EASE

Study overview:  A Pioneering Malaysian Study Investigates the Efficacy of an 8-Week SOF-RVD Combination Treatment for Non-Cirrhotic Chronic Hepatitis C. This multicenter, open-label, randomized controlled trial represents a significant advancement in Hepatitis C treatment strategies. The study, wholly designed and implemented by the Malaysian Ministry of Health, compares the efficacy and safety of an 8-week versus a 12-week regimen of SOF-RVD combination therapy for patients with non-cirrhotic chronic Hepatitis C. All enrolled subjects will receive the designated treatment and be monitored for a 24-week follow-up period following treatment completion. 

This groundbreaking research holds the potential to revolutionize Hepatitis C treatment by:

• Enhancing Patient Adherence: A shorter treatment duration is hypothesized to significantly improve patient compliance, particularly among vulnerable populations such as people who inject drugs (PWID).
• Expanding Treatment Accessibility: The study's inclusion of primary care health clinics provides a more accurate representation of the Hepatitis C patient population in Malaysia. This decentralized approach has the potential to broaden access to treatment across the nation.
• Promoting Non-Invasive Assessment: The study's utilization of non-invasive scoring systems (APRI score & FIB-4 index) for liver cirrhosis evaluation facilitates treatment decentralization to primary care settings. 
• Empowering Primary Care Physicians: By equipping family physicians with highly effective Direct Acting Antivirals (DAAs) and these accessible assessment tools, the study empowers primary care to deliver comprehensive Hepatitis C care.
• Demonstrating LMIC Leadership: This Malaysian-led initiative underscores the potential for effective drug development and implementation within Low- and Middle-Income Countries (LMICs), independent of major pharmaceutical involvement. 

The findings from this pivotal study hold significant implications for the global fight against Hepatitis C. The potential for a shorter, more accessible treatment regimen paves the way for improved patient outcomes and broader access to care, particularly in resource-limited settings. 

Number of subjects screened: 473 

Number of subjects recruited: 322 

Investigator site: 

Study sites: 9 public hospitals and 18 health clinics 

1. Hospital Serdang, Selangor
2. Hospital Selayang, Selangor
3. Hospital Sultanah Nur Zahirah, Terengganu  
4. Hospital Sultanah Bahiyah, Kedah
5. Hospital Tengku Ampuan Afzan, Pahang  
6. Hospital Raja Perempuan Zainab, Kelantan
7. Hospital Sultanah Aminah, Johor
8. Hospital Pulau Pinang
9. Hospital Kuala Lumpur
10. Klinik Kesihatan Petra Jaya, Sarawak
11. Klinik Kesihatan Miri, Sarawak
12. Klinik Kesihatan Kuah, Kedah
13. Klinik Kesihatan Bandar Sungai Petani
14. Klinik Kesihatan Bandar Pusat Jengka, Pahang
15. Klinik Kesihatan Tampin, Negeri Sembilan
16. Klinik Kesihatan Kuala Besut, Terengganu
17. Klinik Kesihatan Batu Pahat, Johor
18. Klinik Kesihatan Serendah, Selangor
19. Klinik Kesihatan Ampang, Selangor
20. Klinik Kesihatan Taiping, Perak
21. Klinik Kesihatan Parit, Perak
22. Klinik Kesihatan Ayer Tawar, Perak
23. Klinik Kesihatan Masjid Tanah, Melaka
24. Klinik Kesihatan Bachok, Kelantan
25. Klinik Kesihatan Senawang
26. Klinik Kesihatan Bayan Lepas, Penang
27. Klinik Kesihatan Butterworth, Penang 

Sponsor: Ministry of Health Malaysia (MOH) grant

Collaborators:  DNDI- Drugs for Neglected Disease Initiative, Geneva & Pharco Pharmaceuticals, Egypt