Date of Award

2015

Degree Type

Selective Evidence-Based Medicine Review

Degree Name

Master of Science in Health Sciences - Physician Assistant

Department

Physician Assistant Studies

Department Chair

John Cavenagh, MBA, PhD, PA-C

Abstract

Objective: The objective of this selective EBM review is to determine whether or not Sofosbuvir plus Ribavirin is safer and more effective than Peginterferon plus Ribavirin for treatment of chronic Hepatitis C Virus infection in treatment-naïve patients.

Study Design: Systematic review of three English language primary studies, published in 2013.

Data Sources: Three randomized control trials, two of which are open-label, activecontrolled and one that is double-blind, placebo-controlled, comparing Sofosbuvir and Ribavirin versus other chronic HCV modalities found via PubMed in peer-reviewed journals.

Outcomes Measured: Safety was measured by self-reported adverse events, routine laboratory tests, physical exams, vital signs, and electrocardiography and graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Efficacy was determined by sustained virological response at 12 or 24 weeks post-treatment (SVR12 and SVR24, respectively), which is classified as a HCV RNA concentration below the limit of detection of 15 IU/mL or 25 IU/mL

Results: Gane, et al compared the treatment effects of 400mg Sofosbuvir and Ribavirin (RBV) with that of Sofosbuvir plus RBV and Peginterferon (PEG) for 12 weeks in patients with chronic HCV. Analysis resulted in an equal incidence of SVR24, but with less adverse events in the experimental group. In Lawitz, Lalezari, et al, patients received 12 weeks with either 400mg Sofosbuvir, RBV, and PEG or placebo, PEG, and RBV. SVR24 was higher in the Sofosbuvir group, however more adverse events of fatigue were reported compared to the placebo group. Lawitz, Mangia, et al examined the difference in treatment with 12 weeks of 400mg Sofosbuvir and RBV versus 24 weeks of PEG and RBV. Statistical analysis showed an equal rate of SVR12 between the two groups, yet treatment with Sofosbuvir was safer.

Conclusions: It can be deduced from these three RCTs that Sofosbuvir plus RBV is safer, yet, statistically, nearly equal in efficacy to treatment with PEG and RBV. Given that PEG is a weekly injection with many unfavorable side effects, it would be more beneficial to receive treatment with Sofosbuvir and RBV for treatment of chronic HCV infection.

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