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Favorable Adverse Event Profile of Sofosbuvir/Ribavirin Versus Standard of Care for Hepatitis C
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Reported by Jules Levin
CROI 2014 March 3-6
Boston, MA
Kerry Townsend1, Shivakumar Narayanan2, Amy Nelson1, Adrian Majid2, Luciano Kapelusznik2, Jing Qin1, Robert Redfield2, Shyam Kottilil1, Rohit Talwani2, Anu Osinusi1,2
1 Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD,
2Institute of Human Virology, University of Maryland School of Medicine, Baltimore, MD
Program abstract-
Background: The treatment of Hepatitis C virus (HCV) infection is rapidly evolving from the current standard of care comprised of interferon (IFN)- based triple therapy to IFN free treatment with directly acting antiviral agents (DAAs). Triple therapy with Boceprevir (BOC) or Telaprevir has resulted in improved SVR rates, however adverse events (AEs), pill burden and drug interactions remain significant barriers to successful completion of treatment. The aim of this study was to
evaluate the AEs experienced with the present standard of care compared to sofosbuvir + ribavirin (SOF/RBV) in HCV monoinfected, genotype-1 (GT-1)
individuals.
Methodology: We retrospectively evaluated HCV monoinfected, treatment naive, GT-1 individuals treated with either BOC/IFN/RBV at the Veterans Affairs
Medical Center, Baltimore (n=97) or SOF/RBV in the SPARE clinical trial at the National Institute of Allergy and Infectious Disease (n=60). AEs namely
hematologic (hemoglobin, neutrophil and platelet counts); hepatic (alanine transaminase or bilirubin) and renal (eGFR) were measured and graded from 1
(mild) to 4 (severe) according to the DAIDS toxicity table (version 1.0). Comparisons were carried out using the nonparametric Wilcoxon rank sum and Chi
square tests using GraphPad Prism 6.0.
Results: The BOC/IFN/RBV cohort was older (58 vs. 55, p=0.0006) male (96% vs. 62%, p<0.0001) and had more advanced liver disease (59% vs.
23%, p<0.0001) (Table 1). The SOF/RBV group had a higher proportion of African Americans (83% vs. 65%, p=0.001). The combination of SOF/RBV
was well tolerated, while BOC/IFN/RBV was associated with significantly more AEs, most commonly neutropenia, anemia and low platelets. (Table 1).
In the SOF/RBV cohort, 5(8%) patients discontinued treatment early but none (0%) were for AEs while 34 (35%) patients on triple therapy discontinued
treatment due to AEs.
Conclusions: SOF/RBV treatment was associated with much fewer side effects than BOC-based triple therapy appearing to be a safer and more tolerable
alternative for HCV GT-1 subjects. These results show that emerging IFN/RBV free therapies may enhance patient compliance, allowing treatment of larger
numbers of patients.
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