A 30-member panel of doctors and health experts will, for the first time, address the cost effectiveness of hepatitis C drugs in updated guidelines that may change prescribing and coverage for the medicines, Bloomberg News reports. The panel is a joint effort by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, which together represent more than 10,000 physicians, health workers and scientists. ”The panel will explicitly consider cost and cost- effectiveness,” says Benjamin Linas, a panel member and physician.
Meanwhile, the U.K.’s National Institute for Health and Care Excellence endorsed Harvoni, the newest Gilead Sciences GILD -1.00% treatment for hepatitis C, for use on the state health service in the U.K., where it costs significantly less than in the U.S., according to Reuters. Harvoni, which combines Gilead’s drug Sovaldi with another of its anti-viral medicines into a daily pill, is priced at $58,400 for a 12-week treatment course – a third less than in the U.S. And PMLive notes that, unlike Sovaldi, Harvoni will not face a funding delay in the U.K.
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Tuesday, March 3, 2015
U.S.A; Gilead Announces SVR12 Rates From Phase 3 Study Evaluating Harvoni® for the Treatment of Chronic Hepatitis C in Patients Co-Infected With HIV
“This trial provides strong evidence that people who are co-infected with HIV can achieve very high rates of hepatitis C cure with a combination direct-acting antiviral regimen,” said Susanna Naggie , MD, MHS, Director of Infectious Diseases Research at Duke Clinical Research Institute and Principal Investigator for the ION-4 study. “These high cure rates were observed in most of the historically difficult-to-treat sub-populations, including those who failed previous treatment and those with cirrhosis. We are greatly encouraged by these findings.”
ION-4 is a Phase 3, multicenter, open-label study investigating the efficacy, safety and tolerability of Harvoni treatment for 12 weeks in 335 patients with HCV genotype 1a (75 percent), 1b (23 percent) or 4 (2 percent) and HIV-1 co-infection. The study included HCV treatment-naïve (45 percent) and treatment-experienced (55 percent) patients, including patients with compensated cirrhosis (20 percent), whose HIV was suppressed using one of three HIV antiretroviral (ARV) regimens: tenofovir and emtricitabine with efavirenz (Atripla®), raltegravir or rilpivirine (Complera®).
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HealthWise: Children with Hepatitis C —Lucinda K. Porter, RN
Rick Nash has had hepatitis C his entire 29 years of life. He didn’t know about the infection until the summer prior to starting 7th grade. Rick wasn’t even a teenager, and he was already showing signs of advanced liver disease from chronic hepatitis C virus (HCV).
Rick acquired HCV when he was an infant. Approximately 6% of infants with HCV-positive mothers will acquire the virus perinatally: This is known as vertical transmission. When Rick learned that he had hepatitis C, his mother was diagnosed too. Up to 4000 children in the U.S. contract HCV vertically every year.
According to NHANES-III, about 0.17% of 6-11 year olds (31,000) and 0.39% of 12-19 year olds (101,000) are HCV antibody-positive. This amounts to roughly 23,000 to 46,000 children in the US with HCV. Vertical transmission is the most common way children acquire HCV. Another frequent HCV transmission mode is via drug use, which is infecting adolescents at alarming rates.
Before going further, it is important to note that information about HCV in the pediatric population is disturbingly minimal. The best source of information comes from the practice guidelines by the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) published in June 2012. With no mention of the newest HCV treatments, the guidelines are outdated.
NASPGHAN admits that little is known about the pathophysiology of HCV in infants and children. “Infants may have certain defense mechanisms, possibly age-related, which explain the relative inefficiency of mother-to-infant HCV transmission.”1 Nonetheless, HCV during childhood is still quite serious. There is a 26-fold increased risk of liver-related death associated with chronic HCV acquired in childhood.
Generally, HCV progression in children is not as severe or as rapid as it is in adults. However, significant fibrosis or cirrhosis may occur, as was the case with Rick. Pediatric liver transplantation from HCV is rare. Hepatocellular carcinoma (liver cancer) is extremely uncommon in HCV-positive children.
Cognitive impairment has been observed in children with HCV. This includes developmental delay, learning disorders, and cognitive deficits. Children are less likely than adults to have HCV extrahepatic manifestations; cryoglobulinemia and lymphoma have not been reported. Glomerulonephritis (a kidney disease) may occur in children with chronic HCV.
Hepatitis C in Society
Hepatitis C doesn’t just affect the body; it affects social systems. A child with hepatitis C has complicated social systems. The child’s parents may be worried. Kids may not have the maturity to deal with the shifting sands of living with a chronic, infectious disease. Keeping others safe is a tricky issue, and these issues differ if you are five versus fifteen years old. Conversations about sex and drugs are more complicated when you have a potentially infectious virus. Telling an HCV-positive kid to avoid alcohol is an even more serious discussion than it already is.
Hepatitis C doesn’t just affect the body; it affects social systems. A child with hepatitis C has complicated social systems. The child’s parents may be worried. Kids may not have the maturity to deal with the shifting sands of living with a chronic, infectious disease. Keeping others safe is a tricky issue, and these issues differ if you are five versus fifteen years old. Conversations about sex and drugs are more complicated when you have a potentially infectious virus. Telling an HCV-positive kid to avoid alcohol is an even more serious discussion than it already is.
In the middle of all this is stigma. The public isn’t kind, especially to children living with infectious diseases. Zachary is a second grader in Virginia who is struggling with hepatitis C.2 He contracted HCV at birth and was adopted into a loving family. His family had no experience with HCV, and his mother learned all she could about it. Zach is now six, and has already undergone combination therapy with interferon and ribavirin, but didn't respond.
Zach’s mother Kelly noticed a few changes relating to school. Zach revealed that he would be in trouble if he got a loose tooth at school. He was barred from using the school computer because of concerns that he might sneeze on the keyboard. All the students except Zachary were invited to join an after school wrestling program. This occurred despite the fact that Kelly has educated the teachers and officials at school about HCV transmission.
This is a common story. We saw it with HIV. Ryan White was kicked out of school because he had HIV. The family was constantly harassed and threatened. The Ray brothers, three boys with hemophilia, experienced the same horrors. They were banned from school in Arcadia, Florida. They fought and won the right to attend, but their house was burned to the ground because of arson. Blogger Shawn Decker was another hemophiliac who was dismissed from school because of his HIV status. He also had hepatitis B and C. He lived to share his story. Ryan White and two of the three Ray brothers are dead.
Treating Children for Hepatitis C
Rick’s first glimpse at hepatitis C treatment was watching his mother go through it. “My mother would end up going on two hep C treatments while I was in school. Each treatment she went through gave me a glimpse of the insane side effects and pain she suffered from interferon. This wasn't just my mother’s pain; it was also mine.” Eventually, Rick’s mother would be cured. Rick was not as lucky.
Rick’s first glimpse at hepatitis C treatment was watching his mother go through it. “My mother would end up going on two hep C treatments while I was in school. Each treatment she went through gave me a glimpse of the insane side effects and pain she suffered from interferon. This wasn't just my mother’s pain; it was also mine.” Eventually, Rick’s mother would be cured. Rick was not as lucky.
As shocking as it may sound, the only FDA-approved HCV treatment for children is peginterferon plus ribavirin. Children with genotype 2 or 3 need 24 weeks of treatment; everyone else endures 48 weeks. Response rates are slightly more than 50%. Genotype 1 patients have the lowest rates (47%).
Side effects are common and can be quite severe. Neuropsychiatric side effects can be difficult to manage. Thinking back to my two interferon experiences, I was a wreck. I can’t imagine what it would be like if I was a youngster and didn’t have the coping skills that come with maturity.
Rick’s first treatment began when he was 18 years old. As an adult, he now had access to all the medications, however, at that time there wasn’t much. He started with interferon, a difficult treatment that did not work. He made his way down the menu of HCV treatments, and is now on his fifth attempt, using Harvoni. In the meantime, Rick struggles with decompensated cirrhosis. He has portal hypertension (high blood pressure in the liver), esophageal varices, hepatitis encephalopathy (mental confusion caused by high levels of toxins in the blood), ascites (accumulation of fluid in the abdomen), and jaundice (build-up of bilirubin in the blood which causes yellow skin and eyes, dark urine, and clay-colored stools).
If Rick were still a kid, his choices would be to use peginterferon/ribavirin, look for a clinical trial, or wait. Some pediatric hepatologists will prescribe HCV treatment off-label, but getting insurance companies to cover the cost of off label drugs is challenging. When this article was going to press, there were at least two trials for kids, but there aren’t many slots. (See ClinicalTrials.gov for more information.)
Coping
Coping with hepatitis C is hard, but coping with it when your child has it, or you yourself are a child, takes monumental strength. In his young life, Rick Nash has coped with fragile health and five HCV treatments. “My mother didn't know the risk when she had me, and she told me that in hindsight had she known, she would have been less likely to have taken the risk of having me. I told her that whatever the risk, I am glad of having been born, even if it meant I could have only done so having been given the virus. It is through this hardship I was able to better know myself, and better know my mother. Pandora opened the jar not knowing its contents, but within the dread, there was the greatest gift of all: hope.”
Coping with hepatitis C is hard, but coping with it when your child has it, or you yourself are a child, takes monumental strength. In his young life, Rick Nash has coped with fragile health and five HCV treatments. “My mother didn't know the risk when she had me, and she told me that in hindsight had she known, she would have been less likely to have taken the risk of having me. I told her that whatever the risk, I am glad of having been born, even if it meant I could have only done so having been given the virus. It is through this hardship I was able to better know myself, and better know my mother. Pandora opened the jar not knowing its contents, but within the dread, there was the greatest gift of all: hope.”
To keep up with Rick’s progress and see if he responds to Harvoni, visit Rick Nash’s Blog http://blogs.hepmag.com/ricknash/
Lucinda K. Porter, RN, is a long-time contributor to the HCV Advocate and author of Free from Hepatitis C and Hepatitis C One Step at a Time. Her blog is www.LucindaPorterRN.com
Additional Resources
- NASPGHAN Practice Guidelines: Diagnosis and Management of Hepatitis C Infection in Infants, Children, and Adolescents – Cara L. Mack, et al. Journal of Pediatric Gastroenterology and Nutrition Volume 54, Number 6, June 2013
- PKIDS – Parents of Kids with Infectious Diseases – www.pkids.org
Endnotes
- NASPGHAN Practice Guidelines
- This story first appeared on Kim Bosseley’s blog at http://blogs.hepmag.com/kimbossley
Deferring hepatitis C treatment can lead to liver cancer and death, despite cure
HIV/HCV coinfected people who delay hepatitis C treatment remain at risk for liver failure, hepatocellular carcinoma and liver-related death even after being cured – with outcomes worsening the longer it is put off – indicating that treatment should not be deferred until advanced disease, according to a presentation at the 2015 Conference on Retroviruses and Opportunistic Infections (CROI) last week in Seattle. Treating only after progression to cirrhosis increased the risk of liver-related death by more than five-fold and the duration of infectiousness by four-fold.
Over years or decades chronic hepatitis C virus (HCV) infection can lead to advanced liver disease including cirrhosis (scarring), hepatocellular carcinoma (HCC; a type of primary liver cancer) and end-stage liver failure. People with HIV/HCV coinfection experience faster disease progression, on average, than those with HCV alone. Successful hepatitis C treatment reduces - but does not eliminate - the risk.
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Over years or decades chronic hepatitis C virus (HCV) infection can lead to advanced liver disease including cirrhosis (scarring), hepatocellular carcinoma (HCC; a type of primary liver cancer) and end-stage liver failure. People with HIV/HCV coinfection experience faster disease progression, on average, than those with HCV alone. Successful hepatitis C treatment reduces - but does not eliminate - the risk.
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Monday, March 2, 2015
McHenry man cured of hepatitis through new drugs
McHENRY – Ray Roach reflects on the grim prognosis a doctor delivered to him during a hospital stay nearly four years ago and smiles.
He smiles a lot these days, in fact. Twisting free of a noose will do that for a person.
He smiles a lot these days, in fact. Twisting free of a noose will do that for a person.
Roach, 52, of McHenry is among the first of a new crop of patients celebrating a remarkable cure. Diagnosed at age 46 with Hepatitis C, a liver disease caused by the Hepatitis C virus, Roach spent years on a health see-saw, and at one point, was near death.
Spain: Hepatitis C patients’ demonstration calls for blanket provision of state-of-the-art medication
AT LEAST 4,000 Hepatitis C patients and their relatives and friends took to the streets of Madrid yesterday (Sunday) calling for the government to agree to their being given the correct medication once and for all.
Latest-generation pills which, in most cases, successfully treat the liver disease are not fully available on the Spanish health service at present because of their high cost.
Those who have been denied this medication say they are up against the clock and that if they do not get it soon, it will be too late.
India: Natco Pharma ties up with Gilead on hepatitis C drugs
(Reuters) - Natco Pharma Ltd said on Monday it has agreed a deal with Gilead Sciences Inc to supply generic copies of the U.S. drugmaker's chronic hepatitis C medicines, including $1,000-a-pill drug Sovaldi, in 91 developing nations.
Natco, a mid-sized player in India's crowded pharmaceutical industry, is the latest generic drugmaker to team up with Gilead on Sovaldi, having previously attempted to block the U.S. firm from getting a patent for the breakthrough drug in India in the hope of producing a cheaper version on its own. In September, Gilead announced similar licensing deals with seven other generic drugmakers.
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Natco, a mid-sized player in India's crowded pharmaceutical industry, is the latest generic drugmaker to team up with Gilead on Sovaldi, having previously attempted to block the U.S. firm from getting a patent for the breakthrough drug in India in the hope of producing a cheaper version on its own. In September, Gilead announced similar licensing deals with seven other generic drugmakers.
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