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Efficacy and safety of 8- versus 12-week sofosbuvir-ravidasvir treatment for non-cirrhotic chronic hepatitis C patients: An open-label, randomized, multicenter study in Malaysia

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 
CRC HSB EASE

Sponsor: Ministry of Health Malaysia (MOH) grant

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

ICR
National Institutes of Health (NIH)
Ministry of Health Malaysia
Institute For Clinical Research
Block B4, National Institutes of Health (NIH)
No.1, Jalan Setia Murni U13/52, Seksyen U13
40170 Shah Alam, Selangor Darul Ehsan
Malaysia
 
Phone: 603-3362 7700
Email: contact@crc.gov.my
 

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