Interferon-Free Hep C Combos to Watch for in 2013
For those delaying treatment, we should see progress in 2013 on interferon-free drug regimens for Hepatitis C.
Pegylated interferon and ribavirin have been used to treat Hepatitis C since 2001; and it was another ten years before a new class of drugs to improve treatment were approved. As such, 2011 was the year that two protease inhibitors; Incivek and Telaprevir, joined the Hepatitis C arsenal. Fortunately, experts believe that new medications to fight this challenging virus will emerge before another decade goes by. The pharmaceutical race to produce better, safer, more effective biologics to cure Hepatitis C has intensified – making 2013 the year to keep an eye out for new and improved Hepatitis C drug regimens.
Even though triple therapy that relies on pegylated interferon alfa, ribavirin and a protease inhibitor (Incivek or Telaprevir) has drastically raised the likelihood of successful Hepatitis C treatment, there is still room for improvement. In a recent physician survey, approximately half of surveyed physicians reported intentionally delaying treatment for some Hepatitis C patients until new interferon-free regimens become available. In addition, nearly half of these physicians also reported that many of their Hepatitis C patients are denying treatment in anticipation of the new treatments in development.
The inability to tolerate interferon (an injected medication) is fairly common. Interferon’s side effects are often severe, requiring many people to discontinue their course of treatment – one of the biggest obstacles to a successful outcome. Typical interferon side effects include insomnia, anxiety, depression, severe fatigue, headache, fever, muscle and body aches, no appetite, bad taste in mouth, nausea, vomiting, diarrhea, hair loss, skin rash, reaction at injection site, chest pain, shortness of breath, vision changes, thyroid problems, anemia, low white blood cell and low platelet counts.
Fulfilling the following three elements would create the ideal Hepatitis C treatment plan:
- Simple Dosing – A once daily, all-oral pill regimen.
- Effective – Highly effective in all Hepatitis C populations, regardless of disease severity or genotype.
- Low Impact – Highly safe and tolerable, with few, mild side effects.
Many experts believe that eliminating interferon represents one of the more promising routes. In the hope to get closer to ideal Hepatitis C treatment, the following new classes of drugs are in development:
- Nucleoside/nucleotide polymerase inhibitors
- Nonnucleoside polymerase inhibitors
- NS5A inhibitors
- Host targeting agents
Currently, there are a large and varied number of investigational Hepatitis C regimens in Phase III trials. Listed by pharmaceutical company, in no particular order, four of the interferon-free combinations to watch for in 2013 are:
- Boehringer Ingelheim – Faldaprevir (protease inhibitor) + BI 207127 (non-nucleoside NS5B inhibitor) + ribavirin
- Bristol-Myers Squibb – Daclatasvir (NS5A inhibitor) + asunaprevir (NS3 protease inhibitor)
- Gilead – Sofosbuvir (nucleotide analog polymerase inhibitor) + ribavirin
- Abbott/Enanta – ABT-450 (protease inhibitor) + ABT-333 (non-nucleoside polymerase inhibitor) + ABT-267 (NS5A inhibitor)
The four combinations listed above are not the only players in the quest for an ideal interferon-free Hepatitis C regimen. However, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead and Abbott/Enanta have delivered extremely encouraging data on their investigational drug combos in 2012. Some experts believe there is a chance that one of these drug combos will become available in 2013; others claim at least another year is required. Regardless of the exact timing, those intentionally delaying Hepatitis C treatment in hopes of a better, easier, safer drug regimen have a lot to look forward to in the New Year.
http://hepatitiscnewdrugs.blogspot.com/2012/11/many-physicians-who-treat-hcv-have.html, Many Physicians who Treat HCV Have Begun ‘Warehousing’ and Preparing HCV Patients for the Next Generation of Interferon-Free Treatments to Become Available, According to a Recent BioTrends Report, Retrieved December 30, 2012, Decision Resources Group, 2012.
http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/Road%20Ahead/Interactive%20Virtual%20Presentation/Road_Ahead_Slides.aspx, The Road Ahead: An Update on Investigational Agents and Strategies for HCV Management, Raymond T. Chung, MD, Retrieved December 30, 2012, Clinical Care Options, LLC, 2013.
http://www.empr.com/sofosbuvir-effective-in-phase-3-study-for-hepatitis-c/article/269909/#, Sofosbuvir Effective in Phase 3 Study for Hepatitis C, Retrieved December 30, 2012, Haymarket Media, Inc., 2012.
http://www.enanta.com/pr_101712.html, Enanta’s Lead Hepatitis C Compound ABT-450 Advances into a Phase 3 Clinical Trial Through its Collaboration with Abbott, Retrieved December 30, 2012, Enanta Pharmaceuticals, Inc., 2012.
http://www.hcplive.com/conferences/aasld-2012/Combination-of-Faldaprevir-Non-nucleotide-Inhibitor–and-Ribavirin-Achieves-High-SVR12-in-HCV, Combination of Faldaprevir, Non-nucleoside Inhibitor, and Ribavirin Achieves High SVR12 in HCV, Richard Robinson, Retrieved December 30, 2012, HCPLive, 2012.
http://www.hepatitis.va.gov/patient/treat/side-effects-single-page.asp, Side Effects Guide: Entire Lesson, Retrieved December 30, 2012, US Department of Veteran Affairs, 2012.
http://www.hepmag.com/articles/daclatasvir_asunaprevir_2501_23198.shtml, Daclatasvir, Asunaprevir Regimens Boast High Cure Rates in Hard-to-Treat Hep C, Retrieved December 30, 2012, Smart & Strong, 2012.