Sofosbuvir plus ribavirin for hepatitis C virus-associated cryoglobulinaemia vasculitis: VASCUVALDIC study.
Ann Rheum Dis
; 75(10): 1777-82, 2016 Oct.
Article
em En
| MEDLINE
| ID: mdl-26567178
ABSTRACT
BACKGROUND:
Hepatitis C virus (HCV) is the aetiological agent for most cases of cryoglobulinaemia vasculitis. Interferon-containing regimens are associated with important side effects and may exacerbate the vasculitis.OBJECTIVE:
To evaluate safety and efficacy of an oral interferon-free regimen, sofosbuvir plus ribavirin, in HCV-cryoglobulinaemia vasculitis. PATIENTS ANDMETHODS:
We enrolled 24 consecutive patients (median age of 56.5â years and 46% of women) with HCV-cryoglobulinaemia vasculitis. Sofosbuvir (400â mg/day) was associated with ribavirin (200-1400â mg/day), for 24â weeks. The primary efficacy end point was a complete clinical response of the vasculitis at the end of treatment (week 24).RESULTS:
Main features of HCV-cryoglobulinaemia vasculitis included purpura and peripheral neuropathy (67%), arthralgia (58%), glomerulonephritis (21%) and skin ulcers (12%). Twenty-one patients (87.5%) were complete clinical response at week 24. Complete clinical response was achieved in six (25%) patients at week 4, four (16.6%) at week 8, seven (29.2%) at week 12, three (12.5%) at week 16 and one (4.2%) at week 20. The cryoglobulin level decreased from 0.35 (0.16-0.83) at baseline to 0.15 (0.05-0.45) g/L at week 24. The C4 serum level increased from 0.10 (0.07-0.19) to 0.17 (0.09-0.23) g/L at week 24. Seventy-four per cent of patients had a sustained virological response at week 12 post treatment. The most common side effects were fatigue, insomnia and anaemia. Two serious adverse events were observed.CONCLUSIONS:
Sofosbuvir plus ribavirin combination was associated with a high rate of complete clinical response and a low rate of serious adverse events in HCV-cryoglobulinaemia vasculitis.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Antivirais
/
Ribavirina
/
Vasculite
/
Crioglobulinemia
/
Sofosbuvir
Tipo de estudo:
Observational_studies
/
Risk_factors_studies
Limite:
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Ann Rheum Dis
Ano de publicação:
2016
Tipo de documento:
Article
País de afiliação:
França