New Hepatitis C Drugs Coming in 2015
The scope of chronic Hepatitis C infection seems to be getting the pharmaceutical attention needed to eventually reduce this infectious disease’s burden. Based on the combinations of drugs currently in clinical development, we expect big advances for Hepatitis C treatment in 2015.
Progress seems to be happening rapidly in the Hepatitis C drug treatment arena. Approved by the U.S. Food and Drug Administration (FDA) in 2011, Incivek was a seemingly miraculous new Hepatitis C drug. While it greatly improved the likelihood of beating the Hepatitis C virus in 2011, Incivek has already been discontinued effective October 2014. A breakthrough drug from just three years ago is no longer available because dramatically better options have since been FDA approved. In 2014, major headway in Hepatitis C therapy was made – and much more is in store for us in the New Year.
The end of 2014 finally delivered the long-awaited reality of highly effective, interferon-free, Hepatitis C treatments with Gilead’s Sovaldi, Gilead’s Harvoni and AbbVie’s Veikira Pak. Although they may or may not also require the addition of ribavirin during the course of therapy, these effective, all oral medications come with a high price tag. However, the addition of Hepatitis C drugs to the FDA approved list will greatly benefit Hepatitis C patients by making treatment not just safer and more effective – but also increasing the competition to keep treatment more affordable.
A number of Hepatitis C drugs currently in clinical development have already reached Phase 2 and Phase 3 trials:
- Phase 2 – At this level, clinical trials investigate dosing, safety and efficacy of an investigational medicine in a small number of patients who have the disease or condition under study.
- Phase 3 – At this level, clinical trials investigate the safety and efficacy of an investigational medicine in a larger number of patients who have the disease or condition under study. This phase generally crosses over to include the regulatory approval process prior to gaining market approval in the first major market.
As of the last week in December 2014, the following interferon-free, direct-acting antiviral combinations in Phase 3 include:
1. Daklinza (daclatasvir) – By Bristol-Myers Squibb, this NS5A inhibitor has been approved in Europe to be used in combination with Sovaldi. Daklinza is also being studied in combination with two other Bristol-Myers Squibb contenders, Sunpreva (Asunaprevir) and BMS-791325.
2. Grazoprevir (MK-5172) – By Merck, this protease inhibitor is being studied along with Merck’s Elbasvir (MK-8742).
3. Sovaldi (sofosbuvir) – Gilead’s NS5B polymerase inhibitor, Sovaldi is already FDA approved in combination with ribavirin, with the possible addition of pegylated interferon. However, Gilead Sciences is studying Sovaldi along with GS-5816 (their NS5A inhibitor) and ribavirin in an effort to compare the results from treatment with just Sovaldi and ribavirin.
The following drugs are in Phase 2, not far behind the drug combination contenders in Phase 3:
- ACH-3102 – Achillion’s NS5A inhibitor, this investigational compound is being evaluated in combination with Sovaldi.
- Sovaprevir (ACH-1625) – Previously referred to as ACH-1625, sovaprevir is Achillion’s NS3/4A protease inhibitor. Sovaprevir is being evaluated in combination with Achillion’s ACH-3102 and their NS5B polymerase inhibitor ACH-3422.
- Daklinza – This Bristol-Myers Squibb NS5A inhibitor is also in Phase 2 trials with Janssen’s Olysio (simeprevir) and with Vertex’s VX-135.
- Olysio – Janssen’s NS3/4A protease inhibitor is currently approved for use with interferon and ribavirin, but is currently in Phase 2 trials to evaluate it with Daklinza, Merck’s Samatasvir (IDS719) and Janssen’s TMC647055 with Ritonavir.
There are a handful of pharmaceutical companies that have taken the lead on Hepatitis C medications. Although Gilead, AbbVie, Merck, Janssen, Bristol-Myers Squibb and Achillion are not the only drug manufacturers working to stamp out Hepatitis C, they are currently the frontrunners. We will be closely watching what comes of these Phase 2 and Phase 3 trials in anticipation of improved Hepatitis C treatment being safer, more effective and more affordable.
http://hcvdrugs.com/quickref.html, Hepatitis C Treatments in Current Clinical Development, Retrieved December 21, 2014, Hepatitis C Support Project, 2014.
http://www.achillion.com/ACH3102, ACH-3102 HCV NS5A Inhibitor, Retrieved December 27, 2014, Achillion Pharmaceuticals, 2014.
http://www.achillion.com/sovaprevir_ACH1625, Sovaprevir HCV NS3/4A Protease Inhibitor, Retrieved December 27, 2014, Achillion Pharmaceuticals, 2014.
http://www.bms.com/research/pipeline/Pages/default.aspx, In the Pipeline, Retrieved December 27, 2014, Bristol-Myers Squibb Company, 2014.
http://www.hepmag.com/articles/2512_18756.shtml, What is the Recommended Treatment for Hepatitis C?, Retrieved December 27, 2014, Smart + Strong®, 2014.
http://www.hivandhepatitis.com/hcv-treatment/approved-hcv-drugs/4808-vertex-to-discontinue-sale-of-telaprevir-incivek-for-hepatitis-c, Vertex to Discontinue Sale of Telaprevir (Incivek) for Hepatitis C, hivandhepatitis.com, 2014.
http://www.merck.com/research/pipeline/home.html, Pipeline, Retrieved December 27, 2014, Merck & Co, Inc, 2014.
http://www.olysio.com/shared/product/olysio/prescribing-information.pdf, Olysio Highlights of Prescribing Information, Retrieved December 27, 2014, Janssen Products, 2014.
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