The National Medical Products Administration of China (NMPA) has approved the marketing of AbbVie’s direct-acting antiviral (DAA) Maviret (glecaprevir/pibrentasvir) on May 15, 2019. The hepatitis C drug with the best efficacy in the world has thus entered China, which is used to treat adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection with or without compensated cirrhosis. With the advantage of curing hepatitis C in 8 weeks, Maviret was included in the second batch of clinically imperative overseas new drugs released by the NMPA upon "therapeutic advantages over marketed products".

The global hepatitis C drug market continues to shrink due to the unprecedentedly good clinical efficacy of DAAs. However, upon the advantage of curing hepatitis C in 8 weeks, Maviret has achieved stunning performance since marketed and feels like a hepatitis C terminator. The first DAA was not approved for marketing in China until Apr. 2017, however, there have been so far 10 DAAs that have entered China, and AbbVie’s Maviret just approved has attracted even more attention!

The clinical trial data of Maviret, the performance of some products in the global hepatitis C drug market, and marketing situation of DAAs in China will be introduced below!

I. Curing hepatitis C in 8 weeks: Maviret, the hepatitis C drug with the best efficacy

Maviret (glecaprevir/pibrentasvir) was approved in the U.S. in July 2017, and its sales in 2018 already made it rank among global top 50 pharmaceutical products by sales.

Prescribing Information

According to the clinical trial data of Maviret, the SVR12 rate in patients with all major HCV genotypes (genotype 1-6), who were previously untreated and without cirrhosis, reached up to 99%, and the treatment course could be shortened to 8 weeks. This therapeutic regimen does not require the combination with ribavirin and is taken once daily. Maviret is applicable to patients with any degree of renal function damage (including those who underwent dialysis) without the need to adjust the dosage of administration because it is not metabolized via kidney, and its SVR12 rate approaches 100%, with good safety.

II. Global hepatitis C drug market: from sofosbuvir to Maviret

Gilead launched sofosbuvir, the first generation, in 2013, to start a new era of the global hepatitis C DAAs. Since then, Gilead, J & J, AbbVie, BMS, and MSD have successively launched many DAAs.

Gilead’s Sovaldi, Harvoni, and Epclusa, and AbbVie’s Mavyret have been the most successful among the DAAs, wherein, Harvoni’s sales peaked at USD13.864 billion!

However, the global hepatitis C drug market has rapidly shrunk owing to the hepatitis C disease’s particularity. Mavyret has outshone amid the big decline of the HCV drug market, which was marketed in 2017, with a shorter treatment cycle (the only DAA with a treatment course of 8 weeks) and largely reduced treatment expenses. Its sales performance has skyrocketed since marketed!

Therefore, the global hepatitis C drug market began with sofosbuvir and will be terminated by Maviret!

III. China following closely to enter the era of hepatitis C cure

China will enter the era of hepatitis C cure by following closely the EU and U.S. There have been 8 DAAs regimens approved in China, and 3 DAAs in the marketing review stage; all of them are expected to be approved for marketing in 2019.

According to the prices released by the hospital medical supply companies so far:

1. Prices of imported drugs are between RMB58,000-60,000/12 weeks

2. Prices of Chinese-produced drugs are about RMB40,000/12 weeks

China will enter the new era of complete cure with DAAs + Peg-IFN-α + ribavirin or all-oral DAAs, as DAAs are approved for marketing in China.

DAAs marketed/in the marketing review stage in China

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