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Shortened therapy of eight weeks with paritaprevir/ritonavir/ombitasvir and dasabuvir is highly effective in people with recent HCV genotype 1 infection.
Martinello, M; Bhagani, S; Gane, E; Orkin, C; Cooke, G; Dore, G J; Petoumenos, K; Applegate, T L; Tu, E; Marks, P; Pagani, N; Grebely, J; Nelson, M; Matthews, G V.
  • Martinello M; Viral Hepatitis Clinical Research Program, Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
  • Bhagani S; Department of Infectious Diseases and Immunology, St Vincent's Hospital, Sydney, NSW, Australia.
  • Gane E; Department of Infectious Diseases/HIV Medicine, Royal Free Hospital, London, UK.
  • Orkin C; New Zealand Liver Transplant Unit, Auckland City Hospital, Auckland, New Zealand.
  • Cooke G; Barts Health, Royal London Hospital, London, UK.
  • Dore GJ; Department of Infectious Diseases, Imperial College NHS Trust, St Mary's Hospital, London, UK.
  • Petoumenos K; Viral Hepatitis Clinical Research Program, Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
  • Applegate TL; Department of Infectious Diseases and Immunology, St Vincent's Hospital, Sydney, NSW, Australia.
  • Tu E; Viral Hepatitis Clinical Research Program, Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
  • Marks P; Viral Hepatitis Clinical Research Program, Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
  • Pagani N; Viral Hepatitis Clinical Research Program, Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
  • Grebely J; Viral Hepatitis Clinical Research Program, Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
  • Nelson M; Chelsea and Westminster Hospital, London, UK.
  • Matthews GV; Viral Hepatitis Clinical Research Program, Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
J Viral Hepat ; 25(10): 1180-1188, 2018 10.
Article en En | MEDLINE | ID: mdl-29660224
Paritaprevir/ritonavir/ombitasvir and dasabuvir with or without ribavirin for 12 weeks are approved for treatment of chronic HCV genotype 1 infection. This study assessed the efficacy of shortened duration paritaprevir/ritonavir/ombitasvir and dasabuvir with or without ribavirin for 8 weeks among people with recent HCV infection. In this open-label single-arm trial conducted in Australia, England and New Zealand, adults with recent HCV (duration of infection <12 months) received paritaprevir/ritonavir/ombitasvir and dasabuvir (with weight-based ribavirin for genotypes 1a and 1, no subtype) for 8 weeks. The primary endpoint was sustained virological response at 12 weeks post-treatment (SVR12) in the intention-to-treat (ITT) population. Thirty people (median age 38 years, male 93%) commenced treatment (with ribavirin, 97%), of whom 77% (n = 23) were HIV-positive, 93% (n = 28) had genotype 1a infection and 53% (n = 16) had ever injected drugs. Median maximum ALT in the preceding 12 months was 433 IU/L (IQR 321, 1012). Acute clinical hepatitis with ALT > 10 x ULN was documented in 83% (n = 25); one participant (3%) had jaundice. At baseline, median estimated duration of infection was 30 weeks (range 11, 51), and median HCV RNA was 5.7 log10 IU/mL (range 2.7, 7.3). SVR12 was achieved in 97% (29/30; early discontinuation at week 2, n = 1; per protocol 100%, 29/29). No relapse or reinfection was observed. In conclusion, paritaprevir/ritonavir/ombitasvir and dasabuvir (with ribavirin) for eight weeks were highly effective among HIV-positive and HIV-negative individuals with recent HCV infection. These data support the use of this shortened duration direct-acting antiviral regimen in this population.
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Antivirales / Hepatitis C / Hepacivirus Tipo de estudio: Clinical_trials / Guideline / Observational_studies / Risk_factors_studies País como asunto: Europa / Oceania Idioma: En Año: 2018 Tipo del documento: Article

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Antivirales / Hepatitis C / Hepacivirus Tipo de estudio: Clinical_trials / Guideline / Observational_studies / Risk_factors_studies País como asunto: Europa / Oceania Idioma: En Año: 2018 Tipo del documento: Article