Objectives: HPC3005 is a multicentre, open-label, telaprevir trial in HCV/HIV coinfected patients with severe fibrosis or compensated cirrhosis. Methods: Patients were treated with telaprevir 750 mg every 8 h (1125 mg if on efavirenz) plus pegylated interferon-alpha (PEG-IFN, 180 μg once-weekly) and ribavirin (RBV, 800 mg/day) for 12 weeks, followed by 36 weeks of PEG-IFN/RBV. Results: Mean age was 44 years, 97/118 patients were male and all were Caucasian, 68 had severe fibrosis and 50 had cirrhosis. Seventy-eight had HCV RNA levels ≥800 000 IU/mL, 72 had HCV genotype 1a, baseline HIV RNA was <50 copies/mL in 112 patients. Overall, 114/118 patients continued antiretroviral treatment, 4 were untreated. Seventy-five patients received tenofovir and 74 emtricitabine; in addition 53 received atazanavir/ritonavir, 43 raltegravir, and 24 efavirenz. By intention-to-treat, 78 (66%) patients achieved SVR24. Nineteen discontinued telaprevir, 8 for virological endpoint, 5 for adverse events (2 anaemia, 2 rash, 1 asthenia), 5 for non-compliance and 1 withdrew consent. The most common adverse events were anaemia (36 patients), thrombocytopaenia (33), rash (26), bilirubin increase (17), and neutropenia (16). Conclusions: In this early access programme in coinfected patients with severe fibrosis or cirrhosis, 66% of patients achieved SVR. The most common adverse events were haematological. Clinical Trial Number: NCT01500616.

Gori, A., Doroana, M., Chernova, O., Rockstroh, J., Banhegyi, D., Bergin, C., et al. (2015). Telaprevir-based therapy for treatment of HIV-1 and hepatitis C virus co-infected patients: An early access programme. JOURNAL OF INFECTION, 71(6), 675-682 [10.1016/j.jinf.2015.09.013].

Telaprevir-based therapy for treatment of HIV-1 and hepatitis C virus co-infected patients: An early access programme

GORI, ANDREA
;
2015

Abstract

Objectives: HPC3005 is a multicentre, open-label, telaprevir trial in HCV/HIV coinfected patients with severe fibrosis or compensated cirrhosis. Methods: Patients were treated with telaprevir 750 mg every 8 h (1125 mg if on efavirenz) plus pegylated interferon-alpha (PEG-IFN, 180 μg once-weekly) and ribavirin (RBV, 800 mg/day) for 12 weeks, followed by 36 weeks of PEG-IFN/RBV. Results: Mean age was 44 years, 97/118 patients were male and all were Caucasian, 68 had severe fibrosis and 50 had cirrhosis. Seventy-eight had HCV RNA levels ≥800 000 IU/mL, 72 had HCV genotype 1a, baseline HIV RNA was <50 copies/mL in 112 patients. Overall, 114/118 patients continued antiretroviral treatment, 4 were untreated. Seventy-five patients received tenofovir and 74 emtricitabine; in addition 53 received atazanavir/ritonavir, 43 raltegravir, and 24 efavirenz. By intention-to-treat, 78 (66%) patients achieved SVR24. Nineteen discontinued telaprevir, 8 for virological endpoint, 5 for adverse events (2 anaemia, 2 rash, 1 asthenia), 5 for non-compliance and 1 withdrew consent. The most common adverse events were anaemia (36 patients), thrombocytopaenia (33), rash (26), bilirubin increase (17), and neutropenia (16). Conclusions: In this early access programme in coinfected patients with severe fibrosis or cirrhosis, 66% of patients achieved SVR. The most common adverse events were haematological. Clinical Trial Number: NCT01500616.
Articolo in rivista - Articolo scientifico
Bridging fibrosis; Cirrhosis; Coinfection; Hepatitis C; HIV; Telaprevir; Microbiology (medical); Infectious Diseases
English
2015
71
6
675
682
none
Gori, A., Doroana, M., Chernova, O., Rockstroh, J., Banhegyi, D., Bergin, C., et al. (2015). Telaprevir-based therapy for treatment of HIV-1 and hepatitis C virus co-infected patients: An early access programme. JOURNAL OF INFECTION, 71(6), 675-682 [10.1016/j.jinf.2015.09.013].
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10281/96629
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