HCV New Drugs

This blog is all about current FDA approved drugs to treat the hepatitis C virus (HCV) with a focus on treating HCV according to genotype, using information extracted from peer-reviewed journals, liver meetings/conferences, and interactive learning activities.

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Wednesday, October 10, 2018

Current noninvasive liver reserve models do not predict histological fibrosis severity in hepatocellular carcinoma

Nature Research Journal - Scientific Reports
Current noninvasive liver reserve models do not predict histological fibrosis severity in hepatocellular carcinoma 
Shu-Yein Ho , Po-Hong Liu, Teh-Ia Huo

...No study to date has specifically evaluated the relationship and accuracy between noninvasive liver reserve models and the severity of liver fibrosis in HCC. We aimed to investigate the correlation of the currently used noninvasive liver function models and histological fibrosis in HCC patients undergoing surgical resection...

Abstract
The Ishak scoring system has been used to stage liver fibrosis. Ten noninvasive liver reserve models were proposed to assess the severity of liver fibrosis, but their performance in hepatocellular carcinoma (HCC) is unknown. We aimed to evaluate the correlation between these models and severity of fibrosis in patients with HCC. A total 464 patients with HCC undergoing surgical resection were retrospectively analyzed. Multivariate logistic regression analysis was performed to determine independent factors associated with advanced fibrosis (Ishak score 4 or higher). There were no significant correlations between all noninvasive models and severity of fibrosis in HCC (p for trend all >0.1). In subgroup analysis, cirrhosis discriminant index (CDS) and Lok’s index in hepatitis B-, and fibrosis index based on 4 factors (FIB-4), CDS and Lok’s index in hepatitis C-associated HCC, best correlated with the severity of liver fibrosis. Low platelet count, prolonged prothrombin time, hepatitis C and multiple tumors were independently associated with advanced fibrosis. Among the 10 models, CDS was the best model to predict cirrhosis. Currently used noninvasive liver reserve models do not well correlate with severity of histological fibrosis in HCC. New noninvasive models are required to improve the predictive accuracy of liver fibrosis in HCC.

Read the full-text article:
https://www.nature.com/articles/s41598-018-33536-2

Posted by HCV New Drugs at Wednesday, October 10, 2018 No comments: Links to this post
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File Under liver cancer, Liver Fibrosis, noninvasive tests for fibrosis

Impact of successful HCV treatment on health-related quality of life

Impact of successful treatment with direct-acting antiviral agents on health-related quality of life in chronic hepatitis C patients 
Regina Juanbeltz , Iván Martínez-Baz, Ramón San Miguel, Silvia Goñi-Esarte, Juan Manuel Cabasés, Jesús Castilla
Published: October 9, 2018 https://doi.org/10.1371/journal.pone.0205277 

Abstract
Background
Direct-acting antivirals (DAA) have demonstrated high efficacy to achieve sustained virological response (SVR) in chronic hepatitis C patients. We aim to assess the change in health-related quality of life (HRQoL) among patients successfully treated, and to identify predictors of this variation.

Methods
In a prospective observational study, patients with chronic hepatitis C who started DAA therapy between May 2016 and April 2017 completed the EQ-5D-5L questionnaire at baseline and 12 weeks after the end of therapy before knowing the virological result. Analysis included all patients with SVR.

Results
Median baseline EQ-5D-5L scores of the 206 enrolled patients were 0.857 utility and 70.0 visual analogue scale (VAS). Following SVR, a reduction occurred in the proportion of patients with mobility problems (35% vs 24%, p = 0.012), pain/discomfort (60% vs 42%, p<0.001) and anxiety/depression (57% vs 44%, p = 0.012), with an increase in utility (+0.053, p<0.001) and VAS (+10, p<0.001). Score improvements were also observed in cirrhotic (+0.048 utility, p = 0.027; +15 VAS, p<0.001) and HIV co-infected patients (+0.039 utility, p = 0.036; +5 VAS, p = 0.002). In multivariate analyses, middle age (45–64 years) and baseline anxiety/depression were associated to greater improvement in utility after SVR, and moderate-advanced liver fibrosis and cirrhosis to greater increase in VAS score. Low baseline values were associated to greater improvements in utility value and VAS score.

Conclusions
The cure of chronic hepatitis C infection with DAA has a short term positive impact on HRQoL with improvement in mobility, pain/discomfort, anxiety/depression, utility value and VAS score. Patients with poor baseline HRQoL were the most beneficed.

Full-text: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0205277

Discussion & Conclusion
Full-Text Article - PDF Download  Or View Online 
Successful treatment with DAA on health-related quality of life in patients with chronic hepatitis C was associated to significant improvement in the majority of HRQoL domains measured by the EQ-5D-5L instrument. Improvement of HRQoL started shortly after the initiation of therapy and enhanced after achieving SVR, including cirrhotic and HIV co-infected patients, classically considered “difficult to treat” populations. Main improvements occurred in mobility, pain/discomfort and anxiety/depression dimensions, as well as in the health utility and VAS score. Although evidence from “real life” setting is lacking [23], patient reporting outcomes with DAA in clinical trials also suggest benefit after treatment [33–36]. Relationship between SVR and HRQoL improvement has not been elucidated, but viral clearance has been suggested to result in cytokines and inflammatory biomarkers reduction in periphery and central nervous system, leading to a positively impact on patients’ experience [37, 38]. The improvement observed in the well-being of patients cured with DAA reinforces the idea that chronic HCV infection, far from being a purely hepatic disease, presents a clearly systemic component and impaires HRQoL [39,40]. According the Spanish National Health Survey 2011/12 [41], the general population aged 45–54 years referred a VAS score of 77.2 and utility value of 0.928, being higher figures than those referred by our patients before treatment, 70.0 and 0.875, respectively. Lower scores in our patients suggest a HRQoL impairment associated to chronic hepatitis C infection [7, 29].

In the first 4 weeks of treatment, the median VAS score increased 5 points and improved health dimensions that were negatively affected with interferon treatments [42]. This early improvement in HRQoL has been described for DAA [35], contrary to what happened with peg-IFN + RBV and triple therapy with boceprevir or telaprevir [10,17,43,44], which seems to relate HRQoL deterioration during treatment to interferon and not to second generation DAA. The use of RBV was not associated with significant disutility, a fact that suggests a lower impact of side effects such as anaemia and pruritus, when administered in combination with DAA compared to when administered with interferon. This aspect reinforces the idea of the good tolerability of DAA in real life conditions [45,46].

In clinical practice, patient reporting outcomes constitute useful tools in the evaluation and monitoring of health interventions, since they provide information on patient perception and needs [47]. Knowing the predictors of HRQoL improvement after the treatment of hepatitis C can help to strengthen patient adherence and motivation. Middle age, baseline anxiety-depression, advanced fibrosis and cirrhosis were found to be the most consistent predictors of HRQoL improvements after SVR. Precisely, those factors have been previously associated with impairment in HRQoL among chronic hepatitis C patients [4,29,48] and appear to be key determinants for HRQoL deterioration prior to therapy [14]. The high prevalence of depression and anxiety in HCV patients before treatment initiation [49] would reinforce the need for psychosocial screening, even more when considering that a greater HRQoL improvement may occurs in those patients after SVR. In our study, patients with worse baseline HRQoL score showed more significant improvements, a common finding in all types of clinical trials [50]. This result is consistent with the greater improvement in HRQoL in cirrhotic patients, with comorbidity or HIV co-infection, observed in the stratified analysis of the study.

This study provides useful information for cost-effectiveness analysis. Utility values allow to obtain quality adjusted life years, and to estimate incremental cost-utility ratios in pharmacoeconomic analysis. Since the advent of second-generation DAA, some cost-utility analyses have been published to assess their efficiency [51–54], with more or less favourable incremental cost-utility ratios depending on the degrees of liver fibrosis, the cost of the drugs and the previous treatment experience. More favourable treatment efficiency in patients with a high degree of fibrosis is derived from the potential more imminent progression to severe stages, associated with greater disutility and greater consumption of health resources [51,52]. According to our results, the more significant HRQoL improvement in cirrhotic patients after the SVR reinforces this idea. In any case, a decline in the cost of drugs and the possibility of currently treating patients with a low degree of liver fibrosis with short 8-week regimens, would reduce the incremental cost-utility ratios and improve the efficiency of treatment in all patient subpopulations.

This real-life prospective study included hepatitis C patients who received treatment in a regional reference hospital in northern Spain. Although the epidemiology of HCV infection and the introduction of DAA have been relatively homogeneous in Spain, we can not rule out some geographical differences which would affect representativeness of our study. However, patients were infected by all HCV genotypes with a distribution similar to that of the population in our environment [55], in the different stages of the disease, treated with all available combinations of DAA and without excluding patients with comorbidity. The indication and choice of treatment was based on the same protocol, developed according to clinical and efficiency criteria. HRQoL was analysed including subpopulations of patients usually underrepresented in clinical trials, such as those with psychiatric disorders or persons co-infected with HIV [23], which represent one third of the population in this study. All the interviews were carried out by the same investigator, in order to minimize the potential bias of the interviewer. The timing of the interview may affect the results. The post-12 interview was conducted in our study before knowing the SVR result, in order to avoid the possible overestimation on patient’s HRQoL self-assessment secondary to the euphoria experienced at that moment [43,56]. However, when patients know HCV become negative after treatment, the worry about the complications of the disease probably decrease and an improvement in the anxiety dimension could be greater than that observed in our study. A long-term evaluation of HRQoL after SVR would contribute to understand the effect of timing on HRQoL results.

Two possible shortcomings of our study need to be considered. First, the population size, although similar or greater than that of other observational studies [35,14,57] was not large enough to obtain conclusive results in some subanalyses. In any case, the patients included accounted for 78% of the patients who received treatment successfully during the study period. Second, the EQ-5D-5L is a generic questionnaire. Although it has been used in many scenarios, including chronic hepatitis C and its treatment, its combination with a disease-specific questionnaire would have been desirable. Time-related limitations in terms of patient care in the consulting room and of personnel related to completing the interviews discouraged the use of other questionnaires. However, studies that use both types of tools for measurement of patient reporting outcomes in patients treated with DAA therapy obtained similar results and good correlation between the generic and HCV-specific questionnaires [10,35]. EQ-5D-5L version was used in this study, as it has demonstrated to be a valid extension of EQ-5D-3L, providing more precise measurement at both individual and group level [58–61]. Since no 5L value sets were yet available in Spain, the crosswalk value set was used in this study, as the EuroQol recommended [31].

The new antivirals available recently seem to improve even more the treatment outcomes, being expected this same effect on quality of life.

Conclusions
In summary, this study shows a short-term positive impact of SVR on the HRQoL of patients with chronic hepatitis C treated with interferon-free DAA. The greatest impact was on health dimensions of mobility, pain/discomfort, anxiety/depression, and in utility values and the VAS of the EQ-5D-5L questionnaire. The treatment did not produce disutility, nor did the use of RBV. Predictors of greater improvements in HRQoL with SVR may be baseline depression, anxiety, moderate-advanced fibrosis and cirrhosis; which may help to give priority to patients for treatment. The results obtained provide the patient's perspective in the assessment of DAA and information on patient reporting outcomes to be incorporated in cost-utility studies.
https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0205277&type=printable
Posted by HCV New Drugs at Wednesday, October 10, 2018 No comments: Links to this post
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Hepatitis C - Vosevi safe, effective in ‘triple-infected’ patients with HCV, HBV, HIV

Vosevi safe, effective in ‘triple-infected’ patients with HCV, HBV, HIV

PHILADELPHIA – The direct-acting antiviral Vosevi demonstrated an average sustained virologic response rate of 87% among patients who were “triple-infected” with hepatitis C genotype 3, hepatitis B and HIV, as presented at the American College of Gastroenterology Annual Meeting.

“Chronic hepatitis C treatment is no longer challenging in the era of DAAs with an SVR of up to 97%. However, triple infection treatment with HCV, HIV and hepatitis B has not been explored in real life situations,” Nimy John, MD, from the University of Massachusetts Medical School, said during her presentation.

Read the article: 
https://www.healio.com/gastroenterology/hepatitis-c/news/online/%7B48f981a3-e83f-4e70-8c39-4acd467af6f7%7D/vosevi-safe-effective-in-triple-infected-patients-with-hcv-hbv-hiv

Healio Coverage:
American College of Gastroenterology Annual Meeting 
October 5, 2018 - October 10, 2018
See more from American College of Gastroenterology Annual Meeting
Posted by HCV New Drugs at Wednesday, October 10, 2018 No comments: Links to this post
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File Under geno3, hbv, HIV/HCV, svr, Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir)

Tuesday, October 9, 2018

Tackling the Challenges Associated With Treating Hepatitis C Infection in Pediatric Patients

Tackling the Challenges Associated With Treating Hepatitis C Infection in Pediatric Patients

Infectious Disease Advisor spoke further with Dr Espinosa to learn more about challenges and potential solutions regarding HCV infection in younger patients.

Infectious Disease Advisor: What are some of the challenges pertaining to HCV management in pediatric patients?

Children infected with hepatitis C face environmental, provider, and system-based challenges, such as underreporting. The lack of screening in pregnant women in many states makes it difficult to identify infected children, as the disease may not be symptomatic for years. In fact, Kentucky just recently passed a bill for universal screening. There is a lack of structured protocols to follow-up on those affected children so we can identify earlier, rather than later, those who will require therapy.

There is also a lack of provider education regarding proper follow-up and necessary testing. Some providers may be uncertain about identifying the correct test to use in the setting of many different options.

Read the article here: https://www.infectiousdiseaseadvisor.com/hepatitis-advisor/treating-hepatitis-c-infection-in-infants-and-children/article/806172/
Posted by HCV New Drugs at Tuesday, October 09, 2018 No comments: Links to this post
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Anti-virals cure up to 98% of hepatitis C patients since 2014

Anti-virals cure up to 98% of hepatitis C patients since 2014Paul Cullen 

Use of revolutionary drugs has led to ‘a triumph of science’, says hepatologist

Up to 98 per cent of patients with hepatitis C virus have been cured thanks to the use of revolutionary anti-viral drugs over the past four years, new figures show.

The figures from the national treatment registry for Irish hepatitis C patients represent “a triumph of science”, Dr Diarmuid Houlihan, a hepatologist at St Vincent’s University Hospital told a conference in Dublin on Monday.

Hepatitis C is a virus that infects and damages the liver. It can cause inflammation scarring of the liver, which in some people can progress to cause serious liver damage, such as cirrhosis. It is often referred to as a silent disease, as symptoms can take several years to develop and people do not realize they have the disease. 

Read more: https://www.irishtimes.com/news/health/anti-virals-cure-up-to-98-of-hepatitis-c-patients-since-2014-1.3656345

Posted by HCV New Drugs at Tuesday, October 09, 2018 No comments: Links to this post
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Saturday, October 6, 2018

Oramed; First patient enrolled in study of oral insulin capsule for NASH

Oramed Enrolls First Patient in Its Clinical Study for Oral Insulin in the Treatment of NASH

NEW YORK, Oct. 4, 2018 /PRNewswire/ — Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today it has enrolled the first patient in an exploratory clinical study of its oral insulin capsule, ORMD-0801, in the treatment of nonalcoholic steatohepatitis (NASH).

The three-month treatment study, recently approved by Israel’s Ministry of Health, will assess the effectiveness of ORMD-0801 in reducing liver fat content, inflammation and fibrosis in patients with NASH.

Data from preclinical studies and clinical studies of ORMD-0801 demonstrate Oramed’s oral insulin capsule has the potential to reduce inflammation of the liver.

“Prevalence of NASH is accelerating rapidly and correlates directly with the rising incidence of type 2 diabetes. As we continue our focus on the development of our oral insulin for the treatment of diabetes, we are excited about its potential in this greatly needed NASH indication,” stated Oramed CEO, Nadav Kidron.

NASH, a chronic liver disease caused by excessive fat in the liver, can lead to fibrosis, cirrhosis, liver failure and death. According to the Journal of Hepatology, prevalent NASH cases are expected to increase 63% from 16 million in 2015 to 27 million cases in 2030.

About Oramed Pharmaceuticals 
Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, Oramed’s Protein Oral Delivery (PODTM) technology is based on over 30 years of research by top scientists at Jerusalem’sHadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801). The Company completed multiple Phase II clinical trials under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition, Oramed is developing an oral GLP-1 analog capsule (ORMD-0901).
https://www.oramed.com/oramed-enrolls-first-patient-in-its-clinical-study-for-oral-insulin-in-the-treatment-of-nash/
Posted by HCV New Drugs at Saturday, October 06, 2018 No comments: Links to this post
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File Under clinical trials, Fatty Liver, Liver Fibrosis, NASH, ORMD-0801
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February 2019
HCV Newsletters & Blog Updates
Read easy to understand articles covering HCV-related topics that matter most to patients.

Baby Boomers and the Flu
News Updated:
Feb 15
CDC Update: Every Friday
Week 6 ending Feb 9
click here to view updates.

AASLD / EASL HCV Special Conference 
February 1-2, 2019
Coverage At NATAP:
Baby Boomers; Is There a Need to Re-Focus our Efforts for Hepatitis C Screening Away from Baby Boomers? 23% HCV+ in Rural Drug Users Pennsylvania
Worldwide; HCV Epidemiology and Impact of Treatment
The Controversy 
Rebuttal over Cochrane Review of DAAs 
A systematic review published by the Cochrane Collaboration suggested achieving SVR (cure) for patients using hepatitis C direct-acting antivirals (DAAs) doesn't correlate with any long term benefits. View each rebuttal and all ongoing media coverage.

Latest Update Feb 12, 2019 
Lancet Study: 
Direct-acting antivirals reduce risk of premature mortality and liver cancer for people with chronic hepatitis C 
These findings firmly counter those of a Cochrane review of direct-acting antiviral treatment trials that could neither confirm nor reject if direct-acting antivirals had an effect on long-term HCV-related morbidity and mortality. They also provide the best evidence to date to support guidance documents that recommend direct-acting antiviral treatment for all patients with chronic HCV infection.

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The above links offer data about interferon-free regimens approved to treat HCV, with learning activities,  editorials, and tips from patient bloggers who understand the ups and downs of liver disease, in addition to a list of outstanding hepatitis C websites, blogs and support forums.

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Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"
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