Friday, May 18, 2018

New Treatments Have Changed the Game: Hepatitis C Treatment in Primary Care

Infectious Diseases Clinics of North America June 2018 Volume 32, Issue 2, Pages 313–322

New Treatments Have Changed the Game
Shelley N. Facente, Katie Burk, Kelly Eagen, Elise S. Mara, Aaron A. Smith, Colleen S. Lynch

Key Points
• Although direct-acting antiviral regimens have driven up demand for hepatitis C virus (HCV) treatment, only a fraction of HCV-infected individuals are offered treatment within specialty settings.
• In 2016 to 2017, the San Francisco Health Network (SFHN) worked to improve treatment access and better understand barriers still inhibiting SFHN primary care providers from prescribing HCV treatment.
• Through SFHN’s HCV treatment expansion intervention, primary care providers were offered a 4-hour overview training about HCV treatment, an electronic referral system, and a team of HCV champions providing technical assistance within each clinic.
• Among SVHN patients tested for HCV over 3 years, 13.0% were found chronically infected; 578 patients were treated (19.9%), with no statistically significant differences between age, gender, or race/ethnicity of those treated and untreated.
• With minimal financial and time commitments, the SFHN primary care–based HCV treatment initiative resulted in a 3-fold increase in the number of patients treated for HCV in primary care.

San Francisco residents are profoundly impacted by the hepatitis C virus (HCV), with approximately 2.5% of the general population seropositive for HCV as of 20151 compared with a national seroprevalence estimate of 1.4% (95% CI, 0.9%–2.0%).2 HCV is a significant driver of morbidity, liver cancer, and death3 and disproportionately has an impact on marginalized populations, including people of color, homeless individuals, people with a history of incarceration, and people who inject drugs.4, 5, 6, 7, 8 The availability of highly effective oral HCV treatment with few side effects, known as direct-acting antivirals (DAAs), makes HCV cure possible in nearly all infected patients.8

In the pre-DAA era, HCV treatments were complex and largely managed by hepatologists, gastroenterologists, and infectious disease physicians. As tolerable and highly effective DAA regimens have driven up demand for treatment, the relative scarcity of these specialists to the large number of infected individuals has created a bottleneck effect, resulting in only a fraction of HCV-infected individuals offered treatment in any given year.9 Even with reasonable capacity in the specialty setting, travel to specialty clinics or even the idea of attending appointments in unfamiliar settings with unfamiliar providers can be a barrier for marginalized populations disproportionately impacted by HCV.10 As treatment courses in the DAA era have become shorter, simplified, and remarkably well tolerated, recent studies have demonstrated the efficacy of treating HCV in high-prevalence primary care settings.11, 12

The San Francisco Health Network (SFHN) is San Francisco’s safety net system of care, and serves the majority of the low-income and homeless populations of San Francisco. The percentage of all active adult SFHN primary care patients who have been diagnosed with HCV is 5.5%. Part of the San Francisco Department of Public Health, the SFHN includes primary care in 10 community-based and 4 hospital-based clinics throughout the city. In 2016, in an effort to increase HCV treatment access for all patients, SFHN leadership committed to training its primary care providers to treat uncomplicated cases of HCV in the primary care setting using a team-based model of care.

In 2017, the primary care–based HCV treatment initiative team at SFHN undertook an analysis to measure the impact of these efforts to improve treatment access within the SFHN primary care system and to better understand barriers still inhibiting SFHN primary care providers from providing HCV treatment to their patients.

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Thursday, May 17, 2018

Hepatitis C and Dietary Supplements

Hepatitis C and Dietary Supplements
Most consumers assume that herbs and botanical products in dietary supplements are safe, however they are not regulated by the FDA, in addition these products can interact with prescription drugs, over-the-counter drugs, and other dietary supplements.

As an example milk thistle is the most commonly used herbal supplement in the United States for liver problems, including viral hepatitis. If you are interested in learning more about the science behind milk thistle, probiotics, zinc, or other commonly used supplements, check out the National Center for Complementary and Integrative Health (NCCIH) website, in particular the following publication: Hepatitis C and Dietary Supplements, updated this month.

HCV Next overview from EASL 2018: Dr. Reau’s summary of key HCV data & real-world studies

May/June 2018 Issue
PCPs will play critical role in future HCV treatments
View the latest issue of HCV NEXT, published online at Healio

HCV Next is a monthly publication offering patients the latest research, news and commentary on liver disease and viral hepatitis.

Table of Contents
The Take Home
The Take Home: International Liver Congress 2018
Nancy S. Reau, MD
This year, although there was much buzz about hepatitis B virus (HBV) and nonalcoholic steatohepatitis, hepatitis C virus (HCV) still held a prominent place in the oral presentations. As clinicians, we can take home some new data about 8-week regimens, real-world data, treatment failures and retreatments and how sustained virologic response affects both hepatocellular carcinoma risk as well as the risk for extrahepatic malignancies.

International Liver Congress Offers Insight on the ‘Social Science’ of HCV
Ira M. Jacobson, MD
This month’s issue has a very nice summary of the data on therapeutic regimens presented at the International Liver Congress by Nancy S. Reau, MD. For me, the meeting highlighted how high is the summit to which we’ve climbed after years of a massive international effort to cure HCV, and how much the focus is shifting. We heard little about new HCV regimens and instead focused on real-world data sets on existing regimens and, equally important, the theme that HCV treatment has become as much of as social science as a medical one as we strive toward elimination. We saw an appropriate emphasis being placed on screening, linkage and access to care, including underprivileged and high-risk populations, on a national and global scale.

HCV hospitalizations increasing among baby boomers, men, drug users

PCPs will play critical role in future HCV treatments

In the Journals Plus
HCV finger-stick test accurate, gives results in 1 hour

View the Current Issues
HCV Next
Infectious Diseases in Children
Infectious Disease News

Experts Respond To Latest BMJ Article: Do direct acting antivirals cure chronic hepatitis C?

A review by the Cochrane Collaboration published June 6, 2017/updated September 8 2017, cast doubt on the effectiveness of new hepatitis C treatments, on May 12, 2018, BMJ published;Do direct acting antivirals cure chronic hepatitis C? by Cochrane author Janus Christian Jakobsen. A day later BMJ talk medicine aired this disturbing podcast with Jakobsen; New antivirals for Hepatitis C - what does the evidence prove? 

Experts Respond To Latest BMJ Article: Do direct acting antivirals cure chronic hepatitis C?
May 16, 2018
Experts weigh in with the following response: 

View BMJ Response:

Dear Editor
Viral hepatitis experts are convinced of the benefits of antiviral therapy for hepatitis C.

We were dismayed that the Editors of the BMJ presented the widely discredited Cochrane review of Hepatitis C virus (HCV) therapy as mainstream opinion (1,2). It is not. This Cochrane review contained significant methodological flaws and lacked clinical insight or knowledge of the natural history of HCV. The opinion of informed hepatologists, infectious disease, and public health physicians, as well as the World Health Organisation (WHO), the National Institute for Clinical Excellence (NICE), and all international liver associations, is that directly acting antiviral (DAA) oral therapy for hepatitis C represents a breakthrough development that prevents end stage liver disease and death (3,4). This opinion is based on the dramatic benefits following widespread use of these drugs. Independent surveillance data from the Public Health England hepatitis C annual report (5) show that deaths from hepatitis C related end stage liver disease and hepatocellular carcinoma were increasing, more than doubled, between 2005 and 2014, but have fallen since 2014 with the introduction of HCV treatment with these drugs. PHE data indicates that registrations for liver transplant and transplants undertaken, where post hepatitis C cirrhosis is given as the indication for transplant, had remained relatively stable between 2008 and 2014, but have fallen since 2014 (5). Similar changes have been seen in every country where these drugs have been introduced. There is no credible explanation for the fall in hepatitis C liver disease morbidity and mortality associated with the introduction of effective anti-virals other than the use of these drugs.

Independent experts agreed that the most appropriate end-point in therapy trials for hepatitis C was sustained virological response (SVR). This was chosen, by independent regulators as the trial end-point. It was selected because in almost every infectious disease where there is a link between the pathogen and disease, clearance of the infection is beneficial and there is evidence that SVR with interferon-based therapies reduces mortality. The reasonable assumption that viral clearance with DAAs would reduce liver-related complications has been confirmed by long term follow up studies: the English Early Access Programme (EAP) shows a fall in deaths in patients who achieved SVR (6), and emerging data from large patient cohorts confirm this. There remains a risk of hepatocellular carcinoma in patients who developed cirrhosis prior to viral clearance, but evidence from studies of patients with advanced liver disease suggests that this risk is reduced. The legitimate debate about the value of an inflammatory milieu in patients with liver cancer and the role of viral clearance in this scenario does not obviate the clear mortality benefits from therapy and can not be used to imply that physicians are concerned about therapy in patients without cancer.

Hepatitis C is an infectious virus – the obvious extrapolation that effective therapy prevents transmission has now been confirmed. Dr Jakobsen and colleagues ignore the anxiety suffered by patients who are frightened of infecting their loved ones. Quite apart from the personal benefits of DAA therapy to patients who are already infected and their immediate contacts, reducing the overall burden of infection will reduce the risk of transmission to the rest of the population. DAA treatment of hepatitis C represents a rare opportunity to eliminate hepatitis C as a major public health concern and this opportunity is clearly recognised by WHO in its Global Strategy for Viral Hepatitis.

To suggest to patients that they should continue to suffer and not access safe and highly effective curative treatments that have been used in hundreds of thousands of patients without incident is inhumane.

The clinical utility of a drug is not inversely proportional to its price and NICE’s assessment of hepatitis C antivirals is that they are cost effective. We are not aware of any data questioning the NICE review. Since this review NHSE have negotiated a reduction in the price of these lifesaving drugs and the NHS is now in a position to plan an affordable hepatitis C elimination programme. This will focus on those populations most affected – often vulnerable members of society, such as people who inject drugs and the homeless. Many patients with hepatitis C do not attend primary care physicians to discuss the risks and benefits of therapy – they attend needle exchange, drug and alcohol, and homeless health services where they need to be identified (at considerable expense), engaged and offered antiviral therapy that may save their life. This gives them an opportunity to re-engage with society and move on with their lives. The overwhelming majority of clinicians are confident that there is very convincing evidence of benefit from DAA therapy and are planning to move antiviral services to all patients to amplify the remarkable benefits already demonstrated.

Dr Jakobsen is factually correct that only a large, placebo controlled trial over several decades with death as an end-point will prove beyond all doubt that SVR improves mortality. If the BMJ believes this to be an ethical approach it should have the courage to say so, and should then make the case for patients to live with the clinical, psychosocial and public health consequences of being infected and suffer symptoms until death to prove a scientific point. In the opinion of clinical experts the current data prove, beyond reasonable doubt, that achieving an SVR stops people transmitting and dying from hepatitis C. In the early HIV era a handful of idiosyncratic scientists refused to accept the association between HIV and AIDS and recommended that effective antiretroviral therapy be withheld. Sadly some governments, notably South Africa, followed this ill-informed advice and many vulnerable South Africans died as a direct consequence. It would be unfortunate if Dr Jakobsen’s views led to a similar tragedy in HCV. We hope that the BMJ will make clear that his personal opinion is not shared by reputable clinicians and policy makers. Patients should be encouraged to be tested and then treated for hepatitis C safe in the knowledge that they will join the millions of treated patients who will be protected from liver fibrosis and premature death.

Graham R Foster NHSE ODN Clinical Lead
Kosh Agarwal, Transplant hepatologist, HCV CRG member
Matthew Cramp Chair BASL
John Dillon Chair Scottish HCV Clinical Leads
Ahmed Elsharkawy Chair BVHG
Charles Gore CEO The Hepatitis C Trust
William Irving Chair NSGVH
Sema Mendal PHE HCV Lead
Peter Moss Chair HCV CRG
Chloe Orkin Chair BHIVA
Stephen Ryder Chairman HCV Coalition

1 Jakobsen JC, Nielsen EE, Koretz RL, Gluud C. Do direct acting antivirals cure chronic hepatitis C? BMJ. 2018 May 10;361:k1382

2 Jakobsen JC, Nielsen EE, Feinberg J, etal . Direct-acting antivirals for chronic hepatitis C. Cochrane Database Syst Rev 2017. 10.1002/14651858.CD012143.pub3.

3 Powderly WG, Naggie S, Kim AY, Vargas HE, Chung RT, Lok AS.IDSA/AASLD Response to Cochrane Review on Direct-Acting Antivirals for Hepatitis C
Clin Infect Dis. 2017 Nov 13;65(11):1773-1775.

4 European Association for the Study of the Liver. Electronic address: Response to the Cochrane systematic review on DAA-based treatment of chronic hepatitis C. J Hepatol. 2017 Oct;67(4):663-664

5 Public Health England, Hepatitis C in England 2018 report

6 Cheung MCM, Walker AJ, Hudson BE, Verma S, McLauchlan J, Mutimer DJ, Brown A, Gelson WTH, MacDonald DC, Agarwal K, Foster GR, Irving WL; HCV Research UK. Outcomes after successful direct-acting antiviral therapy for patients with chronic hepatitis C and decompensated cirrhosis. J Hepatol. 2016 Oct;65(4):741-747

Competing interests: Professor Foster has previously received funding from companies that market antivirals for hepatitis C but no longer does so. PHE staff have no competing interests. Other authors have received speaker and consultancy fees from companies that market oral antiviral agents for hepatitis C. Peter Moss and Charles Gore, no personal competing interests. 

On This Blog: View each expert rebuttal and ongoing controversy 

Wednesday, May 16, 2018

Do fatigue and quality of life improve after hepatitis C is cured?

Do fatigue and quality of life improve after hepatitis C is cured?
Keith Alcorn
Published: 16 May 2018

Patient-reported outcomes such as fatigue, vitality and mental health improve substantially in the two years following hepatitis C cure for people with cirrhosis, but people with cirrhosis are less likely than others to experience rapid resolution of severe fatigue after successful hepatitis C treatment, according to two studies from the Center for Outcomes Research in Liver Diseases reported last month at the 2018 International Liver Congress in Paris.

Quality of life can be severely impaired in people with chronic hepatitis C, especially in people with cirrhosis. Fatigue, insomnia, problems in physical functioning, depression, anxiety and mood disorders are reported by a substantial proportion of people with hepatitis C....

Recommended Reading
Conference highlights

For more information on hepatitis visit
Infohep is a project we're working on with the World Hepatitis Alliance and the European Liver Patients Association.

Tuesday, May 15, 2018

Are pharmaceutical marketing payments to physicians for opioids associated with prescribing?

Are Pharmaceutical Marketing Payments to Physicians for Opioids Associated With Prescribing?

Bottom Line: Pharmaceutical industry marketing of opioid products to physicians through nonresearch payments, which can include speaking fees and meals, was associated with greater opioid prescribing.

Why The Research Is Interesting:
Many opioid-related overdose deaths involve prescription opioids, and prescription opioids can commonly be a person’s first encounter on a path to illicit use. Marketing by the pharmaceutical industry to physicians is widespread but marketing of opioids and its influence on prescribing is unclear.

What (Study Methods): Linking of two U.S databases to identify all nonresearch payments from the pharmaceutical industry to physicians marketing opioid products (excluding buprenorphine hydrochloride marketed for addiction treatment) and to gather information on all claims from physicians who wrote opioid prescriptions (initial or refill) filled for Medicare beneficiaries in 2015

Study Limitations: Possibility of reverse causation because physicians who receive industry payments may be inclined to prescribe opioids; study establishes association, not cause and effect
Amidst national efforts to curb the overprescribing of opioids, our findings suggest that manufacturers should consider a voluntary decrease or complete cessation of marketing to physicians. Federal and state governments should also consider legal limits on the number and amount of payments.

Research Letter
JAMA Intern Med. Published online May 14, 2018.
Association of Pharmaceutical Industry Marketing of Opioid Products to Physicians With Subsequent Opioid Prescribing
Scott E. Hadland, MD, MPH, MS1,2,3; Magdalena Cerdá, DrPH, MPH4; Yu Li, MD, PhD5; et al Maxwell S. Krieger, BS5; Brandon D. L. Marshall, PhD5

Despite the increasing contribution of heroin and illicitly manufactured fentanyl to opioid-related overdose deaths in the United States, 40% of deaths involve prescription opioids.1 Prescription opioids are commonly the first opioid encountered in a trajectory toward illicit consumption.2 Although opioid prescribing has declined nationally, rates in 2015 were triple those in 1999 and remain elevated in regions of the country with higher numbers of overdoses.3

Pharmaceutical industry marketing to physicians is widespread, but it is unclear whether marketing of opioids influences prescribing.4 We studied the extent to which pharmaceutical industry marketing of opioid products to physicians during 2014 was associated with opioid prescribing during 2015.
Continue reading:

Related Material: Two other studies, “Weekly and Monthly Subcutaneous Buprenorphine Depot Formulations vs. Daily Sublingual Buprenorphine with Naloxone for Treatment of Opioid Use Disorder: A Randomized Clinical Trial,” and “Association of an Opioid Standard of Practice Intervention with Intravenous Opioid Exposure in Hospitalized Patients,” also are available on the For The Media website.

For more details and to read the full study, please visit the For The Media website.
Editor’s Note: The article contains funding/support disclosures. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

How states could be saving more hepatitis C patients

How states could be saving more hepatitis C patients
BY Stephanie Hedt May 14, 2018

USC’s Neeraj Sood and colleagues propose an approach that leverages competition among drug manufacturers, saving states money and ensuring that more people get treatment

There is a cure or the nation's deadliest infectious disease, hepatitis C, but at tens of thousands of dollars per patient in upfront costs, most insurance companies can't afford to provide the treatment to all of the estimated 2.7 million to 3.9 million of Americans who are infected. This is especially true for patients on Medicaid or in the prison system, where funding has historically been restricted.

Leading experts on hepatitis C treatment policy are recommending a new novel pricing strategy, implemented at the state level, that could help many more patients access the treatment. The recommendations were published on May 14 in the Annals of Internal Medicine, and as an extended USC-Brookings Schaeffer Initiative for Health Policy report.

"These innovative therapies can cure hepatitis C, but the high costs put them out of reach for the most vulnerable populations," said Neeraj Sood, lead author on the report and an economist at the USC Schaeffer Center for Health Policy and Economics. "We wanted to come up with a better solution where we dramatically improve access to cures, control drug spending but still maintain incentives for the development of new cures."

Recognizing the important role state programs could play in this, Sood and his colleagues have developed a novel pricing strategy targeted at state policymakers. They outline an approach that leverages competition among drug manufacturers. The end result would save the state money and would ensure treatment for a larger share of the population -- all while providing incentives for future innovation in treatments.

Leveraging State Programs to Increase Access
Given current financing systems, most states can only afford to provide treatment to a small percentage of patients with hepatitis C each year. Furthermore, drug manufacturers know the only way they can increase profits is by increasing the price per pill.

"Increasing prices raises incentives for pharmaceutical innovation but limits patient access. This is the crux of the problem," said Sood, who is also a Professor and Vice Dean for Research at the USC Price School of Public Policy.

"Negotiating on revenues rather than price is the answer. Revenue-based contracting allows us to increase profits and incentives for innovation without limiting access."

Under the proposed model, states would leverage their resources to make a deal with one pharmaceutical company, offering a lump sum payment over a contracted period. The negotiated amount would be higher than the expected revenue for any one company over that timeframe, but still less than the total amount that the Medicaid program would pay to all the drug companies producing the treatment.

In return, the company would agree to provide a 100 percent rebate on drug purchases for the population designated to receive the cure, such as Medicaid patients or prisoners with hepatitis C. The move would make the drug essentially free of additional cost. It also would give the states the opportunity to significantly expand access to the treatment while maintaining their budget.

Vulnerable Populations Still Face Significant Hurdles in Accessing Treatment
According to a 2017 report, less than 3 percent of the 700,000 people with hepatitis C in state Medicaid programs and prisons receive treatment each year. This is due in large part to restrictions that many state programs implemented that limit access to the cure by requiring patients to have reached a certain decline in liver function or have remained sober for a set timeframe.

Though not supported by clinical guidelines, these restrictions are designed to narrow access, thereby limiting the immediate impact on state budgets that might arise from guaranteeing the treatment to everyone.

The consequences of these decisions are especially concerning given the recent rise in heroin use resulting from the opioid epidemic, which has led to a significant increase in new hepatitis C infections.

"Our concern is that the public health burden of hepatitis C infections will continue to grow even though we have a cure if we don't implement innovative financing programs," said Sood.

Monday, May 14, 2018

Elbasvir and grazoprevir with or without ribavirin, treatment–naive participants HCV genotype 2, 4, 5 or 6

Patients with non-genotype 1 HCV infection differ with regard to response to DAAs. This study evaluated the efficacy and safety of EBR/GZR, with or without RBV, in HCV genotype 2, 4, 5, or 6 infection.

A. Brown C. Hézode E. Zuckerman G. R. Foster A. Zekry S. K. Roberts F. Lahser C. Durkan C. Badshah B. Zhang M. Robertson J. Wahl E. Barr B. Haber on behalf of the C‐SCAPE Study Investigators

J Viral Hepat. 2018;25(5):457-464. 

People with hepatitis C virus (HCV) infection other than genotype 1 represent a heterogeneous group of individuals who differ with regard to their profile of response to all–oral, direct–acting antiviral regimens.[1,2] The recent approval of sofosbuvir/velpatasvir for people infected with HCV genotypes 1–6 now provides a single treatment option across genotypes. However, prior to the introduction of sofosbuvir/velpatasvir, treatment recommendations for genotype 2, 3, 5 and 6 were based on small studies with limited numbers of participants, or on subgroup analyses where small numbers of participants were enrolled alongside participants with genotype 1 or 4 infection.

The fixed–dose combination of elbasvir (EBR, MK–8742), an NS5A inhibitor, and grazoprevir (GZR, MK–5172), an NS3/4A protease inhibitor, is approved in the US, Europe and Canada as a treatment for HCV genotype 1 and 4 infection.[12] In those with HCV genotype 1 or 4 infection, EBR/GZR has shown efficacy in the subpopulations of treatment–naive people,[13] HIV/HCV co–infected people,[14] people who have previously failed treatment[15,16] and people with chronic kidney disease.[17] In vitro, EBR and GZR have shown pangenotypic potency in HCV replicons;[18,19] however, less has been reported about the clinical efficacy and safety of EBR/GZR in people with HCV nongenotype 1/4 infection. The phase 2 C–SCAPE study evaluated the efficacy and safety of EBR/GZR, with or without ribavirin (RBV), in treatment–naive participants with HCV genotype 2, 4, 5 or 6 infection...

Free registration may be required

Sunday, May 13, 2018

HCV in 2018: Success stories and remaining challenges? EASL 2018 Summary from NATAP

Just In Case You Missed It
Coverage highlights of EASL's 2018 International Liver Congress

The National AIDS Treatment Advocacy Project (NATAP)
Available online @ NATAP
May 4, 2018
Summary from EASL 2018 for Hepatitis C (HCV)
HCV in 2018: Success stories and remaining challenges?
With the more recent introduction of the pangenotypic regimens sofosbuvir/velpatasvir and glecaprevir/pibrentasvir, two new fix dose combinations have become available which may even overcome the need for baseline HCV genotype assessment. Larger data sets however, from real-life cohorts still are missing but this gap has been filled at this year EASL.

Healio - HCV Next May/June Issue
May 17, 2018
HCV Next, May/June 2018 Nancy S. Reau, MD 
As we in the United States look ahead to Digestive Disease Week coming up and further to our fall meetings, the International Liver Congress gives us an opportunity to…

HCV Advocate
May 1, 2018
May Newsletter
In this edition of the HCV Advocate we have devoted nearly the entire issue to the 2018 International Liver Congress. Lucinda Porter, RN and I cover some of our favorite posters and presentations in the current issue and in the upcoming June 2018 issue...

infohep bulletin
April 28, 2018
April "infohep bulletin" - Overview of EASL's 2018 International Liver Congress
Patients looking for an overview of EASL's 2018 International Liver Congress can find it in this month's "infohep bulletin"

Clinical Care Options CCO
Expert faculty members summarize key viral hepatitis studies from this important annual conference.
Review Capsules Summaries, download slides, and listen to audio commentary from expert-led Webinars covering critical studies on viral hepatitis.
*Free registration required

Practice Guidelines - EASL Recommendations on Treatment of Hepatitis C 2018
During the meeting The European Association for the Study of the Liver (EASL) released the following four major clinical practice guidelines; hepatocellular carcinoma, decompensated cirrhosis, alcoholic liver diseases and updated recommendations on hepatitis C.

EASL LiverTree - Open To All
This year webcasts and congress materials are open access! Watch freely the conferences and ePosters
*Free registration required

On This Blog
Link to websites offering coverage, meeting highlights, learning activities, and a summary of the meeting, here....