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

Identifieur interne : 002570 ( Main/Exploration ); précédent : 002569; suivant : 002571

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

Auteurs : Abdel-Rahman El-Zayadi ; Mohy Attia ; Hanaa M. Badran ; Ahmed El-Tawil ; Khaled Zalata ; Eman Barakat ; Osaima Selim ; Adham El-Nakeeb [Égypte] ; Ahmed Saied [Égypte]

Source :

RBID : ISTEX:CAECD1DB26E4045B6B15AB1B78D55D9E97FAC416

English descriptors

Abstract

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.

Url:
DOI: 10.1111/j.1478-3231.2005.01110.x


Affiliations:


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<div type="abstract" xml:lang="en">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.</div>
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