Clinical Study

Restoration of Innate and Adaptive Immune Responses by HCV Viral Inhibition with an Induction Approach Using Natural Interferon-Beta in Chronic Hepatitis C

Table 3

Effect of RBV plus PEG-IFN-alpha 2b using an “induction” therapy with CPIT (NCT) on serum HCV RNA in chronic hepatitis C with high viral load, serotype 1 (genotype 1b), and wild or intermediate type in ISDR.

Patient no.HCV RNA in serum (KIU/mL)
Serotype ISDR number of mutations in NS5A geneBaseline4 weeks (RVR)12 weeks (EVR)24 wks
(end of CPIT)
72 weeks
(end of NCT)
96 weeks (24 wks after end of NCT)Virologic breakthroughOutcome

Early virologic responders
1In.d.1480<5.0(−)(−)(−)(−)(−)SVR
2IWild (0)824<5.0(−)(−)(−)(−)(−)SVR
3IWild (0)536<5.0(+)(−)(−)(−)(−)SVR
4IWild (0)3600<5.0(+)(−)(−)(−)(−)SVR
5IIntermediate (1)770<5.0(−)(−)(−)(−)(−)SVR

Late virologic responders
6IIntermediate (2) >5000<5.0(+)(+)(−)$(−)(+) 𝛿 3400(−)TVR
7IIntermediate (1)4400<0.5(+)(+)(−)£(−)600 𝛿 4500§850(−)TVR
M e a n ± S D 2 2 9 8 ± 1 5 2 3 RVREVRETVR (CPIT )ETVR (NCT)SVRWithout BT
7/77/75/77/75/77/7
cEVR (3/7)pEVR (4/7)TVR 2/7

ISDR: IFN sensitivity determining region, IFN: interferon, RVR: rapid virologic response, EVR: early virologic response, cEVR: complete EVR, pEVR: partial EVR, SVR: sustained virologic response, TVR: transient virologic response, CPIT: cyclic and periodic IFN treatment, NCT: novel combination, n.d: not determined, (−) in HCV RNA: undetectable HCV RNA (<50 IU/mL), (+) in HCV RNA: detectable HCV RNA (>50 IU/mL), $29 weeks of NCT, 𝛿 4 weeks after end of NCT, £30 weeks of NCT, §8 weeks after end of NCT, and BT: breakthrough.