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New and experimental hepatitis C treatment news

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AbbVie Demonstrates 96 percent SVR(12) in its Phase III Study of Treatment-Experienced Patients with Genotype 1 Hepatitis C

In the 394-patient SAPPHIRE-II study, 96 percent of patients who previously failed pegylated interferon and ribavirin treatment, including approximately 49 percent of who were prior null responders, achieved sustained virologic response at 12 weeks (SVR(12) ) with the regimen. The majority of patients were GT1a, considered a difficult-to-treat subtype, and the SVR(12) rates of GT1a and GT1b were 96 percent and 97 percent, respectively.

Published
10 December 2013
From
AbbVie press release
Activists Condemn Gilead for Exorbitant Price of Their New Hepatitis C Drug

The Fair Pricing Coalition (FPC) today condemned Gilead Sciences for the price set for its direct acting antiviral (DAA) Sovaldi™ (sofosbuvir) - $84,000 for a 12-week course.

Published
10 December 2013
From
Fair Pricing Coalition / The Body
Beyond the Hype: What Sofosbuvir Means—and Doesn’t—for Global Hepatitis C Treatment

In this new report, Beyond the Hype: What Sofosbuvir Means—And Doesn’t—For Global Hepatitis C Treatment, we examine the new hepatitis C treatment market and projected revenues, and look back at what we can learn from the fight for access to HIV medicines in the 2000s to help secure reductions in the price of these promising new hepatitis C treatments.

Published
10 December 2013
From
Open Society Foundation
US FDA approves Gilead's $1000-a-day hepatitis C pill

Most patients will be treated with the $1,000-a-day drug for 12 weeks, resulting in a total list price of $84,000, according to Gilead spokeswoman Cara Miller.

Published
08 December 2013
From
Reuters
FDA approves Sovaldi for chronic hepatitis C

The U.S. Food and Drug Administration today approved Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection. Sovaldi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon.

Published
08 December 2013
From
US FDA
Sofosbuvir for Hepatitis C: Simpler, Shorter, Safer?

The availability of these agents will provide unprecedented opportunities for off-label use of these therapies in many patients, including those with decompensated cirrhosis or chronic kidney disease, pediatric populations, and those with HIV coinfection. Because many of these populations represent relatively small numbers of patients with HCV, it may be difficult to accumulate the requisite data and possibly cost-prohibitive for manufactur

Published
04 December 2013
From
Medscape (requires registration)
Fair Pricing Coalition Disappointed by the High Price of New Janssen Hepatitis C Drug Olysio (simeprevir)

Janssen has set the wholesale acquisition cost, (WAC) for a single 12-week course of Olysio at $66,360. Though this is in parity with current HCV PIs, the FPC believes that all HCV drugs are priced too high. The WAC price of Olysio represents only part of the cost of an anti-HCV regimen, including at least $18,000 in WAC costs of interferon and ribavirin, plus the additional cost of the NS3 Q80K polymorphism screening test recommended by the FDA for all patients before initiating Olysio therapy.

Published
29 November 2013
From
Fair Pricing Coalition
Gilead responds over India patent pressure on HCV drug

Fresh from picking up a positive opinion in Europe for sofosbuvir, Gilead Sciences is facing a battle to get patent protection in India for its much-touted new hepatitis C drug.

Published
27 November 2013
From
PharmaTimes
Faldaprevir effective across patient sub-groups with several baseline characteristics associated with treatment outcomes

The experimental hepatitis C virus (HCV) protease inhibitor is efficacious across a range of subgroups, according to research presented to the recent Liver Meeting 2013, the 64th annual

Published
27 November 2013
By
Michael Carter
Meeting report of the International multi-stakeholders meeting on the compassionate use of HCV treatment

On 19-20 June 2013, the European AIDS Treatment Group (EATG) and the European Liver Patients Association (ELPA) organised a meeting, dedicated to “Pathways to provide access to novel HCV compounds to people for whom they are yet not authorised, but who have no alternative treatments”.

Published
26 November 2013
From
EATG

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