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Tig


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Improvements following SVR. Positive reports!

Hepatic manifestations and SVR

Vasculitic Manifestations



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Tig

61 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 1-4 years!

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Insight on the Social Science of HCV 



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HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 63 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

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Real world study proves efficacy of Mavyret.

Thomas Berg, MD, Paris, France 

 



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61 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 1-4 years!

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Article about kratom use in U.S.

The good, the bad, and the maybe, about kratom



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HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 63 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

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Lots of info/news/reports starting to come out of Paris, France right now, from the big "International Liver Meeting" being held there Apr 11 - 17:

 

Helio - Meeting News

Early-stage HCV treatment saves money, improves QOL

 

PARIS - Treating hepatitis C virus in the early stage of disease saves money in drug and medical costs while lowering risk for decompensated cirrhosis, hepatocellular carcinoma, liver transplant and liver-related death, according to a presentation at the International Liver Congress 2018.

"For all these outcomes, the best outcome is experienced by those who started at [fibrosis stage 0 and 1] and the worst by those who have advanced disease," Scott Johnson, PhD, MHA, an economist with Medicus Economics LLC, said during a press conference. "The advanced patients have ten-sixteenths of the lifespan and quality of life of those who were treated when they were mild."

Johnson explained that this modeling study was based upon Scotland's estimated 46,657 people with HCV. Scotland restricts access to HCV treatment to those people with late-stage disease, he said. As this model is based upon Mavyret (glecaprevir/pibrentasvir, AbbVie), Johnson explained that this policy to restrict often requires longer treatment of 12 weeks vs. 8 weeks if treating early-stage disease.

Lifetime risk for decompensated cirrhosis when treated at F0/F1 was 4%, as compared to 11.6% when treated at F4 or compensated cirrhosis. Lifetime risk for HCC when treated at F0/F1 was 1.8% vs. 35.2% when treated at F4 or compensated cirrhosis. Lifetime risk for liver transplant was 0.4% at F0/F1 vs. 2.6% at F4/compensated cirrhosis. Lastly, lifetime risk for liver-related death was 3.8% at F0/F1 vs. 41.1% at F4/compensated cirrhosis.

Johnson showed that although overall sustained virologic response rates were very similar, lifetime quality-associated life-years decreased as initial disease level increased. Patients treated for HCV when still at F0/F1 gained 16.2 lifetime QALYs. If patients reached F2/F3 before treatment, they gained 13.9 QALYs. If patients did not receive HCV treatment until F4 or compensated cirrhosis, they gained 10 QALYs.

"The cost of treating the F4/CC patient ... is much higher. It's almost twice what it is to treat the mild patient. The payer is actually paying more to treat these advanced patients," Johnson said. "That's because there's a greater disease burden ... but also because you're treating them with a longer regimen."

Direct medical costs also nearly doubled when treatment is withheld until late-stage disease, Johnson showed. If treated at F0/F1, costs are estimated to be £32,996; at F4 or compensated cirrhosis, costs are estimated to be £60,963. Johnson said £40,000 of the advanced treatment costs are drug costs.

"Even just based on drug treatment cost alone, it makes more sense to treat the earlier stage patient," Johnson said.

"This study shows the impact that delayed treatment can have on a patient's life, including consequences such as liver morbidity and mortality, as well as extrahepatic complications," Sammy Saab, MD, professor of medicine and surgery at the University of California, Los Angeles, said in a press release. "Beyond benefits to the patients, early treatment can generate significant savings by reducing clinical risks and allowing for a shorter, 8-week duration of treatment across all genotypes." - by Katrina Altersitz

For more information:

Pinsky B, et al. PS-058. Presented at: International Liver Congress; Apr. 11-15, 2018; Paris, France.

Disclosure: This study was supported by AbbVie. Medicus Economics, LLC received consulting fees for research from AbbVie. Saab reports being a consultant to and serves on speaker bureaus for AbbVie Inc., Bristol-Myers Squibb, Gilead, Janssen and Merck.

 

 

 



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HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 63 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

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8-weeks Mavyret therapy effective regardless of patient characteristics!

Hepatitis C treatment with Mavyret for 8 weeks had an overall sustained virologic response rate of 98% regardless of baseline patient or viral characteristics in a cohort of patients with genotypes 1 through 6, according to a recently published study.

8 Week Mavyret Success Rates



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61 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 1-4 years!

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According to researchers, more than 6% of baby boomers tested positive for hepatitis C virus antibodies during a recent 7-month period at a small-city New Jersey ED — twice as high as the CDC estimate for the high-risk group. Get tested and get treated! Waiting should not be provided as an option. 

New Jersey Baby Boomers & HCV Rates



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Tig

61 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 1-4 years!

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IN THE JOURNALS

HCV eradication with DAAs improves carotid thickening

 

Hepatitis C eradication by direct-acting antivirals improved carotid atherosclerosis in patients with severe fibrosis regardless of the presence of additional metabolic risk factors, according to recently published data.

"Emerging data ... support a link between HCV infection and cardiovascular alterations," Salvatore Petta, MD, PhD, from the Università di Palermo, Italy, and colleagues wrote. "In our cohort of HCV patients with severe fibrosis and, in two-thirds of cases, compensated cirrhosis, HCV eradication by DAA improved carotid atherosclerosis in terms of reduction of both [intima-media thickness (IMT)] and carotid thickening."

The study comprised 182 patients with advanced chronic HCV or compensated cirrhosis due to HCV who underwent DAA therapy. As controls, Petta and colleagues reviewed data of 76 patients with HCV who previously underwent observation for atherosclerosis progression and had not undergone DAA therapy.

"Concerning this topic, available results on cohorts of patients who underwent [interferon]-based therapies are very controversial, ranging from no impact of liver fibrosis to an improvement in cardiometabolic prognosis, to a more pronounced effect in patients with mild disease or in patients with advanced fibrosis/cirrhosis," Petta and colleagues wrote.

Among the study cohort, 14% were obese, 41.8% had hypertension, 20% had diabetes and 42.9% had carotid thickening and carotid plaques. Mean IMT was 0.94 mm.

The researchers observed that older age was independently linked with carotid thickening (OR = 1.07; 95% CI, 1.03-1.1) and both older age (OR = 1.04; 95% CI, 1.01-1.08) and lower platelets (OR = 1; 95% CI, 1-1.01) were risk factors for carotid plaques.

From baseline to follow-up at 9 months to 12 months, mean IMT decreased significantly after patients achieved sustained virologic response with DAA therapy (0.94 vs. 0.81 mm; < .001). The researchers also observed a significant reduction in the proportion of patients with carotid thickening (42.8% vs 17%; < .001).

Blood glucose levels improved in both patients with (134.7 vs. 90.7; < .001) and without (95.7 vs. 88.6; < .001) diabetes. Some patients with diabetes achieved a reduced need for insulin or oral antidiabetic drugs.

In a subgroup analysis, the researchers found that IMT and carotid thickening (IMT > 1 mm) improved significantly in patients younger than 65 years (P = .001) and those older than 65 years (P < .001), patients without obesity (P < .001), both smokers (P= .003) and nonsmokers (P < .001), patients with (P = .007) and without diabetes (P< .001), patients with (P = .002) and without hypertension (P < .001), and patients with (P = .03) and without hypercholesterolemia (P < .001).

"We found that SVR by DAA leads to reduction in IMT and in the prevalence of patients with carotid thickening at risk for cerebro-cardiovascular events, while no changes were observed in untreated patients," the researchers concluded. "We also found that the effect of SVR on carotid atherosclerosis was maintained independently of the severity of liver damage - cirrhosis vs. advanced fibrosis and lower vs. higher platelet values." - by Talitha Bennett

Disclosure: The authors report no relevant financial disclosures.

So, it seems HCV cures are good, for everyone, on many levels!  smile C.



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HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 63 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

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Small population! The whole country at par with some of the other small "regular" trial studies we have seen! But, nice how this worked out for Iceland and Gilead.

Just too bad all those poor GT 3's (at the beginning of the year - Jan to Oct 2016), if they were first to belly up to the bar, were only offered Harvoni with Riba, as after Oct 2016, (in Nov) the GT 3's got Epclusa.

Had I been one of the lucky Icelander's, getting free treatment, as a GT 3, I woud have wished for my treatment to have commenced later, in Nov!

 smile wink C.

 

 

IN THE JOURNALS

Icelandic HCV elimination program treats majority of viremic population

 

Since its launch in 2016, a hepatitis C elimination program in Iceland has treated approximately 56% to 70% of the estimated viremic population with direct-acting antivirals, according to a recently published update.

"The idea was to offer DAAs to all HCV-positive patients within an entire population within a relatively short time frame and simultaneously initiate an observational study with long-term follow-up," Sigurdur Olafsson, MD, FACP, Landspitali University Hospital, and colleagues wrote. "Gilead would, in a study setting, provide DAAs free of charge for the project."

The Treatment as Prevention for Hepatitis C in Iceland program, or TraP HepC, was designed to treat a majority of Icelanders with HCV, including injection drug users. The concept was initially discussed in 2014 and then put into action in 2016.

"With the TraP Hep C program, Iceland is taking a cohesive, multipronged approach that includes scale-up of prevention, testing and early treatment of hepatitis C in both hospital and community settings," the researchers wrote. "It includes a multidisciplinary public health model of care and cooperation between government, health services, the penitentiary system and community organizations."

According to Olafsson and colleagues, Iceland has seen 40 to 70 new cases of HCV each year over the last 20 years with an estimated viremic population of 1,100 (range, 880-1,300) in 2014 for a population prevalence of 0.3% (range, 0.3-0.4). Most individuals with HCV in Iceland also have a history of injection drug use.

During the initial phase from January to October 2016, all patients with HCV received treatment with Harvoni (ledipasvir/sofosbuvir, Gilead Sciences) for 8 weeks to 12 weeks. Patients with genotype 3 also received ribavirin. After November 2016, all patients received Epclusa (sofosbuvir/velpatasvir, Gilead Sciences).

The program also included an increased focus on screening efforts, especially among injection drug users, and improving harm reduction strategies in the country. The researchers estimated that an 80% reduction in domestic incidence is achievable by 2025 if a minimum of 75 out of 1,000 injection drug users are treated per year. If 188 of 1,000 injection drug users are treated per year, the same reduction rate may be achieved by 2020.

"It has been estimated that by offering treatment to up to 200 patients every 4 months, the majority will be treated within the first two years of the program," the researchers wrote.

Additional goals of the project include measuring the short-term and long-term effects of the program regarding the incidence of HCV infection in Iceland, the incidence rates of cirrhosis and hepatocellular carcinoma related to HCV, virologic response rates, compliance to treatment, and prevalence among injection drug users over a 15-year span.

"These data as well as the data generated during the project will be used to assess the effect of the intervention on the future burden of illness for patients and society," the researchers wrote.

Since its launch, 557 patients with HCV have been evaluated for an estimated range of 56% to 70% of the viremic population. Of those, 526 patients initiated treatment with DAAs, 37% of whom reported injection drug use within 6 months.

Patients who were homeless (74% vs. 94%; = .0005) and those who reported current injection drug use (87% vs. 95%; = .003) were less likely to achieve sustained virologic response compared with others.

"Although some parts of this program are empirical in nature and highly dependent on intangibles, such as vigilance and motivation amongst health care professionals and the public alike, it is hoped that treatment as prevention will lower the incidence and morbidity associated with HCV well in advance of the WHO targets," the researchers wrote. "The results of Icelandic project will provide important data and inform others globally trying to achieve the WHO hepatitis C elimination goals." - by Talitha Bennett

Disclosure: Olafsson reports he received speakers fees from Merck. Please see the full study for the other authors relevant financial disclosures.



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HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 63 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)



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IN THE JOURNALS

Transplanting HCV-infected kidneys safe, feasible

 

Treating recipients of a kidney from a donor with HCV with direct-acting antiviral medications before and after transplantation is safe and prevents chronic HCV infection, according to findings published in Annals of Internal Medicine.

"Right now, most of the usable organs from donors with hepatitis C are discarded because there are very few hepatitis C-positive recipients on the waiting list," Niraj Desai, MD, from Johns Hopkins University School of Medicine, said in a press release. "Figuring out how to use these kidneys is a way to do more transplants and save more lives."

Desai and colleagues conducted an open-label nonrandomized trial to investigate whether using direct-acting antivirals before and after kidney transplant from donors with HCV to recipients without HCV is feasible and well-tolerated.

The researchers enrolled 10 patients aged 50 years or older without HCV who received a kidney transplant from a deceased HCV-positive donor. Immediately before transplantation, patients received a dose of Zepatier (100-mg grazoprevir/50-mg elbasvir, Merck).

Participants who received kidneys from donors with genotype 1 infection continued to take grazoprevir/elbasvir after the transplantation for 12 weeks. Recipients of kidneys from donors with genotype 2 or 3 infection took 400 mg of Sovaldi (sofosbuvir, Gilead Sciences) in addition to the combination of grazoprevir/elbasvir for 12 weeks.

Data showed that adverse events attributable to treatment were not experienced by any of the transplant recipients. After the 12 weeks of treatment, there was no evidence of HCV RNA found in any participants.

"In this era of organ shortages, it's difficult to watch good organs get discarded," Christine Durand, MD, coauthor of the study from Johns Hopkins University School of Medicine, said in the release. "This was a great opportunity to take a neglected public health resource and put it to good use."

The researchers noted that if these results are confirmed in larger studies, using this method for transplantation could significantly increase organ options and decrease mortality risks. - by Alaina Tedesco

Disclosure: Durand reports receiving grants from Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck Sharp and Dohme Corp., GlaxoSmithKline and ViiV Healthcare, and personal fees from Bristol-Myers Squibb, Gilead Sciences and Merck Sharp and Dohme Corp. Please see study for all other authors relevant financial disclosures.



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HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 63 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)

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Newly published research suggests that expanding hepatitis C virus testing to everyone aged 18 years and older in the United States would likely be a cost-effective way to improve HCV outcomes.

Testing all adults = Cost effective and improves outcomes. 

Expanded Testing

 



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61 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 1-4 years!

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Zepatier demonstrated high efficacy among patients with hepatitis C genotype 3, regardless of treatment experience or baseline resistance-associated substitutions, according to recently published data.

Zepatier Update



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Tig

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It affects us all, C. This group of articles describes the effect of gender and ethnicity on SVR rates. It comes down to education. Better to get this information out there so everyone has the best advantage. There are so many variables when fighting this disease. I hope people take the opportunity to read them. That‘s how we‘ll beat this thing.

Diversity in HCV



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Tig

61 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 1-4 years!

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Well that was a doozy. confuse 

Hey, if this was some kind of sick competition between British Columbia, Scotland and New South Wales, then, being that in my household we are British Columbian and Scottish, who exactly is trumping over New South Wales then? 

Weird study. Wonder how much that cost? Not funny, but to whomever holds the bigger pint, cheers eh?



-- Edited by Canuck on Sunday 25th of February 2018 04:31:05 PM

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HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 63 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

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Alcohol & DAA Use



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HCV hospital admissions are increasing. This isn’t the direction we’re striving for. NoHep 2030 will be a challenge if this keeps us...

HCV Admissions Up



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61 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 1-4 years!

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This is old, from May 2016 - and I think it may have been posted here before, but I can't find it, so I'm just putting it here again - this was some of the prior research done which is supporting the current cry for more money to be found (to the tune of 100 million) to fund/address the ongoing HIV/HCV opioid problem, so as to even begin to get a handle on todays continuing epidemic-like state of things. Things are moving slowly toward the goal of eradicating HCV.

 

 

IN THE JOURNALSPERSPECTIVE

CDC: More people die of HCV than any other infectious disease

Joy JB, et al. Lancet Infect Dis. 2016;doi:10.1016/S1473-3099(16)00124-9. 

Ly KN, et al. Clin Infect Dis. 2016;doi:10.1093/cid/ciw111.

May 5, 2016

The CDC reports that the number of hepatitis C virus infection-related deaths reached an all-time high of 19,659 in 2014, making hepatitis C the number one infectious disease that kills people.

"Because hepatitis C often has few noticeable symptoms, the number of new cases is likely much higher than what is reported. Due to limited screening and underreporting, we estimate the number of new infections is closer to 30,000 per year," John W. Ward, MD, director of CDC's division of viral hepatitis, said in a press release. "We must act now to diagnose and treat hidden infections before they become deadly and to prevent new infections."

In a new study, Kathleen N. Ly, MPH, epidemiologist in the CDC's division of viral hepatitis, and colleagues evaluated death certificates from the National Center for Health Statistics database from 2003 to 2013. They sought to measure trends in HCV-related mortality in the U.S. and compare them with 60 other infectious conditions that are routinely reported to the CDC.

Results showed that the number of deaths associated with HCV increased from 11,051 in 2003 to 19,368 in 2013. Comparatively, deaths associated with the other 60 infectious conditions decreased from 24,745 in 2003 to 17,915 in 2013.

The number of deaths from HCV represented an average annual increase of 865 deaths. The annual percentage increase was 6.2% (P <.05), according to the report. The number of deaths from the other 60 infectious conditions represented an average annual decrease of 718 deaths and annual percentage decrease of 3.4% (P < .05).

The decrease in the other infectious conditions is attributed to a decline in HIV-related deaths, as well as pneumococcal disease- and tuberculosis-related deaths. When these three diseases were combined, they were associated with a 39.9% decline in deaths from 2003 (n = 17,764) to 2013 (n = 10,683).

"Why are so many Americans dying of this preventable, curable disease? ... Once hepatitis C testing and treatment are as routine as they are for high cholesterol and colon cancer, we will see people living the long, healthy lives they deserve," Jonathan Mermin, MD, director of CDC's national center for HIV/AIDS, viral hepatitis, STD and TB prevention, said in the release.

According to the study, the HCV-associated mortality rate increased from 3.72 per 100,000 population in 2003 (95% CI, 3.65-3.79) to 5.03 deaths in 2013 (95% CI, 4.96-5.11); these represent an average annual increase of 0.14 deaths per 100,000 population per year and an average annual percentage increase of 3.4% (P < .05).

The researchers also believe that the data they collected in the study may still underestimate the burden of HCV mortality due to the fact 59% of people who died of a liver-related cause and were known to be infected with HCV did not have HCV listed as a cause of death on their death certificate, according to the report.

"There are many putative reasons why there remains underappreciation of the seriousness of HCV infection, an infection among an estimated 3.2 million U.S. residents, and continuing deficiencies in the decades-long asymptomatic incubation period that they may make clinicians and patients discount the importance of the infection; the lack of cohesive and vocal advocacy groups as many patients were former injection drug users; "compassion fatigue" from HIV/AIDS and other large acute public health problems; and currently, a new therapeutic nihilism not about the efficacy of antivirals but about their perceived cost, despite evident cost-effectiveness, " the researchers wrote.

According to the CDC, the greatest HCV burden falls on baby boomers - those born from 1945 to 1965 - many of whom have been living with HCV for many years and don't even know it.

A separate study in March, conducted by researchers at the British Columbia Centre for Excellence in HIV/AIDS and coauthored by CDC, showed the U.S. to be in an HCV genotype 1a epidemic that expanded between 1940 and 1960, subsequently declined in the early 1990s then increased slightly in the late 1990s and early 2000s.

"Many baby boomers were infected during medical procedures in the years after World War II, when injection and blood transfusion technologies were not as safe as they are today," according to the press release from the CDC, adding that without diagnosis and treatment, they were more likely to develop liver cancer and may unknowingly transmitted the disease to others.

"Healthcare providers should screen all people born between 1945 and 1965 for hepatitis C, and help those living with the virus to access treatment that, in most cases, leads to a cure," Ly told Healio.com/Hepatology. "In addition, more must be done to stop new infections resulting from injecting drug use, including the implementation of comprehensive prevention programs that comprise, among other things, rapid links to medical care, substance abuse treatment and access to sterile injection equipment." - by Melinda Stevens

Disclosure: The researchers report no relevant financial disclosures.

 

PERSPECTIVE

We've known for a long time that HCV infection was a major cause of death in the United States.  We now have evidence, among infectious diseases, it is the lead killer. The data emerge from a convergence of factors: HIV is now managed to the point where folks successfully engaged in care are living near normal life-spans and not dying like they did in the 1980s and 90s, along with the 'maturation' of HCV infection, acquired during that same time, where many HCV infected folks are experiencing fatal complications of chronic HCV infection, such as advanced cirrhosis, decompensated liver disease and hepatocellular carcinoma. Additionally, it is clear that chronic inflammation elicited from ongoing HCV viral replication over years accelerates disease progression in other organ systems such as the kidney, heart, and brain, further increasing death rates among those with HCV.

·         Michael S. Saag, MD

·         Professor of medicine, Jim Straley Chair in AIDS Research
Director of the Center for AIDS Research
University of Alabama at Birmingham

 

Disclosures: Saag reports no relevant financial disclosures.



-- Edited by Canuck on Tuesday 30th of January 2018 05:55:37 AM

__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 63 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

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Approved in 2015 in the EU. Good to see easier testing regimens in the US as well.

FDA grants premarket approval to HBV assay

 
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Tom West

Hologic Inc. announced today that the FDA has granted premarket approval to the company’s Aptima HBV Quant Assay. 

The assay is designed to measure hepatitis B virus DNA across all major genotypes, according to a press release. It uses a dual-target approach for accurate quantification over a broad linear range (from 10 IC/mL to 1 billion IU/mL) and can tolerate various mutations in the HBV genome. 

The Aptima HBV Quant Assay is the newest viral load assay that runs on the Panther system, which provides sample-to-result automation, the release said. It can be used in parallel with the Aptima HCV Quant Dx Assay for hepatitis C virus and the Aptima HIV-1 Quant Assay, which recently received WHO prequalification status

“This approval represents a milestone for Hologic’s growing virology assay menu,” Tom West, president of the Diagnostic Solutions Division at Hologic Inc., said in the release. “We now have available on a single system the three major viral load assays that most laboratories are asked to run for patients.” 

Other assays that run on the Panther system can test for chlamydia, gonorrhea, trichomonas, HPV and herpes simplex virus. 

“We hear repeatedly from clinical laboratory customers that menu consolidation is a top priority,” West said in the release. “Offering a robust virology and women’s health menu on a single automated platform will enable them to reach their efficacy goals.” 

Disclosure: West is an employee of Hologic Inc

Reference Article



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This is kinda for Lamont, as he was looking at Vit D, but more in relation to his eye. But, Vit D also comes up along side of "gas" and IBS it appears. This evidence does not look very strong, but ... if you click on the link (at top, just below the title - here, in case it does not open - Williams CE, et al. Eur J Clin Nutr. 2018;doi:10.1038/s41430-017-0064-z. ) it will lead you to another article and at the bottom of that writing are further references to studies. Cal and D with maybe a grain of salt?? wink Always keep an open mind and a jaundiced eye, oh, mm, maybe I should just stick with the "take all theories in progress with the grain of salt". 

 
Healio - Gastroenterology - Irritable Bowel Syndrome - IN THE JOURNALS - January 25, 2018

Vitamin D supplements may ease IBS symptoms

Williams CE, et al. Eur J Clin Nutr. 2018;doi:10.1038/s41430-017-0064-z.

 

Vitamin D could be effective in treating the painful symptoms associated with irritable bowel syndrome, according to a study published in The European Journal of Clinical Nutrition.

Bernard M. Corfe, MD, of the molecular gastroenterology research group and the academic unit of surgical oncology, in the department of oncology and metabolism at the University of Sheffield in the U.K., and colleagues organized and contextualized data from previous studies and found a correlation between vitamin D deficiency and irritable bowel syndrome (IBS).

"This study provides an insight into the condition and, importantly, a new way to manage it," Corfe said in a press release.

The investigators analyzed four observational studies and three randomized controlled trials that all indicated a link between vitamin D and IBS.

In addition to finding a prevalence of vitamin D deficiency in patients with IBS, they found vitamin D supplements could help to ease painful IBS symptoms like bloating, diarrhea and constipation, according to the press release.

In one observational study, researchers found that one woman's IBS symptoms significantly improved after receiving a high-dose, daily supplement of vitamin D.

Intervention studies based in the U.K. and Iran all indicated a link between vitamin D and IBS.

Despite the limited evidence provided by the analyzed studies, Corfe and colleagues feel that there is enough evidence to incorporate vitamin D assessment into the routine treatment of IBS. They also noted a need for further study in the area.

"It is evident from the findings that all people with IBS should have their vitamin D levels tested." Corfe said in the press release. "A large majority of them would benefit from supplements." by Alex Young

Disclosures: The study was funded, in part, by BetterYou Ltd, which markets vitamin D supplements.

 

 

 

 



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GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

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Good news regarding re treatment with Sofosbuvir (Sovaldi) following a relapse with Epclusa. That by itself is rare. Just 3 years ago and earlier, we clawed through treatments looking for one that had a 50/50 rate of success and it took 6 months to a year to find out. Forgive me for wavering, but the current rates of success, without the side effects in most cases, are becoming the norm. How cool is that? Very!

Retreatment After Epclusa

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Moderate coffee intake reduces risk of liver cancer, cirrhosis and fibrosis. Drink up!

Coffee Benefits   



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In recent years, mortality rates and progression of disease severity has decreased among patients with hepatitis C on the liver transplant waitlist, according to recently published data.

Healio TP Article

Waitlist Decreasing

 



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Hm, last count, 9 countries eh? and the USA not one of them? The Who's who list of who's gonna meet the 2030 hepc erradication goal ... uh, what's the name of that country again ... oh, you know ... oh ya! - Canada!, um, where is that again? ... oh ya, somewhere near the USA isn't it?

Huh, not even a dishonourable mention in that article for little ole Canada!

Wonder how Canada compares, on the big scale of hurry up eh?

Could you guess how we are doing? - we can't even seem to get our head count right for how many hepc'ers we have here! Now, with that kind of math, Canada should reach erradication either VERY quickly, or, maybe never!



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HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 63 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

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Nine countries on track to end HCV by 2030, US not among them

 

Australia, Brazil, Egypt, Georgia, Germany, Iceland, Japan, the Netherlands and Qatar are on course to eradicate hepatitis C by 2030, according to data presented at the World Hepatitis Summit in Brazil. 

“This new data shows that elimination of hepatitis C is possible. It also shows more must be done to support governments in tackling viral hepatitis,” Charles Gore, president of the World Hepatitis Alliance, said in a press release. 

At this year’s summit, Brazil, Egypt, Australia and Georgia were given special attention for their work to eliminate viral hepatitis. Egypt is committed to screening 30 million people for HCV before 2019 and mass produce generic versions of direct-acting antivirals (DAAs) to lower costs of treatment (less than $200 per 12-week course), according to the release... (cont)

Eradicate by 2030?

 



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Sadly, the rate of new infection is on an alarming rise. Still, the risk of vertical transmission is  low, as this article indicates. That isn’t a reason to dismiss the increased infections as no big deal. The simple fact that we’re seeing the infection rates rise, tells me we have a long road ahead. We are hoping to eradicate it by 2030, these numbers are going the wrong way. Thanks to Healio for content.

Mother-to-infant HCV transmission risk on the rise in Wisconsin

 

The proportion of pregnant women with hepatitis C virus infection who receive Medicaid in Wisconsin has risen dramatically, suggesting an increased risk for mother-to-infant transmission, according to an MMWR.

As HCV infection among women of child-bearing age increases both in the Midwest state and nationally, clinicians must step up diagnostics and surveillance, researchers wrote in the report.

“Enhanced identification through HCV screening during pregnancy and public health follow-up to monitor infants at risk for vertical transmission are needed,” Theresa Watts, MPH, of the University of Wisconsin School of Nursing, and colleagues said.

To assess the risk for vertical HCV transmission in Wisconsin, the researchers examined data from reports of infection in the Wisconsin Electronic Disease Surveillance System and childbirths among women on Medicaid in Wisconsin between 2011 and 2015.

During that period, HCV infection among pregnant women increased by 93% — from one in 368 pregnancies to one in 192. Out of 183 children born to women with evidence of HCV viremia, 34% were tested for the virus as recommended, the researchers said, and vertical transmission was reported in 4% of infants.

Watts and colleagues also cited prior research showing that, nationwide, one in 308 infants were born to women with HCV in 2014. The findings from Wisconsin and the United States as a whole call for improved surveillance, the researchers said.

They recommended following a recent position statement on notification of HCV vertical transmission issued by the Council of State and Territorial Epidemiologists. The statement, in part, recommends that all U.S. states and territories make it a notifiable condition.

“Adoption of this position statement by state and local health departments, along with enhanced identification of HCV among women of childbearing age, can improve care for HCV-infected women and infants at risk for HCV vertical transmission,” Watts and colleagues wrote. – by Joe Green

References: 

Council of State and Territorial Epidemiologists. Public Health Reporting and National Notification of Perinatal Hepatitis C Virus Infection. http://c.ymcdn.com/sites/www.cste.org/resource/resmgr/2017PS/2017PSFinal/17-ID-08.pdf. 2017. Accessed October 26, 2017.

Watts T, et al. MMWR Morb Mortal Wkly Rep. 2017;10.15585/mmwr.mm6642a3.



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HCV clearance lowers liver cancer risk by 70% no matter drug of choice

 

WASHINGTON — Reaching sustained virologic response with direct-acting antivirals reduced the occurrence of hepatocellular carcinoma by 71%, but all treatments that cleared the virus saw a similar reduction in risk, according to a presenter at The Liver Meeting 2017. 

“Our results show that DAA-induced SVR is associated with a 71% reduction in HCC,” George N. Ioannou, MD, from the University of Washington, said in his presentation. “Eradication of HCV is associated with a similar reduction in HCC  irrespective of the regimen used to achieve that eradication.

Link to Healio article



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Thank you, Tig.  That is an extremely interesting article and among other things, confirms for me the fact that there is still a stigma attached to those affected by HepC.  For me, the emotional battle is just as difficult to overcome as the physical one.  I honestly have no idea how I contracted HepC, and know it's pointless to dwell on it, but can't help wondering how long I've had it and how I got it.



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diag. 6/2017, GT 1a, VL 7.64 mil

Fibrotest-.41 (F1-F2) ; Actitest/Metavir 0.18; Apri: 0.266

Mutations detected: Q30H/Y, H58Q

Alt-33;  Ast-28

4 week:  VL<15; ALT-7 AST-11: 8 week: VL-UND, ALT-9, AST- 9

 Epclusa SOT 8-31-17; EOT 11-22-17

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I found some barriers to treatment that still exist. As individuals that complete treatment on these incredibly effective DAA’s, it’s important to get the word out, just how effective, and how easy the side effects profile is. People shouldn’t be afraid to start treatment! These aren’t the treatments from the recent dark ages of Interferon, Ribavirin and whatever else they could throw at you! They were awful drugs and difficult at the best of times. That was then and today is all about the new DAA’s! Effective, easy and getting more accessible all the time. Spread the word!  Credit to Healio.com for HCV Next.

Cost, fear of side effects key barriers to HCV treatment

 

Cost, insurance and apprehension of side effects were the leading barriers to hepatitis C treatment, according to results from a recent survey of individuals either cured or not cured of HCV.

Sara Hayes, MPH
Sara Hayes

Hepatitis C in America was the third annual survey by Health Union and primarily included community members from HepatitisC.net. The survey design was to evaluate the community’s perceptions of HCV and HCV treatment, how those perceptions may have changed over time, and to engage newly diagnosed people.

“We find that these are a lot of the questions they want to be asked because they might not be asked these questions by anybody else and they like to see how they stack up against others,” Sara Hayes, MPHSenior Director of Community Development at Health Union, told Healio.com/Hepatology. “It’s nice to take a survey, see the results, and say, ‘Wow, I thought I was the only one experiencing this’ — to know that a large percentage of other people, in your community, are going through exactly what you’re going through.”

From May 3 to June 26, 2017, 296 individuals cured of their infection and 313 individuals with current HCV infection responded to the survey. Most respondents were women aged between 50 and 60 years, or the baby boomer generation.

While 62% of respondents were aware of HCV prior to their diagnosis, 33% were unaware of what the infection was. Of the 55% who knew how they were infected, 47% reported current or previous injection drug use.

Thirty-nine percent of the respondents received an HCV diagnosis due to a health care provider recognizing related symptoms. Other respondents received a diagnosis after routine medical exams (31%) or after they donated blood (14%). Fatigue was the most common symptom among both respondents who were cured (79%) and not cured (85%). Fatigue (70%), depression (69%) and anxiety (63%) affected respondents’ daily lives the most.

Barriers to treatment

Most of the respondents not cured said they actively seek out information on the latest treatments and play an active role in treatment decisions for their HCV. However, 52% of the uncured respondents have yet to receive treatment and 33% received treatment in the past but are no longer on treatment.

“Upon diagnosis, one of the top concerns that respondents had was how they were going to afford treatment in addition to how it would affect their body,” Hayes said. “There is a large percentage who reported they’re not sure what their next step is, and they don’t really have any plans. Anecdotally, based on what we see in the community, there are a lot of people who have a bit of hopelessness and feel they may never be able to access a life-saving cure for them.”

Respondents who have not yet received treatment said they are worried they cannot afford treatment (53%), their insurance provider denied coverage for HCV treatment (25%), they have not decided with their doctor what course to take (19%), or they are worried about the potential side effects of treatment (19%).

Of those who received HCV treatment, either cured or not cured, 28% stopped treatment early. The reason for 40% of those who stopped early was drug-related side effects. Overall, 148 respondents reported they had received treatment but were not cured.

“When treatment fails, there’s both an emotional and physical toll that it takes on people,” Hayes said. “It can be really brutal to go through a whole treatment regimen and really get your hopes up and then hear that you haven’t cleared the virus. There are some open-ended responses and one respondent wrote that when the virus came back after treatment, ‘I had never been so depressed in my life.’”

Education and awareness

Among 52% of the respondents who said they had never used manufacturer-sponsored financial support programs, 37% were unaware that those programs existed for HCV.

Most of the uncured respondents (69%) were interested in HCV clinical trials as means to benefit themselves (67%) and benefit others (60%), because it may be the only way they can receive treatment (55%), or because it may be the only way they can afford treatment (47%).

Educational topics that most interested respondents included complications related to HCV, long-term outcomes, related symptoms, new HCV treatments, and managing the infection.

Resources respondents turned to most often included health care professionals (62%), HCV-specific websites (56%), internet searches (46%), general health websites (28%), and social media outlets (26%).

Respondents also listed community as an important resource, as most of those cured (93%) said they still feel like they are part of the HCV community and 30% continue to engage in community activities such as support groups, liver walks, and work with the American Liver Foundation.

According to Hayes, while recent awareness efforts have been successful, she was concerned that a focus on risk factors, such as injection drug use, could affect outreach. “It’s important for both the general public and health care professionals to be aware that a risk factor someone had for a very short amount of time 30 years ago could influence what’s going on in their health today.

“It’s really an emotional battle that many are going through because there is still so much stigma that surrounds hepatitis C,” Hayes concluded. “If we could see people for who they really are, beyond just the condition or what the label represents to you, it’s important to really see people for what their struggle is and not necessarily what the condition represents.” – by Talitha Bennett

Reference: Health Union. Hepatitis C in America 2017 Findings. July 2017. Accessed October 11, 2017.



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September Healio updates:

http://www.healio.com/hepatology/news/print/hcv-next

Tig



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I pushed the LIKE button



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  HCV Genotype 3a , now Psot-Tx was on S/riba. First VL was 5.8 mil on 7-5-13 then "und" at 3.8 weeks. 06/13/14 still und. off meds 3 days back on 7/29 Last pill 08/10/14 SVR+4

 

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I just received this update and found a number of articles pertinent to our favorite subject!

http://www.healio.com/infectious-disease/hepatitis-c

Tig



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