Adherence to combination therapy enhances sustained response in genotyp-1-infected patients with chronic hepatitis C

被引:784
作者
McHutchison, JG
Manns, M
Patel, K
Poynard, T
Lindsay, KL
Trepo, C
Dienstag, J
Lee, WM
Mak, C
Garaud, JJ
Albrecht, JK
机构
[1] Duke Univ, Med Ctr, Duke Clin Res Inst, Durham, NC 27715 USA
[2] Hannover Med Sch, Div Gastroenterol & Hepatol, D-3000 Hannover, Germany
[3] Grp Hosp Pitie Salpetriere, F-75634 Paris, France
[4] Univ So Calif, Div Gastroenterol & Hepatol, Los Angeles, CA USA
[5] Hop Hotel Dieu, Serv Hepato Gastroenterol, Lyon, France
[6] Harvard Univ, Sch Med, Massachusetts Gen Hosp, Gastrointestinal Unit, Boston, MA 02115 USA
[7] Univ Texas, SW Med Ctr Dallas, Dallas, TX 75235 USA
[8] Schering Plough Res Inst, Kenilworth, NJ USA
关键词
D O I
10.1053/gast.2002.35950
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Background & Aims: Patient adherence to prescribed antiviral therapy in human immunodeficiency virus infection enhances response. We evaluated the impact of adherence to combination therapy with interferon or peginterferon plus ribavirin in chronic hepatitis C patients. Methods: We assessed the effect of dose reduction on sustained virologic response (SVR) from prior trials with interferon alpha-2b plus ribavirin (n = 1010) or peginterferon alpha-2b 1.5 mug/kg/week plus ribavirin (n = 511). The actual treatment administered was verified from drug dispensing/return records and patient diaries. Two groups were defined: (1) patients who received greater than or equal to80% of both their total interferon and ribavirin doses for greater than or equal to80% of the expected duration of therapy and (2) patients who received reduced doses (<80% of one or both drugs for greater than or equal to80% of the expected duration of therapy). A statistical model provided comparative estimates of the response rates in compliant patients. Results: Most patients were at least 80% compliant with interferon alpha-2b/ribavirin or peginterferon alpha-2b/ribavirin therapy and had SVR rates of 52% and 63%, respectively, for the 2 regimens. This was most apparent for HCV-1-infected patients. The impacts of adherence on efficacy from subgroup analysis and the statistical modeling approach were similar. Conclusions: HCV-1-infected patients who can be maintained on >80% of their interferon or peginterferon alpha-2b and ribavirin dosage for the duration of treatment in the setting of a clinical trial exhibit enhanced sustained response rates. Our results suggest that adherence will enhance the likelihood of achieving an initial virologic response. Adherence beyond 12-24 weeks will be advantageous only for those patients who have achieved such an early virologic response.
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页码:1061 / 1069
页数:9
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