Kuala Lumpur, Malaysia – Malaysia has registered the world’s first affordable and effective new drug for hepatitis C, offering hope of accessible treatment to millions of people around the world at risk for a disease that has few early symptoms, is difficult to diagnose, and seen often. 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 drug research organization. and non-profit 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 that we will also put an affordable treatment on the market.”
The new drug is a direct-acting antiviral (DAA) developed with Pharco, an Egyptian manufacturer of generic drugs, and is an effort to attract more competition to a market dominated by the world’s largest pharmaceutical companies. Sofosbuvir, the first DAA, was approved in the United States in 2013.
Around 71 million people worldwide are believed to be living with hepatitis C, a blood-borne virus that can cause 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 a variety of medications that had 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, patented by US drugmaker Gilead, was expensive and out of reach for many developing and middle-income countries. “Hepatitis C drugs have always been very expensive in the Western Pacific region, because we only have high- and middle-income countries, as classified by the World Bank,” explained Dr. Po-Lin Chan, medical officer of the WHO for viral hepatitis.
China, Malaysia and Thailand were among the countries excluded from Gilead’s voluntary licensing in 2014.
That year, a study from the University of Malaya estimated that Malaysia had at least 400,000 people living with hepatitis C.
Among them was Ng Song Ping, 49.
The disease had drained all of his energy.
“Even if I worked a little, I was exhausted, sleepy, I couldn’t work for a long time,” he said. “Even showering, eating, watching television made me feel tired.”
Ng was one of 300 people who joined the ravidasvir plus sofosbuvir clinical trial that began in 2016. Three months after starting treatment, tests showed no traces of the virus.
“Now I’m fine, the tiredness and the drowsiness are gone,” he told Al Jazeera. “Now I work every day, 365 days a year, I don’t take vacations. I made a vegetable farm, I plant the vegetables, harvest them and deliver them to the stores every day. “
Change of patents
Under the legal conditions of the clinical trial, Malaysia was able to access sofosbuvir at an affordable price by importing the drug from Egypt, which had rejected the drug’s patent, allowing it to be produced by generic manufacturers.
In 2017, Malaysia took a controversial step further by issuing a compulsory license for sofosbuvir, which allowed it to import the drug into the country under World Trade Organization rules.
“In international law, if the product is patented and a country wants to use that product for non-commercial public use, if it is an emergency situation, then there is no need to negotiate with the patent holder first,” he said. Chee Yoke Ling, international lawyer and CEO of Third World Network, a Malaysian research and advocacy organization. “In Malaysia, our laws implement that as the rights of the government.”
What seemed like a controversial decision in 2017 is now becoming more widely accepted thanks to the COVID-19 pandemic, which has changed the way intellectual property is viewed in the pharmaceutical field.
“What happened in Malaysia is a useful example for other countries. There could be an opportunity to move forward in reducing intellectual property provisions that do not benefit countries, as there is a change in the way these superpowers think about intellectual property. For example, the United States supports the TRIPS exemption for COVID-19 technologies, ”said Fifa Rahman, who led hepatitis C advocacy efforts at the AIDS Council of Malaysia in 2016 and is now working on ACT-Accelerator for the COVID-19 global response.
The ravidasvir plus sofosbuvir trial, which was published in The Lancet in April, showed that the drug combination is 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 the diagnosis and treatment of hepatitis C, targeting local government clinics.
“In the long term, it will also save us costs to prevent liver cancer, cirrhosis and liver failure, since the treatments for these diseases are more expensive, so it is very important for us to invest in public health and this is where the prevention comes into play, ”Dr. Noor Hisham Abdullah, Malaysia’s chief health officer and also director of DNDi, told reporters at a press conference announcing the advance of drugs.
The government worked closely with civil society groups, running outreach programs in affected communities to identify people at risk and facilitate access to screening and treatment.
A screening study conducted in three prisons in Malaysia by MTAAG +, a Malaysian HIV and Hepatitis C Treatment Access and Advocacy Group, revealed that inmates are a vulnerable population, leading to the inclusion of people in the prisons. prisons and rehabilitation centers among the priority groups in the Malaysian national hepatitis. Programs C.
Convenient access to screening and treatment for key populations, such as drug users, men who have sex with men, transgender people and sex workers, was improved through stigma reduction training provided by the AIDS Council of Malaysia.
“I can’t say 100 percent that we have eradicated the stigma, but it has been improved,” said Anushiya Karunanithy, who runs the hepatitis C program at the council.
“Health workers are more welcoming now, they know the key populations. We have good family medicine specialists in some of the clinics who are also very close to the clients, so the clients feel very comfortable with the doctors. “
Starting in mid-2018, when affordable DAA treatments became available to the Malaysian market, the number of people treated has grown rapidly. “Now, we have treated more than 10,000 patients,” said Dr. Muhammad Radzi Abu Hassan, Malaysia’s national director of gastroenterology and hepatology. “Last year, despite the COVID-19 pandemic, we managed to treat 4,000 patients. This is incredible, with all the odds we have. “
Cheaper treatment is also expected to encourage countries to test more for hepatitis, which the WHO wants to eliminate as a public health problem by reducing new infections by 90 percent and deaths by 65 percent by 2030. .
“When the treatment exists but is too expensive, countries often don’t do extensive testing because if a person tests positive. It is unethical not to provide treatment, especially when it is one that cures, ”Chee said. “Without affordable treatment, we end up without testing and in this vicious cycle. Hepatitis C remains a long-term silent killer. “
This month Egypt, which has one of the highest incidences of hepatitis C in the world, also registered the drug, and there are expectations that the combination therapy of ravidasvir plus sofosbuvir will gain approval 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 various international agencies to see if we can use this idea of a value chain to create a coalition in the global south, a kind of south-south value chain for the elimination of hepatitis C.” Piedagnel said.