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|Enanta Pharmaceuticals Announces 96 Percent SVR12 in Treatment Experienced Genotype 1 Hepatitis C Patients in SAPPHIRE-II Study|
- Second of Six All-Oral, Interferon-Free Phase 3 Hepatitis C Studies Using Regimen Containing ABT-450
Results from the 394-patient SAPPHIRE-II trial demonstrated a sustained virologic response at 12 weeks post-treatment (SVR12) of 96 percent in chronically infected GT1 HCV treatment experienced adult patients who had previously failed pegylated interferon and ribavirin treatment. Approximately 49 percent of these patients were prior null responders, namely patients defined as not achieving a significant reduction in the HCV virus during their prior treatment. The majority of patients were GT1a, considered the more difficult-to-treat subtype, and the SVR12 rates of GT1a and GT1b were 96 percent and 97 percent, respectively. These results were based on an intent-to-treat analysis and were achieved after 12 weeks of treatment. Virologic relapse or breakthrough was noted in 2 percent of patients receiving the 3D regimen plus ribavirin. The treatment regimen was well tolerated, with 1 percent of patients discontinuing treatment due to adverse events.
“The high SVR rates in this SAPPHIRE-II trial and the previously reported SAPPHIRE-I trial further validate this 3D regimen plus ribavirin for both treatment-naive and treatment-experienced patients,” stated
About Study M13-098 (SAPPHIRE-II)
Following SAPPHIRE-I, SAPPHIRE-II is the second placebo-controlled trial and the second of six phase 3 trials supporting AbbVie’s investigational 3D regimen for the treatment of GT1 hepatitis C patients.
SAPPHIRE-II is a global, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 12 weeks of treatment with ABT-333 (250mg), ribavirin (weight-based), both dosed twice daily, and the fixed-dose, co-formulated combination of ABT-450/ritonavir (150/100mg) and ABT-267 (25mg) dosed once daily in non-cirrhotic, GT1a and GT1b HCV-infected, treatment-experienced adult patients who previously failed treatment with pegylated interferon and ribavirin.
The study population consisted of 394 GT1 treatment-experienced patients with no evidence of liver cirrhosis. 297 patients were randomized to the 3D regimen plus ribavirin for 12 weeks, and 97 patients were randomized to placebo for the initial 12 weeks. Patients initially randomized to placebo for the first 12 weeks then received open-label treatment with the 3D regimen plus ribavirin for 12 weeks. In the study, 49 percent of patients were prior null responders to pegylated interferon and ribavirin, generally considered among the most difficult to treat successfully.
Following 12 weeks of treatment with AbbVie’s 3D regimen plus ribavirin, 96 percent (n=286/297) of patients achieved SVR12 based on an intent-to-treat analysis, where patients with missing values for any reason were considered treatment failures. The SVR12 rates in GT1a and GT1b patients were 96 percent (166/173) and 97 percent (119/123), respectively. One subject had HCV genotype 1 and achieved SVR12, but was unable to be sub-genotyped.
The most commonly reported adverse events in both the 3D and placebo arms were headache, fatigue and nausea. Discontinuations due to adverse events were reported in three (1 percent) patients receiving the 3D regimen and no patients receiving placebo. Virologic relapse or breakthrough was noted in 2 percent of patients receiving the 3D regimen plus ribavirin.
Overview of AbbVie’s phase 3 clinical programs:
a projected study population
Additional information about AbbVie’s phase 3 studies can be found at www.clinicaltrials.gov.
Protease Inhibitor Collaboration with
About Hepatitis C Virus (HCV)
Hepatitis C is a liver disease affecting over 170 million people worldwide. The virus is typically spread through direct contact with the blood of an infected person. Hepatitis C increases a person’s risk of developing chronic liver disease, cirrhosis, liver cancer and death. There is an acute need for new HCV therapies that are safer and more effective for many variants of the virus.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including with respect to clinical data, plans for announcing additional data, and the planned clinical development and regulatory submissions for ABT-450. Statements that are not historical facts are based on our management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate and our management’s beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors that may affect actual results include final results of ongoing clinical trials, the development and marketing efforts of