Sofosbuvir plus ribavirin in treatment-naïve patients with chronic hepatitis C virus genotype 1 or 3 infection in India.

Until 2014, pegylated interferon plus ribavirin was the recommended standard of care for the treatment of chronic hepatitis C virus (HCV) infection in India. This open-label phase 3b study, conducted across 14 sites in India between 31 March 2014 and 30 November 2015, evaluated the efficacy and safety of sofosbuvir plus ribavirin therapy among treatment-naïve patients with chronic genotype 1 or 3 HCV infection. A total of 117 patients with genotype 1 or 3 HCV infection were randomized 1:1 to receive sofosbuvir 400 mg and weight-based ribavirin (1000 or 1200 mg) daily for 16 or 24 weeks. Among those with genotype 1 infection, the primary efficacy endpoint of sustained virologic response at 12 weeks post-treatment (SVR12) was reported in 90% (95% confidence intervals [CI], 73-98) and 96% (95% CI, 82-100) of patients following 16 and 24 weeks of treatment, respectively. For patients with genotype 3 infection, SVR12 rates were 100% (95% CI, 88-100) and 93% (95% CI, 78-99) after 16 and 24 weeks of therapy, respectively. Adverse events, most of which were mild or moderate in severity, occurred in 69% and 57% of patients receiving 16 and 24 weeks of treatment, respectively. The most common treatment-emergent adverse events were asthenia, headache and cough. Only one patient in the 24-week group discontinued treatment with sofosbuvir during this study. Overall, sofosbuvir plus ribavirin therapy achieved SVR12 rates ≥90% and was well tolerated among treatment-naïve patients with chronic genotype 1 or 3 HCV infection in India.

Bipolar vessel sealing system versus silk ligation of lymphatic vessels in renal transplant recipient lymphatic complications: a randomized controlled trial.

PURPOSE: This study was aimed to compare lymphatic complications of bipolar vessel sealing system with silk ligation of lymphatic vessels among renal transplant recipients. METHODS: This was a prospective randomized controlled trial done among 68 patients undergoing renal transplantation in Tribhuvan University Teaching Hospital. They were randomly assigned to either silk ligation or Enseal bipolar vessel sealing lymphatic dissection. Postoperative drain volume and duration of drain placement were measured in all patients. Ultrasound was used to find lymphocele formation in six and 12 weeks. RESULTS: Total of 30 patients in silk ligation group and 28 patients in bipolar vessel sealing group were analyzed. The baseline characteristics of the patients in each group were similar. Overall, lymphatic complications (either lymphorrhea or lymphocele formation) were in 16 cases (27.58%), 7 (25%) in the bipolar group, and 9 (30%) in the silk ligation group (p = 0.67). A total of 13 patients (22.41%) had lymphorrhea, 6 (21.4%) patients in the bipolar group, and 7 (23.3%) patients in the silk ligation group. Median drain volume was 415 ml (Q1 275 ml, Q3 675 ml) in the bipolar group and 542 ml (Q1 290, Q3 775) in silk group (p = 0.72). Median drain removal day was 5 in each bipolar and silk group with Q1 and Q3 being 5 days in each arm (p = 0.95). A total of five patients (8.62%) developed symptomatic lymphocele, two (7.1%) in the bipolar group, and three (10%) in the silk ligation group, but the difference was not statistically significant. In univariate analysis, double renal arteries in the donor's kidney (p = 0.03) and graft rejection (p = 0.04) were risk factors for the development of lymphatic complications. However, in multivariable analysis, these factors were not statistically significant. CONCLUSIONS: This study did not find any significant differences in lymphatic complications between bipolar vessel sealing system and silk ligation. However, large sample multi-centric studies should be done to add evidences on lymphatic complications differences between these two techniques. TRIAL REGISTRATION NUMBER: UMIN000039354, Date of registration-2020, Feb 01.

Renal transplantation in Nepal: the first year's experience.

A successful renal transplantation service was started in Nepal at the Tribhuvan University Teaching Hospital in August 2008, and a continuing regular service is being provided currently to needy people. We report here our experience in thirty five end stage renal disease patients who received kidneys from close relatives during a one year period. The mean age of donors was 46.7 years. Seventeen (49%) donations were from parents, 13 (37%) from spouses, four (11%) between siblings and one (3%) between mother and daughter in law. Although the left kidney was given preference, right sided donor nephrectomy was needed in five (14%) cases. Six (17%) donors had minor postoperative problems. The mean age of recipients was 33.2 years, four (11%) of whom had pre-emptive renal transplantation. Recipients were immunosuppressed with dacluzimab, prednisolone, mycophenalate, and cyclosporine or tacrolimus. The average time taken for graft implantation was 137 minutes. The mean cold ischemia time and second warm ischemia time were 133 and 36 minutes respectively. Four (11%) patients developed urinary tract infection, three (9%) had significant hematuria, one (3%) developed a peri-transplant abscess, and one (3%) had ureteric ischemia and urine leak which required re-exploration in the early post-operative period. Four patients (11%) developed acute rejection of which three were cell-mediated rejection and one was antibody-mediated. There were two (6%) deaths, one due to transplant-related sepsis and the other due to subarachnoid hemorrhage following rupture of a posterior communicating artery aneurysm. No kidney has been lost otherwise.