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New and experimental hepatitis C treatment news

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Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir/Velpatasvir for Treatment of All Genotypes of Chronic Hepatitis C Infection

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the company’s New Drug Application (NDA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF), approved as Sovaldi® in December 2013, and velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection. FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 28, 2016.

Published
05 January 2016
From
Gilead press release
A quarter of people with HCV initially refused access to sofosbuvir/lepidasvir, says US study, but most successfully appeal

Insurers deny almost a quarter of requests for sofosbuvir/lepidasvir (Harvoni) to treat people with chronic hepatitis C virus (HCV) infection, investigators from Yale Liver Center report in

Published
29 December 2015
By
Michael Carter
Grazoprevir/elbasvir cures more than 90% of people with HIV/HCV co-infection

Merck's grazoprevir/elbasvir combination cured 93% of people with HIV and hepatitis C co-infection, was well-tolerated and did not appear to interact with antiretrovirals, according to final results from

Published
11 December 2015
By
Liz Highleyman
AbbVie Announces FDA Acceptance of New Drug Application for a Once-Daily Formulation of VIEKIRA PAK®

AbbVie today announced its New Drug Application (NDA) has been accepted by the U.S. Food and Drug Administration (FDA) for a once-daily, fixed-dose formulation of the components of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets).

Published
02 December 2015
From
AbbVie press release
Triple DAA regimen cures hepatitis C patients with rapid response in just 3 weeks

Response-guided therapy using an all-oral regimen of three direct-acting antivirals cured a majority of easier-to-treat genotype 1b hepatitis C patients in just 3 weeks, according to results from

Published
26 November 2015
By
Liz Highleyman
Daclatasvir and sofosbuvir with ribavirin cures 90% of people with genotype 3 hepatitis C

An all-oral combination of daclatasvir, sofosbuvir and ribavirin taken for 12 or 16 weeks led to high sustained virological response rates for people with hard-to-treat hepatitis C virus

Published
20 November 2015
By
Liz Highleyman
Daclatasvir plus sofosbuvir works well for people with genotype 3 hepatitis C and advanced liver disease in real-world clinical practice

Interferon-free treatment with daclatasvir plus sofosbuvir, with or without ribavirin, led to sustained virological response in a majority of people with genotype 3 hepatitis C virus (HCV) and

Published
20 November 2015
By
Liz Highleyman
New AbbVie hepatitis C combination cures 93 to 97% with genotype 3

A combination of two experimental direct-acting antivirals developed by AbbVie cured 93 to 97% of people with genotype 3 hepatitis C infection after a 12-week course of

Published
18 November 2015
By
Keith Alcorn
Sofosbuvir/ledipasvir plus vedroprevir shows 96% response rate for hard-to-treat genotype 1 hepatitis C patients

A triple combination of Gilead Sciences' sofosbuvir/ledipasvir (Harvoni) plus the experimental HCV protease inhibitor vedroprevir cured 96% of treatment-experienced, genotype 1 hepatitis C patients with cirrhosis, without the need

Published
18 November 2015
By
Liz Highleyman
Sofosbuvir/velpatasvir shows high cure rates for all HCV genotypes, works well for patients with liver decompensation

A co-formulation of sofosbuvir and the pan-genotypic HCV NS5A inhibitor velpatasvir from Gilead Sciences produced sustained response in 99% of people with hepatitis C virus genotypes 1,

Published
17 November 2015
By
Liz Highleyman

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