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Safety and Efficacy of Limited Laboratory Monitoring for Hepatitis C Treatment: A Blinded Clinical Trial in Rwanda
Author(s) -
Grant Philip,
Shumbusho Fabienne,
Van Nuil Jennifer Ilo,
Kateera Fredrick,
Mukherjee Joia,
Kabahizi Jules,
Ntaganda Fabien,
Nsanzimana Sabin,
Mbituyumuremyi Aimable,
Damascene Makuza Jean,
Muvunyi Claude Mambo,
Mukabatsinda Constance,
Musabeyezu Emmanuel,
Ntirenganya Cyprien,
Gupta Neil
Publication year - 2020
Publication title -
hepatology communications
Language(s) - English
Resource type - Journals
ISSN - 2471-254X
DOI - 10.1002/hep4.1482
Subject(s) - medicine , tolerability , adverse effect , sofosbuvir , hepatitis c , hepatitis c virus , clinical trial , viral load , human immunodeficiency virus (hiv) , ribavirin , immunology , virus
Direct‐acting antivirals for hepatitis C virus (HCV) are highly effective and well‐tolerated. However, only a small percentage of HCV‐infected individuals globally have received therapy. Reducing the complexity of monitoring during HCV therapy, if shown to be safe, could facilitate greater access to HCV services, particularly in resource‐limited settings such as sub‐Saharan Africa. We enrolled a total of 300 patients who were chronically infected with genotype 4 HCV in Rwanda and treated them with fixed‐dose ledispasvir/sofosbuvir for 12 weeks. For 60 consecutive participants enrolled, we blinded the study clinician to on‐treatment laboratory results. We compared the efficacy, safety, and tolerability in those with blinded laboratory results to those with standard laboratory monitoring. Baseline characteristics among those with blinded laboratory values were comparable to those with standard monitoring. Among both groups, the median age was 63 years, and the median HCV viral load was 5.9 log (versus 64 years and 6.0 log, respectively). Sustained virologic response rates at 12 weeks after treatment completion were similar in those with blinded laboratories (87%) compared to those with standard laboratory monitoring (87%). There was no increase in adverse events in those with blinded laboratory results, and no participants discontinued the study medication because of an adverse event. Conclusion: On‐treatment laboratory monitoring did not improve patient outcomes in those treated with ledispasvir/sofosbuvir. Eliminating this monitoring in treatment programs in resource‐limited settings may facilitate and accelerate scale‐up of HCV therapy.

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