Bristol-Myers said the FDA has asked it for data involving use of daclatasvir with other drugs, and that the company is in discussions with the agency about the scope of the required information.
27 November 2014 | Reuters
The maker of Sovriad (simeprevir) has revised its package insert labeling on the order of Japanese health officials following the deaths of three people who took the hepatitis C drug.
24 November 2014 | HCP Live
The fixed price reduced the cost by about 27%, and so a 12-week regimen will now be priced at $51,400, instead of $71,100. This makes this the “lowest price in Europe,” according to the Economic Committee for Health Products. There is also stipulation that rebates will be made in the event of “treatment failure,” according to a statement from the agency.
21 November 2014 | Wall Street Journal
Nice is due to finish its final assessment of sofosbuvir in January. It is usual for them to give the NHS three months to find the money or put staff – if needed – in place. NHS England is thought to have asked them to delay this by six months.
19 November 2014 | Channel 4 News (blog)
Gilead Sciences, Inc. today announced that the European Commission has granted marketing authorization for Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen to treat the majority of chronic hepatitis C genotype 1 and 4 infection in adults. Harvoni combines the NS5A inhibitor ledipasvir (LDV) with the nucleotide analog polymerase inhibitor sofosbuvir (SOF), approved by the European Commission under the tradename Sovaldi® in January 2014.
19 November 2014 | Gilead press release
The aim of this document is to reinforce the need for urgent leadership from the Department of Health, PHE and NHS England and concerted action from Local Authorities, Health and Wellbeing Boards, Clinical Commissioning Groups (CCGs) and service providers to improve hepatitis C testing and treatment services in London for people with a history of using drugs – the group most affected by chronic hepatitis C – in order to find and treat significantly more people affected by the disease.
17 November 2014 | London Joint Working Group on Substance Use and Hepatitis C
This interim revision of the Guidelines includes a revised section on Hepatitis C Virus (HCV)/HIV Coinfection, with emphasis on considerations for use of antiretroviral (ARV) drugs in patients who also receive treatment for HCV infection. A new table (Table 12) provides clinicians with guidance on the concomitant use of HCV drugs and ARV drugs, with a focus on potential pharmacokinetic drug interactions. The Panel refers clinicians to http://www.hcvguidelines.org for guidance on the diagnosis and treatment of HCV infections.
17 November 2014 | AidsInfo
Clinical trials for some of the new direct-acting agents against hepatitis C (HCV) have yielded some impressive efficacy numbers. But how well do the drugs stack up in the real world?
11 November 2014 | MedPage Today
Janssen Therapeutics, Division of Janssen Products, LP (Janssen) announced the U.S. Food and Drug Administration (FDA) has approved OLYSIO® (simeprevir), a hepatitis C virus (HCV) NS3/4A protease inhibitor, in combination with sofosbuvir as an all-oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis C (CHC) infection in adult patients as part of a combination antiviral treatment regimen. Sofosbuvir is an HCV nucleotide analog NS5B polymerase inhibitor developed by Gilead Sciences, Inc.
07 November 2014 | Johnson & Johnson press release
Bristol-Myers Squibb’s HCV developing world access approach will utilize tiered pricing, licensing agreements and working in collaboration with other stakeholders who share in our commitment to working toward the eradication of hepatitis C.
03 November 2014 | Bristol-Myers Squibb press release