Costs for generic hepatitis C drugs available in India would be paid back in 5 to 10 years
Use of the generic versions of directly-acting antiviral (DAA) drugs that are available in India to treat hepatitis C virus (HCV) infection is not only cost effective but actually saves lifetime costs for treating infected patients in that country. A report from an international research team appears in the open-access journal PLOS ONE and describes finding that the upfront costs of DAA are offset by the avoidance of costs incurred to treat late-stage disease.
“More than 9 million people are infected with HCV in India, and more than 70 million worldwide,” says Jagpreet Chhatwal, PhD, of the Institute for Technology Assessment at Massachusetts General Hospital (MGH), senior and corresponding author of the paper. “These persons are at risk of developing serious conditions such as cirrhosis and liver cancer, which can be fatal. However, only a fraction of them have been treated with these drugs so far.”
First introduced in 2011, DAAs such as sofosbuvir (Sovaldi) and ledipasvir (which is combined with sofosbuvir in Harvoni) have proven to be remarkably successful in the battle against HCV infection, with cure rates exceeding 95 percent. In developed countries, treatment with DAAs is very expensive — reaching nearly $65,000 in the U.S. — although it meets standards for cost effectiveness. In those countries the advent of these drugs has drastically changed the landscape of HCV infection. But other countries have lagged behind in their use.
Through agreements with the pharmaceutical companies that developed these drugs, generic drug manufacturers in India are now able to produce versions that cost as little as $300 for the entire duration of treatment. But the absence of data on the cost effectiveness of these drugs in that country and low budgets for HCV treatment have meant that only a small proportion of people needing these drugs have received them.
The research team — including investigators from Sanjay Gandhi Postgraduate Institute of Medical Sciences in Lucknow, India, and the World Health Organization — used a mathematical model to compare the outcomes of DAA treatment with those of no DAA treatment based on profiles of 30 hypothetical patients with characteristics typical of Indian patients with HCV infection. Factors incorporated into the model included the natural history of HCV disease, the costs of DAA administration, the costs of treating the adverse outcomes of HCV disease, and quality of life of individuals infected with HCV.
The model indicated that, compared with no DAA treatment, use of the generic drugs in HCV-infected Indian patients would increase life expectancy by more than eight years while reducing lifetime health care costs by more than $1,300 per person. Payback for the upfront costs of DAA drugs would be achieved in an overall average of less than 10 years — under 5 years for patients at advanced stages of HCV disease and almost 12 years if treatment begins at earlier stages. Even though there was wide variation in the factors — such as patient age, disease stage, and viral genotype — input to the model, results always indicated that generic DAA treatment reduced lifetime costs.
“Our hypothesis was that treatment would be cost saving, given the low drug costs in India. However, we were pleasantly surprised to find that the full payback was achieved so soon after treatment,” says Chhatwal, who is an assistant professor of Radiology at Harvard Medical School. “Our finding that treatment pays back its initial costs makes a very strong statement — that investment in HCV screening and treatment should be a priority for public health agencies in India and other countries where generic DAAs are available. It could also be argued that generic DAAs should be made available in other low- and middle-income countries where HCV infection is common and budgets for treatment limited.”
Lead author Rakesh Aggarwal, MD, DM, of the Department of Gastroenterology at Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS), a WHO Collaborating Center on Viral Hepatitis, says, “This is a win-win situation for the low- and low-middle-income countries where the generic DAAs can be sold. If these countries spend money on HCV treatment today, they will recoup it in the form of reduced health care expenditure within less than one decade. There is hardly any other health care intervention with such good return. Our results should show political leaders in those countries that they have a wonderful opportunity to make a difference for their constituents.”
Story Source:Materials provided by Massachusetts General Hospital.
URL: https://www.sciencedaily.com/releases/2017/05/170517184519.htm
Cutting down on cancer surgeries
New microscopy technique could reduce repeat surgeries for breast cancer patients
Engineers at the Optical Imaging Laboratory led by Caltech’s Lihong Wang have developed an imaging technology that could help surgeons removing breast cancer lumps confirm that they have cut out the entire tumor — reducing the need for additional surgeries.
About 300,000 new cases of invasive breast cancer are discovered annually. Of these, 60 to 75 percent of patients underwent breast-conserving surgery.
Breast-conserving surgeries, or lumpectomies, attempt to remove the entire tumor while retaining as much of the undamaged breast tissue as possible. (In contrast, a mastectomy removes the entire breast.) The extracted tissue is then sent to a lab where it is rendered into thin slices, stained with a dye to highlight key features, and then analyzed. If tumor cells are found on the surface of the tissue sample, it indicates that the surgeon has cut through, not around, the tumor — meaning that a portion of the tumor remains inside the patient, who will then need a follow-up surgery to have more tissue removed.
After a week or two waiting for lab results, 20 to 60 percent of patients find out that they must return for a second surgery to have more tissue removed. But, asks Wang, “what if we could get rid of the waiting? With 3D photoacoustic microscopy, we could analyze the tumor right in the operating room, and know immediately whether more tissue needs to be removed.” Wang is a Bren Professor of Medical Engineering and Electrical Engineering in Caltech’s Division of Engineering and Applied Science. His lab invented 3D photoacoustic microscopy.
Photoacoustic microscopy, or PAM, excites a tissue sample with a low-energy laser, which causes the tissue to vibrate. The system measures the ultrasonic waves emitted by the vibrating tissue. Because nuclei vibrate more strongly than surrounding material, PAM reveals the size of nuclei and the packing density of cells. Cancerous tissue tends to have larger nuclei and more densely packed cells.
Indeed, as described by Wang and his team in a paper publishing in the journal Science Advances on May 17, PAM produces images capable of highlighting cancerous features, with no slicing or staining required.
Wang conducted this research while the Optical Imaging Laboratory was located at Washington University in St. Louis. He moved the lab to Caltech’s Andrew and Peggy Cherng Department of Medical Engineering in January 2017.
Although Wang’s team has focused primarily on breast cancer tumors, his work has potential applications for any analysis of excised tumors — from melanoma to pancreatic cancer. In a proof-of-concept scan described in the new paper, PAM analyzed a sample in about three hours. Comparable traditional microscopy takes about seven hours to achieve the same results. However, Wang says that PAM’s analysis time could be cut down to 10 minutes or less with the addition of faster laser pulse repetition and parallel imaging. This would make the technology useful for clinical applications.
“Because the device never directly touches a patient, there will be fewer regulatory hurdles to overcome before gaining FDA approval for use by surgeons,” Wang says. “Potentially, we could make this tool available to surgeons within several years.”
Story Source: Materials provided by California Institute of Technology.
URL: https://www.sciencedaily.com/releases/2017/05/170517154728.htm
Stool microbes predict advanced liver disease
Proof-of-concept study suggests a noninvasive test for specific microbial population patterns could be used to detect advanced nonalcoholic fatty liver disease
Nonalcoholic fatty liver disease (NAFLD) — a condition that can lead to liver cirrhosis and cancer — isn’t typically detected until it’s well advanced. Even then, diagnosis requires an invasive liver biopsy. To detect NAFLD earlier and more easily, researchers in the NAFLD Research Center at University of California San Diego School of Medicine, Human Longevity, Inc. and the J. Craig Venter Institute report that the unique microbial makeup of a patient’s stool sample — or gut microbiome — can be used to predict advanced NAFLD with 88 to 94 percent accuracy.
The proof-of-concept study, which involved 135 participants, is published May 2 in Cell Metabolism.
“We estimate that as many as 100 million adults and children in the U.S. may have NAFLD. Determining exactly who has or is at risk for the disease is a critical unmet medical need,” said first author Rohit Loomba, MD, professor of medicine in the Division of Gastroenterology, director of the NAFLD Research Center and a faculty member in the Center for Microbiome Innovation at UC San Diego. “There are about 50 new NAFLD drugs in the pipeline, including about five that will likely be approved for use in the next two years. If we are better able to diagnose this condition, we will be better at enrolling the right types of patients in these trials, and ultimately will be better equipped to prevent and treat it.”
The precise cause of NAFLD is unknown, but diet and genetics play substantial roles. Up to 50 percent of obese people are believed to have NAFLD. As mounting evidence continues to suggest that the makeup of a person’s gut microbiome may influence his or her risk for obesity, Loomba and team began to wonder if the gut microbiome might also be linked to obesity-associated liver disease. If so, they hypothesized that a stool-based “read-out” of what’s living in a person’s gut might provide insight into his or her NAFLD status.
To answer these questions, Loomba and team examined two different patient groups. The first group included 86 patients with NAFLD, as diagnosed by biopsy. Of these, 72 had mild/moderate NAFLD and 14 had advanced disease. Collaborators at Human Longevity, Inc. sequenced the microbial genes extracted from each participant’s stool sample and used that information to determine which species were living where, and the relative abundance of each. The researchers found 37 bacterial species that distinguished mild/moderate NAFLD from advanced disease, allowing them to predict which patients had advanced disease with 93.6 percent accuracy.
The team validated this finding with a second study group that included 16 patients with advanced NAFLD and 33 healthy people as controls. In this case, they found nine bacterial species whose relative numbers allowed them to distinguish NAFLD patients from the healthy volunteers, with 88 percent accuracy. Seven of these bacterial species overlapped with the signature 37 used in the previous group.
There are four main types of bacteria found in the human gut: Firmicutes, Proteobacteria, Bacteroidetes and Actinobacteria. Loomba and team found that patients with advanced NAFLD tend to have more Proteobacteria and fewer Firmicutes in their stool than those with early stage NAFLD. At the species level, one major difference the researchers found was in the abundance of E. coli — these bacteria were three-fold more common in advanced NAFLD patients than early stage patients.
“We believe our study sets the stage for a potential stool-based test to detect advanced liver fibrosis based simply on microbial patterns,” said senior author Karen E. Nelson, PhD, president of the J. Craig Venter Institute, “or at least help us minimize the number of patients who have to undergo liver biopsies.”
While Loomba estimates that a stool-based microbiome diagnostic might cost $1,500 if it were on the market today, he predicts that cost will lower to less than $400 in the next five years due to advances in genomic sequencing and analysis technologies.
While excited, the researchers caution that so far this new diagnostic approach has only been tested in a relatively small patient group at a single, highly specialized medical center. The team is now applying for grant funding to expand their study in a larger cohort across multiple sites. Even if successful, a stool-based test for NAFLD wouldn’t be available to patients for at least five years, they said. Loomba also points out that while a distinct set of microbial species may be associated with advanced NAFLD, this study does not suggest that the presence or absence of these microbes causes NAFLD or vice versa.
“We are looking forward to further studies to assess the role, if any, these microbial species play in gut permeability, liver inflammation and cross-talk with other factors to induce liver injury, and ultimately influence disease progression in NAFLD,” said study co-author David A. Brenner, MD, vice chancellor of UC San Diego Health Sciences and dean of UC San Diego School of Medicine.
“Understanding the microbiome, just as sequencing the human genome, is one part of the puzzle on human health and disease,” said study co-author J. Craig Venter, PhD, co-founder and executive chairman of Human Longevity, Inc. “New technologies, such as machine learning, are allowing for tremendous advances to interpret these data.”
Story Source:
Materials provided by University of California – San Diego.
Original written by Heather Buschman.Note: Content may be edited for style and length.
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Antibiotics may up miscarriage risk
Women who take common antibiotics to treat infections during the early stages of pregnancy may be at a two-fold higher risk of suffering a miscarriage, a new study warns.
Researchers from the Universite de Montreal in Canada looked at data from about 8,702 cases, defined as clinically detected spontaneous abortions, which were matched with 87,020 controls. The mean gestational age at the time of miscarriage was 14 weeks.
Researchers found that many classes of common antibiotics, such as macrolides, quinolones, tetracyclines, sulfonamides and metronidazole, were associated with increased risk of miscarriage in early pregnancy.
Erythromycin and nitrofurantoin, often used to treat urinary tract infections in pregnant women, were not associated with increased risk, the researchers said.These findings may be useful for policy-makers to update guidelines for the treatment of infections during pregnancy , the researchers noted.
The study was published in the ‘Canadian Medical Association Journal’.
Source: http://timesofindia.indiatimes.com/life-style/health-fitness/health-news/antibiotics-may-up-miscarriage-risk/articleshow/58471222.cms
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A Cup of Coffee Every Day May Lower the Risk of Liver Cancer
Finally, some respite for caffeine lovers! Your daily cup of coffee may not be as bad as you have been told.
A new study, published in the journal BMJ Open, suggests that a your daily dose of coffee can help prevent the risk of liver cancer by nearly 50 per cent. For the longest time, coffee has been regarded as a villain primarily because of its high caffeine content. Caffeine is a central nervous system (CNS) stimulant that is responsible for perking you up and giving you an instant boost of energy on drinking coffee. It is also present in other beverages like energy drinks.
A lot of previous studies have indicated that too much consumption of caffeine may cause an upset stomach, indigestion, high blood pressure, increased heart rate and anxiety. However, this new study suggests that one cup of coffee daily may actually be good for you.
For the study, researchers from the University of Southampton and the University of Edinburgh universities examined data from 26 previous studies that involved more than 2.25 million participants. The results showed that people who drank one cup of coffee daily had a 20 per cent lower risk of developing the most common type of liver cancer known as hepatocellular carcinoma. Further, they found that those who drank two cups of coffee daily had a 35 per cent reduced risk of suffering the disease while drinking five cups cut their risk by half. Decaffeinated coffee may also be able to lend similar benefits but its effect was very small in comparison to regular coffee.
The researchers are not suggesting that everyone should start consuming lots of coffee every day but they found a link and more study is required to strengthen the evidence that shows positive effects of moderate consumption of coffee. When consumed in moderation, coffee may act as a ‘wonderful natural medicines’, they say. They are still working on trying to find why coffee has a liver cancer-protective effect. Drinking coffee has also been linked to better heart health and increased mental alertness.
We know that moderation is the key but how much is too much? According to the US FDA, 400 to 500 milligrams of coffee consumption per day is considered to be ‘safe’ (that’s almost 4 cups). However, the effects may vary from person to person. Excess coffee consumption can have side effects like stomach pain, diarrhea, acid reflux, insomnia and restlessness. If you’ve been experiencing any of these frequently for a long time, it’s time to cap your coffee intake. Bangalore-based Nutritionist, Dr. Anju Sood does caution us and suggests,”Drinking one or two cups of coffee may be fine but if you exceed that it may cause dehydration in your body. In that case, the essential water soluble minerals and vitamins are also flushed out of the body. Therefore, you must stick to your daily dose and combine it with other fluids like warm herbal teas, fresh juices or buttermilk to keep yourself hydrated all day,”
Source: http://food.ndtv.com/health/a-cup-of-coffee-every-day-can-lower-the-risk-of-liver-cancer-1703890
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Pregnant mothers, beware! Pre-eclampsia may increase stroke risk by 6 times
Pre-eclampsia (PE) is a disorder of pregnancy characterized by the onset of high blood pressure and often a significant amount of protein in the urine
Pregnant women, who suffer from chronic hypertension, bleeding disorders or urinary tract infections are at risk of stroke during or after childbirth.
One in ten pregnant women, who suffer preeclampsia — characterised by high blood pressure, swollen feet, ankles and face and severe headaches — may be six times more at risk of suffering a stroke during or after childbirth, researchers said.
Preeclampsia — a high-blood pressure disorder unique to pregnancy — develops in about 3 to 8 per cent of all pregnant women.
The study showed that certain conditions like chronic hypertension, bleeding disorders or urinary tract infections may increase the risk of stroke in women with preeclampsia.
Pregnancy-associated stroke occurs up to 6 times more often in women with preeclampsia compared with pregnant women overall.
“Women with preeclampsia who had chronic hypertension, bleeding or clotting disorders, or infections — particularly urinary tract infections — appeared to be at significantly increased risk of stroke,” said lead author Eliza C Miller, postdoctoral student at Columbia University in the US.
Infections cause inflammation, which is known to play an important role in triggering stroke, especially in young people.
Preeclampsia itself is an inflammatory disorder. Infections may be what pushed some of these women over the edge, the researchers explained.
For the study, published in the journal Stroke, the team analysed the health records of 197 women who had a preeclampsia-related stroke and 591 women with preeclampsia who did not have a stroke.
The incidence of stroke in women with preeclampsia was over 200 per 100,000 deliveries, and more than one in 10 women in the study who had a preeclampsia-related stroke died in the hospital.
“It’s important to note that the risk of stroke in women with preeclampsia doesn’t end with delivery, as is commonly thought. Nearly two-thirds of preeclampsia-related strokes occur after birth, when the mother has gone home,” Miller said.
“Women with preeclampsia should take any neurological symptoms, such as severe headache, very seriously, especially during the postpartum period,” she suggested.
Source: http://indianexpress.com/article/lifestyle/health/health-pregnant-mothersbeware-preeclampsia-may-increase-stroke-risk-by-6-times-4675003/
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