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What You Need to Know About New Hepatitis C Drugs

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What You Need to Know About New Hepatitis C Drugs


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The hepatitis C market is big and global The most affected regions are Central and East Asia and North Africa. An estimated 3 million to 4 million people in the U.S. are have chronic HCV.  The number of people with chronic HCV in the EU totals between 7.3 million and 8.8 million. Sources: http://www.easl.eu/assets/application/files/bdb06ff135c7ccb_file.pdf http://www.who.int/mediacentre/factsheets/fs164/en/ 130–150 million people globally have chronic hepatitis C infection, with 3 million to 4 million new cases diagnosed annually.


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The 2 Current Leading Treatments Gilead’s Sovaldi Sovaldi’s sales totaled $2.2 billion in Q1, 2014. A 12-week course of treatment costs $84,000. Industry guidelines support its use in all HCV patients, including those intolerant to interferon. Johnson & Johnson’s Olysio Olysio’s sales totaled $350 million in Q1, 2014. A 12-week course of treatment costs $67,000. Industry guidelines support its use alongside Sovaldi in interferon intolerant patients.


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3 Treatments awaiting FDA approval 1. Gilead’s Sovaldi/Ledapisvir Gilead’s second generation Sovaldi treatment. Potentially eliminates the use of peginterferon and ribavirin. Cleared 94% of genotype 1 patients in 8 weeks (Ion 3 Trials). Cleared 98% of treatment naive genotype 1 patients in 12 weeks (Ion 1 trials). FDA decision is expected on October 10th.


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3 Treatments awaiting FDA approval 2. AbbVie’s 3D 3 drug , 2 pill combination therapy for use with or without ribavirin. Received FDA breakthrough status in May 2013. Cleared 97% of genotype 1a patients when dosed with ribavirin (Pearl IV trials). Cleared 99% of genotype 1b patients (Pearl III trials). Filed for FDA approval on April 22nd.


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3 Treatments awaiting FDA approval 3. Bristol-Myers daclatasvir/asunaprevir Daclatasvir is already included in the European Association for the Study of the Liver guidelines for use alongside Sovaldi. Viral clearance rates were between 92% and 100% when used in combination with Sovaldi during phase 2 trials. Clearance rates were 98% for HCV genotype 1a and 100% for 1b. An official EU decision on daclatasvir’s approval is expected in September 2014. Bristol filed for FDA approval of daclatasvir and asunaprevir on April 7th.


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Fool-Worthy Final Thoughts: Important investor themes Will approval of new competing therapies reduce treatment costs? Gilead’s Sovaldi is priced at $84,000 for 12 weeks, and combination therapy costs are far higher. Payer pushback from insurers and drug formularies hope to drive down costs. Next generation drugs are arguably less expensive than total cost of care for chronic HCV cases experiencing liver failure. 2. Will the the market share battle shift from cure rates to treatment duration? Cure rates for next generation therapies are increasingly similar over 12 week periods. Second generation oral therapies will similarly eliminate interferon and ribavirin. Treatment duration could provide a significant differentiator.


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