Making Hepatitis C Treatment More Accessible In Malaysia

Malaysia has granted a conditional registration for an affordable hepatitis C treatment developed through public-private partnerships with organizations in Egypt and Thailand.

AsianScientist (Jul. 1, 2021) – Though travel restrictions still remain across parts of the world, collaboration transcends borders—as in the case of Malaysia, who joined forces with partners in Egypt and Thailand to clinically assess an affordable hepatitis C drug combination. The resulting clinical trial results are described in The Lancet Gastroenterology & Hepatology.

COVID-19 may still dominate global headlines, but diseases like hepatitis C continue to lurk in the background. Currently, hepatitis C affects about 58 million people worldwide—causing chronic liver disease, cirrhosis and cancer—yet only 13 percent have received treatment to date. With these stark statistics, around 300,000 individuals die from a potentially curable disease each year.

“Although hepatitis can be cured, there is a vicious circle that stands in the way of providing treatment to all in need: the disease is mostly a ‘silent killer’, the diagnostic process is complex, so [patients are missed] and [treatment] is often too expensive,” explained Dr Noor Hisham Abdullah, Director General of Malaysia’s Ministry of Health.

While various aspects of hepatitis care remain tricky, the lack of access to powerful treatments called direct-acting antivirals that can cure patients in three to six months is perhaps the greatest challenge.

To address this gap, an international team from the Malaysian Ministry of Health, non-profit Drugs for Neglected Diseases initiative (DNDi), Egyptian pharmaceutical Pharco, Malaysian pharmaceutical Pharmaniaga Berhad and non-governmental organization Médecins Sans Frontières (MSF) banded together to develop and bring affordable, accessible hepatitis C treatments to middle-income countries across Southeast Asia.

The treatment in question is a combination of ravidasvir—which binds to the hepatitis C virus’ NS5A protein and blocks its ability to regulate viral replication—and sofusbuvir, which blocks the enzyme the replicates viral RNA.

In an open-level clinical trial across Malaysia and Thailand involving 301 individuals, the team assessed the efficacy, safety and pharmacokinetics of the drug combination against hepatitis C.

Incredibly, the combination resulted in cure rates of 97 percent and was tolerated well even by patients considered difficult to treat. Moreover, no conflicting drug interactions were observed with antiretrovirals used to treat HIV, meaning that clinicians can safely prescribe both treatments to co-infected patients.

With a price tag of US$300-500 over 12 weeks, the ravidasvir-sofusbuvir combination is expected to be among the most affordable hepatitis C treatments on the market.

“[Malaysia is] actively screening to find ‘missing’ patients, rolling out simpler diagnostic tests, and ensuring we have access to the best prices for treatments, including by conducting clinical research to identify additional affordable treatment options,” concluded Noor Hisham. “Today’s announcement is a milestone on Malaysia’s long journey to achieve the World Health Organization goal of eliminating hepatitis C by 2030.”

The article can be found at: Andrieux-Meyer et al. (2021) Efficacy and Safety of Ravidasvir Plus Sofosbuvir in Patients with Chronic Hepatitis C Infection Without Cirrhosis or With Compensated Cirrhosis (STORM-C-1): Interim Analysis of a Two-stage, Open-label, Multicenter, Single Arm, Phase 2/3 Trial.


Source: Drugs for Neglected Diseases Initiative; Photo: Shutterstock.
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