The pathogenesis of chronic hepatitis C (CHC) is associated to severe oxidative stress that leads to necro-inflammation and progression of fibrosis. Previous trials suggested that antioxidative therapy may have a beneficial effect. We evaluated the efficacy and safety of Viusid in combination with interferon a-2b (IFN a-2b) and ribavirin in patients with CHC. Methods: We randomly assigned 100 patients, between October 2002 and December 2004, in two arms: IFN a-2b (5 MU on alternate days), ribavirin at a dose of 13 mg/kg daily and Viusid (three sachets daily) vs. IFN a-2b (5 MU on alternate days) and ribavirin at a dose of 13 mg/kg daily. Subjects were treated for 48 weeks and then followed for an additional 24 weeks. The primary end point was the histologic response (reduction of at least two points without fibrosis worsening in the total score on the Histological Activity Index).
A significantly high proportion of patients who received combined therapy plus Viusid had a histologic response better than those patients who received IFN a-2b and ribavirin (57% vs. 37%, P = 0.03). The patients with virologic response achieved the highest percentages of histologic response, irrespective of assigned treatment. Among non-responders, the highest reduction in the mean change from baseline score for necro-inflammatory activity (NA) and fibrosis (F) was reported in patients treated with Viusid [NA, À 1.50 (Viusid), À 1.20 (without Viusid); F, À 0.31 (Viusid), 0.00 (without Viusid)]. Sustained normalization of serum alanine aminotransferase concentration was highest in the Viusid group compared with standard therapy (67% vs. 41%, P = 0.009). The overall safety profile was similar in both groups, but interestingly, the anemia was less intense in the group with Viusid (P = 0.04).
Our results suggest that triple therapy with Viusid, IFN a-2b and ribavirin was well tolerated and may have a beneficial effect on histologic and biochemical variables. The intensity of anemia is reduced in patients treated with Viusid.
Full details of this clinical study are available in the “Clinical studies” section of the Viusid eLeaflet.