Date of Award

2013

Degree Type

Selective Evidence-Based Medicine Review

Degree Name

Master of Science in Health Sciences - Physician Assistant

Department Chair

John Cavenagh, PhD, PA-C

Abstract

OBJECTIVE: The objective of this selective EBM review is to determine if the addition of telaprevir reduces treatment time and is more effective than the presently available pegylated interferon α2a-ribavirin combination 48 week therapy.

STUDY DESIGN: Review of three English language primary studies published in 2011.

DATA SOURCES: Articles selected for review, are randomized, double blind, placebo controlled trials found in peer-reviewed journals using Cochrane, Medline and PubMed databases.

OUTCOMES MEASURED: Effectiveness of telaprevir was measured by determining the potentiality of reducing treatment outcome from 48 weeks to 24 weeks and the overall success rate of telaprevir as an add-on drug to the current therapy.

RESULTS: Jacobsen et al. (2011) found that 75% of patients using telaprevir as an add-on medication had SVR rates compared to 44% using placebo add-on. Sherman et al. (2011) found that a 24 week regimen of the currently available therapy with telaprevir added in the first 12 weeks was non-inferior to the same regimen at 48 weeks duration. No statistical differences were seen in variable dosing frequencies and intervals (P ≥0.787) and SVR was achieved in most
patients with similar adverse reactions (Marcellin et al., 2011).

The safety profile monitored adverse reactions seen including anemia, nausea, diarrhea and skin rashes. Similar adverse reactions are seen with the current therapy; however incidence rate does increase with the triple therapy regimen. All adverse reactions dissipated once medication was discontinued.

CONCLUSIONS: Data shows that telaprevir is an effective addition to the currently available therapy of peginterferon α-2a/ribavirin for chronic HCV genotype 1 patients. The three studies selected for review suggest that a large proportion of patients would show promising results with addition of telaprevir for a 24 week treatment duration being used twice daily for the first 12 weeks with similar adverse reactions and greater patient compliance than seen with the currently
available therapy.

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