HCV often infects patients with chronic renal failure (CRF) on hemodialysis (HD) and significantly affects the prognosis of these patients. Recently, HCV treatment has been revolutionized by the new generation of direct-acting antivirals (DAAs) which offers short, IFN-free, highly efficacious, well-tolerated curative therapies, but data are limited on the efficacy of these therapies for HCV infection in patients with CRF on HD. Aim: We examined the efficacy and safety of Ombitasvir (OBV), Paritaprevir (PTV), Ritonavir combination therapy in 9 patients with CRF on HD and chronic HCV infection. Patients and Methods: Nine patients with CRF on HD and untreated HCV genotype 1 infection were treated with OBV/PTV/r combination therapy for 12 weeks. Results: All 9 cases completed the 12 weeks therapy and serum HCV-RNA became negative after 4 weeks of the therapy and continued to be negative even 12 weeks after the therapy in all cases (SVR12, 100%). Serum ALT values were normalized in all cases. Calcium channel blockers (CCB), which had been taken by 5 cases, were required to change to other anti-hypertensive drugs considering that CCB causes hypotension due to drug-drug interactions with ritonavir, but all adverse events were mild or moderate in this study.
ABSTRACT Aim: GEM plus CDDP has been established as standard first-line chemotherapy based on the results of the phase III study (ABC-02) in ABTC. An oral FU derivative, S-1 showed a similar activity to GEM in a phase II study and is mainly used in GEM-refractory pts in Japan. To develop a triplet regimen, GEM + CDDP + S-1 (GPS), we assessed its safety in this phase I study. Methods: The main eligibility criteria were; histologically or cytologically confirmed ABTC, ECOG Performance Status (PS) 0-2, no prior chemotherapy, and written informed consent. Dose limiting toxicities (DLT) were evaluated in following 2 dose levels; GEM (1000 mg/m2 at level 1 and 1200 mg/m2 at level 2 on day 1) + CDDP (fixed dose of 30 mg/m2 on day 1) + S-1 (fixed dose of 40—60 mg/day bid for 7 days), repeated every 2 weeks until progression. The relative dose intensity of GEM and CDDP at level 2 corresponded to 90% of standard GEM plus CDDP regimen. In each level, 6-10 pts were enrolled and assessed. DLTs were evaluated during the first 2 cycles. Results: Between Oct 2011 and Oct 2013, 18 pts were enrolled and 16 pts were evaluated (median age: 71 years, ECOG PS 0/1: 10/6, intrahepatic/extrahepatic/gallbladder: 7/3/6). DLTs (grade 3 nausea to stop S-1 in cycle 1 and treatment delay due to grade 3 neutropenia in cycle 2) at level 1 were observed in 2 of the first 6 pts. Additional 4 pts enrolled at this dose level experienced no DLTs. A DLT (G3 anorexia) at level 2 was observed in 1 of 6 pts. Grade 3 or 4 treatment-related adverse events within the first 2 cycles were leukocytopenia (38%), neutropenia (50%), thrombocytopenia (0.6%), nausea (0.6%), and anorexia (0.6%). Of 14 pts with measurable lesions, 7 (50%) pts had partial response and 6 (43%) patients had stable disease. Median progression free survival was 9.2 months (95%CI 6.8-11.6, event in 63%) and overall survival did not reach the median value (event in 38%). Conclusions: GPS of dose level 2 (GEM 1200 mg/m2 and 30 mg/m2 on day 1 plus S-1 for 1-7 days, given bi-weekly) was well tolerated, and showed preliminary anti-tumor activity. Further study is warranted. Clinical trial information: UMI06123. Disclosure: T. Moriwaki: Research funding for other study and honoraria from Taiho Pharmaceutical; I. Hyodo: Research funding for other study from Taiho Pharmaceutical and Lilly. Honoraria from Taiho Pharmaceutical. All other authors have declared no conflicts of interest.
A 68-year-old man was admitted because of an infected pancreatic pseudocyst after alcoholic pancreatitis. Computed tomography revealed multiple pancreatic duct stones and multilocular pancreatic pseudocysts in his pancreatic tail. We performed endoscopic ultrasonography-guided transmural drainage of the pancreatic pseudocyst adjacent to the fundus of the stomach. It was effective for the punctured cyst, but not for the distant cysts. Therefore, we additionally performed transcutaneous drainage. Although the size of the cysts decreased, the drainage tube could not be removed because of continuous drainage of pancreatic juice. Then, we performed trans-papillary drainage by using a pancreatic duct stent. After that, the amount of pancreatic juice drained from the transcutaneous tube decreased and was successfully removed. Combined drainage from various routes is effective for treating multilocular pancreatic pseudocysts, not only when the cysts do not communicate with each other but also when they communicate with an obstructed pancreatic duct.
