Disease burden of primary biliary cholangitis and associated pruritus based on a cross-sectional US claims analysis.

OBJECTIVE: In order to identify areas of unmet need in patients with primary biliary cholangitis (PBC), this study sought to use real-world observational healthcare data to characterise the burden in patients with PBC and in PBC patients with a recorded diagnosis of pruritus. DESIGN: This retrospective, cross-sectional database study compared prevalence of prespecified comorbidities and medications in the PBC population and PBC-pruritus subpopulation with non-cases using an indirect standardisation approach. The PBC population was identified from the US IBM MarketScan Commercial Claims and Medicare Supplemental Database during 2016 using International Classification of Diseases 10th Revision, Clinical Modification codes (≥2 claims for PBC); the PBC-pruritus subpopulation additionally had ≥1 claim for pruritus during this period. Non-cases had no claims for PBC. Indirect age-sex standardised prevalence ratios (iSPR) and 95% confidence intervals (CIs) were calculated for prespecified comorbidities and medications recorded during 2017. RESULTS: The PBC population (N=1963) and PBC-pruritus subpopulation (N=139) had significantly higher prevalence of fatigue (19.9%, iSPR (95% CI): 1.51 (1.36 to 1.66); 26.6%, 2.10 (1.48 to 2.90)), depression/anxiety (21.3%, 1.09 (0.99 to 1.20); 28.1%, 1.46 (1.04 to 2.00)) and sleep-related issues (6.9%, 1.18 (0.99 to 1.40); 14.4%, 2.58 (1.58 to 3.99)) compared with non-cases. Bile acid sequestrants were prescribed in 5.8% and 18.0% of the PBC and PBC-pruritus populations, respectively. In general, a higher prevalence of comorbidities and medication use was observed in the PBC-pruritus subpopulation compared with the PBC population and non-cases. CONCLUSION: Despite availability of treatments for PBC, the PBC population had a higher burden of comorbidities than non-cases. This burden was even greater among the PBC-pruritus subpopulation, with a particularly high prevalence of sleep disorders and depression/anxiety. Despite this, pruritus remains undertreated highlighting a need for treatments specifically indicated for cholestatic pruritus.

Systemic treatment for advanced hepatocellular carcinoma: the search of new agents to join sorafenib in the effective therapeutic armamentarium.

INTRODUCTION: Hepatocelullar carcinoma (HCC) is the third leading cause of cancer-related death worldwide. Despite the implementation of screening programs for high-risk individuals, a significant proportion of patients present with advanced disease at the moment of diagnosis. AREAS COVERED: In this review we will focus in the current treatment of advanced HCC, the research that has been done in the past few years, the achievements and failures in this setting and future perspectives. EXPERT OPINION: Sorafenib was the first drug that has shown to increase survival in patients with advanced hepatocelullar carcinoma with an adequate safety profile. Recently, regorafenib was reported to improve survival in a second line randomised placebo controlled phase 3 clinical trial, which represents a major breakthrough in this field after many disappointing results coming from several clinical trials. However, still there is an unmet need for an effective and tolerable treatment for patients who progressed and/or have intolerance to sorafenib. The ultimate goal of the research is to provide drugs that improve survival with acceptable adverse events. Understanding of mechanisms of hepatocarcinogesis, individualizing therapy according to the profile of the population and finding reliable surrogate end-points for survival for early phase trials with new agents should improve the likelihood of achieving these objectives.

Impact of human immunodeficiency virus infection in patients infected with the hepatitis C virus.

BACKGROUND/AIMS: The objective of the present study is to evaluate the impact of human immunodeficiency virus (HIV) in patients with hepatitis C virus (HCV) infection. METHODS: Three different groups of patients were considered: group 1, 385 HCV/HIV coinfected; group 2, 198 HIV monoinfected; and group 3, 311 HCV monoinfected. Demographic and epidemiological data were collected. Blood tests included anti-HCV, HCV-RNA test, genotyping, CD4 cell count, anti-HIV, and HIV viral load. Treatment with interferon and ribavirin was proposed. The fibrosis progression rate was assessed. RESULTS: The most prevalent risk factor in the group of coinfected was the use of intravenous drugs; in the HIV monoinfection group, heterosexual relations at risk; in the HCV monoinfection group, the transfusion of blood. There was no difference concerning the distribution of genotypes or HCV viral load between groups 1 and 3. Although the mean time of duration of HCV infection was greater in group 3 than in group 1, there was no difference when the fibrosis progression rate was evaluated. The response to treatment was similar. CONCLUSION: In the present series there was no relevant impact of HCV infection in patients with HIV.