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Title: Efficacy and safety of sofosbuvir/velpatasvir/voxilaprevir for 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: Bathurst Base Hospital, New South Wales, Australia
Bendigo Health, Victoria, Australia
University of Sunshine Coast, Queensland, Australia
Sunshine Coast University Hospital, Queensland, Australia
Fiona Stanley Hospital, Western Australia, Australia
Westmead Institute for Medical Research, The University of Sydney, New South Wales, Australia
Westmead Hospital, New South Wales, Australia
Burnet Institute, Victoria, Australia
University Hospital Geelong, Victoria, Australia
St Vincent's Hospital Sydney, New South Wales, Australia
Kirby Institute, UNSW Sydney, New South Wales, Australia
Medical School, University of Western Australia, Nedlands, Western Australia, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Canberra Hospital, Australian Capital Territory, Australia
Princess Alexandra Hospital, Queensland, Australia
The University of Sydney, New South Wales, Australia
Royal Prince Alfred Hospital, New South Wales, Australia
Monash University, Victoria, Australia
The Alfred Hospital Melbourne, Victoria, Australia
Victorian Infectious Diseases Reference Laboratory, Victoria, Australia
St Vincent's Hospital Melbourne, Victoria, Australia
The University of Melbourne, Victoria, Australia
Western Health, Victoria, Australia
Royal Adelaide Hospital, South Australia, Australia
Royal Melbourne Hospital, Victoria, Australia
Monash Health, Victoria, Australia
Deakin University, Victoria, Australia
Liverpool Hospital, New South Wales, Australia
Blacktown Mount Druitt Hospital, New South Wales, Australia
Mater Hospital Brisbane, Queensland Australia
Royal Hobart Hospital, Tasmania, Australia
Nepean Hospital, New South Wales, Australia
Wollongong Hospital, New South Wales, Australia
University of Queensland, St Lucia, Queensland, Australia
The Prince Charles Hospital, Queensland, Australia
Austin Health
Eastern Health, Victoria, Australia
Flinders Medical Centre, South Australia, Australia
Issue Date: 5-Sep-2020 2020-09-05
Publication information: Clinical Infectious Diseases 2020; online first: 5 September
Abstract: In clinical trials, 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 four serious AEs including one death and three 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
Journal: Clinical Infectious Diseases
PubMed URL: 32887983
Type: Journal Article
Subjects: Hepatitis C
genotype 3
Appears in Collections:Journal articles

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