AbbVie's Pan-Genotypic Hepatitis C Drug Epclusa Receives NMPA Approval in China with Over 99% Virologic Cure Rate in 8-Week Regimen

Today (May 17), AbbVie’s official WeChat account announced that Maviret (glecaprevir/pibrentasvir tablets), a single-tablet, pan-genotypic regimen for hepatitis C treatment, was approved by China’s National Medical Products Administration (NMPA) on May 15. It is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) infection of genotype 1, 2, 3, 4, 5, or 6, who have no cirrhosis or have compensated cirrhosis.

It is understood that Ainuquan is a novel pan-genotypic hepatitis C treatment regimen in China. For treatment-naïve patients without cirrhosis infected with all major genotypes (genotypes 1–6), the virologic cure rate exceeds 99%, with a treatment duration as short as 8 weeks. This regimen does not require co-administration with ribavirin and involves once-daily oral dosing. As it is not metabolized by the kidneys, Ainuquan is suitable for patients with any degree of renal impairment (including those undergoing dialysis) without the need for dose adjustment, achieving a virologic cure rate of nearly 100% with a favorable safety profile.

Previously, Ainuoquan was granted priority review status by the Center for Drug Evaluation (CDE) of the National Medical Products Administration due to its significant therapeutic advantages over existing treatments, and was included in the “Second Batch of Overseas New Drugs Urgently Needed for Clinical Use” published by the CDE on March 28, 2019.

According to Wei Lai, Director of the Hepatobiliary and Pancreatic Center at Beijing Tsinghua Changgung Hospital, affiliated with Tsinghua University: A pooled analysis of nine Phase 2/3 clinical trials conducted in Europe and the United States demonstrated that Eluonza achieved an SVR12 rate of over 99% in treatment-naïve patients with chronic hepatitis C genotypes 1–6 without cirrhosis, allowing the treatment duration to be shortened to eight weeks with a favorable safety profile. A pooled analysis of eight Phase 2/3 clinical trials in Europe and the United States showed that no dosage adjustment of Eluonza is required for patients with any degree of renal impairment, including those undergoing dialysis, and that both efficacy and safety are unaffected by renal function status. In vitro data indicate that Eluonza possesses potent viral suppression capabilities and a high barrier to resistance, thereby enabling high viral cure rates in a shorter timeframe and improving patient adherence to treatment.

To date, Viekira Pak has been approved in 58 countries and regions worldwide, including the United States, all 28 member states of the European Union, and Japan. In the United States, the treatment regimen of Viekira Pak for patients with genotype 1 hepatitis C who had previously failed direct-acting antiviral therapy received “Breakthrough Therapy Designation” from the U.S. Food and Drug Administration (FDA) and was approved under priority review eligibility. In the European Union, Viekira Pak was granted accelerated assessment by the European Medicines Agency (EMA) as a “new medicinal product of major public health interest” and subsequently approved. In Japan, due to its clinical efficacy and the severity of hepatitis C, Viekira Pak also received priority review status from the Ministry of Health, Labour and Welfare (MHLW) and was approved.

Currently, the two major pharmaceutical companies in the hepatitis C market are AbbVie and Gilead. AbbVie previously stated that hepatitis C represents a market that will persist for an extended period, and currently, only our company and our competitor, Gilead, remain in this market.

However, hepatitis C represents a continuously shrinking market. Data from Gilead Sciences show that the number of patients initiating treatment has steadily declined since 2015, and the company predicts that all major markets will continue to decline in the future.

Currently, hepatitis C therapies on the market, including AbbVie’s Mavyret and Gilead’s medications, are generally considered “curative.” This means that patients who successfully complete an 8- or 12-week treatment regimen will not require further therapy. While this is good news for patients, it has led to a shrinking pool of individuals awaiting treatment, consequently resulting in a contraction of the hepatitis C market.