Virological response and safety outcomes in therapy–naïve patients treated for chronic hepatitis C with taribavirin or ribavirin in combination with pegylated interferon alfa-2a: A randomized, phase 2 study

Safety and efficacy of viramidine versus ribavirin in ViSER2: Randomized, double-blind study in therapy-naive hepatitis C patients

“…These results may be explained by suboptimal VRD dosing. Patients were given a fixed dose of VRD 600 mg bid, despite increasing evidence that weight-based dosing of RBV is the best treatment strategy for chronic HCV to obtain higher SVR rates [14,16]. A large, prospective, multicenter study comparing peg-IFN alfa-2b and weight-based or fixed RBV doses showed that SVR was achieved in significantly more patients receiving weight-based doses (44.2% vs. 40.5%; p = 0.008) [17].…”

“…Nine hundred patients were to be enrolled (600 on VRD, 300 on RBV). Patients were randomized using an interactive voice response system and assigned in a 2:1 ratio to receive twice-daily (bid) VRD 600 mg ( dose was based on a dose-ranging phase II study [14], wherein VRD 600 mg bid appeared to provide the best safety profile while maintaining efficacy comparable to that of RBV. Ribavirin dose was determined by baseline body weight: 1000 mg/ day for patients 6 75 kg, 1200 mg/day for patients > 75 kg.…”

“…It is known that VRD does not accumulate in red blood cells [12,13], so this agent is likely to be associated with lower anemia rates. A phase II clinical study of VRD versus RBV in combination with peg-IFN demonstrated similar overall SVR rates in chronic HCV patients [14], and substantial Hb decreases and severe anemia in a substantially larger proportion of RBV-treated patients [14].…”

Novel therapies in hepatitis B and C

“…Peginterferon alfa-2a with either ribavirin or Viramidine showed sustained virological response rates of 37% in the optimal dose group for Viramidine and 44% in the ribavirin group. Significantly fewer patients within the Viramidine group developed anemia compared with the ribavirin group (4% vs 27%) [60]. Unfortunately, two phase 3 trials (VISER 1 and VISER 2) comparing Viramidine plus peginterferon alfa-2a or peginterferon alfa-2b showed that sustained virological response rates in the Viramidine group were inferior to those in the ribavirin group [61].…”

Anemia and clinical outcomes in hepatitis C

“…It is not transported efficiently into red blood cells, which may explain the lower rates of anemia when compared with ribavirin [17,18]. In this issue of the Journal, Gish et al examine the safety and efficacy of taribavirin in treating patients who have CHC [19]. This phase II, multicenter, randomized, active-controlled study was conducted in 180 treatment-naïve patients with CHC and assessed virologic outcomes and safety of taribavirin.…”