Telaprevir-based therapy for treatment of HIV-1 and hepatitis C virus co-infected patients: An early access programme.
J Infect
; 71(6): 675-82, 2015 Dec.
Article
em En
| MEDLINE
| ID: mdl-26416471
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.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Antivirais
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Oligopeptídeos
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Infecções por HIV
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HIV-1
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Hepatite C
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Coinfecção
Idioma:
En
Ano de publicação:
2015
Tipo de documento:
Article