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People with type 2 diabetes often have undiagnosed advanced fibrosis and cirrhosis, a new study suggests (1).
Researchers at Pontificia Universidad Católica de Chile, Santiago, studied 145 type 2 patients (median age 60, mean BMI 29.6 kg/m2 and mean diabetes duration 7.6 years).
There was a high rate of liver steatosis (63.9%), advanced fibrosis assessed by NAFLD fibrosis score (12.8%) and evidence of liver cirrhosis assessed by MRI (6.0%). In a multivariate analysis GGT > 82 IU/L and no alcohol intake were independently associated to advanced fibrosis.
A literature review suggested that metformin may improve the survival of diabetic patients with liver cancer (2).
The reviewers, from Central South University, Changsha, China, found 11 studies involving 3,452 liver cancer patients. Metformin use was associated with better survival (hazard ratio 0.59) of liver cancer patients, and the beneficial effect persisted (hazard ratio 0.64) when the population was restricted to diabetic liver cancer patients. Adjusting for age, etiology, index of tumour severity and treatment of liver cancer, the association between metformin use and better survival of liver cancer patients was stable. Pooled hazard ratios ranged from 0.47 to 0.57.
The reviewers warned that the results should be interpreted with caution because of possible residual confounding.
1. High prevalence of undiagnosed liver cirrhosis and advanced fibrosis in type 2 diabetic patients. Arab JP, Barrera F, Gallego C et al. Ann Hepatol. 2016 Sep-Oct;15(5):721-8
2. Metformin use improves survival of diabetic liver cancer patients: systematic review and meta-analysis. Ma SJ, Zheng YX, Zhou PC et al. Oncotarget. 2016 Aug 2 [Epub ahead of print]
Many patients with liver disease use complementary and alternative medicines (CAMs) despite some being potentially hepatotoxic, often don’t tell their healthcare providers.
These were the findings of researchers at Duke University School of Medicine who analysed data from the 2012 [US] National Health Interview Survey. Of 647 adults with liver disease, 41% reported using CAMs in the prior year, compared with 33% of adults without liver disease. The most common modality was herbs and supplements (23%), and 3% of respondents reported consumption of a potentially hepatotoxic substance in the previous 30 days. Only a small proportion of CAM therapies were used specifically for liver disease, with milk thistle being the most common. Among respondents with liver disease, CAMs were used more commonly for anxiety or depression, fatigue, and substance use. The majority believed that these therapies improved health. Nearly one-third of therapies were not reported to healthcare providers, mostly because they don’t ask.
Complementary and alternative medicine use in United States adults with liver disease. Henson JB, Brown CL, Chow SC et al. J Clin Gastroenterol. 2016 Jul 29. [Epub ahead of print]
A new study has identified the risk factors for, and clinical characteristics of, depressive states induced by pegylated interferon (PegIFN) therapies for HCV
In this Japanese multicentre study, 69 people with HCV who received PegIFN therapy were evaluated before treatment, using the Neuroticism-Extraversion-Openness Five-Factor Inventory and the List of Threatening Events Questionnaire. The Beck Depression Inventory (BDI) was also evaluated at baseline, two to four weeks after initiating therapy, and every four weeks thereafter.
During the study, 18 of the 69 patients developed a depressive state (BDI ≥ 10). A bimodal peak of onset was seen during early (two to eight weeks) and late (after 20 weeks) therapy phases. Moreover, baseline BDI scores (odds ratio 1.40) and neuroticism (odds ratio 1.14) were significant risk factors for developing a depressive state.
To determine the specific characteristics of this condition, the study researchers compared the BDI subscales between the "PegIFN-induced" and "general" depressive state reported previously. They found that the score at "somatic symptoms" were higher in the "PegIFN-induced" group.
The reviewers concluded PegIFN-induced depressive states most frequently developed during the first eight weeks of therapy, and that baseline BDI and neuroticism scores are risk factors for PegIFN-induced depressive state. The core symptoms of PegIFN-induced depressive state are different from those of "general" depression, they added.
Risk factors and clinical characteristics of the depressive state induced by pegylated interferon therapy in patients with hepatitis C virus infection: a prospective study. Kawase K, Kondo K, Saito T et al. Psychiatry Clin Neurosci. 2016 Jul 29 [Epub ahead of print]
In the era of direct-acting antivirals (DAAs), ribavirin continues to provide clinical benefit for defined groups of patients with HCV, a review has concluded.
Over the past two decades, ribavirin has been an integral component of HCV treatment, where it has been shown to improve the efficacy of pegylated interferon. However, write an international group of reviewers, because of to its treatment-limiting side effects and additive toxicity with interferon, the search for interferon- and ribavirin-free regimens has been underway.
The recent approvals of all-oral DAAs have revolutionised the HCV therapeutic landscape, and initially it was expected that the role of ribavirin with DAA regimens would be eliminated.
Yet reviewers say we have witnessed ribavirin retaining an important role in the optimal treatment of some subgroups, particularly those that historically have been considered the most difficult to cure.
Fortunately, it has also been recognized that the safety profile , of ribavirin is improved when co-administered with all-oral DAA combinations in the absence of interferon.
The reviewers summarise that, despite the antiviral mechanism of action of ribavirin being poorly understood, we now have a range of novel insights into the potential role of ribavirin in all-oral DAA HCV treatment.
Ribavirin revisited in the era of direct-acting antiviral therapy for hepatitis C virus infection. Feld JJ, Jacobson IM, Sulkowski MS et al. Liver Int. 2016 Jul 30 [Epub ahead of print]
People receiving liver transplants (LTs) seem to have a considerably increased risk of cerebrovascular events (CBVEs), a new study concluded.
A new score (PROCAM-Stroke) estimates the 10-year risk of cerebrovascular events (CBVE) in a German standard population. Researchers, from Berlin’s Virchow Klinikum and Aachen’s University Hospital, retrospectively studied 313 LT patients. Six months after LT (T1) and 10 years after LT (T2) CBVE risk factors were recorded and PROCAM-stroke was calculated. Ten (T2) and 20 years (T3) after LT, the recipients were screened regarding CBVE. PROCAM-stroke estimates of CBVE were compared with the incidence of observed CBVE.
In both ten-year time frames the incidence of observed CBVE was higher than expected based on the PROCAM-stroke estimates: Six months - 10 years after LT (T1-T2): observed: 11, expected: 3.2; Ten years - 20 years after LT (T2-T3): observed: 7, expected: 3.4.
The researchers suggest that the progressive impairment of renal function in the long-term LT survivors may be one reason for the underestimation of CBVE in this patient group.
Cerebrovascular events in 20-years of follow-up after liver transplantation. an underestimated issue? Schoening W, Buescher N, Neidel N et al. Clin Transplant. 2016 Jul 22 [Epub ahead of print]
Patients with HCV genotypes 2 and 3 reported significantly better outcomes with sofosbuvir plus velpatasvir (SOF/VEL) compared with those receiving SOF and ribavirin (RBV).
Patient-reported outcome (PRO) data were collected from 818 participants in the multinational ASTRAL-2 and ASTRAL-3 studies before, during and after treatment using four PRO instruments (SF-36v2, FACIT-F, CLDQ-HCV, WPAI:SHP), and compared between the SOF/VEL and SOF+RBV groups.
The rates of nearly all adverse events were lower in the RBV-free SOF/VEL group. The SOF/VEL group also experienced improvement of their PROs by treatment week four (+1.8% on average across all PROs) which continued throughout treatment (+4.1%) and post-treatment (+5.5%). In contrast, the SOF+RBV group had a modest decline in their PROs starting at treatment week four (up to -3.7%) which lasted until the end of treatment (up to -6.4%).
In multiple regression analysis, the association of a treatment regimen with end-of-treatment PROs was significant for nearly all PROs; the average beta was +5.0% for the use of the SOF/VEL (reference: SOF+RBV).
Ribavirin-free regimen with sofosbuvir and velpatasvir is associated with high efficacy and improvement of patient-reported outcomes in patients with genotypes 2 and 3 chronic hepatitis C: results from Astral-2 and 3 clinical trials. Younossi ZM, Stepanova M, Sulkowski M et al. Clin Infect Dis. 2016 Jul 20 [Epub ahead of print]
Following total shoulder arthroplasty (TSA), patients with HCV are more likely to have such complications as infection, dislocation, fracture, revision TSA, systemic complications and blood transfusion.
These were the findings of US national data, compiled at the University of Virginia, and involving 1,466 HCV patients and 21,502 matched controls who underwent TSA.
The HCV patients, when compared with the controls, had greater odds of infection within three months (odds ratio 1.7), six months (odds ratio 1.7), and one year (odds ratio 2.1); revision TSA within one year (odds ratio 1.5) and two years (odds ratio 1.6); dislocation within one year (odds ratio 1.6); postoperative fracture within one year (odds ratio 1.8); systemic or medical complications within three months (odds ratio 1.3); and blood transfusion within three months (odds ratio 1.7).
The researchers say that although this study was able to identify increased odds of complications in patients with HCV, the mechanism by which these occur was likely not solely related to the virus, and was more likely related to a higher degree of case complexity in addition to other postoperative socioeconomic factors.
Is hepatitis C infection associated with a higher risk of complications after total shoulder arthroplasty? Cancienne JM, Dempsey IJ, Holzgrefe RE et al. Clin Orthop Relat Res. 2016 Jul 22 [Epub ahead of print]
A large literature review and meta-analysis confirms that HCV-infected patients are at an increased risk of cardio-cerebrovascular disease (CCD).
Reviewers from three academic centres in Italy found 27 studies which showed a significantly increased CCD risk in 297,613 HCV patients as compared with 557,814 uninfected controls (odds ratio 1.428).
These results were confirmed when separately considering the risk of coronary artery disease (CAD, 20 studies, odds ratio 1.382) and of cerebrovascular disease (13 studies, odds ratio 1.485).
Similar results were confirmed when analyzing 21 studies reporting adjusted risk estimates (odds ratio 1.448) and when, after excluding studies defining CAD as positive angiographic or electrocardiographic evidence, the reviewers specifically included the 17 studies reporting on acute CCD-related events (odds ratio 1.357). Moreover, four studies evaluating CCD-related deaths showed a higher risk in HCV patients than controls (odds ratio 1.772).
Meta-regression models suggested a direct association between the prevalence of cirrhosis and difference in CCD risk between HCV patients and controls.
The risk of coronary artery disease and cerebrovascular disease in patients with hepatitis C: A systematic review and meta-analysis. Ambrosino P, Lupoli R, Di Minno A et al. Int J Cardiol. 2016 Jul 4; 221:746-754 [Epub ahead of print]
Three HCV patients who underwent lung transplant have been safely treated with IFN-free sofosbuvir-based regimens.
They all received anti-HCV treatment after lung transplant with sofosbuvir-based regimens, and all achieved a SVR. No unexpected safety signals were observed and no modifications in immunosuppressants were required.
The authors of the case report, from the University of Milan, also carried out a literature review and found no other data on the safety and efficacy of IFN-free regimens in HCV patients who received lung transplants.
They suggested that their case report opens the door for refined clinical management of this category of patients.
Sofosbuvir-based regimens for the treatment of HCV in patients who underwent lung transplant: case series and review of the literature. D'Ambrosio R, Aghemo A, Rossetti V et al. Liver Int. 2016 Jul 18 [Epub ahead of print]
After HB immunoglobulin (HBIG) was ended in liver transplant (LT) patients with HBV/HDV coinfection, maintenance therapy with nucleos(t)ide analogue(s) (NAs) prevented its recurrence.
In a study at Greece’s Medical School of Aristotle University, 34 patients transplanted for HBV/HDV cirrhosis were evaluated. After LT, each patient received HBIG + NAs and then continued with NAs prophylaxis. All patients were followed up with HBV serum markers and HBV DNA, while anti-HDV/HDV RNA was performed in those with HBV recurrence. After HBIG discontinuation, the NAs were received as monoprophylaxis (lamivudine, adefovir, entecavir or tenofovir; or dual prophylaxis (lamivudine plus adefovir or tenofovir)).
Two of the 34 patients had HBV/HDV recurrence after HBIG withdrawal at a median follow-up of 28 months. These two patients had undetectable HBV DNA at LT. Statistical analysis revealed those with recurrence had received HBIG for shorter periods, compared to those without recurrence (median nine months versus 28 months).
Nucleos(t)ide analogue(s) prophylaxis after hepatitis B immunoglobulin withdrawal against hepatitis B and D recurrence after liver transplantation. Cholongitas E, Goulis I, Antoniadis N et al. Transpl Infect Dis. 2016 Jul 15 [Epub ahead of print]