Predictive variables of sustained virological response after early discontinuation of triple therapy with telaprevir for genotype-1 HCV infection

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• 作者：Doroteo Acero Ferná ; ndez^a ; ^{doroteoacero@yahoo.es" class="auth_mail" title="E-mail the corresponding author} ; Rosa Morillas Cunill^b ; Marí ; a José ; Ferri Iglesias^a ; Xavier Torras Collell^c ; Mercedes Vergara Gó ; mez^d ; Natividad Zaragoza Velasco^e ; Carmen Ló ; pez Nuñ ; ez^a ; Montserrat Forné ; Bardera^f ; Mercedes Delgado Gó ; mez^g ; Mercè ; Barenys Lacha^h ; Miquel Torres Salinasⁱ ; Margarita Villar Ferná ; ndez^j ; Rosa Durá ; ndez Lá ; zaro^k ; Zoe Mariñ ; o Mendez^l
• 关键词：BOV ; boceprevir ; TLV ; telaprevir ; PI ; protease inhibitor ; RVR ; rapid virological response ; eRVR ; extended virological response ; P ; pegylated-interferon ; R ; ribavirin ; PR ; pegylated-inteferon plus ribavirin ; SAE ; severe adverse effect ; ROC ; receiver operating characteristics
• 刊名：Gastroenterología y Hepatología
• 出版年：2016
• 出版时间：June-July 2016
• 年：2016
• 卷：39
• 期：6
• 页码：377-384
• 全文大小：541 K

文摘

Pivotal phase studies of telaprevir (TLV) and boceprevir (BOV) showed 10–56% rates of early treatment interruption. However, there have been no reports on the sustained virological response (SVR) rates of these patients.

Aim

To assess the SVR rate in a large cohort of patients who discontinued triple therapy with TLV or BOV for reasons other than stopping rules and to identify variables predicting SVR.

Material and method

A survey was sent to 15 hospitals in Catalonia asking them to report all TLV/BOV treatments finished by 31 May 2014. Demographic, clinical, laboratory, liver fibrosis and therapeutic data were recorded for treatments with early discontinuation. Logistic regression analysis, ROC curves and prognostic assessment of the variables identified were calculated.

Results

Twelve hospitals responded to the survey, representing 467 treatments and 121 (21.2%) early discontinuations, 76 (62.8%) due to stopping rules and 45 (37.2%) for other reasons. Early discontinuation was more frequent with BOV [38.2% (50/131) versus 21.1% (71/336) p < 0.005], mainly due to stopping rules [78% (39/50) versus 52.1% (37/71); p = 0.004]. SVR was achieved in 21/121 patients (17.4%), 19/71 (26.8%) treated with TLV and 2/50 (4.0%) treated with BOV. In patients discontinuing treatment for reasons other than stopping rules, SVR was achieved in 19/37 (55.9%) treated with TLV and in 2/11 (18.2%) treated with BOV. The SVR rate in patients treated with TLV who discontinued due to a severe adverse event was 61.5% (16/26). A logistic regression analysis was performed only with triple therapy with TLV and early discontinuation. The predictive variables of SVR were undetectable HCV-RNA at treatment week 4 and treatment length longer than 11 weeks. Treatment duration longer than 11 weeks showed the best accuracy (0.794), with a positive predictive value of 0.928.

Conclusions

Early discontinuation of TLV-based triple therapy due to reasons other than stopping rules still have a significant SVR rate (55.9%). Undetectable HVC-RNA at week 4 of treatment and treatment duration longer than 11 weeks are predictive of SVR in this subset of patients.