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Phase 3 UNITY Trials Demonstrate High Cure Rates for Investigational, All-Oral Daclatasvir TRIO Fixed-Dose Combination in Genotype 1 Hepatitis C Patients, Including Those with Cirrhosis

Daclatasvir TRIO achieves 98% cure rate in treatment-naïve and 93% cure rate in treatment-experienced genotype 1 patients with cirrhosis when used with ribavirin, as shown in UNITY 2. 12-week, all-oral treatment halves current regimen duration for hard-to-manage treatment-experienced genotype 1 patients with cirrhosis. Fixed-dose regimen also demonstrates 91% SVR rates in non-cirrhotic genotype 1 patients without requiring use of ribavirin

Published
10 November 2014
From
Bristol-Myers Squibb press release
ALLY Trial Demonstrates High Cure Rates for Investigational Daclatasvir and Sofosbuvir Combination among Genotype 3 Hepatitis C Patients

Daclatasvir+sofosbuvir regimen achieves SVR12 in 90% of treatment-naïve and 86% of treatment-experienced genotype 3 patients. ALLY-3 is the first Phase 3 study of an all-oral, ribavirin-free treatment regimen for genotype 3 HCV patients with a 12-week treatment duration

Published
10 November 2014
From
Bristol-Myers Squibb press release
Achillion Reports 100% SVR12 in a Phase 2 Combination Study With ACH-3102 at the Liver Meeting 2014 (AASLD)

In a late breaker poster presentation, Achillion reported updated interim results from an ongoing interferon-free, ribavirin-free, Phase 2 open-label, randomized, partial-crossover study to evaluate the efficacy, safety, and tolerability of eight weeks or six weeks of ACH-3102 and sofosbuvir. Eighteen patients were enrolled, including six observational patients. Twelve patients completed eight weeks of treatment consisting of 50 mg of ACH-3102 and 400 mg of sofosbuvir administered once daily while observational patients received no drug during this phase of the trial. Of the 12 patients treated, 100 percent (n=12/12) achieved SVR12.

Published
10 November 2014
From
Achillion press release
Merck's Four-Week Hepatitis C Regimen Fails to Top Gilead

Merck & Co. (MRK) won't move forward with an ultra-short hepatitis C regimen that attempted to cut treatment durations in half by combining two of its drugs with another from Gilead Sciences Inc. In patients whose livers weren’t already badly damaged by the virus, 38.7 percent were cured in four weeks and 86.7 percent were cured in six weeks, according to data presented today at the American Association for the Study of Liver Diseases conference in Boston.

Published
10 November 2014
From
Bloomberg
Sofosbuvir/ledipasvir cures nearly all genotype 1 HCV for people with HIV co-infection

All but one participant treated for hepatitis C virus (HCV) with a co-formulation of sofosbuvir and ledipasvir (Harvoni) achieved sustained virological response at 12 weeks post-treatment, in a

Published
10 November 2014
By
Liz Highleyman
Sustained virological response to hepatitis C treatment reduces mortality, liver cancer and liver transplants

People who achieve sustained virological response (SVR) when treated with interferon-based therapy for hepatitis C have a lower risk of death, are less likely to develop liver

Published
10 November 2014
By
Liz Highleyman
Olysio (simeprevir) approved for use in combination with sofosbuvir

Janssen Therapeutics, Division of Janssen Products, LP (Janssen) announced the U.S. Food and Drug Administration (FDA) has approved OLYSIO® (simeprevir), a hepatitis C virus (HCV) NS3/4A protease inhibitor, in combination with sofosbuvir as an all-oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis C (CHC) infection in adult patients as part of a combination antiviral treatment regimen. Sofosbuvir is an HCV nucleotide analog NS5B polymerase inhibitor developed by Gilead Sciences, Inc.

Published
07 November 2014
From
Johnson & Johnson press release
Bristol-Myers Plan to Widen Access to its Hep C Drug is Criticized

“Unfortunately, history seems to be repeating itself with BMS, who hasn’t learned from the company’s poor track record responding to the HIV epidemic,” says Rohit Malpani of Doctors Without Borders.

Published
05 November 2014
From
Wall Street Journal
Half of people with hepatitis C unaware

Dr Vivian Hope of Public Health England said: "With around half of those people living with hepatitis C still unaware of their infection, we need to do more to increase diagnosis rates. Ultimately, this will help reduce the current high level of infection we’re still seeing among people who inject drugs."

Published
05 November 2014
From
Public Health England press release
Bristol-Myers Squibb announces HCV global access plans

Bristol-Myers Squibb’s HCV developing world access approach will utilize tiered pricing, licensing agreements and working in collaboration with other stakeholders who share in our commitment to working toward the eradication of hepatitis C.

Published
03 November 2014
From
Bristol-Myers Squibb press release

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