HCV/HBV COINFECTED PATIENTS Test all patients for evidence of current or prior hepatitis B virusBOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B Patient management for HBV infection as clinically indicated. Monitor HCV/HBV coinfected patients for hepatitisįlare or HBV reactivation during HCV treatment and post-treatment follow-up. Increased in patients taking these other agents. Cases have been reported in patients who are HBsAg positive, in patients with serologicĮvidence of resolved HBV, and also in patients receiving certain immunosuppressant orĬhemotherapeutic agents the risk of HBV reactivation associated with treatment with HCV DAAs may be Some cases have resulted in fulminant hepatitis, hepatic failure,Īnd death. Who were undergoing or had completed treatment with HCV direct-acting antivirals (DAAs) and were not HBV reactivation has been reported in HCV/HBV coinfected patients PATIENTS Test all patients for evidence of current or prior hepatitis B Sustained virologic response (SVR12) was the primary endpoint for all clinical trialsīOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV COINFECTED Or sofosbuvir/velpatasvir/voxilaprevir for 8 weeks.
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Trial in DAA-naïve GT 3 cirrhosis patients (N=219) who were randomized to receive EPCLUSA for 12 weeks Sofosbuvir/velpatasvir/voxilaprevir for 8 weeks. Trial in GT 1-6 DAA-naïve patients (N=941) who were randomized to receive EPCLUSA for 12 weeks or Screening, were excluded from the ASTRAL pivotal trials. Patients without cirrhosis or with compensated cirrhosis Sofosbuvir and velpatasvir for HCV genotype 2 and 3 Sofosbuvir and velpatasvir for HCV genotype 1, 2, 4, 5, and Foster City, CA: Gilead Sciences, Inc April 2022.įeld JJ, Jacobson IM, Hézode C, et al. Virologic response 12 or 24 weeks after treatment completion TE = treatment-experienced TN = Ribavirin SOF = sofosbuvir SVR12 = sustained virologic response 12 weeks after treatment completion Interferon NC = non-cirrhotic Peg-IFN = peginterferon alfa The Real-World Integrated Analysis was supported by Gilead Sciences, Inc.ĬC = compensated cirrhosis DAA = direct-acting antiviral DC = decompensated cirrhosis GT = Results from the Real-World Integrated Analysis may differ from those observed in clinical practice. Real-world data are observational in nature and are not based on controlled clinical studies.
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The Real-World Integrated Analysis is not presented in the EPCLUSA full Prescribing Information. Treatment and patient monitoring were based on local clinical practice and standard of care, at the discretion of the treating physician. Patients were treated in different clinical settings, including university hospitals, academic centers, community centers, outpatient clinics and private practices. DC patients and patients who had previously failed other DAA treatments were excluded. TN patients and patients who had previously received IFN-based therapy (Peg-IFN + RBV with or without telaprevir, boceprevir or simeprevir) were included. HCV RNA <15 IU/mL at 12 weeks after the end of treatment.Ī retrospective, pooled analysis of SVR12/24 in adult NC/CC chronic HCV patients treated for 12 weeks with EPCLUSA (400 mg/100 mg) once-daily without RBV in 12 real-world cohorts in Canada, Europe, and the US (N=5552) (ANRS-Hepather, Borgia, DHC-R, Greek Cohort, HCV-TARGET, HepaC, HELIOS, Mangia, NAVIGATORE-II, Ramji, Shafran, TRIO Health). Sustained virologic response (SVR12) was the primary endpoint for all clinical trials and was
TE patients had failed a Peg-IFN + RBV-based regimen with or without an HCV
Patients received EPCLUSA for 12 weeks or SOF Patients received EPCLUSA or SOF + RBV for 12 GT 1, 2,Ĥ, or 6 patients were randomized 5:1 to receive EPCLUSA or placebo for 12 weeks GT 5 patients Patients who were active injection drug users (use within 12 months), or those with aĭrug test at screening, were excluded from the ASTRAL pivotal trials. Patients without cirrhosis or with compensated
Randomized trials in TN and TE adult chronic HCV
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