Over a 6-month period, treatment with rifaximin maintained remission from hepatic encephalopathy more effectively than did placebo. Rifaximin treatment also significantly reduced the risk of hospitalization involving hepatic encephalopathy. (ClinicalTrials.gov number, NCT00298038.)

Background & Aims The drug-induced liver injury network (DILIN) is conducting a prospective study of patients with DILI in the United States. We present characteristics and subgroup analyses from the first 1257 patients enrolled in the study. Methods In an observational longitudinal study, we began collecting data on eligible individuals with suspected DILI in 2004, following them for 6 months or longer. Subjects were evaluated systematically for other etiologies, causes, and severity of DILI. Results Among 1257 enrolled subjects with suspected DILI, the causality was assessed in 1091 patients, and 899 were considered to have definite, highly likely, or probable DILI. Ten percent of patients died or underwent liver transplantation and 17% had chronic liver injury. In the 89 patients (10%) with pre-existing liver disease, DILI appeared to be more severe than in those without (difference not statistically significant; P=.09) and mortality was significantly higher (16% vs 5.2%; P<.001). Azithromycin was the implicated agent in a higher proportion of patients with pre-existing liver disease compared to those without liver disease (6.7% vs. 1.5%, p=0.006). Forty-one cases with latency ≤ 7 days were caused predominantly by antimicrobial agents (71%). Two most common causes for 60 DILI cases with latency >365 days were nitrofurantoin (25%) or minocycline (17%). There were no differences in outcomes of patients with short vs long latency of DILI. Compared to individuals younger than 65 y, individuals 65 y or older (n=149) were more likely to have cholestatic injury, although mortality and rate of liver transplantation did not differ. Nine patients (1%) had concomitant severe skin reactions; implicated agents were lamotrigine, azithromycin, carbamazepine, moxifloxacin, cephalexin, diclofenac, and nitrofurantoin. Four of these patients died. Conclusion Mortality from DILI is significantly higher in individuals with pre-existing liver disease or concomitant severe skin reactions compared to patients without. Further studies are needed to confirm the association between azithromycin and increased DILI in patients with chronic liver disease. Older age and short or long latencies are not associated with DILI mortality.

Historically, clinical trials of regimens to treat chronic infection with hepatitis C virus (HCV) have used, as their primary efficacy endpoint, a sustained virological response (SVR)-defined as HCV RNA levels below a designated threshold of quantification-24 weeks after the end of treatment (SVR24). More recently, regulatory authorities have begun to accept SVR at 12 weeks post-treatment (SVR12) as a valid efficacy endpoint because of its high rate of concordance with SVR24. However, the concordance between SVR12 and SVR24 has not been systematically assessed with new regimens of recently approved directacting antiviral agents. The aim of this study was to assess the concordance between SVR at various post-treatment time points in phase III clinical trials of sofosbuvir (SOF)-containing regimens. We conducted a retrospective analysis of five trials enrolling 863 patients infected with HCV genotypes 1-6. The concordance between SVR at 4 weeks post-treatment (SVR4) and SVR12, and between SVR12 and SVR24, were determined, as well as positive predictive values (PPVs) and negative predictive values (NPVs). Overall, 779 of 796 patients (98.0%) with an SVR4 also achieved an SVR12, making the PPV of SVR4 for SVR12 98% and the NPV 100%. Of the 779 patients with an SVR12, 777 (99.7%) also achieved an SVR24, making the PPV of SVR12 for SVR24 >99% and the NPV 100%. Of patients who relapsed posttherapy, 77.6% did so within 4 weeks of completing therapy. Conclusion: Data from phase III studies demonstrate that with SOF-based regimens, with or without interferon, SVR12 and SVR24 correlate closely. Thus, SVR12 can be used effectively to determine "cure" rates in trials and in clinical practice. (HEPATOLOGY 2015;61:41-45)

The aim if this study is to determine donor morbidity associated with right lobectomy for living donor liver transplantation (LDLT) to adult recipients through a systematic review of the published literature. Data sources were English-language reports on donor outcome after LDLT. MEDLINE (1995 to June 2001) was searched using the MeSH terms "living donors" and "liver transplantation." Limits were set for human only and English language only. Bibliographies of retrieved references were cross-checked to identify additional reports; 211 reports were obtained. Population studies and consecutive and nonconsecutive series were included. All studies reported at least one of the following outcomes specific to living donors (LDs) of right hepatic lobes to adult recipients: surgical and hospital complications, length of hospital stay, readmissions, recovery time, return to predonation occupation, health-related quality of life, or mortality. Abstracts of relevant articles were reviewed independently using predetermined criteria, and appropriate articles were retrieved. Study design and results were summarized in evidence tables. Summary statistics of combined data were performed when possible. Twelve studies met the inclusion criteria. Data on donor morbidity associated with right lobectomy are limited. On the basis of reported data, morbidity associated with LD right lobectomy ranges from 0% to 67%. In conclusion, reported morbidity associated with right lobe donation for LDLT varies widely. Standardized definitions of morbidity and better methods for observing and measuring outcomes are necessary to understand and potentially improve morbidity. It is important that LDs receive accurate and unbiased information on the risks of donor surgery. 7 Additionally, to improve outcomes, problems that donors experience must be understood. To this end, a growing body of literature documents the morbidity and mortality associated with right-lobe donation surgery. A meaningful aggregate of this collective experience with right-lobe LDLT will allow the opportunity to provide better information to potential donors, as well as identify any shortcomings in the published literature. Therefore, the goal of this study is to determine morbidity associated with right-lobe donation surgery for LDLT to adult recipients through a systematic review of the published literature. Materials and Methods Criteria for Selecting Studies for ReviewWe performed a systematic review of published data according to a predefined protocol. Eligibility was restricted to studies published in English of LDs undergoing right lobectomy for donation to recipients 18 years and older. No restrictions were placed on the design of included studies. Population studies and consecutive and nonconsecutive series were included. We excluded studies not published as full reports, with the exception of a single article from the authors' institution that was in press at the time of data collection. 8 OutcomesRisks of donation surgery were assessed by examination of reported postop...

Despite the increasing use of living donor liver transplantation, little is known about donor needs, concerns, and experiences. The goal of this study is to assess morbidity associated with living donation from a donor perspective, functional status after donation, and overall satisfaction with the donation process. We surveyed all living donors (LDs) from our center. Demographics, perioperative experience, and satisfaction with donation were assessed. The Medical Outcomes Study 12-Item Short-Form Survey (SF-12), a well-validated tool, measured overall health-related quality of life. Of 27 subjects eligible for the study, 27 subjects (100%) participated. Forty percent reported an event they deemed an immediate complication, of which 60% were recorded in the medical record. Complications requiring readmission were reported by 22%.