Blog Updates on Hepatitis - Inactivated Zoster Vaccine, Harvoni Cures Hep C patient & Opioids

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Harvoni Cures Hep C patient Brenda in Clinical Trial part 1

September 19, 2017

This week on Life Beyond Hep C we’re hearing Hep C patient Brenda’s courageous Hep C treatment fight and experience.

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All Swiss hepatitis C sufferers can access costly drugs like Harvoni

swissinfo.ch

All patients suffering from hepatitis C can be treated with the drugs Harvoni and Epclusa from next month, after the Federal Office of Public Health lifted ...

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Opioid overdoses shorten US life expectancy by 2½ months

By Nadia Kounang, CNN

Opioid drugs -- including both legally prescribed painkillers such as oxycodone and hydrocodone, as well as illegal drugs such as heroin or illicit fentanyl -- are not only killing Americans, they are shortening their overall life spans. Opioids take about 2½ months off our lives, according to a new analysis published in the medical journal JAMA.

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States expand investigation of opioid makers, distributors
Geoff Mulvihill, Associated Press - Houston Chronicle
Attorneys general from most states are broadening their investigation into the opioid industry as a nationwide overdose crisis continues to claim thousands of lives. They announced Tuesday that they had served subpoenas requesting information from five companies that make powerful prescription painkillers and demanded information from three distributors. Forty-one attorneys general are involved in various parts of the civil investigation.

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Addiction clinics need physician education, lifted restrictions to treat HCV

HCV Next - HEALIO - Meeting News
Opioid agonist therapy clinics represent an important conduit for people who inject drugs to receive information, screening and treatment for hepatitis C. Within these clinics, however, physicians and addiction specialists self-reported low competence regarding current HCV treatments. Additionally, policies that restrict treatment for current and recent drug users present an ongoing barrier.
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My 2 cents: College friend doing good work

Written by Karen Shuey - Staff Writer For Reading Eagle.

The proposal in Philadelphia would be modeled on a supervised injection center in Vancouver, British Columbia, called Insite that has showed tremendous promise over the last 14 years. Statistics show Insite has saved lives, proponents say, reversing nearly 5,000 overdoses since 2003, with no deaths. At the same time, studies show the center has prevented the spread of diseases such as HIV and hepatitis C and reduced dangerous litter, including needles strewn on local streets.
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Ontario study to lift six-month-sober rule for liver transplant patients

Tom Blackwell - National Post 

Faced with a widow's legal challenge, Ontario will transplant livers into almost 100 alcoholic-liver-disease patients, as evidence suggests they do as well as others.

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What parents should know about tattoos

Posted September 19, 2017,
Claire McCarthy, MD, Faculty Editor, Harvard Health Publications
These days, tattoos are increasingly common. According to a 2015 Harris poll, three in 10 American adults have a tattoo — up from two in 10 in 2012. They are particularly popular in young people; among Millennials, nearly half have a tattoo. To help parents make this tough decision, the American Academy of Pediatrics (AAP) released a clinical report entitled “Adolescent and Young Adult Tattooing, Piercing, and Scarification.” Here are some highlights — and some points parents and teens really need to talk about.
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Fighting Hepatitis in Cambodia: Beginnings and Endings
Theresa Chan - Theresa is an MSF doctor, currently working at a hepatitis C clinic in Cambodia.
Beginnings and endings have been leaking into my to-do list as well. Right now I’m working on writing the MSF guidelines for treating hepatitis C, which will be the basis for the Cambodian national guidelines one day when our clinic is turned over to the Ministry of Health, so even as we are recovering from the busy beginning of this clinic, we are contemplating its end.
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Inactivated Zoster Vaccine Soon to Be Approved — Should Patients Wait for It?
Paul E. Sax, MD - Contributing Editor NEJM Journal Watch 
For the last year or so, conversations with patients about getting the zoster vaccine have gone something like this:

Patient: So should I get the shingles vaccine? I saw an ad for it on TV.
Me:  Well, yes … and no.
Patient (confused — he/she has never heard me say anything but an enthusiastic “Yes!” to vaccines):  What does that mean?
Me:  There’s a better shingles vaccine coming soon, likely within a year. So I’d wait.

Now it looks like that wait is almost over.
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Can Restricting Fructose Intake Reduce Fatty Liver Disease in Children?
Kristine Novak - Dr. Kristine Novak is the science editor for Gastroenterology and Clinical Gastroenterology and Hepatology.
Reducing dietary fructose for as little as 9 days decreases liver fat, visceral fat, and de novo lipogenesis and increases insulin sensitivity, secretion, and clearance in children with obesity and metabolic syndrome, researchers report in the September issue of Gastroenterology. These findings support efforts to reduce sugar consumption.
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Only One-Quarter of Hepatitis C Patients Got Treatment Before Widespread DAA Use

SEPTEMBER 19, 2017

Gail Connor Roche - MD Magazine

Only one-quarter of patients worldwide with the chronic hepatitis C virus (HCV) received antiviral treatment before the widespread use of direct-acting antiviral (DAA) drugs, a review that considered almost 500,000 people has found.

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Adolescents With HCV Achieve 98% Cure Rate in Direct-Acting Antiviral Study
Gail Connor Roche - MD Magazine
Adolescents treated for hepatitis C achieved a 98% cure rate with a direct-acting antiviral drug (DAA) therapy, a study has found.
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HCV Drug Resistance: Infrequent, and Frequently Overcome
Kenneth Bender - MD Magazine
Hepatitis C virus (HCV) mutations that can resist drug treatment are infrequent, and are unlikely to withstand longer treatment durations or the addition of a synergistic drug, according to new analysis of resistance testing, treatment response and re-treatment interventions. Resistance testing does appear to Wyles and Luetkemeyer to be indicated, however, in patients with genotype 1a before treatment with elbasvir/grazoprevir (Zepatier, Merck), and should be considered prior to treatment with ledipasvir/sofosbuvir (Harvoni) for those with genotype 1a and cirrhosis or with prior NS5A treatment failure...
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Hepatitis A: frequently asked questions

Paul Sisson Contact Reporter The San Diego Union-Tribune

In an effort to combat a deadly hepatitis A outbreak, San Diego will begin washing streets in ...

Q: If I've had hepatitis B or hepatitis C am I immune to hepatitis A?

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Cannabis in Gastroenterology: Physicians Lack Answers as Patient Interest Peaks
Healio Gastroenterology, September 2017
Despite a lack of high quality evidence due to federal regulations on research, many state medical marijuana programs have designated GI conditions like severe nausea, inflammatory bowel disease (IBD) and hepatitis C as qualifying conditions, and studies show that many patients are self-medicating with marijuana. Experts agreed physicians should equip themselves to explain the known risks and benefits to inquiring patients, and understand the legal frameworks of their state medical marijuana programs.

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On Twitter
Tweeted By Don Crocock, Follow here--->  @dcrocock   
Rationale for cannabis-based interventions in the opioid overdose crisis
Harm Reduction Journal https://doi.org/10.1186/s12954-017-0183-9

Published: 18 August 2017

The growing body of research supporting the medical use of cannabis as an adjunct or substitute for opioids creates an evidence-based rationale for governments, health care providers, and academic researchers to consider the implementation and assessment of cannabis-based interventions in the opioid crisis.
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Resistance testing for the treatment of chronic hepatitis C with direct acting antivirals: when and for how long?

Resistance testing for the treatment of chronic hepatitis C with direct acting antivirals: when and for how long?
Pérez AB, Chueca N, García F.

GERMS 2017;7(1):40-44. doi: 10.18683/germs.2017.1107

View Full Text Article

Abstract
The need to test for resistance associated substitutions (RAS) has been intensively debated in the past two years. In the absence of pangenotypic combinations, it seems reasonable that, if available, RAS testing in the NS5A gene at baseline for genotypes 1a and 3 may help to avoid overtreatment in terms of ribavirin usage and/or prolonged treatment duration. When patients fail treatment, RAS testing may also be useful to guide the selection of the new regimen, especially for those that need urgent retreatment and that have failed a combination including an NS5A inhibitor. However, there are new drugs in the pipeline that in combination are pangenotypic, very potent and with a high genetic barrier to resistance. In this new scenario, RAS testing may not play such an important role.

Keywords: HCV, RAS, DAA, baseline, failure, new drugs

The key to achieve sustained viral response (SVR) in the treatment of chronic hepatitis C with direct anting antivirals (DAAs) is to eliminate all the hepatitis C virus (HCV) quasispecies that infect the patient; if this is achieved, and the entire viral population has been eradicated, there is no opportunity for viral relapse and the patient is cured of HCV infection. Achieving SVR is a multifactorial event relying not only on virological factors, but also on factors related to the host and the drugs used for treating chronic hepatitis C.1 Being infected by genotypes 1a or 3, cirrhotic, and previously exposed to interferon-containing regimens are predictors of non-response. Among other virological factors that may impact SVR, the presence of resistance associated substitutions (RAS) may be clinically relevant, both before the patient is going to start the first DAA regimen and when the patient has failed treatment.

Although phenotypic tests may be performed to assess resistance to DAAs, genotyping (e.g. sequencing of the HCV genomic region of interest) is considered the gold standard to detect RASs. Next generation sequencing is now available for DNA sequencing and many laboratories have adopted this technology; however, unlike other scenarios, next generation sequencing has not been proven clinically relevant for HCV RASs testing; in fact, the detection of RASs present with a low relative frequency in the quasispecies viral population, below a 15% cutoff, failed to demonstrate any impact on SVR.2,3 In addition, to score resistance in HCV, the type of RAS is also critical, especially for the NS5A inhibitors, where class RASs (all substitutions in NS5A with a fold-change (FC) greater than 2.5X to any drug in the class) do not necessarily have the same impact as drug specific RASs (specific RASs for each drug in the class, in general with FC values above 100X).

The need to test for RASs at baseline has been highly debated through the last two years. In general, expert opinion at major conferences has always been that baseline RAS testing has no or a minimum impact on SVR, and therefore baseline RAS testing was not needed for clinical practice.

However, clinical guidelines from the American Association for the Study of Liver Diseases4(AASLD) recommend testing for Q80K in genotype 1a prior to using simeprevir in interferon-containing regimens, and more recently in cirrhotic patients that are going to start sofosbuvir (SOF) and simeprevir (SIM). For NS5A inhibitors, AASLD guidelines recommend to test for RASs in NS5A if the combination grazoprevir (GZR) and elbasvir (EBR) is going to be used, as the detection of clinically relevant RASs against EBR will aid to decide if prolonging treatment to 16 weeks and adding ribavirin (RBV) is necessary.

For other regimens, such as the AbbVie combination (paritaprevir/r-dasabuvir-ombitasvir, known as 3D) RAS testing is not necessary as there is no impact for HCV genotype 1b treatment, as there also isn´t for all the other DAA combinations and genotype 1b. For genotype 1a, the 3D approved regimen always includes RBV to make the regimen more potent and overcome the effect of RASs. Guidelines from the European Association for the Study of Liver diseases5 (EASL) have been updated September 2016; EASL panel state that if RAS testing is accessible, reliable and interpretable, then testing for baseline RAS for HCV genotypes 1a, 4, 5 and 6 will help to decide on extending treatment duration and adding RBV for any of the SOF and ledipasvir (LDV), SOF and daclatasvir (DCV) combinations, and as AASLD for GZR/EBR for genotype 1a.

Very recently, Zeuzem et al.3 clearly showed that HCV genotype 1a infected patients starting SOF/LDV with LDV specific RASs (15% cutoff) and prior interferon treatment experience, irrespective of the cirrhosis status, and those interferon-naïve with cirrhosis, are prone to achieve lower SVR rates when compared to HCV genotype 1b infected patients or treatment-naïve non cirrhotic genotype 1a, who achieve SVR rates of 96-98%.

Results for treatment-naïve and treatment-experienced genotype 1 infected patients, with and without liver cirrhosis are illustrated in Figure 1.

Figure 1. SVR12 rates achieved considering LDV specific RAS and a 15% cutoff. Data are presented in relation to prior interferon treatment (TN=treatment naïve; TE= treatment experienced), and cirrhosis status (C=cirrhosis; NC=non cirrhosis)

HCV genotype 3 is also difficult to treat with currently available DAAs. NS5A baseline RAS, especially Y93H, may condition lower SVR12 rates (75%) when starting SOF/DCV in real life conditions.6Data from the ASTRAL 3 study,7 where SOF and velpatasvir (VEL) were used for the treatment of genotype 3 infected patients, have also shown the impact on SVR12 of the Y93H RAS in NS5A (88%). In fact, AASLD guidelines recommend testing for Y93H before genotype 3a cirrhotic patients start any SOF/NS5A inhibitor combination, to decide whether extending treatment duration and adding RBV may be necessary.

Regarding patients that have failed a prior DAA regimen, and that are in urgent need of retreatment, there is a general consensus that RAS testing provides added value for clinical practice. Lawitz et al.8 addressed the retreatment with SOF/LDV and RBV for 24 weeks in patients that had failed a previous course of SOF/LDV for 8-12 weeks ± RBV; although only 41 patients were studied, the results showed a clear impact of the number and the type of RAS in NS5A on SVR12: patients that had no RASs at failure achieved 100% SVR12 rates when they were retreated with the same regimen they had failed, but with a 24 week duration and with RBV. Some other trials such as QUARTZ-I9 and CSWIFT-retreatment10 have also addressed the retreatment of patients failing the 3D regimen or GZR/EBV with the addition of SOF and RBV, with excellent results. Real-life studies have also addressed the importance of resistance testing for the retreatment of patients who have failed a first line DAA therapy: Vermehren et al.11showed excellent results in a German real life cohort when retreatment was resistance-guided; in a similar way, Cento et al.12 and Perez et al.13 also show data on resistance-guided retreatment of first line DAA failures in large Italian and Spanish cohorts, respectively.

Although resistance has been proven to play a role on both initial treatment and retreatment, there are some important caveats for the introduction of resistance testing in clinical practice that need to be highlighted. As EASL guidelines underline, the test needs to be reliable and interpretable. Reliability is certainly an issue, and only accredited laboratories with sufficient expertise both on technical issues on DNA sequencing and HCV RAS interpretation should provide results. Variability of interpretation is also important, as no clinically validated rules of interpretation are available so far. Although the Lontok et al. consensus14on HCV interpretation may help for a uniform interpretation of the results, the document is now outdated, as new drugs that are currently available, and new RASs that have been described, are not in the text. Several actions aiming to provide guidance on sequencing methods and RAS interpretation are currently being evaluated for publication in high impact HCV journals and will soon be available for public use. Hopefully, these guidance documents may help to make resistance testing for HCV more reliable and interpretable, and will certainly contribute to improve access to resistance testing in many settings.

New combinations of drugs, including very potent and pangenotypic drugs, such as voxilaprevir (VOX), glecaprevir (GLE), pibrentasvir (PIB), ruzasvir (RZR), uprifosbuvir (MK-3682), are currently in different phases of drug development and have entered phase II/III clinical trials. Some of these combinations are proving to be extremely efficacious for the treatment of interferon treatment-experienced, cirrhotic patients infected with the difficult to treat genotypes 1a and 3, and have already shown excellent SVR rates for treating patients that have also failed interferon free DAA containing regimens (Table 1). Presumably, when these combinations become available, RAS testing may not play an important role for clinical practice. However, we do not know yet how these drugs will be used, and how will they be rolled-out across different countries. In the meantime, until they are here, there is a clear role of RAS testing in the clinical practice, and a need to improve access to reliable testing and interpretation. HCV infected patients will certainly benefit from it.

Table 1. New drug combinations that have demonstrated high SVR rates in patients who have failed a prior course of interferon free DAA regimen

Authors’ contributions statement: ABP and NC drafted the paper; FG reviewed and edited the paper. All authors read and approved the final version of the manuscript.

Conflicts of interest: all authors – none to declare.

Source - http://www.germs.ro/en/Articles/Resistance-testing-for-the-treatment-of-chronic-hepatitis-C-with-direct-acting-antivirals-when-and-for-how-long--586

Clinical Thought - How I Use Resistance Testing to Guide Management of Patients With Chronic Hepatitis C

How I Use Resistance Testing to Guide Management of Patients With Chronic Hepatitis C

Mark S. Sulkowski MD - 9/15/2015

Recently, I have begun to hear many questions from colleagues and trainees regarding the use of resistance testing in the management of HCV-infected patients. To be honest, my answers to their questions are not always straightforward, as this is a rapidly evolving area of discussion in the field and I am confident that my opinion will evolve along with the data.

When Resistance Testing Is Recommended 

That said, the AASLD/IDSA guidance has now highlighted at least one patient population for whom resistance testing with commercially available assays can be used to guide treatment decisions: Persons for whom treatment is urgent and previous treatment with NS5A inhibitors has failed to achieve cure. This would include previous exposure to such regimens as ledipasvir/sofosbuvir, ombitasvir/paritaprevir/ritonavir plus dasabuvir, and daclatasvir plus sofosbuvir. We know from follow-up data of patients treated in clinical trials that resistance associated variants (RAVs) against any of the available DAAs are likely to be detected upon on-treatment virologic breakthrough or posttreatment relapse with the exception of the nucleotide analogue NS5B inhibitor sofosbuvir. More importantly, we know that variants that are associated with resistance to NS5A inhibitors, including ledipasvir, ombitasvir, and daclatasvir, are likely to be stable and detectable for as long as 2 years after treatment. 

Read more 

• Module (Coming soon)
  • •
    HCV Resistance Alert Module (Coming soon)
• CCO Slideset (Coming soon)
  • •
    HCV Resistance Alert Slides (Coming soon) 

Lab21 Secures European and USA Patents for HCV Drug Resistance Genotyping

press release
May 15, 2012, 5:00 a.m. EDT

Lab21 Secures European and USA Patents for HCV Drug Resistance Genotyping

CAMBRIDGE, England, May 15, 2012 (BUSINESS WIRE) -- Lab21 Limited, the Cambridge, UK-based specialist in personalised medicine has secured new patents in Europe and the USA relating to Hepatitis C (HCV) drug resistance as it continues to expand its intellectual property portfolio in infectious disease testing.

The patents cover technology allowing the genotypic identification of drug resistant mutations in the 4 major global genotypes of HCV. The new patents represent successful extensions of the original European approval, granted in 2009. The US patent is the first successful patent Lab21 has secured in North America to protect its growing business.

There is significant commercial interest in the development of small molecule HCV therapeutics with two licensed protease (NS3) inhibitors already available today and at least 10 new molecules in clinical trials.

Dr Berwyn Clarke, CSO at Lab21 commented: 'Lab21 has extensive experience in the area of antiretroviral drug resistance from many years of working in HIV. With the number of new HCV therapeutics in development and the changeable nature of the virus, we expect routine resistance analysis for HCV patients to be introduced into clinical guidelines in the near future. Our IP in this area will be of great importance to the clinical management of these patients and will enable easy drug resistance monitoring during clinical trials.

The patents build on Lab21's growing intellectual property portfolio, which includes pharmacogenetic markers, disease markers and proprietary assay technology. Lab21 is investing in the development of a number of novel infectious disease and cancer assays which will secure a highly competitive position in diagnostic markets which are undergoing significant change, such as companion diagnostics.

Graham Mullis, Lab21 CEO added 'The development of an extensive IP portfolio which adds novel content to our offering in the market is an important part of Lab21's growth strategy. Given the significant market opportunity that HCV drug resistance presents in the future, Lab21 is looking to not only have its own commercially available assay but is actively seeking partners who are interested in developing such products too'.

About Lab21

Lab21 is a global leader in personalised healthcare. It provides diagnostic products and services and supports blood bank screening, medical diagnostics and drug discovery. Lab21 customers include international healthcare providers, pharmaceutical and diagnostic companies. The Products division of Lab21 manufactures immunodiagnostic kits and reagents that are distributed internationally and is focused on infectious diseases for the blood-banking and clinical markets. Our clinical services operations has a growing test portfolio providing companion diagnostics and high technology molecular assays. Lab21's corporate offices are based in Cambridge, UK and South Carolina, with a GMP manufacturing site in Cambridge and other manufacturing facilities in Newmarket, Camberley, Manchester and Bridport. Website: www.lab21.com

SOURCE: Lab21
Lab21
Graham Mullis, CEO
or Dr Berwyn Clarke, CSO
t: +44 (0)1223 395461
e:graham.mullis@lab21.com  
berwyn.clarke@lab21.com
For media and investor enquiries:
College Hill
Nicole Yost or Gemma Howe
t: +44 (0)20 7457 2020
e: lab21@collegehill.com

http://www.marketwatch.com/story/lab21-secures-european-and-usa-patents-for-hcv-drug-resistance-genotyping-2012-05-15