$300 to cure hepatitis C? DNDI and Pharco release the latest results

$300 to cure hepatitis C? DNDI and Pharco release the latest results

April 17, 2018 Source: Sina Pharmaceutical

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The non-profit organization Drug Research and Development Initiative for Neglected Diseases (DNDi) and Pharco Pharma, Egypt's largest pharmaceutical company, are developing a new and affordable combination therapy for hepatitis C. The combination therapy consists of Gilead's hepatitis C drug Sovaldi (sofosbuvir, sofosbuvir) and another hepatitis C drug, ravidasvir, the former being a highly potent NS5B polymerase inhibitor, the latter being a novel pan-genotype NS5A Inhibitor. According to the latest data from Phase II/III clinical studies (STORM-C-1) published at the 53rd European Society of Liver Research (EASL) Annual Meeting and International Liver Disease Congress (ILC 2018) in Paris, France, the combination therapy Hepatitis C can be cured very efficiently, including cases of hepatitis C that are traditionally difficult to treat.

Image Credit: BruceBlaus

The study was an open-label study designed to assess the safety, tolerability, and pharmacokinetics of the combination of sofosbuvir+ravidasvir. The study was jointly funded by DNDi and the Malaysian Ministry of Health and was conducted at 10 medical sites in Malaysia and Thailand, all of which were produced by Pharco.

In the study, 301 patients with chronic hepatitis C were enrolled, of whom 42% were genotype 1 hepatitis C and 53% were genotype 3 hepatitis C. In the study, patients were divided into two groups: patients without cirrhosis, treated with sofosbuvir + ravidasvir combination therapy for 12 weeks; patients with compensated cirrhosis, treated with combination therapy for 24 weeks. According to the internationally defined hepatitis C cure criteria, the 12-week sustained virological response rate (SVR12) data shows that the cure rate is as high as 97% (95% CI: 94.4-98.6), even those most difficult to treat. Patients: patients with cirrhosis (96% cure rate), HIV/HCV co-infected patients (97%), genotype 3 hepatitis C patients (97%, 96% with cirrhosis), previous HCV acceptance Patients with medication (96%). Importantly, patients who combined the above risk factors were cured and no unexpected safety signs were detected.

The overall cure rate for the study and the analysis data for each of the predefined subgroups of intentional treatments are shown below:

Datuk Dr Noor Hisham Abdullah, Health Director of the Malaysian Ministry of Health, said that hepatitis C has become a major public health problem in Malaysia, and increasing access to high-efficiency medicines is very important to national interests. In September 2017, the Malaysian government issued a “Government Use” license (a compulsory license) for sofosbuvir, enabling 400,000 hepatitis C patients in Malaysia to obtain a generic version of HCV treatment in a public hospital.

Although the current cost of hepatitis C treatment in the market is as high as $84,000 (for example, Sovaldi), the combination therapy developed by Pharco and DNDi has a target price of only $300 in Malaysia's 12-week treatment plan and $500 in Latin America. But it will gradually drop to $300 over time. Both parties expect this combination therapy to be available in Malaysia within two years. Currently, Pharco and DNDi are also conducting clinical research in countries such as South Africa and Ukraine to evaluate the potential of this combination therapy for all six genotypes of hepatitis C.

According to Bernard Pécoul, executive director of DNDi, the study showed that sofosbuvir+ravidasvir combination therapy is comparable to the best hepatitis C therapy available on the market today, but at a very affordable price, for countries that are excluded from projects acquired by pharmaceutical companies. Provide an alternative treatment option.

Currently, there are more than 71 million hepatitis C patients worldwide, with 400,000 deaths per year. Although high-efficiency hepatitis C therapy has been on the market for several years, there are still no more than 3 million people receiving treatment. The current situation is that more people are infected each year than the number of people receiving treatment. The World Health Organization (WHO) has set a goal to treat 80% of hepatitis C patients worldwide by 2030. (Sina Pharmaceutical Compilation/newborn)

Article reference source:

1. New hepatitis C combo boasts 97% cure rate for just $300

2, New affordable hepatitis C combination treatment shows 97% cure rate

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