Юлия Волкова » Публикация

Аннотация We read with great interest the article by Saadoun et al1 who investigated the efficacy and safety of a 24-week treatment with sofosbuvir and ribavirin in a small, open-label and uncontrolled study of patients with hepatitis C virus (HCV)-associated cryoglobulinemia vasculitis. However, the limitations of the VASCUVALDIC study diminish the validity of the conclusions, although we agree with the authors that it would be unethical to delay effective antiviral therapy given the established role of HCV in the development of cryoglobulinemia vasculitis and its unfavourable prognosis. As expected, the rate of sustained virological response (SVR) was higher (74%) than in previous trials of interferon-based antiviral treatment in patients with HCV-associated cryoglobulinemia vasculitis.2 ,3 However, this looks relatively moderate in light of the current efficacy of the interferon-free, all-oral antiviral regimens (up to 95%–100%). Nonetheless, the SVR rate was comparable with that identified in the previous phase III sofosbuvir plus ribavirin trial in patients with HCV infection.4 We can also assume that the proportion of virological responders among patients with HCV-associated cryoglobulinemia vasculitis will increase further due to the use of other available and emerging direct-acting antivirals. Moreover, ribavirin-free regimen may improve the safety of antiviral treatment, given a high rate of anaemia (25%) in this study. Over 24 months, almost 90% of patients achieved a complete clinical response that was defined by an improvement in all vasculitis manifestations and the absence of clinical relapse. In the majority of responders, the clinical and virological effects were rapid and apparent within the first 12 weeks of treatment. Approximately 30% of patients received treatment with immunomodulatory or immunosuppressive therapy (including rituximab) that may contribute to, but could not explain, the impressive results of the VASCUVALDIC study. Notably, SVR12 was achieved in all three patients who received a rituximab infusion 1 month prior to the antiviral therapy. Rituximab did not seem to impair the antiviral activity of sofosbuvir plus ribavirin and it can be used concomitantly with direct-acting antivirals. These reassuring findings are important, as antiviral treatment does not eliminate the need for immunosuppression in patients with severe cryoglobulinemia glomerulonephritis or nervous system disease. http://dx.doi.org/10.1136/annrheumdis-2016-210636