Kuala Lumpur, Malaysia – Malaysia has registered the world’s first affordable and effective hepatitis C drug, providing hope for millions of people around the world to obtain treatment. The disease has few early symptoms, is difficult to diagnose and Often appears as a “silent killer”.
After five years of collaboration between the Malaysian government and the Neglected Disease Drugs Initiative (DNDi), the drug ravidasvir was approved in June for use with the existing drug sofosbuvir, a cooperative non-profit drug research organization that aims to develop drugs.
“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 have started clinical trials in Malaysia and Thailand, indicating that we will also introduce an affordable treatment to the market.”
The new drug is a direct-acting antiviral drug (DAA) developed in cooperation with Egyptian generic drug manufacturer Pharco, and aims to bring more competition to the market dominated by the world’s largest pharmaceutical company. Sofosbuvir-the first DAA-was approved in the United States in 2013.
According to the World Health Organization, approximately 71 million people worldwide are believed to have hepatitis C. Hepatitis C is a blood-borne virus that can cause liver cirrhosis and is one of the main causes of liver cancer. There is no vaccine for this disease, and the disease usually has no special symptoms before the liver is infected.
Over the years, this disease has been treated with a series of drugs that have debilitating side effects and often make people feel worse.
According to Piedagnel, DAA is a “revolution”, providing patients with effective treatments and fewer side effects for the first time.
But Sofosbuvir (patented by the American drugmaker Gilead) is expensive and cannot be afforded by many middle-income countries and developing countries. “Hepatitis C drugs in the Western Pacific region have always been very expensive because we only have high- and middle-income countries classified by the World Bank,” explained Dr. Chen Baolian, a medical officer for viral hepatitis at WHO.
China, Malaysia, and Thailand are countries that were excluded from Gilead’s voluntary license in 2014.
That year, a study by the University of Malaya estimated that at least 400,000 people in Malaysia had hepatitis C.
Among them is Wu Songping, 49.
The illness exhausted all his energy.
“Even if I only work a little, I’m exhausted and sleepy, and I can’t work long hours,” he said. “I feel tired even taking a shower, eating, and watching TV.”
Ng is one of 300 people in the ravidasvir plus sofosbuvir clinical trial that started in 2016. Three months after he started treatment, tests showed no signs of the virus.
“Now, I am well, tiredness and sleepiness are gone,” he told Al Jazeera. “Now, I work every day, 365 days a year, and I don’t take vacations. I have built a vegetable farm, and I grow vegetables, harvest, and deliver to the store every day.”
Under the legal conditions of clinical trials, Malaysia was able to obtain sofosbuvir at an affordable price and imported the drug from Egypt. Egypt rejected the patent for the drug and allowed it to be produced by generic drug manufacturers.
In 2017, Malaysia took a controversial step forward, issuing a compulsory license for Sofosbuvir, allowing it to import drugs into the country in accordance with the regulations of the World Trade Organization.
“In international law, if a product is patented and a country wants to use the product for public non-commercial use, if the situation is urgent, there is no need to negotiate with the patentee first,” said. Chee Yoke Ling is an international lawyer and executive director of the Third World Network, a Malaysian research and advocacy organization. “In Malaysia, our laws treat it as a government right.”
As the COVID-19 pandemic has changed perceptions of intellectual property in the pharmaceutical sector, the seemingly controversial decision in 2017 is now being more widely accepted.
“What happened in Malaysia provides a useful example for other countries. As these superpowers have changed their views on intellectual property rights, there may be an opportunity to promote the reduction of intellectual property provisions that are detrimental to the country. For example, the United States supports the COVID- 19 technology TRIPS exemption,” said Fifa Rahman, who was responsible for hepatitis C advocacy work at the Malaysian AIDS Commission in 2016 and is now working on ACT-Accelerator to respond to global COVID-19.
The ravidasvir plus sofosbuvir trial was published in The Lancet in April and showed that the drug combination was very effective and well tolerated, curing 97% of patients.
With the success of the trial, Malaysia has formulated a comprehensive hepatitis C diagnosis and treatment strategy for local government clinics.
“In the long run, preventing liver cancer, liver cirrhosis and liver failure can also save costs for us, because these diseases are more expensive to treat, so this is very important for us to invest in public health, and this is where prevention comes in”, Malaysian Health Director-General and Director of DNDi, Dr. Noor Hisham Abdullah, told reporters at a press conference announcing the drug breakthrough.
The government works closely with civil society groups to carry out outreach programs in affected communities to identify at-risk people and promote access to screening and treatment.
A screening study conducted by the Malaysian HIV and hepatitis C treatment access and advocacy organization MTAAG+ in three Malaysian prisons revealed that prisoners are a vulnerable group, leading to the inclusion of prisons and rehabilitation centers in Malaysia’s national hepatitis C priority group program.
Provide comfortable screening and treatment services for key populations, such as Drug addict, Men who have sex with men, transgender people, and female sex workers have been improved through the stigma reduction training conducted by the Malaysian AIDS Commission.
“I can’t say that we have eliminated 100% of the stigma, but the situation has improved,” said Anushiya Karunanithy, head of the committee’s hepatitis C program.
“Medical staff are more popular now, they understand the key population. We have very good family medicine specialists in some clinics close to our clients, so the clients feel very comfortable with the doctor.”
Starting in mid-2018, when affordable DAA treatment entered the Malaysian market, the number of people receiving treatment increased rapidly. “Now, we have treated more than 10,000 patients,” said Dr. Muhammad Radzi Abu Hassan, National Head of Gastroenterology and Hepatology in Malaysia. “Last year itself, despite the COVID-19 pandemic, we managed to treat 4,000 patients. This is incredible. We have all the possibilities.”
It is expected that cheaper treatment will also encourage countries to conduct more hepatitis tests, and the World Health Organization hopes to eliminate this public health problem by reducing new infections by 90% and deaths by 65% by 2030.
“When treatment exists but is too expensive, the state usually does not conduct extensive testing because if a person tests positive. It is unethical not to provide treatment, especially when it can be cured,” Chee said. “If there is no affordable treatment, we will eventually be unable to test and fall into this vicious circle. Hepatitis C remains a long-term silent killer.”
This month, Egypt, which has the highest incidence of hepatitis C in the world, also registered the drug, and it is expected that the combination therapy of Ravidadvirgasofosbuvir will be approved in other countries in Southeast Asia and South America.
DNDi aims to replicate the competitive market created in Malaysia in other middle-income countries.
“We are discussing with some international organizations to see if we can use this idea of value chains to build an alliance in the global South, a South-South value chain that eliminates hepatitis C,” Piedagnel said. .