B型慢性肝炎患者に対するペグインターフェロンα-2aの有効性及び安全性の検討
B型慢性肝炎に対するペグインターフェロンアルファ-2a（PEG-IFNα-2a）の有効性，安全性を検討した． HBe抗原陽性例はPEG-IFNα-2a 90 μg，180 μg/週の各々24週投与，48週投与又は天然型IFNα6 MIU週3回24週投与（HLBI群）の5群に無作為割付けし，投与終了後24週時のALT正常化，HBeセロコンバージョン及びHBV-DNA量抑制の複合評価で有効性を評価した． PEG-IFNα-2a群では用量，投与期間に応じて高い有効率を示した．PEG-IFNα-2a 48週併合群とHLBI群の有効率の差は11.3％（95％CI：0.0-22.6）とHLBI群に対し非劣...
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| Published in | 肝臓 Vol. 53; no. 3; pp. 135 - 146 |
|---|---|
| Main Authors | , , , , |
| Format | Journal Article |
| Language | Japanese |
| Published |
一般社団法人 日本肝臓学会
2012
|
| Subjects | |
| Online Access | Get full text |
| ISSN | 0451-4203 1881-3593 |
| DOI | 10.2957/kanzo.53.135 |
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| Abstract | B型慢性肝炎に対するペグインターフェロンアルファ-2a（PEG-IFNα-2a）の有効性，安全性を検討した． HBe抗原陽性例はPEG-IFNα-2a 90 μg，180 μg/週の各々24週投与，48週投与又は天然型IFNα6 MIU週3回24週投与（HLBI群）の5群に無作為割付けし，投与終了後24週時のALT正常化，HBeセロコンバージョン及びHBV-DNA量抑制の複合評価で有効性を評価した． PEG-IFNα-2a群では用量，投与期間に応じて高い有効率を示した．PEG-IFNα-2a 48週併合群とHLBI群の有効率の差は11.3％（95％CI：0.0-22.6）とHLBI群に対し非劣性が検証され，安全に使用できた． HBe抗原陰性例に対するHBV-DNA抑制率は，180 μg，90 μg/週48週投与でそれぞれ37.9％，37.5％であった． 以上，B型慢性肝炎に対する有効性，安全性が確認された． |
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| AbstractList | B型慢性肝炎に対するペグインターフェロンアルファ-2a（PEG-IFNα-2a）の有効性，安全性を検討した． HBe抗原陽性例はPEG-IFNα-2a 90 μg，180 μg/週の各々24週投与，48週投与又は天然型IFNα6 MIU週3回24週投与（HLBI群）の5群に無作為割付けし，投与終了後24週時のALT正常化，HBeセロコンバージョン及びHBV-DNA量抑制の複合評価で有効性を評価した． PEG-IFNα-2a群では用量，投与期間に応じて高い有効率を示した．PEG-IFNα-2a 48週併合群とHLBI群の有効率の差は11.3％（95％CI：0.0-22.6）とHLBI群に対し非劣性が検証され，安全に使用できた． HBe抗原陰性例に対するHBV-DNA抑制率は，180 μg，90 μg/週48週投与でそれぞれ37.9％，37.5％であった． 以上，B型慢性肝炎に対する有効性，安全性が確認された． |
| Author | 岡上, 武 清澤, 研道 熊田, 博光 坪内, 博仁 林, 紀夫 |
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| Copyright | 2012 一般社団法人 日本肝臓学会 |
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| References | 8) Marcellin P, Piratvisuth T, Brunetto M. On-Treatment decline in serum HBsAg levels predicts sustained immune control 1 year post-treatment and subsequent HBsAg clearance in HBeAg-negative hepatitis B virus-infected patients treated with peginterferon Alfa-2a [40KD] (PEGASYS). Hepatology INT 2010; 4 (1) : P151 3) Ha NB, Ha NB, Garcia RT, et al. Medication Nonadherence with Long-Term Management of Patients with Hepatitis B e antigen-Negative Chronic Hepatitis B. Dig Dis Sci 2011. Published online 9) Piratvisuth T, Marcellin P, Brunetto M. Sustained immune control 1 year post-treatment and is associated with a high rate of HBsAg clearance in HBeAg-negative chronic hepatitis B. Hepatology INT 2010; 4 (1): P151 10) Lampertico P, Vigano M, Bhoori S, et al. Extended (2 years) treatment with peginterferon alfa-2a [40KD] improves sustained response rates in genotype D patients with HBeAg negative chronic hepatitis B. J Hepatol 2010; 52 (Suppl. 1): S45 4) Lau GK, Piratvisuth T, Luo KX. Peginterferon Alfa-2a, lamivudine, and the combination for HBeAg-positive chronic hepatitis B. NEJM 2005; 352: 2682-2695 5) Marcellin P, Lau GK, Bonino F, et al. Peginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B. NEJM 2004; 351: 1206-1217 1) Lok AS, McMahon BJ. Chronic Hepatitis B. Hepatology 2007; 45: 507-539 6) Liaw Y-F, Jia J-D, Chan HLY, et al. Shorter duration and lower dose of peginterferon alfa-2a are associated with inferior HBeAg seroconversion rates in HBV genotypes B or C. Hepatology 2011; 54: 1591-1599 2) Moucari R, Lada O, Marcellin P. Chronic hepatitis B: back to the future with HBsAg. Expert Rev Anti Infect Ther 2009; 7: 633-666 7) Marcellin P, Bonino F, Lau GK. Sustained response of hepatitis B e antigen-negative patients 3 years after treatment with peginterferon alfa-2a. Gastroenterology 2009; 136: 2169-2179 |
| References_xml | – reference: 3) Ha NB, Ha NB, Garcia RT, et al. Medication Nonadherence with Long-Term Management of Patients with Hepatitis B e antigen-Negative Chronic Hepatitis B. Dig Dis Sci 2011. Published online – reference: 4) Lau GK, Piratvisuth T, Luo KX. Peginterferon Alfa-2a, lamivudine, and the combination for HBeAg-positive chronic hepatitis B. NEJM 2005; 352: 2682-2695 – reference: 7) Marcellin P, Bonino F, Lau GK. Sustained response of hepatitis B e antigen-negative patients 3 years after treatment with peginterferon alfa-2a. Gastroenterology 2009; 136: 2169-2179 – reference: 6) Liaw Y-F, Jia J-D, Chan HLY, et al. Shorter duration and lower dose of peginterferon alfa-2a are associated with inferior HBeAg seroconversion rates in HBV genotypes B or C. Hepatology 2011; 54: 1591-1599 – reference: 9) Piratvisuth T, Marcellin P, Brunetto M. Sustained immune control 1 year post-treatment and is associated with a high rate of HBsAg clearance in HBeAg-negative chronic hepatitis B. Hepatology INT 2010; 4 (1): P151 – reference: 1) Lok AS, McMahon BJ. Chronic Hepatitis B. Hepatology 2007; 45: 507-539 – reference: 10) Lampertico P, Vigano M, Bhoori S, et al. Extended (2 years) treatment with peginterferon alfa-2a [40KD] improves sustained response rates in genotype D patients with HBeAg negative chronic hepatitis B. J Hepatol 2010; 52 (Suppl. 1): S45 – reference: 2) Moucari R, Lada O, Marcellin P. Chronic hepatitis B: back to the future with HBsAg. Expert Rev Anti Infect Ther 2009; 7: 633-666 – reference: 5) Marcellin P, Lau GK, Bonino F, et al. Peginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B. NEJM 2004; 351: 1206-1217 – reference: 8) Marcellin P, Piratvisuth T, Brunetto M. On-Treatment decline in serum HBsAg levels predicts sustained immune control 1 year post-treatment and subsequent HBsAg clearance in HBeAg-negative hepatitis B virus-infected patients treated with peginterferon Alfa-2a [40KD] (PEGASYS). Hepatology INT 2010; 4 (1) : P151 |
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| SubjectTerms | B型慢性肝炎 HBe抗原陰性 HBe抗原陽性 ペグインターフェロン 臨床試験 |
| Title | B型慢性肝炎患者に対するペグインターフェロンα-2aの有効性及び安全性の検討 |
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