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Hepatitis C

AASLD 2014: AbbVie Next-Generation Hepatitis C Drugs Promising in Early Studies

AbbVie's investigational HCV protease inhibitor ABT-493 and NS5A inhibitor ABT-530 demonstrated good antiviral activity in patients with genotype 1 chronic hepatitis C in a 3-day monotherapy study, as well as potent and synergistic activity against multiple HCV genotypes in laboratory replicon studies, according to presentations at the American Association for the Study of Liver Diseases (AASLD) Liver Meeting held recently in Boston.

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AbbVie's Viekirax + Exviera "3D" Hepatitis C Regimen Approved in Europe

The European Commission last week approved AbbVie's interferon-free Viekirax plus Exviera combination regimen -- formerly known as "3D" -- for the treatment of genotype 1 chronic hepatitis C. This approval includes people with compensated liver cirrhosis, liver transplant recipients, HIV/HCV coinfected patients, and people on opioid substitution therapy for drug addiction. The commission also approved Viekirax plus ribavirin for HCV genotype 4.

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3. High Hepatitis C Treatment Cost Leads to Restrictions, Sets Off Price War

The high cost of new interferon-free hepatitis C treatments has raised concerns about how public payers and private insurers will be able to afford them and sparked a more general discussion about the cost of pharmaceuticals in a changing healthcare landscape.

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Sofosbuvir/Ledipasvir + Third Drug Cures Most HCV Patients in 6 Weeks

A short and well-tolerated regimen of sofosbuvir, ledipasvir, and a third drug -- either GS-9669 or GS-9451 -- taken for as little as 6 weeks can cure a majority of previously untreated people with genotype 1 chronic hepatitis C, including those with traditional predictors of poor response, according to study results published in the January 12 advance edition of The Lancet.

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9. Evolving Hepatitis C Therapy Guidelines and Treatment Cascade

The first U.S. hepatitis C treatment guidelines incorporating interferon-free direct-acting antiviral regimens were issued in January 2014 and periodically updated to reflect new drug approvals and emerging data from studies and real-world use. The new therapies have cure rates above 90%, but cost and other barriers have limited their use.

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Merck Plans to Discontinue Boceprevir for Hepatitis C by December 2015

Merck will stop selling its HCV protease inhibitor boceprevir (Victrelis) by December of this year, and no new patients should be started on the drug, the company announced in a recent "Dear Healthcare Professional" letter. While the first-generation HCV protease inhibitors improved the effectiveness of pegylated interferon plus ribavirin, they are no match in terms of efficacy or tolerability for the newer interferon-free combinations approved over the past 2 years.

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10. Hepatitis C Cures for HIV/HCV Coinfected and Advanced Liver Disease

New interferon-free direct-acting antiviral regimens have high cure rates for chronic hepatitis C patients who were previously considered "difficult to treat," including HIV/HCV coinfected people and patients with liver cirrhosis, decompensated liver disease, and liver transplant recipients. New treatment can now cure a majority of people even with multiple negative predictive factors.

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2. Harvoni and Viekira Pak: Effective Oral Combinations for HCV Genotype 1

2014 saw the long-awaited U.S. Food and Drug Administration (FDA) approval of new interferon-free combination regimens for people with genotype 1 chronic hepatitis C: Gilead Sciences sofosbuvir/ledipasvir coformulation (Harvoni) in October and AbbVie's paritaprevir/ritonavir/ombitasvir plus dasabuvir regimen (Viekira Pak, formerly known as "3D") in late December. 

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Updated Hepatitis C Treatment Guidelines Add New Therapies, Hard-to-Treat Patients

The American Association for the Study of Liver Diseases (AASLD), Infectious Diseases Society of America (IDSA), and International Antiviral Society-USA (IAS-USA) recently updated their hepatitis C treatment guidelines to add newly approved interferon-free direct-acting antiviral regimens and to provide more information about treating patients with HIV/HCV coinfection and decompensated liver disease. The evolving guidelines are available online at HCVguidelines.org.

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