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DAA regimen yields high SVR despite presence of mixed cryoglobulinemia

In a prospective study, a majority of patients with hepatitis C virus infection-associated mixed cryoglobulinemia vasculitis experienced high sustained virologic response rates after therapy with an interferon-free, direct-acting antiviral-based regimen, according to published findings.

“Interferon-free, guideline-tailored therapy with direct-acting antivirals is highly effective and safe for HCV-associated MC patients; the overall 100% rate of clinical response of vasculitis, on an intention-to-treat basis, opens the perspective for curing the large majority of these so far difficult-to-treat patients,” Laura Gragnani, MD, of the Interdepartmental Center for Systemic Manifestations of Hepatitis Viruses, department of experimental and clinical medicine, University of Florence, Florence, Italy, and colleagues wrote.

The researchers evaluated 44 patients with active mixed cryoglobulinemia (MC) vasculitis for safety, clinical efficacy and virological response during follow-up for a minimum of 24 weeks’ post-treatment with ribavirin in addition to either Sovaldi (sofosbuvir, Gilead Sciences), Harvoni (sofosbuvir/ledipasvir, Gilead Sciences), sofosbuvir plus Olysio (simeprevir, Janssen Therapeutics) or sofosbuvir plus Daklinza (daclatasvir, Bristol-Myers Squibb).

Each regimen was individually tailored based on the latest HCV treatment guidelines, according to the research, and more than half of the patients had failed previous therapy with interferon-based regimens (57%).

Among all patients, HCV RNA was undetectable at week 4 of therapy and remained negative throughout 12 and 24 weeks. All had negative HCV viremia at SVR12 and SVR24 posttreatment, at which time all had a clinical response of vasculitis.

By SVR12, 34% of patients were full-complete responders and showed no manifestation of vasculitis; 32% were complete responders with improvements in all vasculitis manifestations; 27% were partial responders and experienced either a disappearance or improvement in at least half of their vasculitis manifestations; and 7% were nonresponders. At SVR24, all patients had a clinical response of vasculitis, according to the researchers, with 36% being full-complete responders, 41% complete responders and 23% partial responders.

The researchers observed a decrease, or improvement, in mean alanine aminotransferase levels at SVR12 and SVR24 (P < .0001 for both), as well as improved asparate aminotransferase levels at SVR12 (P < .0001) and SVR24 (P < .001) compared with baseline.  

Also, compared with baseline, the mean Birmingham Vasculitis Activity Score decreased from 5.41 to 2.35 (P < .001) at 4 weeks during treatment, and decreased to 1.39 (P < .001) at SVR12 and to 1.27 (P < .001) at SVR24. The mean cryocrit value decreased from 7.2% at baseline to 2.9% (P < .01) at SVR12 and to 1.8% (P < .001) at SVR24.

Adverse events were minimal and mild in nature, with no patients discontinuing treatment due to an event. The most common events were anemia, fatigue and nausea.

“This study strongly supports the opportunity of an early eradication of HCV, before MC-related tissue damage becomes irreversible and/or the lymphomagnetic process becomes independent from the etiologic agent,” the researchers wrote.  – Melinda Stevens

Disclosure: Gragnani reports no relevant financial disclosures. Please see the study for a list of all other authors’ relevant financial disclosures.