A high-level meeting chaired by Federal Minister Syed Mustafa Kamal brought together Huahui Health, IQVIA Pakistan and DRAP leadership in Islamabad to establish a strategic response to the rising threat of Hepatitis Delta in Pakistan. The session focused on clinical data, regulatory pathways and partnerships to accelerate patient access to innovative therapies for Hepatitis Delta.
Officials reviewed national estimates that suggest more than one million people may be affected, with roughly 20 percent of those living with Hepatitis B at risk of co-infection with HDV. Participants underscored that delayed diagnosis and limited routine testing leave many patients vulnerable to rapid progression to liver cirrhosis and hepatocellular carcinoma, heightening the urgency of an integrated public health response.
Representatives from Huahui Health provided an update on their investigational therapy Libevitug (HH-003), reporting successful completion of Phase 2 multi-centre international trials and regulatory approval in China based on demonstrated safety and efficacy. The treatment has also received Breakthrough Therapy designation from the US FDA, highlighting its potential to address unmet needs in Hepatitis Delta care.
The federal government pledged to facilitate a partnership between Huahui Health and a leading local pharmaceutical manufacturer to enable technology transfer and localized production of advanced biologics. The goal is to secure sustainable, affordable supply chains so that novel Hepatitis Delta treatments reach patients across Pakistan without undue cost barriers.
DRAP emphasized its commitment to a transparent, science-based approval process that protects patient safety while enabling timely access to life-saving innovations. Regulators and stakeholders agreed to expedite the regulatory roadmap for Phase 3 clinical trials in Pakistan, with stringent oversight aligned to international standards to maintain data integrity and patient protections.
Participants concluded with a shared commitment to move quickly on trial approvals, local manufacturing arrangements and diagnostic scale-up so that proven Hepatitis Delta therapies can be deployed to those in need under rigorous regulatory supervision.
