Hepatitis C giant Gilead is developing a pan-genotypic hepatitis C cocktail SOF/VEL (sofosbuvir/velpatasvir) has recently received good news on the U.S. regulatory front, with the FDA granting priority review status to the cocktail for the treatment of all six genotypes of hepatitis C. The review period will be shortened from the usual 10 months to six months. It is expected that this pan-genotypic hepatitis C cocktail will be marketed earlier for the benefit of the hepatitis C community in the United States. SOF/VEL is a once-daily pan-genotypic hepatitis C cocktail developed for the treatment of patients with all six genotypes (GT-1,-2,-3,-4,-5,-6). The cocktail consists of Gilead’s marketed hepatitis C drug Sovaldi (sofosbuvir) and another antiviral drug, velpatasvir. Of these, sofosbuvir is a nucleoside analogue polymerase inhibitor and velpatasvir is a pan-genotypic NS5A inhibitor. Gilead submitted a New Drug Application (NDA) for SOF/VEL, a pan-genotypic hepatitis C cocktail, to the FDA on October 28, 2015, and the FDA has assigned its Prescription Drug User Fee Act (PDUFA) target date of June 28, 2016. Previously, the FDA has also granted breakthrough drug status for SOF/VEL for the treatment of all six genotypes of hepatitis C. In addition, in the EU, the EMA has formally accepted SOF/VEL’s marketing authorization application (MAA) in December 2015. The SOF/VEL regulatory submission was based on positive data from four Phase III ASTRAL clinical studies that evaluated the efficacy and safety of SOF/VEL in all six genotypes (GT-1,-2,-3,-4,-5,-6) of the hepatitis C population. The data showed that the cocktail was effective in all six genotypes of hepatitis C, including those with compensated and decompensated cirrhosis. In the study, 1,035 patients with pan-genotypic hepatitis C achieved a 98% cure rate after 12 weeks of dosing. SOF/VEL: will greatly simplify clinical treatment of hepatitis C and eliminate the need to test for hepatitis C genotypes SOF/VEL, as the first pan-genotypic hepatitis C cocktail therapy consisting of 2 pan-genotypic, direct-acting antivirals (DAAs), marks a major advance in the clinical treatment of hepatitis C. In the United States, genotype 1 hepatitis C is the most common type of hepatitis C; however, globally, more than half of all hepatitis C patients have other genotypes of hepatitis C. Currently, despite the maturity of clinical treatment for hepatitis C, there is still a critical need for a simple and highly effective pan-genotypic hepatitis C drug for many patients, especially for patients with the extremely difficult-to-treat genotype 3 HCV. SOF/VEL, the first pan-genotypic hepatitis C cocktail therapy, will complement Gilead’s current hepatitis C assets (Sovaldi and Harvoni) perfectly and will provide high clinical cure rates while promising to simplify hepatitis C treatment and, more importantly, will hopefully eliminate the need to test patients for their hepatitis C genotype. Industry prediction: SOF/VEL will become the best-selling hepatitis C cocktail therapy ever The industry is also very optimistic about the commercial prospects of SOF/VEL, that this pan-genotypic hepatitis C cocktail, once marketed, will become another heavyweight product in Gilead’s hepatitis C assets, and is likely to become the best-selling hepatitis C drug ever. Currently, there are 2 drugs in Gilead’s hepatitis C assets, Sovaldi and Harvoni, which are currently the company’s main source of revenue. In the first three quarters of 2015, these 2 drugs accounted for more than 60% of Gilead’s total revenue, with Harvoni alone contributing 40% of Gilead’s sales. Harvoni itself, a step-up from Sovaldi, was launched in October 2014 and now has cumulative sales of $12.6 billion, while Sovaldi (sofosbuvir) was acquired by Gilead following its $11 billion acquisition of Pharmasset in 2011, and is now the main active drug ingredient in Gilead’s hepatitis C assets. The unprecedented success of Sovaldi and Harvoni has helped establish Gilead as the absolute dominant player in the hepatitis C treatment space. Despite the launch of another hepatitis C cocktail therapy by rival AbbVie in December 2014, the Gilead hepatitis C franchise still holds the majority of the market and continues to control over 85% of the market. However, the Gilead Hepatitis C franchise continues to face considerable pressure in the marketplace. Recent data shows that the rate of growth in prescription volume for the Gilead Hepatitis C franchise is slowing and can be safely assumed to be entering a period of maturity. However, the decline in hepatitis C franchise sales will have a direct negative impact on the company’s revenue stream, creating an extreme thirst for new hepatitis C therapies. It is safe to say that the launch of SOF/VEL will come at the right time.