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Two otherwise unrelated studies have testified to the efficacy and safety of the combination of simeprevir and sofosbuvir in patients with HCV.
In the US-based GALAXY study, the combination, with or without ribavirin, was efficacious and well tolerated in patients with recurrent HCV genotype 1 post-orthotopic liver transplant (1).
Thirty-three such patients without cirrhosis were randomised into three arms: Arm 1, received simeprevir+sofosbuvir+ribavirin for 12 weeks; Arm 2, received simeprevir+sofosbuvir for 12 weeks; Arm 3 received simeprevir+sofosbuvir for 24 weeks; 13 additional subjects (two with cirrhosis, 11 without cirrhosis) entered Arm 3.
Among the randomised subjects, SVR12 was achieved by 81.8% in Arm 1, 100% in Arm 2, and 93.9% in Arm 3; two subjects did not achieve SVR12: one viral relapse
(follow-up Week 4; Arm 1) and one missing follow-up Week 12 data. Five subjects had a serious adverse event, considered unrelated to treatment per investigator.
In Spain’s PLUTO study, the combination of simeprevir plus sofosbuvir for 12 weeks resulted in SVR12 rates of 100% in treatment-naïve and -experienced patients with HCV genotype 4 with or without compensated cirrhosis, and was well tolerated (2).
Forty patients received the combination for 12 weeks. Seven of the patients had compensated cirrhosis. All achieved SVR12. Adverse events, all Grade 1 or 2, were reported in 20 patients. No serious adverse events were reported and no patients discontinued study treatment. Grade 3 treatment-emergent laboratory abnormalities occurred in two patients.
Efficacy and safety of simeprevir and sofosbuvir with and without ribavirin in subjects with recurrent genotype 1 hepatitis C post-orthotopic liver transplant: the randomized GALAXY study. O'Leary JG, Fontana RJ, Brown K et al. Transpl Int. 2016 Nov 29 [Epub ahead of print]
Simeprevir in combination with sofosbuvir in treatment-naïve and -experienced patients with hepatitis C virus genotype 4 infection: a Phase III, open-label, single-arm study (PLUTO). Buti M, Calleja JL, Lens S et al. Aliment Pharmacol Ther. 2016 Nov 29 [Epub ahead of print]
The overall rate of increase in hepatocellular carcinoma (HCC) slowed between 2010 and 2012, found a nationwide US study. However, it did increase in some sub-groups such as men aged 55 to 64, and whites/Caucasians.
Researchers at Baylor College of Medicine in Texas analysed data from the US Cancer Statistics registry, which covers 97% of the population of all 50 states.
They found that the HCC incidence increased from 4.4/100,000 in 2000 to 6.7/100,000 in 2012, increasing by 4.5% annually between 2000 and 2009, but only by 0.7% annually between 2010 and 2012.
The average annual percentage change (AAPC) between 2000 and 2012 was higher in men (increase of 3.7%) than women (increase of 2.7%), and highest in 55 to 59-year-olds (AAPC 8.9%) and 60 to 64-year-olds (AAPC 6.4%).
By 2012, rates in Hispanics surpassed those in Asians, and rates in Texas surpassed those in Hawaii (9.71/100,000 vs 9.68/100,000). Geographic variation within individual race and ethnic groups was observed, but rates were highest in all major race and ethnic groups in Texas.
Incidence of hepatocellular carcinoma in all 50 United States, from 2000 through
2012. White DL, Thrift AP, Kanwal F et al. Gastroenterology. 2016 Nov 23 [Epub ahead of print]
A comparison of three different anti-HCV regimens concluded that all of them appeared highly effective in achieving sustained virologic response (SVR).
A study at the University of Southern California compared the SVR rates achieved 12 weeks post-treatment in 11,464 patients treated with three such agents by the Veterans Health Administration.
Without controlling for other risk factors, a SVR at least 12 weeks post treatment was achieved in 92% of ledipasvir/ sofosbuvir, 86% of ombitasvir/paritaprevir/ritonavir/dasabuvir, and 83% of simeprevir/sofosbuvir patients.
After adjusting for patient characteristics, simeprevir/sofosbuvir (93.3%) and ledipasvir/sofosbuvir (96.2%) patients were statistically more likely than ombitasvir/paritaprevir/ritonavir/dasabuvir (91.8%) patients to demonstrate a SVR.
HIV, HBV, diabetes, obesity, previous treatment history and augmentation therapy using ribavirin did not impact the SVR rates. Sustained SVR rates were lower for patients under age 65, with cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, indications of fibrosis or a non-genotype 1 infection. Women and Caucasian patients were more likely to achieve a SVR.
Comparative treatment effectiveness of direct acting antiviral regimens for hepatitis C: data from the Veterans Administration. Fox DS, McGinnis JJ, Tonnu-Mihara I et al. J Gastroenterol Hepatol. 2016 Nov 21 [Epub ahead of print]
A new study finds that people with viral hepatitis are at an increased risk of uveitis, particularly those with both HBV and HCV.
Researchers at China Medical University, Taichung, used data from the Taiwan National Health Insurance system to identify 17,389 patients newly diagnosed with viral hepatitis between 2000 and 2011 and matched these with 34,778 controls.
The risk of uveitis in the hepatitis cohort was 1.30-fold. Those with HBV and HCV coinfection had the highest risk (hazard ratio = 2.88), followed by HCV only infection (hazard ratio 1.75). Patients with cirrhosis had a higher risk in the multivariable model but did not attach statistic difference.
Relationship between uveitis, different types of viral hepatitis, and liver cirrhosis: a 12-year nationwide population-based cohort study. Tien PT, Lin CJ, Tsai YY et al. Retina. 2016 Dec;36(12):2391-2398
The use of statins by people with type 2 diabetes may help them avoid developing hepatocellular carcinoma (HCC), new evidence suggests.
Researchers at Yonsei University College of Medicine in Seoul, carried out a Korean nationwide population-based study involving 47,738 patients with type 2 diabetes.
After at least a five-year HCC-free period there were 229 incident HCC cases and 1,145 matched controls. Of these 229 incident HCC cases, 27 were statin users, whereas 378 were statin users among 1,145 controls.
Statin use was associated with a reduced risk of HCC development (adjusted odds ratio 0.36) after adjustment for chronic viral hepatitis, liver cirrhosis, alcoholic liver disease, previous cancer, aspirin use, insulin use, sulfonylurea use, metformin use, thiazolidinedione use, history of chronic obstructive pulmonary disease, Charlson comorbidity score, household income level, and residential area.
The risk reduction was accentuated with an increase of cumulative defined daily doses (cDDD) compared with non-users (adjusted odds ratios 0.53, 0.36, 0.32, and 0.26 in ≤60, 60-180, 181-365, and >365cDDD, respectively).
The risk reduction was apparent in the presence of liver disease (adjusted odds ratio 0.27), including heterogeneous groups of clinical diagnosis of liver disease, but not significant in the absence of liver disease (adjusted odds ratio 0.64).
Effect of statin on hepatocellular carcinoma in patients with type 2 diabetes: A
nationwide nested case-control study. Kim G, Jang SY, Han E et al. Int J Cancer. 2016 Nov 7 [Epub ahead of print]
A large study found that the risk of hepatocellular carcinoma was reduced by 80% in people cured of HCV compared to those who were not cured.
This was a study of the entire population of people treated for HCV in British Columbia province, Canada, between 1990 and 2013. The study identified 8147 people treated with interferon-based regimens, 57% of whom were cured. Treated individuals were followed for a median of 5.6 years.
The liver cancer incidence was highest among those with cirrhosis who did not achieve a SVR (21 cases per 1000 patient-years of follow-up). In comparison, the liver cancer incidence was 6.4 per 1000 patient-years in those with cirrhosis who achieved SVR, 7.2 in those without cirrhosis who did not achieve SVR12 and 1.1 per 1000 patient-years in those without cirrhosis who achieved SVR12.
In a multivariable analysis liver cancer was associated with cirrhosis, age over 50 years, genotype three infection versus genotype one, alcohol consumption and being male in those who were not cured. In those who were cured of hepatitis C, only cirrhosis, age over 50 and being male were associated with an increased risk of liver cancer.
The researchers concluded that although curing HCV greatly reduces the risk of developing liver cancer, it does not eliminate the risk entirely. Older people and those with cirrhosis are at higher risk than others, underlining the importance of early diagnosis and treatment.
The impact of sustained virological response to HCV infection on long term risk of hepatocellular carcinoma: the BC Hepatitis Testers Cohort. Janjua NZ et al. The 67th Meeting of the American Association for the Study of Liver Diseases, Boston 2016. Abstract 175
An analysis of published studies on direct acting antivirals (DAAs) found that regimens containing sofosbuvir and velpatasvir were the best option for patients with HCV genotype three (G3).
The analysis indicated that ribavirin significantly increased rates of SVR and should be considered if tolerated.
Researchers at Radboud University Medical Centre in the Netherlands performed a Bayesian network meta-analysis using a random effects model to indirectly compare DAA regimens in HCV G3 patients with and without cirrhosis. They found 27 appropriate studies involving 3,415 patients.
Among patients without cirrhosis, the greatest rates of SVR were estimated for those receiving sofosbuvir + velpatasvir with ribavirin (99%) and without ribavirin (97%), for sofosbuvir + daclatasvir + ribavirin (96%), and for sofosbuvir + peginterferon + ribavirin (95%), all for 12 weeks.
Among patients with cirrhosis, the highest rates of SVR were estimated for those receiving sofosbuvir + velpatasvir for 24 weeks (96%), for sofosbuvir + daclatasvir + ribavirin for 24 weeks (94%), and for sofosbuvir + velpatasvir + ribavirin for 12 weeks (94%).
Ribavirin increases efficacy in patients with and without cirrhosis (odds ratios 2.6 and 4.5).
Identification of the best direct-acting antiviral regimen for patients with hepatitis C virus genotype 3 infection: a systematic review and network meta-analysis. Berden FA, Aaldering BR, Groenewoud H et al. Clin Gastroenterol Hepatol. 2016 Nov 10 [Epub ahead of print]
A new study suggests young people being treated for HCV and their families experience increasing psychosocial distress.
During the study period, 10 children with HCV and their families began treatment at New York’s Icahn School of Medicine. Each family was given a battery assessing patient quality of life, caregiver distress related to their child's illness and overall family functioning.
At baseline, the patients displayed a poorer quality of life than population norms, caregiver distress was elevated and family functioning was also in the "stressed" range. After treatment, all parameters worsened.
The researchers suggest caregivers may benefit from additional support given the implications of HCV and grueling nature of its treatment. Broadly, the impact of continuous intensive treatments on families perhaps should be monitored.
Children with hepatitis C: the impact of disease and treatment on patients, caregivers and families. Annunziato RA, Lee SG, Galici E et al. J Pediatr Nurs. 2016 Nov 8 [Epub ahead of print]
There are large gaps in the quality and diversity of HCV and HBV testing in many European countries, a literature review suggests.
Reviewers from the University of Copenhagen found 136 English-language studies from 24 European countries published between January 2007 and June 2013. Most of the studies took place in six countries: France, Germany, Italy, the Netherlands and the United Kingdom.
Thirty-seven studies addressed HBV, 46 addressed HCV, and 53 addressed both diseases. The largest categories of study populations were people who use drugs (18%) and health care patient populations (17%). Far fewer studies focused on migrants, prison inmates, or men who have sex with men. The reviewers concluded that more research is needed throughout Europe to guide efforts to provide testing to certain key populations.
Are the testing needs of key European populations affected by hepatitis B and
hepatitis C being addressed? A scoping review of testing studies in Europe. Lazarus JV, Sperle I, Spina A et al. Croat Med J. 2016 Oct 31;57(5):442-456
People who drink coffee are less likely to develop nonalcoholic fatty liver disease (NAFLD), a new literature review suggests. And people with NAFLD who drink coffee regularly are less likely to develop liver fibrosis.
Reviewers from the Bassett Medical Centre, New York, carried out two meta-analyses. The first included observational studies comparing the risk of NAFLD in patients who did and did not drink coffee. The second analysis included studies comparing the risk of liver fibrosis between NAFLD patients who did and did not drink coffee.
Out of 355 articles, five studies fulfilled the eligibility criteria and were included in the analysis. The risk of NAFLD in patients who drank coffee was significantly lower than that in patients who did not (pooled risk ratio 0.71). There was also a significantly decreased risk of liver fibrosis among NAFLD patients who drank coffee compared with those who did not, with a pooled risk ratio of 0.70.
However, say the reviewers, it should be noted that the definition of regular coffee consumption varied between studies, which is the main limitation of this meta-analysis. They add that whether consumption of coffee could be considered a preventative measure against NAFLD needs further investigation.
Coffee consumption and risk of nonalcoholic fatty liver disease: a systematic review and meta-analysis. Wijarnpreecha K, Thongprayoon C, Ungprasert P. Eur J Gastroenterol Hepatol. 2016 Nov 7. [Epub ahead of print]