Intravenous silibinin as 'rescue treatment' for on-treatment non-responders to pegylated interferon/ribavirin combination therapy
Standard
Intravenous silibinin as 'rescue treatment' for on-treatment non-responders to pegylated interferon/ribavirin combination therapy. / Rutter, Karoline; Scherzer, Thomas-Matthias; Beinhardt, Sandra; Kerschner, Heidrun; Stättermayer, Albert F; Hofer, Harald; Popow-Kraupp, Theresia; Steindl-Munda, Petra; Ferenci, Peter.
In: ANTIVIR THER, Vol. 16, No. 8, 01.01.2011, p. 1327-33.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
Harvard
APA
Vancouver
Bibtex
}
RIS
TY - JOUR
T1 - Intravenous silibinin as 'rescue treatment' for on-treatment non-responders to pegylated interferon/ribavirin combination therapy
AU - Rutter, Karoline
AU - Scherzer, Thomas-Matthias
AU - Beinhardt, Sandra
AU - Kerschner, Heidrun
AU - Stättermayer, Albert F
AU - Hofer, Harald
AU - Popow-Kraupp, Theresia
AU - Steindl-Munda, Petra
AU - Ferenci, Peter
PY - 2011/1/1
Y1 - 2011/1/1
N2 - BACKGROUND: Intravenous silibinin (ivSIL) is a potent antiviral agent against HCV. In vitro silibinin (SIL) inhibits viral replication, possibly by inhibiting HCV RNA polymerase. In this proof-of-concept study, ivSIL was tested in on-treatment non-responders to full-dose of pegylated interferon-α2a/ribavirin (standard of care [SOC]).METHODS: A total of 27 treatment-naive patients with <2 log drop in viral load after 12 weeks or still detectable HCV RNA after 24 weeks of SOC treatment (mean age 54.4 ±6.8 years, male/female 19/8, HCV genotype 1 n=19, 3a n=4 and 4 n=4, liver fibrosis F4 n=14, F3 n=5 and F2 n=3, and interleukin 28B polymorphism C/C n=1, T/C n=22 and T/T n=4) received additionally 20 mg/kg/day SIL (Legalon-SIL(®); Rottapharm-Madaus, Monza, Italy) intravenously for 14 or 21 days. Thereafter, pegylated interferon/ribavirin was continued. HCV RNA was quantified by TaqMan(®) (Roche Diagnostics, Pleasanton, CA, USA).RESULTS: At the end of ivSIL treatment, 23/27 (85.1%) patients had undetectable HCV RNA. In one of the four remaining patients HCV RNA became undetectable 8 weeks after ivSIL on SOC. Five patients relapsed after ivSIL, three of them responded to repeated administration of ivSIL, but relapsed again. The best predictor of response was a low pre-ivSIL HCV RNA level. A total of 19 patients reached one treatment end point (end of SOC treatment HCV RNA undetectable n=11 and non-response n=8); 8 patients were still on SOC (all HCV-RNA-negative). All 11 patients with end-of-treatment response completed 24 weeks of follow-up; 7 patients remained HCV-RNA-negative and 4 relapsed. Except for a slight increase in bilirubin (mean ±SD 0.98 ±0.35 to 2.12 ±0.99 mg/dl), treatment was well-tolerated.CONCLUSIONS: ivSIL is an effective 'rescue treatment' for on-treatment non-responders to full-dose of SOC.
AB - BACKGROUND: Intravenous silibinin (ivSIL) is a potent antiviral agent against HCV. In vitro silibinin (SIL) inhibits viral replication, possibly by inhibiting HCV RNA polymerase. In this proof-of-concept study, ivSIL was tested in on-treatment non-responders to full-dose of pegylated interferon-α2a/ribavirin (standard of care [SOC]).METHODS: A total of 27 treatment-naive patients with <2 log drop in viral load after 12 weeks or still detectable HCV RNA after 24 weeks of SOC treatment (mean age 54.4 ±6.8 years, male/female 19/8, HCV genotype 1 n=19, 3a n=4 and 4 n=4, liver fibrosis F4 n=14, F3 n=5 and F2 n=3, and interleukin 28B polymorphism C/C n=1, T/C n=22 and T/T n=4) received additionally 20 mg/kg/day SIL (Legalon-SIL(®); Rottapharm-Madaus, Monza, Italy) intravenously for 14 or 21 days. Thereafter, pegylated interferon/ribavirin was continued. HCV RNA was quantified by TaqMan(®) (Roche Diagnostics, Pleasanton, CA, USA).RESULTS: At the end of ivSIL treatment, 23/27 (85.1%) patients had undetectable HCV RNA. In one of the four remaining patients HCV RNA became undetectable 8 weeks after ivSIL on SOC. Five patients relapsed after ivSIL, three of them responded to repeated administration of ivSIL, but relapsed again. The best predictor of response was a low pre-ivSIL HCV RNA level. A total of 19 patients reached one treatment end point (end of SOC treatment HCV RNA undetectable n=11 and non-response n=8); 8 patients were still on SOC (all HCV-RNA-negative). All 11 patients with end-of-treatment response completed 24 weeks of follow-up; 7 patients remained HCV-RNA-negative and 4 relapsed. Except for a slight increase in bilirubin (mean ±SD 0.98 ±0.35 to 2.12 ±0.99 mg/dl), treatment was well-tolerated.CONCLUSIONS: ivSIL is an effective 'rescue treatment' for on-treatment non-responders to full-dose of SOC.
KW - Adult
KW - Antioxidants
KW - Antiviral Agents
KW - Austria
KW - Cohort Studies
KW - Drug Therapy, Combination
KW - Female
KW - Hepacivirus
KW - Hepatitis C, Chronic
KW - Humans
KW - Injections, Intravenous
KW - Interferon-alpha
KW - Interleukins
KW - Male
KW - Middle Aged
KW - Polyethylene Glycols
KW - RNA, Viral
KW - Recombinant Proteins
KW - Recurrence
KW - Ribavirin
KW - Silymarin
KW - Treatment Outcome
KW - Viral Load
KW - Virus Replication
U2 - 10.3851/IMP1942
DO - 10.3851/IMP1942
M3 - SCORING: Journal article
C2 - 22155914
VL - 16
SP - 1327
EP - 1333
JO - ANTIVIR THER
JF - ANTIVIR THER
SN - 1359-6535
IS - 8
ER -