Tuesday, November 22, 2016

(Epclusa) Sofosbuvir plus velpatasvir “best options” for HCV G3

Epclusa for Hep C: What Pharmacists Should Know
JANUARY 04, 2017
Hepatitis C is an infection of the liver caused by the hepatitis C virus (HCV). It is one of the leading causes of chronic liver disease in the United States with the CDC estimating that between 2.7 and 3.9 million people in the United States are infected with chronic HCV.1 Over the past several years, a number of direct acting antivirals have been approved to treat the infection.

In June 2016, the FDA approved Epclusa, a fixed-dose combination product containing sofosbuvir, an HCV NS5B polymerase inhibitor, and velpatasvir, an HCV NS5A inhibitor, for treatment of chronic hepatitis C genotypes 1, 2, 3, 4, 5, or 6. With its approval, Epclusa became the first antiviral indicated for all 6 major forms of HCV.

This article highlights several key therapeutics areas with Epclusa that every pharmacist should know

Sofosbuvir plus velpatasvir “best options” for HCV G3

An analysis of published studies on direct acting antivirals (DAAs) found that regimens containing sofosbuvir and velpatasvir were the best option for patients with HCV genotype three (G3).

The analysis indicated that ribavirin significantly increased rates of SVR and should be considered if tolerated.

Researchers at Radboud University Medical Centre in the Netherlands performed a Bayesian network meta-analysis using a random effects model to indirectly compare DAA regimens in HCV G3 patients with and without cirrhosis. They found 27 appropriate studies involving 3,415 patients.

Among patients without cirrhosis, the greatest rates of SVR were estimated for those receiving sofosbuvir + velpatasvir with ribavirin (99%) and without ribavirin (97%), for sofosbuvir + daclatasvir + ribavirin (96%), and for sofosbuvir + peginterferon + ribavirin (95%), all for 12 weeks.

Among patients with cirrhosis, the highest rates of SVR were estimated for those receiving sofosbuvir + velpatasvir for 24 weeks (96%), for sofosbuvir + daclatasvir + ribavirin for 24 weeks (94%), and for sofosbuvir + velpatasvir + ribavirin for 12 weeks (94%).

Ribavirin increases efficacy in patients with and without cirrhosis (odds ratios 2.6 and 4.5).

Identification of the best direct-acting antiviral regimen for patients with hepatitis C virus genotype 3 infection: a systematic review and network meta-analysis. Berden FA, Aaldering BR, Groenewoud H et al. Clin Gastroenterol Hepatol. 2016 Nov 10 [Epub ahead of print]

Nov 21, 2016
Sofosbuvir/velpatasvir improved patient-reported outcomes, knocked out HCV genotypes 1-6
– When given with ribavirin, a fixed-dose combination of sofosbuvir/velpatasvir (Epclusa) achieved a sustained viral response at 12 weeks (SVR-12) in 94% of decompensated cirrhotic patients with hepatitis C virus (HCV) genotypes 1-6 infection, according to Zobair M. Younossi, MD.

Patients with and without cirrhosis also reported meaningful improvements across a variety of outcome measures after successfully completing treatment with Epclusa or sofosbuvir (Harvoni), said Dr. Younossi of Inova Fairfax Hospital in Falls Church, Va. “Although on-treatment patient-reported outcomes improved more with ribavirin-free regimens, post-SVR improvements were similar,” regardless of whether patients had received ribavirin, he reported at the annual meeting of the American Association for the Study of Liver Diseases.
Continue reading..

Of Interest
Nov 17, 2016
AbbVie Pangenotypic Combination Cures Hard-to-Treat People with HCV Genotype 3

October 2016
Short-duration Treatment With Elbasvir/Grazoprevir and Sofosbuvir - HCV GT1 or GT3 with or without cirrhosis

Vol 4, Supplement 1 (October 2016): Annals of Translational Medicine

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