Anti-infective Agents : Antiviral Agents
OROBA1 “Robatrol capsule” 200 mg/cap
適應症：與interferon alfa併用治療：1.曾經使用interferon alfa單一療法治療後又復發的慢性Ｃ型肝炎。2.首次接受治療的慢性Ｃ型肝炎。
Usual dose:
< 75 kg, with interferon alfa-2b: 400 mg every morning and 600 mg every evening.
> 75 kg, with interferon alfa-2b: 600 mg bid for 24-48 wks.
< 65 kg, with peginterferon alfa-2b: 400 mg bid for 48 wks in genotype 1 p’ts, or for 24 wks in genotype 2 and 3 p’ts.
66-85 kg, with peginterferon alfa-2b: 400 mg in the morning and 600 mg in the evening for 48 wks in genotype 1 p’ts, or for 24 wks in genotype 2 and 3 p’ts.
86-105 kg, with peginterferon alfa-2b: 600 mg bid for 48 wks in genotype 1 p’ts, or for 24 wks in genotype 2 and 3 p’ts.
>105 kg: with peginterferon alfa-2b:600 mg in the morning and 800 mg in the evening for 48 wks IN genotype 1 p’ts, or for 24 wks in genotype 2 and 3 p’ts.
Dose adjustment:
Renal failure: CrCl < 50 ml/min, should not be used.
Adverse effect:
Common: pruritus, rash, dyspepsia, loss of appetite, nausea, headache, conjunctivitis, fatigue.
Serious: bradyarrhythmia, inhalation, cardiac arrest, hypotension, pancreatitis, hemolytic anemia, cardiac and pulmonary events have occurred. (In combination with peginterferon alfa-2a: liver failure, bacterial infectious disease, suicide).
健保使用規範：（100/4/1）
1.限用於參加「全民健康保險加強慢性Ｂ型及慢性C型肝炎治療試辦計畫」之下列慢性病毒性C型肝炎患者且應與interferon-alfa 2a或interferon-alfa 2b或interferon alfacon-1或peginterferon alfa-2b或peginterferon alfa-2a合併治療：
2.限ALT值異常者，且Anti-HCV 與HCV RNA 均為陽性，或經由肝組織切片（血友病患及類血友病患經照會消化系專科醫師同意後，得不作切片），以METAVIR system證實輕度纖維化大於或等於F1及肝炎變化，且無肝功能代償不全者。（98/11/1）
3.療程依Viral Kinetics區分如下:（98/11/1）
(1) 有RVR (rapid virological response, 快速病毒反應)者，給付治療不超過24週。
(2) 無RVR，但有EVR (early virologic response)者，給付治療48週。
(3) 到第12週未到EVR者，應中止治療，治療期間不超過16週。
(4) 第一次治療24週後復發者，可以給予第二次治療，給付不超過48週。