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April 23 (Reuters) - AbbVie Inc's experimental hepatitis C treatment cured up to 96 percent of patients in just 12 weeks, according to data released on Tuesday, shoring up its position in the race to deliver a potent oral therapy for the serious liver disease.
AbbVie's treatment, a combination of five oral medications, is expected to be a close contender to a treatment in development by Gilead Sciences Inc.
AbbVie said on Tuesday that about 88 percent of new patients with hepatitis C were deemed cured after only eight weeks of treatment, while 96 percent of those treated for 12 weeks eliminated the liver virus, as verified by blood tests 24 weeks after completion of treatment. If the virus is undetectable 24 weeks after completing treatment - known as sustained virologic response, or SVR 24 - a patient is considered cured. The latest findings from an ongoing trial sponsored by AbbVie, called Aviator, were unveiled at a meeting of the European Association for the Study of the Liver (EASL) in Amsterdam.
Hepatitis C affects an estimated 170 million people worldwide, and if left untreated can lead to cirrhosis, liver cancer or the need for a new liver. Existing treatments must be taken by patients for either 24 or 48 weeks and the most effective have a cure rate as high as 80 percent. The latest results from AbbVie confirmed interim data presented in October, which showed a 99 percent SVR rate for patients evaluated 12 weeks after completing a 12-week regimen of the treatment.
Gilead has been given an edge by many analysts because its experimental regimen involves fewer drugs and may be closer to reaching the market.
Bristol-Myers Squibb unveiled data on Tuesday at the meeting from a smaller mid-stage study of its three-drug combination that does not include ribavirin.
Patients in the AbbVie Aviator study had the most common, but hardest to treat, genotype 1 variation of the infectious virus.
The AbbVie regimen included three experimental direct acting antiviral drugs that each attack a different target necessary for virus replication. Kowdley, director of the Liver Center of Excellence at Virginia Mason Medical Center in Seattle, said the trial also showed impressive results among patients who had failed to benefit from earlier therapy. The cure rate after 12 weeks of treatment was 93 percent for those patients, called null responders, assessed both 12 weeks and 24 weeks after completion of their drug regimens. AbbVie said the safety of the tested drugs was similar to that seen in results presented last year. Less-serious side effects seen in more than 10 percent of patients included headache, fatigue, nausea, insomnia and diarrhea. I remember many days of pulling my car over while driving home from work, or a doctors appointment and leaning back for a nap.
I heard years ago that a study of tears was done and that the chemicals in tears of laughter differs from tears of sadness.
Autoimmune Hepatitis (AIH) is a periportal hepatitis with increased immunoglobulins and auto antibodies, which primarily responds to immunosuppression. Current treatment of AIH is based on guidelines published by the American Association for the Study of Liver Diseases (AASLD) in 2002 and comprises of corticosteroids with azathioprine.
The term Autoimmune Hepatitis (AIH) is used to describe a mostly chronic, but many times, acute and fulminant form of inflammatory liver disease, which can affect any age group but tends to predominate in women. This disease entity was first described in 1950 by Waldenstrom as a chronic form of Hepatitis in young women.2 In 1965, it became designated by Mackay et al.
The marked heterogeneity of AIH in regard to its variable presenting features, spectrum of disease severity, and presence of characteristic auto antibodies as well as response to therapy has led to several proposals for classification of the disease. Historically, Type 3 AIH represented patients with SLA antibodies or antibodies against the liver pancreas antigen (LP). Approximately 18% of patients with auto-immune liver disease present with features characteristic of a second auto-immune hepatobiliary disease, usually Primary Biliary Cirrhosis (PBC) or Primary Sclerosing Cholangitis (PSC).8 These are the so-called "autoimmune hepatobiliary overlap syndromes". The most common theory of the mechanism of inflammatory injury in AIH postulates that an environmental agent, either a drug or a virus or another agent seems to trigger a T-cell mediated cascade directed against liver antigens in genetically predisposed individuals. HLA-DR3 serotype is associated with a more severe disease pattern with an early onset and occurs in girls and young women. HLA-DR4 serotype associated disease occurs more commonly in older adults and usually responds well to immunosuppressive therapy and exhibits more extra-hepatic manifestations.10,11 HLA-DR4 serotype associated disease is more common in Japan.
The diagnostic criteria were last revised by the International Autoimmune Hepatitis Group in 2008 (Table-1) and a simplified scoring system was introduced to quantify the strength of the diagnosis. The aminotransferases are typically elevated in AIH.  A cholestatic picture although less common might also be present with an elevation of Alkaline Phosphatase and conjugated bilirubin.
Classic or Type I Autoimmune Hepatitis is mainly characterized by circulating antibodies to nuclei (ANA) and smooth muscle (SMA).
Extrahepatic manifestations of AIH may take the form of constitutional symptoms.  Dermatologic and rheumatologic manifestation may occur.
Liver biopsy findings vary from minimal non specific changes to a predominantly lymphoplasmacytic or mononuclear portal infiltrate, with the occasional presence of eosinophils, with or without fibrosis. As disease progresses, this lymphocytic or lymphoplasmacytic infiltrate, usually associated with fibrosis, invades the sharply demarcated hepatocyte boundary surrounding the portal triad and percolates into the surrounding lobule.  This periportal infiltrate is also referred to as "piecemeal necrosis" or more commonly "interface hepatitis" (Figure). Inflammatory cells actively penetrate into, and, through larger liver cells, a process called emperipolesis. The third typical feature of AIH histology is the presence of hepatic rosettes; which are clusters of reactive hepatocytes surrounded by inflammatory cells (Figure). When AIH presents as an acute fulminant hepatitis, histologic diagnosis still helps in the diagnosis through the presence of plasma cell infiltrate in the portal areas which helps distinguish it from other forms of acute hepatitis.
The absolute and relative indications that were formulated by the American Association for the Study of Liver Diseases (AASLD) in 2002 were meant to be more or less guidelines (Table-2). Corticosteroids and Azathioprine alone or combined have yielded good results when used as maintenance regimens in both adults and children, but side effects and intolerability of both these drugs remain a major concern. There are currently ongoing, open label as well as randomized controlled trials, in which mycophenolate mofetil (MMF), tacrolimus, as well as budesonide are being tested in order to limit the use of systemic prednisone in patients with AIH and avoid its long term side effects. For patients who develop End Stage Liver Disease, Decompensated Cirrhosis or severe and fulminant forms of Autoimmune Hepatitis, steroids, which are otherwise the standard of care, have little to offer and might even, worsen the prognosis.14,15,29 The only option for patients who are either intolerant, or resistant to all kinds of medical therapy , and those who have ESLD or decompensated cirrhosis, severe or fulminant liver failure, seems to be urgent liver transplantation. It is now becoming evident that therapy should not be permanently withdrawn in any patient who has not achieved complete alleviation of all significant symptoms, complete normalization of biochemical markers as well as end of inflammation on histology.

According to previous prognostic studies, 40 percent of patients with untreated severe disease may die within six months of diagnosis. The response to treatment seems to be very good in children treated with corticosteroids and Azathioprine.
Newer modalities include different immunomodulators which may be used in a more effective manner to cause cytokine manipulation. AIH is not a common condition but it is an important condition to identify in view of its poor prognosis if not recognized and appropriately treated, as well as its amenability to traditional immunosuppressive treatment.
As pointed out above, the generally agreed hypothesis as to the etiopathogenesis of AIH, points towards an environmental agent (viral infections, or drugs) as a trigger to a T cell mediated hepatocyte injury in genetically predisposed individuals. Diagnosis requires careful exclusion of other causes of liver disease together with the finding of a suggestive pattern of clinical, laboratory and histologic abnormalities, which have been clearly defined in a simplified scoring system introduced by IAIHG in 2008.
The AASLD formulated absolute and relative indications of treatments as well as treatment guidelines in 2002 based on previously conducted clinical trials as well as expert opinion in order to come up with the best possible management plan. There are currently ongoing open label as well as randomized controlled trials with newer immunomodulators and biologics, to assess their safety and efficacy in the treatment of patients with AIH, and minimize steroid related side effects. As we advance into the future, we will see the treatment of autoimmune hepatitis become one with a multi-disciplinary approach.
The ultimate goal of therapy is, and will remain the improvement of quality of life of patients, and reduce the risk of end stage liver disease requiring transplantation.
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Treatment cost for the average patient would go down by 16 to 20 percent, but for 40 percent of patients, the cost may go down by as much as 50 percent. MAYWOOD, Ill., March 23 (UPI) -- Hepatitis C patients are often cured before completing a treatment regimen, suggesting patients require less of the drugs needed to fight the disease, according to a recent study.
Researchers at Loyola University devised a mathematical model that predicts the length of time patients need direct-acting antiviral drugs, potentially limiting the cost of being treated with an expensive drug.
Using more frequent blood testing, the researchers were able to determine hepatitis C levels and predict when the drug sofosbuvir, combined with one of three others, could be stopped.
For the study, published in the Journal of Hepatology, researchers required 58 people with hepatitis C being treated at three medical centers in France.
Using early viral-kinetic analysis, researchers tested participants for blood levels of the virus at the start of the study, on the second day, every other week, at the end of the study and then 12 weeks after the study concluded. The researchers found hepatitis C levels could be predicted with frequent blood testing, and by using the calculations researchers found the projected cost of treatment dropped by 16 percent to 20 percent per 100 patients receiving treatment.
SILVER SPRING, Md., May 26 (UPI) -- A person in the United States was found to have a strain of E. Heavy drinking may fuel the risk of suicide among men when the economy is sinking, new research suggests. Women who carry common gene variants linked to breast cancer can still cut their risk of the disease by following a healthy lifestyle, a large new study suggests.
JACKSONVILLE, Fla., May 26 (UPI) -- A rare form of pancreatic cancer is susceptible to a chemotherapy drug typically used for colorectal cancers, according to new research from the Mayo Clinic. Are health officials in the United States overreacting to the threat posed by the Zika virus this summer? BOSTON, May 26 (UPI) -- Plaques that build up in the brain and cause Alzheimer's disease may be part of the innate immune response to bacterial infection, scientists found in a study.
EDMONTON, Alberta, May 26 (UPI) -- The children of mothers who ate more fruit during pregnancy had better cognitive development a year after birth, according to a study of Canadian one-year-olds. SYDNEY, May 26 (UPI) -- Opioid painkillers such as oxycodone and Percocet have minimal effects on chronic back pain, according to researchers in Australia. LONDON, May 26 (UPI) -- More than 260,000 additional people died of cancer after the economic crash in 2008, an increase researchers suggest was caused by the economic crash. With a history of reliable reporting dating back to 1907, today's UPI is a credible source for the most important stories of the day, continually updatedA A - a one-stop site for U.S. Hepatitis A is passed through feces, so you can get it by having anal sex with someone who is infected and not washing afterwards or from oral to anal contact with someone who is infected. You can also get Hepatitis A from someone who is infected and doesn’t wash their hands after using the bathroom or changing a baby’s diaper. Sharing household items like razors, toothbrushes, nail clippers or earrings with someone who has HBV. Analysts see the Gilead drug winning regulatory approval as early as 2014, with AbbVie close behind.
Several companies are working to eliminate infusions of difficult-to-tolerate interferon from the regimen, while raising cure rates and shortening the length of treatment. AbbVie said it is testing regimens with fewer drugs and ones that do not include the older oral drug ribavirin, which can also be difficult for some patients to tolerate. Its program is behind those of Gilead and AbbVie, but cure rates in excess of 90 percent and a relatively clean safety profile are expected to make it a formidable player in the field.
The drugs were the protease inhibitor ABT-450, whose effect was boosted by a widely used antiviral called ritonavir; the polymerase inhibitor ABT-333, and ABT-267 from a class known as NS5A inhibitors.
In addition, data showed a cure rate of 95 percent for patients treated for 24 weeks, and then assessed 24 weeks after treatment stopped. Of the 247 patients evaluated, serious side effects were seen in four patients (1.6 percent), while seven patients had elevated levels of liver enzymes that can be considered a potential sign of toxicity.
Just got Lucinda Porter’s comment and it make me think to add a link to her hepatitis comics. The diagnostic criteria have been defined in a simplified scoring system introduced by the International Autoimmune Hepatitis Group (IAIHG) in 2008. Steroids tend to carry a high complication risk profile; hence several newer immunomodulators and biologics are in different stages of trials to assess their efficacy and safety. Since its first description, there have been eight types of AIH proposed but as the extensive overlap of different autoantibodies in the various proposed types became clearer, their clinical significance declined.

It was characterized by antibodies to a particular epitope on cytochrome P450 (IID6) enzyme located in liver and kidney microsomes.
Type 2 AIH seems to be more frequent in southern Europe, whereas Type I AIH seems to be much more common in the US and Northern Europe.
Weisner and colleagues6 reported a liver transplantation incidence of 5.9 percent for patients with AIH in the United States. Patients diagnosed with PBC seem to be on an average 12 years older than patients with AIH and PSC.
It also usually signifies a decreased response to corticosteroids; however extra-hepatic manifestations are less common in HLA-DR3 serotype associated AIH. These criteria have a sensitivity of 88 percent and a specificity of 97 percent in diagnosing probable AIH and a sensitivity of 81 percent with specificity of 98 percent in diagnosing definite AIH.
Antiactin antibodies (AAA) may be more sensitive and specific than SMA in the diagnosis of AIH Type 1, but the testing is not available in most commercial laboratories. The presentation varies between asymptomatic disease to acute fulminant liver failure.  Subclinical disease may also occur with eventual progression to overt symptoms of inflammatory hepatitis. The decision to treat should be based on a thorough review of the symptoms, the histological features on liver biopsy and the AST and gamma globulin levels. There are at least three randomized controlled trials which unequivocally provide evidence for the effectiveness of steroids with azathioprine in decreasing morbidity as well as mortality. At least six months of maintenance treatment seems to be appropriate in most adult patients.
Studies have indicated that patients, with or without cirrhosis on biopsy, generally but not always, respond to corticosteroid treatment.
Understanding the exact pathogenesis of inflammatory injury in AIH can and will provide insights into developing new preventive and therapeutic strategies while limiting toxicity of currently used treatment. Pathogenesis of autoimmune hepatitis: from break of tolerance to immune-mediated hepatocyte apoptosis. Linkage disequilibrium between HLA class II region and autoimmune hepatitis in pediatric patients. A functional Fas promoter polymorphism is associated with a severe phenotype in type 1 autoimmune hepatitis characterized by early development of cirrhosis. Usefulness of corticosteroids for the treatment of severe and fulminant forms of autoimmune hepatitis.
International Autoimmune Hepatitis Group Report: review of criteria for diagnosis of autoimmune hepatitis.
Clinical, biochemical, and histological remission of severe chronic active liver disease: a controlled study of treatments and early prognosis. Each was treated for 12 weeks, with 19 receiving sofosbuvir and simeprevir, 19 given sofosbuvir and daclatasvir and 20 treated with sofosbuvir and ledipasvir. It increases the risk for cirrhosis (scarring of the liver), liver cancer, and liver failure, all of which can result in death. Our body releases good chemicals while laughing, so go ahead and give your brain a shower of positive endorphins.
All of a sudden, out of the corner of my eye I see a little guy in a booth with his parents. It is postulated that an environmental agent, either a drug or a virus or another agent seems to trigger a T-cell mediated cascade directed against liver antigens in genetically predisposed individuals to cause AIH. AIH Type 2 seems to occur more commonly in young adults and children, but the female to male preponderance persists even in children. UPI also provides insightful reports on key topics of geopolitical importance, including energy and security. It became known as UPI after a merger with the International News Service in 1958, which was founded in 1909 by William Randolph Hearst.
The word relief means to bring ease or deliverance from stress; to offer a pleasing change. There are countless stories of people who watched comedies throughout a mental or physical hardship.
Some of the most ridiculous situations occur while on heavy medications like Telaprevir, Interferon, and Ribavirin. I’d wake up and reach for proteins and fat to eat, and lay back down until I felt good enough to drive.
Yesterday while driving on a crowded expressway, there was this little bitty car with a huge queen size mattress and box springs tied to the top.
One day, I just sat there, looked in the mirror, and started laughing at how ridiculous it was. Not only was my eczema covered skin shining with drool, my barely there hair was fuzzy, and my feet were swollen. I though to myself that if he had a whole household full of stuff, he had a long day ahead of him. You could almost hear him growl as he tried his best to maneuver food toward his mouth, which is now twisting in a effort to reach some noodles.
His eyes got wider and he flipped a few more pieces of broccoli until one huge bite flew through the air and landed right on dad. Too young to understand any of this, he kept waving those chopsticks while opening his mouth, and his eyes, wider and wider. I was the only one at my table with the vantage point that allowed me to see him, and my family gave me an odd look.

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