Retreatment With Sofosbuvir-Velpatasvir-Voxilaprevir Effective and Well Tolerated: Presented at EASL

By Walter Alexander

VIENNA, Austria -- April 16, 2019 -- In patients with chronic hepatitis C virus infection and prior direct-acting antiviral failure, retreatment with sofosbuvir-velpatasvir-voxilaprevir is effective and well tolerated, according to a real-world study (the German Hepatitis C Registry) presented here at The International Liver Meeting, the 54th Annual Meeting of the European Association for the Study of the Liver (EASL).

“In the past, treatment options for these patients were limited,” said Johannes Vermehren, MD, Goethe University Hospital, Frankfurt, Germany, on April 11.

Although chronic hepatitis C virus infection can be cured with all-oral direct-acting antivirals in >90% of patients, few retreatment options are available after treatment failure. When virological relapse/failure occurs, hepatitis C virus RNA appears a few weeks after completion of therapy, Dr. Vermehren said. In Europe, the only approved direct-acting antiviral regimen for patients after nonstructural protein 5A inhibitor-based therapy has failed is a 12-week fixed-dose combination of sofosbuvir-velpatasvir-voxilaprevir.

Investigators enrolled 110 consecutive patients (median age, 54 years; 86% male; 27% with cirrhosis) for whom prior regimens (paritaprevir-ritonavir-
ombitasvir ± dasabuvir ± ribavirin; ledipasvir-sofosbuvir ± ribavirin; sofosbuvir-velpatasvir ±
ribavirin; daclatasvir + sofosbuvir ± ribavirin; elbasvir-grazoprevir; sofosbuvir ± ribavirin and simeprevir + sofosbuvir + ribavirin) had failed. Four had received sofosbuvir-velpatasvir-voxilaprevir + ribavirin). Most patients (71%) had hepatitis C virus genotype 1, with 34% genotype 3 and 5% genotype 4.

The aim of the current analysis was to evaluate the efficacy and tolerability of sofosbuvir-velpatasvir-voxilaprevir under real-world conditions.

Among 74 evaluable patients, the sustained virological response rate was 100%. The sofosbuvir-velpatasvir-voxilaprevir regimen was well tolerated, with no severe adverse events. The most common adverse events were fatigue (14%) and headache (10%). Two severe adverse events (pneumonia, urothelial carcinoma) were considered unrelated to treatment.

“Retreatment with sofosbuvir-velpatasvir-voxilaprevir was highly effective and well tolerated in this real-world cohort,” concluded Dr. Vermehren.

[Presentation title: Retreatment With Sofosbuvir/Velpatasvir/Voxilaprevir in Patients With Chronic Hepatitis C VirusInfection and Prior DAA Failure: An Analysis From the German Hepatitis C Registry (DHC-R). Abstract THU-188]

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