Publication from CGHE and partners: "Retreatment of Chronic Hepatitis C Infection: Real-World Regimens and Outcomes From National Treatment Programs in Three Low- and Middle-Income Countries"
In low- and middle-income countries (LMICs), there is limited guidance on appropriate and available second-line therapy options for patients living with hepatitis C that fail first-line direct acting antiviral treatment. The only recommended regimen by the World Health Organization is sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX), but this therapy is not yet accessible in generic form and remains unaffordable in most LMICs. To date, clinicians in LMICs have been using their own judgment on which second-line HCV therapy options to use or have made the difficult decision to defer HCV second-line treatment for patients.
To address this gap, the Coalition for Global Hepatitis Elimination (CGHE) in partnership with the Clinton Health Access Initiative (CHAI), CGHE Technical Advisory Board Members, and National Hepatitis Elimination programs organized an operational research study to pool retrospective data on second-line, or retreatment, regimens being used across LMICs and the associated patient outcomes.
In 2020, national programs from Egypt, Georgia, and Myanmar and clinical sites from Rwanda contributed data on initial therapy failures, retreatments with second-line therapy, or both. Data from Rwanda was not included in the final analysis.
The results of this study were published in Clinical Infectious Diseases on July 3rd, 2021 in the article "Retreatment of Chronic Hepatitis C Infection: Real-World Regimens and Outcomes From National Treatment Programs in Three Low- and Middle-Income Countries."
Key findings included:
- The most commonly used second-line therapy regimens were SOF/LDV+RBV, SOF/DCV+RBV, and SOF/VEL+RBV for 24 weeks.
- Alternative retreatment regimens to SOF/VEL/VOX resulted in over 93% of patients cured of HCV infection; All alternative regimens resulted in greater than 90% SVR
These real-world results suggest that there are effective and affordable retreatment options in LMICs. Looking forward, these preliminary results indicate a prospective, randomized controlled trial in LMICs is needed to establish high-quality evidence on preferred second-line therapy regimens and ensure all patients benefit from HCV cures.
Full article citation: Caroline E Boeke, Lindsey Hiebert, Imam Waked, Tengiz Tsertsvadze, Lali Sharvadze, Maia Butsashvili, Mamuka Zakalashvili, Win Naing, Neil Gupta, Fredrick Kateera, Craig McClure, John W Ward, Christian B Ramers, Retreatment of Chronic Hepatitis C Infection: Real-World Regimens and Outcomes From National Treatment Programs in Three Low- and Middle-Income Countries, Clinical Infectious Diseases, 2021;, ciab461, https://doi.org/10.1093/cid/ciab461