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HCV

FDA warns three Hepatitis C drugs may worsen liver function in some rare cases

The FDA has warned that three Hepatitis C (HCV) drugs made by AbbVie, Gilead and MSD are worsening liver function and causing liver failure in some patients.

The US regulator said it has identified 63 cases in which HCV drugs Mavyret, Zepatier, and Vosevi were worsening liver function in patients with symptoms of moderate-to-severe liver impairment and other serious liver problems.

FDA approves AbbVie's Mavyret for children with Hepatitis C (HCV)

The FDA has approved AbbVie’s Mavyret tables (glecaprevir/pibrentasvir) as a treatment for hepatitis C (HCV) in children aged 12 to 17 years old.

AbbVie’s two drug combo tablets have been approved as a treatment for all six genotypes of HCV in children. The combination of glecaprevir and pibrentasvir was approved for adults in 2017.

AbbVie's case against the NHS thrown out of court

A judge has thrown US multinational AbbVie’s case against NHS England’s hepatitis C procurement process, out of court.

Mr Justice Choudhury, a judge at the Technology and Construction Court, dismissed AbbVie’s case against the NHS, after the US firm alleged that NHS England’s procurement process for curative drugs for Hepatitis C (HCV) was unfair.

The Judge rejected the arguments of the Illinois-based multinational, after the firm launched a legal challenge against NHS England’s £1 billion procurement of drugs for HCV.

New hepatitis C combo boasts 97% cure rate for just $300

Image Credit: BruceBlaus

A partnership of the not-for-profit organisation Drugs for Neglected Diseases initiative (DNDi) and Egyptian drug firm Pharco Pharmaceuticals is working to bring a new, effective and affordable combination therapy to patients with hepatitis C (HCV).

Contaminated blood inquiry to probe thousands of deaths

UK Government has announced that it will launch an inquiry to discover how 4,670 people were given blood infected by HIV and hepatitis C (HCV) in the 1970s and 1980s. The scandal directly led to the deaths of 2,400 but no party has ever been deemed responsible for the public health disaster.

Gilead says US FDA approves Epclusa to treat hepatitis C

US drug firm Gilead Sciences (Nasdaq: GILD) said the US Food and Drug Administration has approved its Epclusa (sofosbuvir/velpatasvir), in combination with ribavirin, to treat hepatitis C virus (HCV) infection.

The company said the drug is also the first single-tablet regimen authorised for the treatment of HCV genotype 2 and 3 infection without ribavirin.

Merck says its Zepatier showed better efficacy and safety compared with competition in Phase III trials

US pharma giant Merck (NYSE: MRK) on Thursday said late-stage trials for its Zepatier (elbasvir and grazoprevir) to treat chronic hepatitis C (HCV), in patients who have already received therapy, showed efficacy and safety compared with the competition.

Charity challenges Sovaldi patent

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Charity Doctors of the World says generic versions of Sovaldi could be produced for as little as £66

Doctors of the World (also known as Médecins du Monde) has filed an opposition to the patent for Gilead’s blockbuster hepatitis C drug Sovaldi.

The international non-profit organisation claims that the drug’s ‘exorbitant’ price and Gilead’s monopoly in the area is hindering many people’s access to the treatment, and is unsustainable for healthcare systems. In the UK Sovaldi (sofosbuvir) costs £33,000 for a 12-week course of treatment.

New drug added to generic Sovaldi licensing

Gilead image

Gilead has expanded the licensing of generic versions of its blockbuster hepatitis C treatment Sovaldi to include a new experimental pill.

The firm’s manufacturing partners will now be allowed to produce the protein inhibitor GS-5816, which is currently in Phase III studies investigating its use in combination with Sovaldi (sofosbuvir) for the treatment of all six genotypes of hepatitis C (HCV).

Gilead gets Harvoni boost for Europe

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Gilead Sciences’ new hepatitis C (HCV) tablet Harvoni has been approved across the European Union to treat the majority of chronic patients with genotype 1 and 4.

It follows a CHMP recommendation for the once-daily combination, which consists of 90mg of NS5A inhibitor ledipasvir, and 400mg of nucleotide analog polymerase inhibitor Sovaldi (sofosbuvir).

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