HCV Programs

Hepatitis C Research
Advances in HCV.

New therapies for HCV have evolved rapidly since 2013, using different combinations of inhibitors of HCV’s replication to demonstrate high cure rates in HCV patients.

We have successfully identified clinical development candidates for inhibitors of three of the fundamental, validated targets within the HCV field.  Our protease inhibitors have been combined with AbbVie’s combination therapies for HCV.  Given the high sustained virologic response rates (SVR) demonstrated in phase 3 studies of treatment with G/P, AbbVie’s latest combination therapy in development, we now believe that G/P has the best and most timely potential for us to participate in the treatment of HCV patients, including those who have failed on other treatment regimens.  Therefore, we have stopped our development of our inhibitors of other HCV targets.

About Hepatitis C Virus

Hepatitis C virus is a virus that is a common cause of viral hepatitis, an inflammation of the liver. HCV is typically contracted by contact with the blood or other body fluids of another individual infected with HCV. HCV is a leading cause of chronic liver disease, including cirrhosis, organ failure and cancer, and the leading cause of death from liver disease in the United States. HCV disease progression occurs over a period of 20 to 30 years, with the majority of HCV-infected individuals generally exhibiting no symptoms of the disease. Therefore, until a major symptom is diagnosed, many individuals are unaware they are infected and live undiagnosed without seeking treatment.

An estimated 150-170 million people worldwide are chronically infected with HCV and have an increased risk of eventually developing liver cirrhosis or liver cancer. It is estimated that more than 350,000 people die every year from HCV-related liver diseases. As of October 2016, the CDC estimated that approximately 2.7- 3.9 million people in the United States are chronically infected with HCV, with an estimated 30,000 new infections in 2014.

Our Licensed HCV Compounds.

Paritaprevir, a Protease Inhibitor for HCV Infection

Paritaprevir is an NS3/4A protease inhibitor discovered during the ongoing collaboration between Enanta and AbbVie for HCV protease inhibitors and treatment regimens that include protease inhibitors.

Paritaprevir is one of the direct-acting-antivirals, in VIEKIRA PAK and the other treatment regimens that AbbVie is currently commercializing worldwide.

AbbVie is responsible for all worldwide development and commercialization of paritaprevir-containing treatment regimens for HCV.

Glecaprevir (ABT-493), HCV Protease Inhibitor

AbbVie is also developing glecaprevir, the second protease inhibitor discovered within the Enanta-AbbVie collaboration. In Phase 3 clinical studies, eight weeks of therapy with a fixed-dose, once daily, ribavirin-free combination of glecaprevir and pibrentasvir (G/P), demonstrated high sustained virologic response (SVR) rates across all major genotypes (GT1-6) in patients without cirrhosis and who are new to treatment, which represent the majority of HCV patients. In patients with compensated cirrhosis, high SVR rates were achieved after 12 weeks of therapy. High SVR rates were also achieved in patients with limited treatment options, such as those with severe chronic kidney disease (CKD).

Glecaprevir was designed to enable once-daily dosing without ritonavir.  AbbVie has co-formulated it in a fixed-dose combination with AbbVie’s next-generation NS5A inhibitor, pibrentasvir (ABT-530).  AbbVie has filed a New Drug Application (NDA) for this G/P combination with the U.S. Food and Drug Administration in December 2016.

 

 

HCV