Glecaprevir/pibrentasvir in patients with chronic HCV and recent drug use: An integrated analysis of 7 phase III studies
| Autor: | Yiran Hu, Daniel F. Jackson, Michael Gschwantler, Jason Grebely, Gregory J. Dore, Brian Conway, Armen Asatryan, Axel Baumgarten, Tarik Asselah, Stanley Wang, Federico J. Mensa, Kenneth E. Sherman, Humberto Aguilar, Krzysztof Tomasiewicz, Graham R. Foster |
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| Rok vydání: | 2018 |
| Předmět: |
Cyclopropanes
Liver Cirrhosis Male Aminoisobutyric Acids Pyrrolidines Sofosbuvir Sustained Virologic Response Hepacivirus Toxicology Drug Users 0302 clinical medicine Pharmacology (medical) 030212 general & internal medicine media_common Aged 80 and over Sulfonamides Hepatitis C Middle Aged Pibrentasvir Psychiatry and Mental health Treatment Outcome Drug Therapy Combination Female medicine.drug Drug Adult medicine.medical_specialty Proline media_common.quotation_subject Lactams Macrocyclic Antiviral Agents 03 medical and health sciences Young Adult Leucine Internal medicine Quinoxalines Ribavirin medicine Humans Adverse effect Aged Pharmacology business.industry Glecaprevir Hepatitis C Chronic medicine.disease Discontinuation Regimen Benzimidazoles business 030217 neurology & neurosurgery |
| Zdroj: | Drug and alcohol dependence. 194 |
| ISSN: | 1879-0046 |
| Popis: | Background: Injection drug use is the primary mode of transmission for hepatitis C virus (HCV), and treatment guidelines recommend treating HCV-infected people who use drugs; however, concerns about adherence, effectiveness, and reinfection have impeded treatment uptake. Methods: Data were pooled from seven phase III trials that evaluated the efficacy and safety of 8 or 12 weeks of glecaprevir/pibrentasvir (G/P) in patients chronically infected with HCV genotypes 1–6. Patients had compensated liver disease, with or without cirrhosis, and were HCV treatment-naive or -experienced with interferon or pegylated interferon ± ribavirin, or sofosbuvir plus ribavirin ± pegylated interferon. Patients were grouped into recent drug users (injection drug use ≤12 months before screening, positive urine drug screen [UDS], and/or drug-related adverse event), former drug users (>12 months before screening and negative UDS), or non-drug users. Assessments included sustained virologic response at 12 weeks posttreatment (SVR12), treatment adherence, and safety. Results: Among 1819 patients, 5%, 34%, and 61% were recent, former, and non-drug users, respectively. Treatment adherence and completion were high (≥96%) regardless of drug use status. SVR12 was achieved by 93% (n/N = 91/98), 97% (n/N = 591/610), and >99% (n/N = 1106/1111) of recent, former, and non-drug users, respectively (intention-to-treat analysis). The overall rates of virologic failure were ≤1.5% across all three subpopulations, with no HCV reinfections among recent drug users. Drug-related serious adverse events and adverse events leading to treatment discontinuation were experienced by ≤1% of patients. Conclusions: G/P is a well-tolerated and efficacious pangenotypic regimen for chronic HCV-infected people with recent or active drug use. |
| Databáze: | OpenAIRE |
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