Affordable Hepatitis Drug Brings New Hope to Millions | Health Info

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Kuala Lumpur, Malaysia – Malaysia registered the world’s first affordable – and effective – new drug for hepatitis C, offering hope for an affordable treatment for millions of people globally at risk for a disease with few symptoms early, is difficult 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 (DNDi) initiative, a collaborative research organization on non-profit drugs 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 have started the clinical trial in Malaysia and Thailand saying that we will also bring affordable treatment to market.”

The new drug is a direct-acting antiviral (DAA) developed with Pharco, an Egyptian generic drug maker, and is an effort to increase competition in a market dominated by the world’s largest pharmaceutical companies. Sofosbuvir – the first DAA – gained approval in the United States in 2013.

According to the World Health Organization, some 71 million people around the world are living with hepatitis C, a blood-borne virus that can cause cirrhosis and is one of the main causes of liver cancer. There is no vaccine for the disease, which often has no particular symptoms until the liver is infected.

For years the disease has been treated with a range of drugs which have had debilitating side effects and often made people feel worse.

DAAs were a “revolution”, according to Piedagnel, offering patients, for the first time, an effective remedy and fewer side effects.

But sofosbuvir – under patent from US drug maker Gilead – was expensive and out of reach of many middle-income and developing countries. “Hepatitis C drugs have always been very expensive in the Western Pacific region because we only have high and middle income countries, classified by the World Bank,” Dr Po-Lin Chan explained, WHO chief medical officer for viral hepatitis.

China, Malaysia and Thailand were among the countries excluded from Gilead’s voluntary licenses in 2014.

An electron microscope image from the US CDC shows a cluster of hepatitis virions of an unknown strain. Hepatitis C can cause long-term liver damage and cancer [File: EH Cook Jr/CDC via AP Photo]

That year, a study from the University of Malaysia estimated that at least 400,000 people lived in Malaysia with hepatitis C.

Among them was Ng Song Ping, 49.

Illness had drained him of all energy.

“Even though I was working just a little, I was exhausted, drowsy, couldn’t work for long,” he said. “Even taking a shower, eating, watching TV made me tired. “

Ng was one of 300 people who joined the clinical trial for ravidasvir plus sofosbuvir that began in 2016. Three months after starting treatment, tests showed no evidence of the virus.

“Now I’m already fine, the fatigue and drowsiness are gone,” he told Al Jazeera. “Now I work every day, 365 days a year, I don’t take any vacation. I have made a vegetable farm, I plant the vegetables, harvest them, deliver them to stores every day.

Patent change

Under the legal conditions of the clinical trial, Malaysia was able to access affordable sofosbuvir by importing the drug from Egypt, which had rejected the patent on the drug, allowing it to be produced by generic manufacturers. .

In 2017, Malaysia took a controversial step by issuing a compulsory license for sofosbuvir, which allowed it to import the drug into the country under World Trade Organization rules.

“Under 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 go negotiate with the patent holder first, ”said Chee Yoke Ling, international lawyer and executive director of Third World Network, a Malaysian research and advocacy organization. “In Malaysia, our laws implement this as government rights. “

What seemed like a controversial decision in 2017 is now increasingly accepted thanks to the COVID-19 pandemic, which has changed the way intellectual property in pharmaceuticals is viewed.

“What happened in Malaysia provides a useful example for other countries. There might be an opportunity to advance the reduction of intellectual property provisions that do not benefit countries because there is a shift in the way these superpowers view intellectual property. For example, the United States approving the TRIPS exemption for COVID-19 technologies, ”said Fifa Rahman, who led hepatitis C advocacy efforts at the Malaysian AIDS Council in 2016 and is currently working on it. ACT accelerator for the global response to COVID-19.

The ravidasvir plus sofosbuvir trial, which was published in The Lancet in April, showed the combination of drugs to be very effective and well tolerated, curing patients 97% of the time.

With the success of the trial, Malaysia has developed a comprehensive access strategy for hepatitis C diagnosis and treatment, targeting local government clinics.

“In the long term, it will also be economical for us to prevent liver cancer, cirrhosis and liver failure, because the treatments for these diseases are more expensive, so it is very important for us to invest in public health. and that’s where prevention comes in, ”Dr Noor Hisham Abdullah, Malaysia’s director general of health and also director of DNDi, told reporters at a press conference announcing the drug’s breakthrough.

The government has worked closely with civil society groups, carrying out outreach programs in affected communities to identify those at risk and facilitate access to testing and treatment.

A screening study conducted in three Malaysian prisons by MTAAG +, a Malaysian HIV and hepatitis C treatment access and advocacy group, found that inmates were a vulnerable population, which led to inclusion prisoners and rehabilitation centers among the priority groups of the Malaysian national hepatitis C program.

Hepatitis C is a blood-borne disease that is particularly prevalent among drug users, sex workers and other marginalized groups [File: Kate Mayberry/Al Jazeera]

Comfortable access to testing and treatment for key populations, such as drug addicts, men who have sex with men, transgender people and sex workers, has been improved through training on drug reduction. stigma carried out by the Malaysian AIDS Council.

“I can’t say 100% that we have eradicated the stigma, but it has improved,” said Anushiya Karunanithy, who heads the hepatitis C program at the council.

“Healthcare workers are more welcoming now, they understand key populations. We have good family medicine specialists in some of the clinics who are also very close to the clients, so that the clients feel very comfortable around the doctors.

‘Silent killer’

From mid-2018, when affordable DAA treatments became available in the Malaysian market, the number of people being treated increased rapidly. “Now, we have treated over 10,000 patients,” said Dr Muhammad Radzi Abu Hassan, National Head of Gastroenterology and Hepatology in Malaysia. “Even last year, despite the COVID-19 pandemic, we managed to treat 4,000 patients. It’s amazing, with all the chances we have.

Cheaper treatment should also encourage countries to conduct more tests for hepatitis, which the WHO wants to eliminate as a public health problem by reducing new infections by 90% and deaths by 65% ​​of by 2030.

“When the treatment exists but is too expensive, countries generally wouldn’t do large-scale testing because if a person tests positive. It is unethical not to provide the treatment, especially when it is a cure that cures, ”Chee said. “Without affordable treatment we end up not testing and in this vicious cycle. Hepatitis C continues to be 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 the ravidasvir plus sofosbuvir combination therapy is expected to 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 talking with a number of international agencies to see if we can use this value chain idea to create a coalition in the south of the world, a kind of south-south value chain for hepatitis elimination. C, ”Piedagnel said. .


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