A Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection (DORA)
An open-label study to assess the pharmacokinetics (PK), safety, and efficacy of glecaprevir (GLE)/pibrentasvir (PIB) (Mavyret) in pediatric (children) participants divided into 4 age groups: 3 to < 6, 6 to < 9, 9 to < 12, and 12 to < 18 years of age. Within each age group, some participants will be enrolled for intensive pharmacokinetics (IPK) to characterize the PK of a particular age group and the remainder of participants will be enrolled for the evaluation of safety and efficacy of each age group. Intensive PK sampling is designed to allow for dose adjustment, based on available PK and clinical data to achieve therapeutic exposures that have been safe and efficacious in adults.
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Mavyret: A Phase 3b, single arm, open-label, multicenter study to evaluate the safety and to demonstrate the non-inferiority of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with the glecaprevir (GLE)/pibrentasvir (PIB) combination regimen to the historical SVR12 rate of 12 weeks of treatment with the GLE/PIB in treatment-naïve adults with chronic HCV GT 1, 2, 4, 5, or 6 infection and compensated cirrhosis.
The study is evaluating the treatment of HCV genotype 1 with the Viekira regime in people coinfected with hepatitis C and HIV. Viekira regime is approved by the Food and Drug Administration (FDA) to treat people mono-infected with HCV and in people coinfected with HCV and HIV. Previous studies have achieved cure rates of 95% to 100%.
Evaluating the Safety and Effectiveness of Interferon-Free Treatment of Hepatitis C Virus Infection in HIV-Coinfected Adults on Antiretroviral Therapy (C_ASCENT)
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The study is evaluating the safety and effectiveness of Viekira Pak to treat pediatric patients with chronic hepatitis C genotypes 1 and 4. Viekira Pak is already approved by the Food and Drug Administration to treat adults with hepatitis C. This is the first clinical trial of Viekira Pak to treat pediatric patients.
A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects (ZIRCON)
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This is an observational study to find out the ‘real world’ effectiveness (cure) of AbbVie’s Viekira Pak (with and without ribavirin) in genotype 1 and 4 patients. This includes treatment-naïve and treatment experienced patients. AbbVie’s drug combinations are approved by the Food and Drug Administration (FDA) to treat hepatitis C genotype 1 (cure rates = 95 to 100%) and genotype 4 (cure rates = 91 to 100%).
Israel: Real World Evidence of the Effectiveness of Paritaprevir/r – Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C (CITRINE)