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Experimental HCV Drugs

Gilead and AbbVie Seek FDA Approval of Pangenotypic Hepatitis C Treatments

Gilead Sciences and AbbVie both announced this month that they have applied for U.S. Food and Drug Administration approval of new all-oral ribavirin-free combination regimens to treat all genotypes of hepatitis C virus (HCV). Gilead's sofosbuvir/velpatasvir/ voxilaprevir and AbbVie's glecaprevir/pibrentasvir have demonstrated high cure rates in Phase 3 clinical trials.

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AASLD 2016: Glecaprevir/ Pibrentasvir Effective for Hepatitis C Patients with Severe Kidney Disease

A 2-drug pangenotypic regimen combining AbbVie's glecaprevir and pibrentasvir demonstrated a high sustained response rate for chronic hepatitis C patients with severe kidney impairment, according to results from the EXPEDITION-4 study presented at the 2016 AASLD Liver Meeting last month in Boston.

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AASLD 2016: 8-Week Triple Combo Cures Most Patients with Genotype 1-6 Hepatitis C

A 3-drug regimen of sofosbuvir, velpatasvir, and voxilaprevir taken for 8 weeks demonstrated an overall sustained virological response rate of 95% for previously untreated patients with all hepatitis C virus (HCV) genotypes, while a 12-week regimen cured 96%-97% of people who experienced prior treatment failure on direct-acting antivirals (DAAs), according to a set of Phase 3 studies presented last week at the AASLD Liver Meeting in Boston.

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AASLD 2016: Grazoprevir Triple Regimen Demonstrates High Cure Rates, Even for Hard-to-Treat Patients

A new 3-drug coformulation containing Merck's grazoprevir plus the investigational agents MK-3682 and ruzasvir was highly effective for people with hepatitis C virus (HCV) genotypes 1, 2, or 3, with sustained response rates of 86% to 100% depending on treatment duration, according to study results presented this month at the AASLD Liver Meeting in Boston. Related studies showed that the combination is also effective for retreating people who were not cured with a previous course of direct-acting antivirals (DAAs).

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AASLD 2016: AbbVie Pangenotypic Combination Cures 98% or More Across HCV Genotypes

AbbVie’s combination of glecaprevir and pibrentasvir cured at least 98% of people with hepatitis C in 3 large clinical trials covering 5 out of 6 genotypes of the virus, and it is likely to receive marketing approval in the United States and European Union as the first ribavirin-free pangenotypic direct-acting antiviral combination next year, according to a report at the AASLD Liver Meeting last week in Boston.

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