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Valpatasvir/sofobuvir; a panacea for HCV?

By: Takako Schaninger, MD
Associate Professor of Medicine | UK HealthCare

    This month, the FDA is expected to approve a new hepatitis C virus (HCV) drug. The once-daily, single-tablet, fixed-dose coformulation of velpatasvir and sofosbuvir is the latest addition to the arsenal of drugs introduced over the past few years to treat HCV. These drug regimens have revolutionized the treatment of HCV, but just how different is this drug from the ones currently in use? A number of highly effective drugs are available for the treatment of HCV, but despite their efficacy, they are not without their limitations. We have been waiting for a panacea to treat all types of HCV and while this latest drug may not meet this lofty goal, it may bring us closer to the day when a drug exists that does address the various types of HCV infections.

    Researchers presented the results of the ASTRAL-5 study at the Annual Meeting of the European Association for the Study of the Liver in April 2016; a coformulation containing velpatasvir (a pangenomic NS5A inhibitor) and sofosbuvir (a nucleotide NS5B RNA polymerase inhibitor) was highly effective in treatment-naïve and treatment-experienced patients with hepatitis C genotypes 1, 2, 3, and 4 and HIV coinfection receiving stable antiretroviral therapy. Ninety-two to 100% of patients achieved systemic vascular resistance (SVR) across HCV genotypes. Patients with genotype 3 or complicated with cirrhosis have been known to have lower SVR; the associated SVR rates were also high in these populations at 92% (n=12) and 100% (n=19) respectively.

    In the current potent direct-acting anti-HCV agent era, patients coinfected with HCV and HIV are no longer considered to be a “difficult-to-treat” population; however, treatment of HCV in patients coinfected with HIV continues to require attention to the complex drug interactions that can occur between anti-HCV agents and antiretrovirals. Currently available HCV regimens have significant drug-drug interactions with many of antiretrovirals. New research presented at the Conference on Retroviruses and Opportunistic Infections in March 2016 demonstrated that velpatasvir/sofosbuvir can be safely administered with NRTI, rilpivirine, all integrase inhibitors, protease inhibitors (ATVr, DRVr, and LPVr), and boosting agents. Efavirenz decreased the velpatasvir levels by 50%; hence, coadministration of these two drugs requires further research.

    In summary, the forthcoming combination HCV agent, velpatasvir/sofosbuvir, can effectively treat all HCV genotypes and can be safely administered with widely used antiretroviral regimens. While the cure rates utilizing this latest regimen are not high-90s for all genotypes yet, its ability to treat the various HCV genotypes and the fact that it can be used without compromising antiviral agents used in the treatment of HIV, make it a template for future advances in the development of drugs possessing the abilities of a panacea.