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Hepatitis C

Gilead Announces Generic Licensing Agreements for Hepatitis C Drug Sofosbuvir

Gilead Sciences announced this week that it has granted a license to 7 generic drug companies in India to produce cheaper versions of its groundbreaking hepatitis C polymerase inhibitor sofosbuvir (Sovaldi) and its forthcoming sofosbuvir/ledipasvir coformulation for use in more than 90 developing countries.

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Simeprevir Label Adds Interactions with Transplant Rejection Drugs

The U.S. Food and Drug Administration recently approved revisions to the product label information for Janssen's new hepatitis C protease inhibitor simeprevir (Olysio), noting drug interactions with cyclosporine and tacrolimus, which are used to prevent organ rejection after a transplant.

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ICAAC 2014: AbbVie 3D Combination Works Well for People with HIV/HCV Coinfection

An all-oral regimen of 3 direct-acting antivirals plus ribavirin taken for 12 weeks led to sustained virological response in 94% of HIV positive people with mostly genotype 1a hepatitis C coinfection in the TURQUOISE-I study, according to data presented at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy this week in Washington, DC.

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Community Leaders, HIV Doctors Oppose Hepatitis C Treatment Barriers

A coalition of hepatitis C advocacy organizations and medical providers has issued an open letter to the Secretary of Health and Human Services calling for an end to restrictions on access to hepatitis C treatment by private insurers and public payers seeking to avoid the cost of newly approved direct-acting antivirals. HIV medical providers also called for reducing barriers to treatment, including restrictions on which medical specialists may treat people with hepatitis C.

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European Regulators Approve Daclatasvir for Hepatitis C

The European Medicines Agency, which handles regulatory approval for 28 countries of the European Union, this week approved Bristol-Myers Squibb's hepatitis C virus NS5A inhibitor daclatasvir (Daklinza) for use in combination therapy for HCV genotypes 1, 2, 3, and 4.

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ICAAC 2014: AbbVie 3D Hepatitis C Regimen Is Well-Tolerated in Phase 3 Trials

AbbVie's 3D hepatitis C regimen containing paritaprevir (ABT-450), ombitasvir, and dasabuvir was generally well-tolerated in the Phase 3 SAPPHIRE trials, according to a pooled analysis presented at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy last week in Washington, DC. While most patients experienced some adverse events, serious side effects were rare and few people discontinued treatment early for this reason.

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Achillion HCV NS5A Inhibitor + Sofosbuvir Shows High Early Cure Rate

An interferon-free dual combination of Achillion's hepatitis C virus NS5A inhibitor ACH-3012 plus Gilead Science's HCV polymerase inhibitor sofosbuvir (Sovaldi) taken for 8 weeks led to sustained virological response at 4 weeks post-treatment for people with HCV genotype 1 in a Phase 2 study, according to a company announcement.

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ICAAC 2014: AbbVie 3D Regimen Shows High Cure Rates for Genotype 1b HCV Patients

AbbVie's interferon-free 3D regimen containing ABT-450, ombitasvir, and dasabuvir led to sustained virological response in nearly 100% of people with genotype 1b chronic hepatitis C regardless of unfavorable patient or viral characteristics, researchers reported at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy this week in Washington, DC.

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Vertex to Discontinue Sale of Telaprevir (Incivek) for Hepatitis C

Vertex Pharmaceuticals announced last week that it will stop selling its HCV protease inhibitor telaprevir (Incivek or Incivo) as of October 16, 2014. While the first generation direct-acting antivirals are more effective than pegylated interferon plus ribavirin alone, they are no match for newer drugs such as Gilead Sciences' sofosbuvir (Sovaldi) or AbbVie's forthcoming "3D" regimen in terms of efficacy or tolerability.

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