1. Final challenges: real-world experience with sofosbuvir, velpatasvir and voxilaprevir in patients with advanced cirrhosis.
- Author
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Thomas J., O'Beirne J., Hazeldine S., Valaydon Z., Douglas M., Bowden S., O'Keefe J., Holmes J., Thompson A., Papaluca T., Roberts S., Strasser S., Stuart K., New K., Farrell G., Dore G., WIGG A., Woodward A., Wade D.A., George J., Sinclair M., McGarity B., Fisher A.L., Sawhney R., Wilson M., Valiozis I., Levy M., Tse E., Ahlenstiel G., Haque M., Prewett E., Sievert W., Sood S., Thomas J., O'Beirne J., Hazeldine S., Valaydon Z., Douglas M., Bowden S., O'Keefe J., Holmes J., Thompson A., Papaluca T., Roberts S., Strasser S., Stuart K., New K., Farrell G., Dore G., WIGG A., Woodward A., Wade D.A., George J., Sinclair M., McGarity B., Fisher A.L., Sawhney R., Wilson M., Valiozis I., Levy M., Tse E., Ahlenstiel G., Haque M., Prewett E., Sievert W., and Sood S.
- Abstract
Background and Aims: In clinical trials, salvage therapy including Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) achieved an SVR12 rate of 96% in NS5A-experienced participants. An extended access program (EAP) for SOF/VEL/VOX was sponsored by Gilead Pharmaceuticals for Australian patients with advanced liver disease or prior liver transplantation (LT), who had relapsed. We determined the real-world efficacy and safety of this regimen in this cohort with advanced liver disease. Method(s): In this Australian multicentre EAP study, adult patients with chronic HCV infection genotype(GT)1-6 with prior failure on a DAA NS5A inhibitor containing regimen were eligible to access 12 weeks of SOF/VEL/VOX 400 mg/100 mg/100 mg. Other eligibility criteria included compensated liver disease with at least one of the following i) Child Pugh (CP)A cirrhosis with clinically significant portal hypertension or platelets <100 x 109/L, ii) prior LT, or iii) severe extra hepatic manifestations. Hospitals with >1 EAP recipient were invited to participate. Clinical characteristics and treatment outcomes were recorded at baseline, end-of-treatment (EOT) and SVR12. HCV NS5A RAS testing was performed prior to retreatment, where serum was available. The primary outcomes was SVR12 rate. Result(s): To date, baseline data is available for 89 patients from 24 participating hospitals. 85 have reached end-of-treatment (EOT), and 80 have SVR12 data available for analysis. Four patients have incomplete data due to early discontinuation of therapy (n = 2), loss to follow up (n = 1) and death (n = 1). 74 (83%) were male and the median age was 53. GT3 was the most common (n = 64), then GT1a (n = 18), GT1b (n = 4), GT6 (n = 2) and GT4 (n = 1). The median platelet count was 127. 68 (75%) had cirrhosis and of these, 35 (51%) had portal hypertension. 14 (16%) had prior hepatoma and 15 (17%) prior LT. All participants were NS5A-experienced and 8 (9%) had received?>1 DAA course (1-4). Three participants were
- Published
- 2021