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Simtuzumab, a monoclonal antibody directed against lysyl oxidase-like 2 enzyme, has been shown to be well-tolerated in HCV- and HIV-infected subjects with advanced liver disease.
In an open-label, pilot multi-centre clinical trial, 18 patients with HCV, HIV or HCV-HIV co-infection and advanced liver fibrosis received simtuzumab 700mg intravenously every two weeks for 22 weeks. Transjugular liver biopsies were performed during screening and at the end of treatment to measure hepatic venous pressure gradient (HVPG) and to stage fibrosis.
The treatment was well-tolerated with no discontinuations because of adverse events. No significant changes were seen in HVPG or liver biopsy fibrosis score after treatment. Exploratory transcriptional and protein profiling using paired pre- and post-treatment liver biopsy and serum samples suggested up-regulation of TGF-β3 and IL-10 pathways with treatment.
The researchers suggest that putative modulation of TGF-β3 and IL-10 pathways during simtuzumab treatment merits investigation in future trials.
Simtuzumab treatment of advanced liver fibrosis in HIV and HCV-infected adults: results of a 6-month open-label safety trial. Meissner EG, McLaughlin M, Matthews L et al. Liver Int. 2016 May 27 [Epub ahead of print]
A new survey has found a low rate of prescribing amongst physicians when treating HCV patients who inject drugs.
Researcher at the University of California, San Francisco surveyed clinicians attending the Liver Meeting in 2014 who reported prescribing HCV treatment in the past three years.
Among 108 clinicians completing the survey, 10% were willing to treat a person who injected drugs (last injection within 30 days) using interferon-containing regimens, and 15% with all-oral regimens.
For each increasing time interval of injection abstinence, there was an increase in the odds of a clinician reporting willingness to treat with direct-acting antivirals (odds ratio 2.57) and with interferon-based treatment (odds ratio 2.22), Reinfection and medication cost were cited as most important concerns when determining candidacy.
The researchers concluded that a cure is now the norm in HCV treatment, and that there is an increasing need to address the barriers to treating people who inject drugs, the population with the highest burden of infection. Understanding treatment candidacy assessments is essential to improving uptake.
Clinicians' views of Hepatitis C Virus treatment candidacy with direct-acting antiviral regimens for people who inject drugs. Asher AK, Portillo CJ, Cooper BA et al. Subst Use Misuse. 2016 May 24:1-6 [Epub ahead of print]
Some degree of renal impairment is common in people with HCV, including those with advanced liver fibrosis, researchers have found.
In a population-based prospective, observational cohort study at four large US health systems, data on 5,772 HCV patients was analysed.
The prevalence of estimated glomerular filtration rate (eGFR) = 80 was 33% and eGFR < 30 was 2%, including among patients with hepatic fibrosis. Diagnosed extra hepatic renal manifestations were rare: vasculitis- 0.2%, nephrotic syndrome- 0.3%, and cryoglobulinemia- 0.9%.
The researchers concluded that, while the prevalence of severe renal impairment was low, mild-to-moderate renal impairment was common in HCV patients, including those with advanced liver fibrosis for whom treatment is urgent.
Prevalence of renal Impairment and associated conditions among HCV-infected persons in the Chronic Hepatitis Cohort Study (CHeCS). Moorman AC, Tong
A tablet containing elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide (E/C/F/TAF) was effective in HIV/HBV co-infected adults, a new study showed.
In this US multi-centre, open-label, non-comparative switch study, at week 48, 91.7% of the 72 participants maintained or achieved virologic suppression (HIV-1 RNA <50 c/mL; HBV DNA <29 IU/mL.)
Seroconversion occurred in 2.9% of HBsAg positive participants and 3.3% of HBeAg positive participants; 40% of those with abnormal ALT normalized. E/C/F/TAF was associated with improved renal function and reduced bone turnover.
Efficacy and safety of switching to a single-tablet regimen of elvitegravir/cobicistat/emtricitabine/tenofovir Aaafenamide (E/C/F/TAF) in HIV-1/Hepatitis B coinfected adults. Gallant J, Brunetta J, Crofoot G et al. J Acquir Immune Defic Syndr. 2016 May 11 [Epub ahead of print]
Findings from a meta-analysis of published studies suggest chronic HBV may decrease the risk of pre-eclampsia.
The reviewers found three observational cohort studies and eight case-control studies, including 11,566 preeclampsia patients, conducted up to 1 January 2016 in Asian populations. A significant negative association between chronic HBV infection and pre-eclampsia was observed (odds ratio 0.77).
The reviewers suggest future prospective cohorts in different countries with larger sample sizes are warranted to ascertain the causality. Pathophysiological studies are required to explore the possible biological mechanisms involved, they added.
Chronic hepatitis B infection is associated with decreased risk of preeclampsia: a meta-analysis of observational studies. Huang QT, Chen JH, Zhong M et al. Cell Physiol Biochem. 2016 May 9;38(5):1860-1868 [Epub ahead of print]
HBV infection is possible following hemodialysis, especially among severely immunosuppressed patients.
Following an investigation of a report made in March 2013, US public health authorities, from the Epidemic Intelligence Service, have warned of this possibility, and recommended stringent infection control.
They found that the patient's only identified HBV risk factor was hemodialysis treatment, and that the facility had no other patients with known active HBV infection.
An investigation of one patient with evidence of a resolved HBV infection indicated HBV reverse seroconversion and reactivation had occurred in the setting of HIV infection and a failed kidney transplant.
HBV whole genome sequences analysis from the index and source patients indicated 99.9% genetic homology. Facility observations revealed multiple infection control breaches. Inadequate dilution of the source patient's sample during HBV testing might have led to a false-negative result, delaying initiation of hemodialysis in isolation.
Hepatitis B reverse seroconversion and transmission in a haemodialysis centre: a public health investigation and case report. Rhea S, Moorman A, Pace R et al. Am J Kidney Dis. 2016 May 7 [Epub ahead of print]
Although in HCV studies, SVRs above 90% have been achieved with direct-acting antiviral (DAA) combinations, outcomes in real-world patients are lower. In a review, authors from Spain and the UK have discussed the management of HCV treatment failure and the impact of resistance-associated variants (RAVs) on re-treatment strategies.
The authors say that failure to DAA combinations occurs more often in chronic HCV patients with baseline predictors of poor response, such as those with RAVs, genotypes 3 or 1a, advanced liver cirrhosis, elevated serum HCV-RNA and perhaps HIV coinfection. Impaired antiviral efficacy is more frequent when multiple factors are present.
On-treatment predictors of DAA failure are poor drug adherence and development of side effects. Extending the length of therapy, adding ribavirin and/or using DAA from other drug families may allow successful re-treatment of most prior DAA failures.
Prevention and management of treatment failure to new oral hepatitis C drugs. Benítez-Gutiérz L, Barreiro P, Labarga P et al. Expert Opin Pharmacother. 2016 May 5. [Epub ahead of print]
Findings from a new study suggest a significant relationship between skeletal muscle weakness and neurological impairment in cirrhotic patients.
This cross-sectional multi-centre study in Brazil included 54 cirrhotic outpatients with hepatic encephalopathy (HE) varying from subclinical to grade II, who were submitted to neuropsychometric tests, electroencephalogram, brain Single Photon Emission Computed Tomograph, anthropometric measurements, handgrip strength and dual energy X-ray absorptiometry exam.
Analysis of the area under the receiver operator characteristic curve revealed the values related to neurological manifestations (HE grades I and II). Reductions in adductor pollicis muscle thickness and hand grip strength were associated with higher HE grades, suggesting a big impact caused by the loss of muscle mass and function on HE severity.
Lower values of handgrip strength and adductor pollicis muscle thickness are associated with hepatic encephalopathy manifestations in cirrhotic patients. Augusti L, Franzoni LC, Santos LA et al. Metab Brain Dis. 2016 Apr 30. [Epub ahead of print]
New evidence from the USA has found “unexplained” race and gender differences in the use of new direct acting antiviral agents (DAAs) amongst people with HCV.
Researchers at Baylor College of Medicine, Houston, studied HCV patients who received care at Veterans Administration facilities nationwide. Those who were treated in the current DAA era were compared with those who were seen in the previous standard of care era.
Of the 145,596 patients seen in the current DAA era, 17,791 received treatment during the first 16 months of DAA approval. African American
(AA) patients had 21% lower odds of receiving DAA than whites (odds ratio 0.79). Overall, women were as likely to receive treatment as men (odds ratio 0.99). However, the odds of receiving DAAs were 29% lower for younger women compared with younger men (odds ratio 0.71).
In the previous era, similar to the DAA cohort, AA patients had significantly lower odds of receiving treatment than whites (odds ratio 0.74). The racial difference between the two eras did not reach statistical significance.
The researchers described their findings as “unexplained”
Race and gender differences in the use of direct acting antiviral agents for HCV. Kanwal F, Kramer JR, El-Serag HB et al. Clin Infect Dis. 2016 Apr 30 [Epub ahead of print]
Myrcludex B is a new drug to treat HBV and HDV. In a multi-centre German first-in-human study (1), single ascending doses of myrcludex B were administered up to 20 mg intravenously and 10 mg subcutaneously in 36 healthy volunteers.
Myrcludex B was well tolerated and no serious or relevant adverse events representing off-target effects, and no immunogenic effects were observed up to the highest applied dose. The pharmacokinetic model suggested that subcutaneous doses of 10 mg and above reach a target saturation of over 80% for at least 15 hours.
In a pilot trial conducted at centres in Russia and Germany, 24 patients with chronic HDV were equally randomized to myrcludex B, or pegylated interferon alpha (pegIFNα-2a) or their combination (2).
Interim results showed that, after 24 weeks of treatment, HDV RNA, a relevant marker for HDV infection, decreased in all patients. Two of eight patients who received either myrcludex B or pegINF2a became negative for HDV RNA, and five of seven patients who received both drugs at the same time became negative. The drug was well tolerated.
1. Myrcludex B: a first-in-human clinical study with a first-in-class hepatitis B and hepatitis D virus entry inhibitor. Blank A, Markert C, Hohmann N et al. J Hepatol. 2016 Apr 27 [Epub ahead of print]
2. Interim results of a Phase Ib/IIa study of the entry inhibitor myrcludex B in chronic hepatitis D infected patients. Bogomolov P, Alexandrov A, Voronkova N et al. J Hepatol. 2016 Apr 27 [Epub ahead of print]