Non-interferon-based therapy: an option for amelioration of necro-inflammation in hepatitis C patients who cannot afford interferon therapy.
OBJECTIVE
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.


CONCLUSIONS
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.
Department of Tropical Medicine, Ain Shams University, Cairo, Egypt. clcz@tedata.net.eg
Abdel-Rahman
AR
El-Zayadi
Mohy
M
Attia
Hanaa M
HM
Badran
Ahmed
A
El-Tawil
Khaled
K
Zalata
Eman
E
Barakat
Osaima
O
Selim
Adham
A
El-Nakeeb
Ahmed
A
Saied
D000410:Alanine Transaminase / Q000032:analysis; D000547:Amantadine / Q000627:therapeutic use; D000998:Antiviral Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000473:pathology / Q000821:virology; D006801:Humans; D007372:Interferons / Q000191:economics / Q000627:therapeutic use; D008099:Liver / Q000187:drug effects* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009336:Necrosis; D020011:Protective Agents / Q000627:therapeutic use*; D012367:RNA, Viral / Q000032:analysis; D012254:Ribavirin / Q000627:therapeutic use; D012838:Silymarin / Q000627:therapeutic use*; D016896:Treatment Outcome; D014580:Ursodeoxycholic Acid / Q000627:therapeutic use
D000998:Antiviral Agents; D020011:Protective Agents; D012367:RNA, Viral; D012838:Silymarin; D012254:Ribavirin; D014580:Ursodeoxycholic Acid; D007372:Interferons; D000547:Amantadine; D000410:Alanine Transaminase