| Title |
HCVerso1 and 2: faldaprevir with deleobuvir (BI 207127) and ribavirin for treatment-naïve patients with chronic hepatitis C virus genotype-1b infection
|
|---|---|
| Published in |
Clinical and Experimental Gastroenterology, November 2016
|
| DOI | 10.2147/ceg.s111116 |
| Pubmed ID | |
| Authors |
Christoph Sarrazin, Francesco Castelli, Pietro Andreone, Maria Buti, Massimo Colombo, Stanislas Pol, Filipe Calinas, Massimo Puoti, Antonio Olveira, Mitchell Shiffman, Jerry O Stern, George Kukolj, Michael Roehrle, Stella Aslanyan, Qiqi Deng, Richard Vinisko, Federico J Mensa, David R Nelson |
| Abstract |
The interferon-free combination of once-daily faldaprevir 120 mg, twice-daily deleobuvir 600 mg, and weight-based ribavirin was evaluated in two Phase III studies (HCVerso1, HCVerso2) in hepatitis C virus genotype-1b-infected, treatment-naïve patients, including those ineligible for peginterferon (HCVerso2). Patients without cirrhosis were randomized to 16 weeks (Arm 1; n=208 HCVerso1, n=213 HCVerso2) or 24 weeks (Arm 2; n=211 in both studies) of faldaprevir + deleobuvir + ribavirin. Patients with compensated cirrhosis received open-label faldaprevir + deleobuvir + ribavirin for 24 weeks (Arm 3; n=51, n=72). Primary endpoints were comparisons of adjusted sustained virologic response (SVR) rates with historical rates: 71% (HCVerso1) and 68% (HCVerso2). Adjusted SVR12 rates were significantly greater than historical controls for Arms 1 and 2 in HCVerso2 (76%, 95% confidence interval [CI] 71-81, P=0.002; 81%, 95% CI 76-86, P<0.0001) and Arm 2 in HCVerso1 (81%, 95% CI 77-86, P<0.0001), but not for Arm 1 of HCVerso1 (72%, 95% CI 66-77, P=0.3989). Unadjusted SVR12 rates in Arms 1, 2, and 3 were 71.6%, 82.5%, and 72.5%, respectively, in HCVerso1 and 75.6%, 82.0%, and 73.6%, respectively, in HCVerso2. Virologic breakthrough and relapse occurred in 24-week arms in 8%-9% and 1% of patients, respectively, and in 16-week arms in 7%-8% and 9%-11% of patients, respectively. The most common adverse events were nausea (46%-61%) and vomiting (29%-35%). Adverse events resulted in discontinuation of all medications in 6%-8% of patients. In treatment-naïve patients with hepatitis C virus genotype-1b infection, with or without cirrhosis, faldaprevir + deleobuvir + ribavirin treatment for 24 weeks resulted in adjusted SVR12 rates significantly higher than historical controls. Both studies were registered in ClinicalTrials.gov (NCT01732796, NCT01728324). |
X Demographics
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Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United States | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 20 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 20 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Librarian | 2 | 10% |
| Professor > Associate Professor | 2 | 10% |
| Student > Master | 2 | 10% |
| Lecturer | 1 | 5% |
| Student > Doctoral Student | 1 | 5% |
| Other | 4 | 20% |
| Unknown | 8 | 40% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 5 | 25% |
| Nursing and Health Professions | 2 | 10% |
| Biochemistry, Genetics and Molecular Biology | 1 | 5% |
| Economics, Econometrics and Finance | 1 | 5% |
| Pharmacology, Toxicology and Pharmaceutical Science | 1 | 5% |
| Other | 0 | 0% |
| Unknown | 10 | 50% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 07 December 2016.
All research outputs
#17,286,379
of 25,374,647 outputs
Outputs from Clinical and Experimental Gastroenterology
#196
of 331 outputs
Outputs of similar age
#205,210
of 317,808 outputs
Outputs of similar age from Clinical and Experimental Gastroenterology
#3
of 5 outputs
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