PEARL-III Study Results in Patients with Chronic Hepatitis C Presented at the 21st Conference on Retroviruses and Opportunistic Infections (CROI)
- High SVR12 rates of 99 percent achieved in patients with and without ribavirin in treatment-naïve genotype 1b patients
- High response rates also observed in patients across a range of gender, race and patient characteristics
PEARL-III is one of the six phase 3 registrational studies conducted by
The PEARL-III study met its primary and secondary endpoints. In the 419-patient study, sustained virologic response rates 12 weeks post-treatment (SVR12) of 99.5 and 99.0 percent were achieved with the three-direct-acting antiviral regimen with and without RBV, respectively. There were no study drug discontinuations due to adverse events.
PEARL-III enrolled patients across different demographics and characteristics. Response rates in patients with certain characteristics (male gender, Black race and IL28B non-CC genotypes) were examined, as these patient populations have historically been associated with having a decreased response rate to treatment. High response rates were observed across all patients in the study, including those with these characteristics.
About Study M13-961 (PEARL-III)
PEARL-III is a global, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 12 weeks of treatment with AbbVie’s regimen with and without RBV in non-cirrhotic, GT1b HCV-infected, treatment-naïve adult patients.
The study population consisted of 419 GT1b treatment-naïve patients with no evidence of liver cirrhosis: 209 patients randomized to the regimen without RBV for 12 weeks, and 210 patients randomized to the regimen with RBV for 12 weeks. Following 12 weeks of treatment, 99.0 percent receiving the regimen without RBV (n=207/209) and 99.5 percent receiving the regimen with RBV (n=209/210) achieved SVR12. Patients in the treatment arm without RBV received placebo in substitution for RBV.
Patients with different demographics and characteristics were enrolled in the study, including gender, race (Black vs. non-Black), Hispanic/Latino ethnicity, age, geographic region, body mass index (BMI), liver fibrosis stage, IL28B genotype and viral load.
Across treatment arms in PEARL-III, there were no documented relapses within 12 weeks post-treatment. No on-treatment virologic failures occurred in the treatment arm without RBV and a single virologic failure occurred in the treatment arm with RBV. While all patients in the study completed therapy, two patients in the arm without RBV were lost to follow-up and therefore were considered treatment failures.
The most commonly reported adverse events (>10 percent for either arm) were headache, fatigue, pruritus, nausea and asthenia, with pruritus and nausea occurring at a statistically higher rate in the treatment arm with RBV compared to the arm without RBV. Anemia occurred more commonly among patients in the RBV-containing arm, with clinically significant anemia requiring RBV dose reductions occurring in 9 percent of these patients.
Additional information about AbbVie’s phase 3 studies can be found on www.clinicaltrials.gov.
Protease Inhibitor Collaboration with
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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. Patients with compensated cirrhosis have a liver that is heavily scarred but that can still perform many important bodily functions with few or no symptoms. There is an acute need for new HCV therapies that are safer and more effective for many variants of the virus.
About Enanta
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including with respect to the clinical data from AbbVie’s phase 3 registrational studies of its HCV treatment regimen containing ABT-450 and the regimen’s prospects for treatment of a range of gender, race and genetic types. 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 detailed results of the other phase 3 registrational studies of the ABT-450-containing regimen, the development, regulatory and marketing efforts of
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Enanta Pharmaceuticals
Carol Miceli, 617-607-0710
cmiceli@enanta.com
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kwatson@macbiocom.com
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