No abstract

In a prospective, multicenter, open-label study, de novo liver transplant patients were randomized at day 30±5 to (i) everolimus initiation with tacrolimus elimination (TAC Elimination) (ii) everolimus initiation with reduced-exposure tacrolimus (EVR+Reduced TAC) or (iii) standard-exposure tacrolimus (TAC Control). Randomization to TAC Elimination was terminated prematurely due to a higher rate of treated biopsy-proven acute rejection (tBPAR). EVR+Reduced TAC was noninferior to TAC Control for the primary efficacy endpoint (tBPAR, graft loss or death at 12 months posttransplantation): 6.7% versus 9.7% (−3.0%; 95% CI −8.7, 2.6%; p<0.001 for noninferiority [12% margin]). tBPAR occurred in 2.9% of EVR+Reduced TAC patients versus 7.0% of TAC Controls (p = 0.035). The change in adjusted estimated GFR from randomization to month 12 was superior with EVR+Reduced TAC versus TAC Control (difference 8.50 mL/min/1.73 m2, 97.5% CI 3.74, 13.27 mL/min/1.73 m2, p<0.001 for superiority). Drug discontinuation for adverse events occurred in 25.7% of EVR+Reduced TAC and 14.1% of TAC Controls (relative risk 1.82, 95% CI 1.25, 2.66). Relative risk of serious infections between the EVR+Reduced TAC group versus TAC Controls was 1.76 (95% CI 1.03, 3.00). Everolimus facilitates early tacrolimus minimization with comparable efficacy and superior renal function, compared to a standard tacrolimus exposure regimen 12 months after liver transplantation.

Summary The purpose of this registry study was to provide an overview of trends and results of liver transplantation (LT) in Europe from 1968 to 2016. These data on LT were collected prospectively from 169 centers from 32 countries, in the European Liver Transplant Registry (ELTR) beginning in 1968. This overview provides epidemiological data, as well as information on evolution of techniques, and outcomes in LT in Europe over more than five decades; something that cannot be obtained from only a single center experience.

Hepatitis C virus-related chronic hepatitis may be associated with various immunological disorders. The aim of this study was to determine prospectively the prevalence of the clinical, biochemical and pathological immunological abnormalities in a series of 61 consecutive patients with chronic hepatitis C, compared with those in 61 age- and sex-matched control subjects without markers of hepatitis C virus and hepatitis B virus infections and with those in 61 patients with chronic hepatitis B. The following investigations were systematically performed before any treatment: detection of serum cryoglobulinemia and rheumatoid factor, detection of a large variety of serum anti-tissue antibodies, biopsy of labial salivary glands, ophthalmological examination, dosage of thyroid-stimulating hormone and in vivo capillary microscopy. Cryoglobulinemia was found in 36% of the hepatitis C virus patients, four of whom had dermatological and/or neurological manifestations of vasculitis, and rheumatoid factor was present in 70%. Serum anti-tissue antibodies were detected in 41% of cases, mostly antinuclear and anti-smooth muscle antibodies. Liver-kidney microsomal and antithyroid antibodies were rare. Salivary gland lesions were found in 49% of the patients: all had lymphocytic capillaritis, sometimes associated with lymphocytic sialadenitis resembling that of Sjögren's syndrome, but without features of sicca syndrome and Ro/SSA antibodies. Five percent of the patients had lichen planus. The prevalences of cryoglobulinemia, rheumatoid factor and anti-tissue antibodies were significantly higher than those in the control group and patients with chronic hepatitis B.(ABSTRACT TRUNCATED AT 250 WORDS)