Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis.

BACKGROUND & AIMS: Although off-label use of sofosbuvir-containing regimens occurs regularly in patients with hepatitis C virus (HCV) infection undergoing dialysis for severe renal impairment or end-stage renal disease (ESRD), these regimens are not licensed for this indication, and there is an absence of dosing recommendations in this population. This study evaluated the safety and efficacy of sofosbuvir/velpatasvir in patients with HCV infection with ESRD undergoing dialysis. METHODS: In this phase II, single-arm study, 59 patients with genotype 1-6 HCV infection with ESRD undergoing hemodialysis or peritoneal dialysis received open-label sofosbuvir/velpatasvir (400 mg/100 mg) once daily for 12 weeks. Patients were HCV treatment naive or treatment experienced without cirrhosis or with compensated cirrhosis. Patients previously treated with any HCV NS5A inhibitor were not eligible. The primary efficacy endpoint was the proportion of patients achieving sustained virologic response (SVR) 12 weeks after discontinuation of treatment (SVR12). The primary safety endpoint was the proportion of patients who discontinued study drug due to adverse events. RESULTS: Overall, 56 of 59 patients achieved SVR12 (95%; 95% CI 86-99%). Of the 3 patients who did not achieve SVR12, 2 patients had virologic relapse determined at post-treatment Week 4 (including 1 who prematurely discontinued study treatment), and 1 patient died from suicide after achieving SVR through post-treatment Week 4. The most common adverse events were headache (17%), fatigue (14%), nausea (14%), and vomiting (14%). Serious adverse events were reported for 11 patients (19%), and all were deemed to be unrelated to sofosbuvir/velpatasvir. CONCLUSIONS: Treatment with sofosbuvir/velpatasvir for 12 weeks was safe and effective in patients with ESRD undergoing dialysis. LAY SUMMARY: Sofosbuvir/velpatasvir is a combination direct-acting antiviral that is approved for treatment of patients with hepatitis C virus (HCV) infection. Despite the lack of dosing recommendations, sofosbuvir-containing regimens (including sofosbuvir/velpatasvir) are frequently used for HCV-infected patients undergoing dialysis. This study evaluated the safety and efficacy of sofosbuvir/velpatasvir for 12 weeks in patients with HCV infection who were undergoing dialysis. Treatment with sofosbuvir/velpatasvir was safe and well tolerated, resulting in a cure rate of 95% in patients with HCV infection and end-stage renal disease. Clinical Trial Number: NCT03036852.

The accident and emergency department virtual consulting room.

The goal was to describe the development of the Virtual Consulting Room (VcR), a unique intranet-based guidance application providing direct access to local specialist knowledge, and to evaluate its usability and whether it has the potential to educate staff while working in the Accident and Emergency (A&E) department. Duty staff of the A&E Department, The Royal Free Hospital, London, participated in a prospective observational study. Two hundred and twenty consecutive patients were identified from the triage section of their casualty card as having a presenting complaint that featured in the VcR. These casualty cards were highlighted with a red sticker alert and a short questionnaire attached. Members of staff were invited to consult with the VcR after assessing each patient by clicking on an icon located on the department's computer desktops. No prior training was provided. The questionnaire was completed in 103 of 220 (46.8%) patients. The VcR was used in the management of 38 of 220 (17.3%) patients. In 21 of 38 (55.3%), users reported the VcR supported clinical decision making, in 20 of 38 (52.6%) the VcR improved knowledge and in 11 of 38 (28.9%) the VcR helped directly influence the decision to discharge the patient. In 2 of 38 (5.3%) users changed their decision to refer and in 1 of 38 (2.6%) investigations were altered. This evaluation indicates that A&E clinicians accessing the VcR found it easy to use and educational in the workplace.

Does cooling Sengstaken-Blakemore tubes aid insertion? An evidence based approach.

OBJECTIVE: To survey current clinical practice concerning the use of Sengstaken-Blakemore (SB) tubes and to determine whether cooling the tubes alters their stiffness. METHODS: A telephone questionnaire was conducted of gastroenterology registrars and ITU departments in the North Thames region. The current clinical practice for insertion of SB tubes and the basis for this practice were determined in each case. The stiffness of the tubes was measured at -10 degrees C and 20 degrees C by measuring the extension (in mm) resulting from an applied load (in newtons). The time for tube warming from -30 degrees C when in stationary air and when in contact with skin was also recorded. RESULTS: Fifty registrars were contacted and 20 ITU departments were surveyed. All ITU departments involved the gastroenterologists in the management of acute variceal bleeds. Eight registrars had never placed an SB tube. The majority of the remainder (95%) used a cooled SB tube. All of the registrars based this practice upon their clinical teaching, and 75% of these registrars thought cooling aided the insertion of the tube. There was no significant difference in the stiffness of the tubes at -10 degrees C and 20 degrees C. Upon warming, an SB tube took 30 s to rise from 0 degrees C to room temperature (20 degrees C) when in skin contact and 120 s when placed in stationary air. CONCLUSION: The current clinical practice of trainees for the insertion of SB tubes is to cool the tubes in the belief that this 'standard' practice aids tube insertion. We found no significant change in SB tube stiffness even after cooling to temperatures that would not be achieved during routine insertion. Furthermore, the rapid rise in tube temperature means that tubes approach room temperature by the time they reach the bedside. In the present era of evidence based medicine the current dogma that SB tubes should be cooled prior to insertion must be discarded.