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

BACKGROUND: 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.

[Severe tubulo-interstitial nephritis secondary to 5-ASA]. / Nefropatía tubulointersticial grave secundaria a 5-ASA.

We report a new case of chronic interstitial nephritis in a patient with ulcerative colitis diagnosed in 2002 who was originally treated with 5-ASA. Three years later deterioration of renal function was apparent with an increase in serum creatinine, which was normal before treatment. Withdrawal of 5-ASA led to partial improvement of renal function. In patients with a delayed diagnosis of kidney damage, recovery of renal function is incomplete and, in some cases, the patient even requires some form of renal replacement therapy. We stress the importance of monitoring renal function in patients diagnosed with inflammatory bowel disease treated with this drug.

[Ileal perforation secondary to intestinal endometriosis]. / Perforación ileal secundaria a endometriosis.

Endometriosis is defined as the presence of endometrial tissue outside the uterus. The bowel is not often affected. There are no specific clinical findings for intestinal endometriosis. It is typically asymptomatic, but sometimes can present with abdominal pain, diarrhoea, constipation or intestinal obstruction. Ileal perforation is a rare complication of intestinal endometriosis and only a few cases have been reported in the literature. Intestinal endometriosis can mimic many gastrointestinal diseases, such as irritable bowel syndrome, inflammatory bowel disease, infections and neoplasms. The diagnosis is made by laparoscopy or laparotomy. We present a case of a woman with intermittent abdominal pain and ileal perforation secondary to intestinal endometriosis.