Efficient direct antiviral hepatitis C treatment plan approved by CFDA

Efficient direct antiviral hepatitis C treatment plan approved by CFDA

September 29, 2017 Source: Bio Valley·

Hepatitis C is one of the major challenges to global public health. There are about 71 million people infected with hepatitis C worldwide. China is the country with the largest number of hepatitis C infections in the world, about 10 million. From the genotyping point of view, the gene type 1b is the most common in China, and the proportion of infected people is as high as 56.8%. Recently, the international biopharmaceutical company Aibowei announced in Shanghai that its Weijianle (Obi Pali film) and Yiqirui (Daspebwe sodium tablets) treatment plan has been approved by the State Food and Drug Administration (CFDA). It can be used to treat adult genotype 1 chronic hepatitis C, including patients without cirrhosis or with compensatory cirrhosis.

A phase 3 clinical study of a chronic hepatitis C patient with gene type 1b showed that regardless of whether the patient was accompanied by compensated cirrhosis and whether he had previously received treatment, after receiving a 12-week treatment with the Weijianle combined with the Yiqirui regimen The sustained virological response is 99.5%-100%, achieving clinical cure.

"A number of recent direct hepatitis B virus (DAA) drugs have been approved for marketing, marking the beginning of a new era of Chinese hepatitis C treatment." Professor Zhuang Hui, academician of the Chinese Academy of Engineering and honorary director of the Chinese Medical Association Liver Diseases Branch, said, "Wei Jianle + Yiqirui can be used not only for patients with hepatitis C without liver cirrhosis, but also for patients with compensatory liver cirrhosis and hepatitis C. Patients with hepatitis C and renal insufficiency are also available, which is beneficial to more patients with hepatitis C receiving DAA treatment. From existing global data In view, DAA real-world efficacy data and clinical research data are basically consistent, and the sustained virological response rate is very high, indicating that DAA is effective in treating hepatitis C. It is hoped that such innovative drugs can be incorporated into the national medical insurance catalogue as soon as possible, so that more patients with hepatitis C Be able to receive DAA treatment and achieve the great goal of 'eliminating hepatitis C' as soon as possible."

In the 12-week, phase 3 clinical study of ONYX-I and ONYX-II for Asian gene type 1b hepatitis C patients, Weijianle and Yiqirui showed extremely high cure rates. Among them, ONYX-I data showed that regardless of whether the patient had received interferon antiviral therapy in the past, the sustained virological response rate was 99.5% after receiving a 12-week treatment with Weijianle + Yiqirui. In another ONYX-II study of hepatitis C patients with compensatory liver cirrhosis, the patient's sustained response rate was 100% after 12 weeks of treatment with the Weijianle + Yiqirui plus ribavirin regimen. During the study, the patient was well tolerated and no one was stopped due to adverse reactions. In terms of efficacy and safety, the results of these two clinical studies are basically consistent with the results of Phase 3 clinical studies worldwide.

Professor Wei Lai, director of the Institute of Liver Diseases, Peking University People's Hospital, said: "A number of clinical studies have shown that Wei Jianle + Yi Qirui treatment of Chinese patients with type 1b chronic hepatitis C can get nearly 100% SVR in 12 weeks." According to Chinese patient data, in the most common type 1b patients, for every 1% improvement in cure rate, nearly 60,000 patients with hepatitis C can benefit. Choosing a high cure rate treatment program also gives physicians a better choice. ”

For a long time, Chinese patients have suffered from the "silent killer" of hepatitis C, and they are full of urgent needs for innovative drugs of hepatitis C with high cure rate. In recent years, with the CFDA Drug Evaluation Center putting a number of the world's leading direct anti-virus (DAA) drugs into the priority review list, China's hepatitis C treatment has entered the era of DAA treatment from the PR era represented by interferon, and the DAA treatment program has Hepatitis C cure becomes a reality. With the cure rate of 99.5%-100% of Weijianle + Yiqirui and other high-hepatitis C treatment rates have been approved, China's goal of achieving "hepatitis-free society" is getting closer and closer.

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