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US FDA Perspective on Elbasvir/Grazoprevir Treatment for Patients with Chronic Hepatitis C Virus Genotype 1 or 4 Infection.

Clinical drug investigation - 1 Apr 2017

Boyd Sarita D, Tracy LaRee, Komatsu Takashi E, Harrington Patrick R, Viswanathan Prabha, Murray Jeff, Sherwat Adam

Abstract excerpt

Elbasvir/grazoprevir demonstrated high sustained virologic response rates 12 weeks after the end of treatment (SVR12) across five clinical trials in subjects infected with chronic hepatitis C virus (HCV) genotype 1, including those with advanced chronic kidney disease (CKD), and GT4. Despite favorable results overall, the US Food and Drug Administration (FDA) encountered challenging regulatory issues due to the...

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Identifiers

PMID: 28102520
DOI: 10.1007/s40261-017-0492-5

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PubMed metadata and Literature Corpus relationships. Corpus snapshot updated 7 Sept 2026. Manifest publication-graph-cohort-2026-09-07.1.

Source receipt: pubmed, retrieved 7 Sept 2026.

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