MALAYSIA has registered the world’s first affordable – and effective – new drug for hepatitis C, offering the hope of accessible treatment to millions of people around the world at risk from a disease that has few early symptoms, is hard to diagnose and is often seen as a “silent killer.” The drug, ravidasvir, was approved for use with an existing drug, sofosbuvir, in June, five years after the Malaysian government, partnered with the Drugs for Neglected Diseases initiative (DNDi), a collaborative, non-profit drug research organization to develop the drug. “We decided to work with middle-income countries to try to develop an effective treatment,” said Jean-Michel Piedagnel, director of DNDi Southeast Asia. “We started the clinical trial in Malaysia and Thailand saying we are also going to put on the market an affordable treatment.” The new drug is a direct-acting antiviral (DAA) developed with Pharco, an Egyptian generic drug manufacturer, and is an effort to bring more competition into a market dominated by the world’s biggest pharmaceutical companies. Sofosbuvir — the first DAA — secured approval in the United States in 2013. Some 71 million people around the world are thought to live with Hepatitis C, a blood-borne virus that can lead to cirrhosis and is one of the leading causes of liver cancer, according to the World Health Organization. There is no vaccine against the disease, which often has no particular symptoms until the liver becomes infected. For years, the disease was treated with an array of drugs that carried debilitating side effects and often made people feel even worse. DAAs were a “revolution,” according to Piedagnel, offering patients, for the first time, an effective cure and fewer side effects. But sofosbuvir — under patent to the U.S. drugmaker Gilead — was expensive and out of the reach of many middle-income and developing countries. “Hepatitis C medicines have always been very expensive in the Western Pacific region, because we have only high- and middle-income countries, as categorized by the World Bank,” explained Dr. Po-Lin Chan, the WHO’s medical officer for viral hepatitis. China, Malaysia and Thailand were among countries excluded from Gilead’s voluntary licensing in 2014. That year, a University of Malaya study estimated Malaysia had at least 400,000 people living with hepatitis C. Under the legal conditions of the clinical trial, Malaysia was able to access sofosbuvir at an affordable price, importing the drug from Egypt, which had rejected the patent on the drug, allowing it to be produced by generic manufacturers. In 2017, Malaysia went a controversial step further, issuing a compulsory license for sofosbuvir, which allowed it to import the drug into the country under World Trade Organization rules. The ravidasvir plus sofosbuvir trial, which was published in The Lancet in April, showed the drug combination to be highly effective and well-tolerated, curing patients in 97 percent of cases. With the success of the trial, Malaysia has developed a full access strategy for diagnosis and treatment of hepatitis C, targeting local government clinics. “In the long term, it will also be cost-saving for us to prevent liver cancers, cirrhosis and liver failure, as the treatments for these diseases are more expensive,” said Dr. Noor Hisham Abdullah, Malaysia’s director-general of health and also a director of DNDi.(SD-Agencies) | 