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New and experimental hepatitis C treatment news

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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
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
Study suggests unprecedented 3-week hepatitis C cure

Yet another stunning victory in the drug battle against the liver-damaging hepatitis C virus (HCV) may be in the offing: A small study suggests it may be possible to cure some people of their infections in as few as 3 weeks.

Published
02 November 2015
From
Science
Gilead Seeks FDA Approval for Hep C Treatment for All Genotypes

Gilead has applied to the FDA for approval of the combo tablet of Sovaldi and velpatasvir to treat those with genotypes 1 through 6 of hepatitis C.

Published
02 November 2015
From
AIDSMeds
'Dallas Buyers' Club' for Hep C treatments under investigation

A "Dallas Buyers Club" of doctors and patients importing potentially life-saving Hepatitis C medication from countries like China is being investigated by the Therapeutic Goods Administration.

Published
22 October 2015
From
Sydney Morning Herald
NICE Recommends Daklinza (daclatasvir) for Treatment of Certain Patients with Chronic Hepatitis C Genotypes 1, 3 and 4

Bristol-Myers Squibb today announced that the National Institute for Health and Care Excellence (NICE) has recommended Daklinza (daclatasvir) in England and Wales for the treatment of adult patients with chronic hepatitis C virus (HCV) infection. Specifically, NICE recommended Daklinza, an oral, once-daily medication used in combination with other agents, to treat certain patients with HCV genotypes 1, 3 and 4.

Published
16 October 2015
From
Bristol-Myers Squibb press release
U.S. FDA Grants Priority Review For Daklinza (daclatasvir) sNDAs

Three applications are under review for Daklinza in combination with sofosbuvir with or without ribavirin to treat chronic hepatitis C patients with decompensated cirrhosis, post-liver transplant recurrence of HCV, and coinfection with HIV-1.

Published
07 October 2015
From
Bristol-Myers Squibb

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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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This content was checked for accuracy at the time it was written. It may have been superseded by more recent developments. NAM recommends checking whether this is the most current information when making decisions that may affect your health.

NAM’s information is intended to support, rather than replace, consultation with a healthcare professional. Talk to your doctor or another member of your healthcare team for advice tailored to your situation.