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Published on: October 1, 2015
Non-interferon-based therapy: an option for amelioration of necro-inflammation in hepatitis C patients who cannot
Abdel-Rahman El-Zayadi1, Mohy Attia, Hanaa M Badran
1Department of Tropical Medicine, Ain Shams University, Cairo, Egypt. clcz@tedata.net.eg
Insights
A non-interferon-based therapy (N-IFN-BT) significantly improved liver health in chronic hepatitis C patients compared to silymarin. This cost-effective treatment regimen offers a viable alternative for those unable to afford interferon therapy.
Area of Science:
- Hepatology
- Virology
- Pharmacology
Background:
- Interferon (IFN) therapy for chronic hepatitis C (CHC) is unaffordable for many Egyptian patients.
- Need for effective and inexpensive treatment options to manage hepatic necro-inflammatory activity in CHC.
Purpose of the Study:
- To develop and evaluate an affordable, non-interferon-based therapeutic regimen for CHC patients.
- To assess the efficacy of this regimen in ameliorating liver inflammation compared to silymarin.
Main Methods:
- 170 treatment-naïve CHC patients with elevated ALT and detectable HCV-RNA were randomized.
- Group I (N-IFN-BT): 87 patients received ribavirin, amantadine, and ursodeoxycholic acid (UDCA) for 24 weeks.
- Group II (Silymarin): 83 patients received silymarin 450 mg/day for 24 weeks.
Main Results:
- ALT normalization at end of treatment: 58.5% in Group I vs. 15.3% in Group II (P<0.001).
- End of treatment virologic response (ETVR): 2.4% in Group I vs. 0% in Group II.
- Sustained biochemical response (SBR) at 24 weeks post-therapy: 28% in Group I vs. 2.8% in Group II (P<0.001).
- Histopathology in Group I showed a significant decrease in liver activity index.
Conclusions:
- The 24-week non-interferon-based therapy (N-IFN-BT) demonstrated significantly higher end-of-treatment and sustained biochemical responses compared to silymarin.
- N-IFN-BT effectively reduced necro-inflammatory activity in CHC patients, as confirmed by repeat liver biopsies.
- This regimen offers a cost-effective and promising alternative for CHC management in resource-limited settings.
Objectives:
Interferon (IFN) therapy is not affordable by the majority of Egyptian patients. Our aim was to tailor an effective and inexpensive regimen that ameliorates hepatic necro-inflammatory activity among chronic hepatitis C (CHC) patients.
Methods:
One hundred and seventy naïve CHC patients with elevated alanine aminotransferase (ALT) (>1.5-fold) and detectable hepatitis C virus (HCV)-RNA by polymerase chain reaction, who cannot afford IFN-based therapy were randomly allocated either to non-interferon-based therapy (N-IFN-BT) (group I) or silymarin therapy (group II). Group I comprised 87 patients (biopsy proved chronic hepatitis in 62 patients) who were administered a daily combination of ribavirin (600-800 mg) plus amantadine (200 mg) and ursodeoxycholic acid (UDCA) (500 mg) for 24 weeks. Group II comprised 83 patients who were administered Silymarin 450 mg/day for 24 weeks.
Results:
Statistical evaluation was conducted on 82 patients from group I and 72 from group II because of the withdrawal of five and 11 patients from Groups I and II, respectively. Age, sex, social status and biochemical parameters were comparable in both groups. Normalization of ALT at the end of treatment was achieved in 58.5% and 15.3% (P<0.001), whereas end of treatment virologic response (ETVR) was achieved in 2.4% and 0% of Groups I and II, respectively. Twenty-four weeks after cessation of therapy, sustained biochemical response (SBR) was achieved in 28% and 2.8% (P<0.001), while sustained virologic response (SVR) was maintained in 2.4% and 0% of the patients in Groups I and II, respectively. In Group I, histopathological examination revealed a decreased activity index by an average score of 1.5 points among 38/62 of the rebiopsied patients.
Conclusion:
Twenty-four weeks N-IFN-BT achieved a fourfold-higher ETBR and a tenfold-higher SBR compared with silymarin therapy, which reflects an improvement of necroinflammatory activity as proven by repeat histopathology.
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