Between 50% and 86% of patients with autoimmune hepatitis (AIH) relapse after immunosuppression withdrawal; long‐term immunosuppression is associated with increased risk of neoplasias and infections. Chloroquine diphosphate (CQ) is an immunomodulatory drug that reduces the risk of flares in rheumatologic diseases. Our aims were to investigate the efficacy and safety of CQ for maintenance of biochemical remission of AIH in a double‐blind randomized trial and to define a subgroup that obtained a greater benefit from its use. A total of 61 patients with AIH in histologic remission (90.1% AIH type 1 [AIH‐1]) were randomized to receive CQ 250 mg/day or placebo for 36 months. Of the 61 patients, 31 received CQ and 30 placebo. At baseline, clinical, laboratory, histologic findings, and human leukocyte antigen (HLA) profile were similar between the two groups. Relapse‐free survival was significantly higher in the CQ group compared to the placebo group (59.3% and 19.9%, respectively P = 0.039). For those patients completing 3‐year treatment, relapse rates were 41.6% and 0% after CQ and placebo withdrawal, respectively. Factors associated with a higher risk of relapse in multiple Cox regression were placebo use (hazard ratio, 2.4; 95% confidence interval [CI], 1.055.5; P = 0.039) and anti‐soluble liver antigen/liver‐pancreas (anti‐SLA/LP) seropositivity (hazard ratio, 5.4; 95% CI, 1.91‐15.3; P = 0.002). Although it was not possible to define a subgroup that obtained a greater benefit from CQ according to anti‐SLA/LP reactivity or HLA profile, 100% of patients who were anti‐SLA/LP‐positive (+) relapsed with placebo compared to 50% with CQ (P = 0.055). In the CQ group, 54.8% had side effects and 19.3% interrupted the drug regimen. Conclusion: CQ safely reduced the risk of relapse of AIH, but it was not possible to define a subgroup that obtained a greater benefit with CQ use, probably because of sample size.

Background and Aim Standard treatment for autoimmune hepatitis (AIH) consists of predniso(lo)ne and azathioprine. However, alternative therapy is required for non‐ or partial responders and in cases of side effects. The aim of this study was to evaluate the treatment outcomes associated with chloroquine plus prednisone in AIH patients. Methods Fifty‐seven patients were recruited to receive either azathioprine or chloroquine, both with prednisone, in a randomized trial. The primary end‐point was complete remission, based on normalization of aminotransferase levels in the first 6 months of treatment plus maintenance for at least 18 months, with minimal or no inflammatory activity in the liver biopsy. Secondary end‐points were partial and nonresponse, severe side effects, and treatment withdrawal. Results There were no differences between groups regarding clinical, serological, histological, and treatment characteristics at baseline. There were no significant differences in the biochemical response rate (67.7 vs 53.8%, P = 0.41) or the complete remission rate (32.26 vs 15.38%, P = 0.217). However, despite the long study period, the sample size was smaller than that required for a noninferiority study. The mean prednisone dose was similar in both groups. There was a nonsignificantly higher rate of adverse effects and a tendency toward improvement in glycemic and cholesterol profiles in the chloroquine group (P = 0.09 and P = 0.07, respectively). Conclusions The combination of chloroquine and prednisone exhibited potentially beneficial effects in AIH patients (https://ClinicalTrials.gov: NCT02463331).

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Background: The treatment of autoimmune hepatitis (AIH) with prednisone and azathioprine provides disease remission. However, a complete biochemical and histological response is unreachable in most patients. Chloroquine is an antimalarial drug used for treating rheumatological diseases. It was studied as a single drug for the maintenance of AIH remission in an open study, which suggested a lower risk of relapse in the chloroquine group. Aims: To evaluate a possible role of chloroquine and prednisone for AIH treatment in a randomized study. Methods: 57 AIH adult patients with indication of treatment were enrolled to receive azathioprine or chloroquine, both with varying doses of prednisone, from 2003 to 2012. For those who had maintained biochemical remission for 18 months, liver biopsy was performed to evaluate histological remission. The primary outcome was the achievement of complete response to treatment. A p-value < 0.05 was considered statistically significant. Results: There were no significant differences between the groups concerning clinical, serological, histological, and treatment features at baseline. The average age was 37.2 ± 16.84 years, 43.8% with advanced fibrosis (F3/4) at baseline. There was no statistical differences in biochemical (67.7% vs. 53.8%, p=0.41) or histological response rate (32.26% vs. 15.38%, p = 0.217), as well as in the mean prednisone dose. There was a higher rate of adverse effects in the chloroquine group, but a lower frequency of comorbidities in this group. Conclusion: When well tolerated, chloroquine with prednisone provided a complete therapeutic response in AIH patients with no statistical difference when compared to the standard treatment. (ClinicalTrials.gov NCT 02463331).

Schistosomiasis is a major health problem that affects over 200 million people worldwide. There are few reports of Schistosoma mansoni found in liver transplants as well as scarce information about the course of the disease and the long-term effects on the graft. Herein, we report two cases of schistosomiasis in liver transplant recipients who presented abnormal serum liver enzymes, with evidence of gradual improvement after antiparasitic treatment. Furthermore, we discuss the possible role of screening the parasite infection in potential liver transplant recipients from endemic areas.

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