ISLAMABAD: The Ministry of Health and the Drug Regulatory Authority of Pakistan (Drap) have launched work to combat the Hepatitis Delta Virus (HDV), a major cause of liver cirrhosis.

According to estimates, over one million people are affected with HDV across the country.

In cirrhosis, the liver is permanently damaged and it becomes unable to filter blood, produce proteins and digest food. Patients feel fatigue, jaundice and swelling. Finally, they are left with no other option but to go for liver transplant.

According to Ministry of Health spokesperson Sajid Shah, Federal Minister Syed Mustafa Kamal convened a consultative meeting with the leadership of Huahui Health (China) and IQVIA Pakistan. “The session focused on establishing a strategic framework to address the escalating prevalence of HDV in Pakistan,” he said.

About 20pc of Hepatitis B patients in Pakistan may be co-infected with HDV, meeting told

During the session, the minister highlighted the significant clinical burden of HDV. With estimates suggesting over one million affected individuals nationwide, the minister emphasised the high risk of rapid disease progression to liver cirrhosis and hepatocellular carcinoma if left unmanaged.

Data presented during the meeting indicated a critical diagnostic gap; approximately 20pc of Hepatitis B patients in Pakistan may be co-infected with HDV, yet routine testing remains underutilised.

Huahui Health shared key updates regarding its investigational HDV therapy, Libevitug (HH-003), which recently concluded a Phase 2 multi-centre, multi-country clinical study. The therapy has received regulatory approval in China based on favourable safety and efficacy data. Notably, the US Food and Drug Administration (FDA) has granted it breakthrough therapy designation, underscoring its potential to provide substantial improvement over existing treatments.

To ensure sustainable and affordable patient access, the minister said the government will facilitate a partnership between Huahui Health and a premier local pharmaceutical manufacturer. “This initiative is aimed at localising the production of advanced biological products and enabling technology transfer,” he added.

Dr Obaidullah Malik, CEO of Drap, remarked: “Drap’s regulatory mandate is to ensure that Pakistani patients have early access to life-saving innovations without compromising on safety or quality. By facilitating the Phase 3 trials of this breakthrough HDV therapy and enabling technology transfer for local manufacturing, Drap is strengthening national health security. We are committed to a transparent, science-based approval process that aligns Pakistan with international best regulatory practices.”

The meeting concluded with a commitment to expedite the regulatory roadmap for Phase 3 clinical trials in Pakistan, ensuring that this innovative treatment reaches those in need under stringent regulatory oversight.

Published in Dawn, February 2nd, 2026