosis, most with portal hypertension (61%, n = 46/76), and 18% had prior-LT. Of the cirrhotic participants, 96% were Child-Turcotte-Pugh class A, and 4% were class B. Of the 72% with GT3, 76% were also cirrhotic. By intention-to-treat analysis, SVR12 rate was 85% (n = 82/97). Per protocol, the SVR12 rate was 90%, including 91% in GT1 (GT1a n = 18/18, GT1b n = 2/4), 89% in GT3 (n = 59/66) and 100% in GT6 (n = 3/3). SVR12 in participants with GT3 and cirrhosis was 90%. No predictors of non-SVR12 were identified. There were 4 serious AEs including 1 death and 3 hepatic decompensation events. NS5A resistance-associated substitutions detected at baseline did not affect SVR12. This real-world study confirms high efficacy of SOF/VEL/VOX for the treatment of difficult-to-cure NS5A-inhibitor experienced patients, including those with GT3 and cirrhosis. Treatment was well tolerated in most; however, serious AEs can occur in those with advanced liver disease.
DOI: 10.1093/cid/ciaa1318
ORCID: 0000-0003-4621-3485
Journal: Clinical Infectious Diseases
PubMed URL: 32887983
Type: Journal Article
Subjects: cirrhosis
genotype 3
hepatitis C
Appears in Collections:Journal articles

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