Effectiveness of Simeprevir Plus Sofosbuvir, With or Without Ribavirin, in Real-World Patients With HCV Genotype 1 Infection
| Autor: | P. Pockros, Ira M. Jacobson, A. M. Di Bisceglie, Gregory T. Everson, Mark E. Mailliard, J.R. Spivey, H.E. Vargas, Thomas G. Stewart, C.A. Kerr, K.R. Reddy, H.A. Elbeshbeshy, Gyongyi Szabo, M.S. Sulkowski, Norah A. Terrault, Nezam H. Afdhal, P. Kwo, K. Rajender Reddy, T.N. Hawkins, Coleman Smith, Eugene R. Schiff, J. Lim, I.M. Jacobson, G. Morelli, Michael W. Fried, Lynn M. Frazier, Andrew J. Muir, Mohamed Hassan, Jordan J. Feld, Giuseppe Morelli, Federico Hinestrosa, Hugo E. Vargas, Mitchell L. Shiffman, Richard K. Sterling, Adrian M. Di Bisceglie, Imtiaz Alam, Nancy Reau, Ziv Ben-Ari, Mark S. Sulkowski, A. Williams, R.T. Chung, J. Darling, C. Trautwein, Josh Levitsky, Stefan Zeuzem, Jonathan M. Fenkel, J. Bredfeldt, Rolland C. Dickson, Kenneth E. Sherman, Ananthakrishnan Ramani, R.S. Brown, Jama M. Darling, M.W. Fried, A. Kuo, David R. Nelson, Joseph S. Galati, Jacqueline G. O'Leary, W. Harlan, D. Nelson, Joseph K. Lim, A.S. Lok, Michael P. Manns, Alexander Kuo, Robert S. Brown, Brian L. Pearlman, K. Watts, S.C. Gordon |
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| Rok vydání: | 2015 |
| Předmět: |
Simeprevir
Male Time Factors Sofosbuvir Hepacivirus medicine.disease_cause Telaprevir chemistry.chemical_compound 0302 clinical medicine 030212 general & internal medicine Prospective Studies Aged 80 and over Gastroenterology virus diseases Middle Aged Viral Load Hepatitis C Treatment Outcome RNA Viral 030211 gastroenterology & hepatology Drug Therapy Combination Female medicine.drug Adult medicine.medical_specialty Genotype Hepatitis C virus Antiviral Agents Article 03 medical and health sciences Young Adult Boceprevir Internal medicine Ribavirin medicine Humans Aged Hepatology business.industry digestive system diseases Discontinuation Regimen chemistry Immunology North America business Biomarkers |
| Zdroj: | Gastroenterology. 150(2) |
| ISSN: | 1528-0012 |
| Popis: | Background & Aims The interferon-free regimen of simeprevir plus sofosbuvir was recommended by professional guidelines for certain patients with hepatitis C virus (HCV) genotype 1 infection based on the findings of a phase 2 trial. We aimed to evaluate the safety and efficacy of this regimen in clinical practice settings in North America. Methods We collected demographic, clinical, and virologic data, as well as reports of adverse outcomes, from sequential participants in HCV-TARGET—a prospective observational cohort study of patients undergoing HCV treatment in routine clinical care settings. From January through October 2014, there were 836 patients with HCV genotype 1 infection who began 12 weeks of treatment with simeprevir plus sofosbuvir (treatment duration of up to 16 weeks); 169 of these patients received ribavirin. Most patients were male (61%), Caucasian (76%), or black (13%); 59% had cirrhosis. Most patients had failed prior treatment with peginterferon and ribavirin without (46%) or with telaprevir or boceprevir (12%). The primary outcome was sustained virologic response (SVR), defined as the level of HCV RNA below quantification at least 64 days after the end of treatment (beginning of week 12 after treatment—a 2-week window). Logistic regression models with inverse probability weights were constructed to adjust for baseline covariates and potential selection bias. Results The overall SVR rate was 84% (675 of 802 patients, 95% confidence interval, 81%–87%). Model-adjusted estimates indicate patients with cirrhosis, prior decompensation, and previous protease inhibitor treatments were less likely to achieve an SVR. The addition of ribavirin had no detectable effects on SVR. The most common adverse events were fatigue, headache, nausea, rash, and insomnia. Serious adverse events and treatment discontinuation occurred in only 5% and 3% of participants, respectively. Conclusions In a large prospective observational cohort study, a 12-week regimen of simeprevir plus sofosbuvir was associated with high rates of SVR and infrequent treatment discontinuation. ClinicalTrials.gov: NCT01474811. |
| Databáze: | OpenAIRE |
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