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New and experimental hepatitis C treatment news

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The 2016 Hepatitis C Drug Approval Outlook

Here’s what’s in store this year for new hepatitis C therapies, as well as approvals for new uses of existing treatments.

Published
18 January 2016
From
Poz
AbbVie Initiates Enrollment of Six Global Phase 3 Clinical Studies for Once-Daily, Pan-Genotypic Hepatitis C Regimen

AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced the initiation of six global Phase 3 clinical studies evaluating the safety and efficacy of its all-oral, once-daily, ribavirin-free investigational hepatitis C virus (HCV) regimen, ABT-493, an NS3/4A protease inhibitor, and ABT-530, an NS5A inhibitor, in patients with genotypes 1-6 (GT1-6) chronic HCV infection. The new investigational regimen evaluates treatment durations of 12 weeks and as short as eight weeks in genotype 1 patients.

Published
11 January 2016
From
AbbVie press release
Mylan Launches Generic Harvoni® (Ledipasvir/Sofosbuvir) Under the Brand Name MyHep LVIR™ in India

Mylan N.V. (NASDAQ, TASE: MYL) today announced that its subsidiary, Mylan Pharmaceuticals Private Limited, has launched generic Harvoni® (Ledipasvir 90 mg/Sofosbuvir 400 mg) tablets under the brand name MyHep LVIR™ in India.

Published
08 January 2016
From
Mylan press release
Inside the hepatitis C virus is a promising antiviral

A peptide derived from the hepatitis C virus (HCV) kills a broad range of viruses while leaving host cells unharmed by discriminating between the molecular make-up of their membranes, reveals a study published January 5 in the Biophysical Journal. The peptide was potent against a range of cholesterol-containing viruses, including West Nile, dengue, measles, and HIV.

Published
06 January 2016
From
Medical Xpress
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

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Community Consensus Statement on Access to HIV Treatment and its Use for Prevention

Together, we can make it happen

We can end HIV soon if people have equal access to HIV drugs as treatment and as PrEP, and have free choice over whether to take them.

Launched today, the Community Consensus Statement is a basic set of principles aimed at making sure that happens.

The Community Consensus Statement is a joint initiative of AVAC, EATG, MSMGF, GNP+, HIV i-Base, the International HIV/AIDS Alliance, ITPC and NAM/aidsmap
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