Gilead's Combination Therapy for HCV Has Been Validated by The EMA

The Marketing Authorization Application (MAA) for Gilead’s investigational, single tablet regimen of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) to be taken once daily as a means to treat hepatitis C virus (HCV) has been fully validated; the combination is under assessment by the European Medicines Agency (EMA).

In a press release, Norbert Bischofberger, PhD, executive vice president of Research and Development, and chief scientific officer at Gilead said, “Direct-acting antiviral treatments have transformed our ability to treat hepatitis C; however, for some patients who have failed to achieve a cure with these regimens, effective and well-tolerated therapies are still needed.”

The MAA for SOF/VEL/VOX is based on data yielded from Phase 3 studies dubbed POLARIS-1 and POLARIS-4. For 12 weeks, these studies evaluated the fixed-dose combination therapy in direct-active antiviral (DAA)-experienced patients possessing HCV genotypes 1 to 6, including patients who had failed prior treatment with a regimen that contained a NS5A inhibitor.

Across both studies, 97% of the patients treated with SOF/VEL/VOX “achieved the primary efficacy endpoint of SVR12,” according to the press release.

Data from the Phase 3 studies, POLARIS-2 and POLARIS-3, were also included in the MAA. The aforementioned studies evaluated 8 weeks of SOF/VEL/VOX in 611 DAA-naïve patients with HCV genotypes 1 to 6. The results of the POLARIS-3 study showed that 96% of patients with genotype 3 infection and cirrhosis who had been treated with the regimen achieved the primary efficacy endpoint of SVR12.

According to the company press release, the most common adverse events among patients who received the regimen included: headache, fatigue, diarrhea, and nausea.

The EMA will review the regimen for the treatment of HCV under the “centralized licensing procedure for all 28 member states of the European Union, Norway, and Iceland.” According to the press release, “The review will follow an accelerated procedure reserved for medicinal products expected to be of major public health interest.” Furthermore, Gilead had submitted a New Drug Application for the regimen back in December to the US Food and Drug Administration.

More than 160 million individuals around the world are infected with chronic hepatitis C. When left untreated, the virus can lead to a number of serious liver-related complications such as liver disease, cirrhosis, and even liver cancer. Ultimately, this global pathogen is responsible for over 350,000 deaths worldwide. Due to these staggering numbers, researchers at biopharmaceutical companies such as Gilead are channeling their efforts into developing new, safe, and effective treatment options for infected individuals.

When speaking of the implications of this news, Dr. Bischofberger said, “The submission of this application reflects our continued commitment to provide treatment options for this life-threatening disease to as many patients as possible, including those who have failed previous direct-active antiviral therapy, in Europe and around the world.”