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Trial suggests method for reducing hemophilia treatment frequency

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Researchers may have found a way for people with severe hemophilia to take their standard treatment less often, if the results of an early trial pan out.

In what experts called a feat of bioengineering, scientists were able to create a “fusion protein” that may extend the interval between treatments for hemophilia — from about every couple of days to once a week.

The early findings are based on a one-time treatment given to 16 patients.

But researchers were hopeful a larger, ongoing trial will prove the approach effective.

Hemophilia is a bleeding disorder caused by a genetic mutation. In the most common form — hemophilia A — people lack a properly functioning factor VIII, a protein that helps blood clot. Some people have relatively mild hemophilia — with excessive bleeding if they sustain a cut, for example. Others have frequent spontaneous bleeding episodes into their joints and muscles.

When hemophilia is that severe, it requires regular treatment to prevent bleeding. Most often, that means infusions of lab-created factor VIII.

That factor VIII activity only lasts so long, however. So patients generally need infusions two or three times a week, explained Dr. Barbara Konkle, the lead researcher on the new trial.

Managing that regimen in daily life can be challenging, Konkle said, particularly when it’s a child with hemophilia.

“Anything you can do to reduce the number of treatments will probably improve patients’ quality of life,” said Konkle, who is associate chief scientific officer at the nonprofit Bloodworks Northwest, in Seattle.

Her team looked at whether the new fusion protein — dubbed BIVV001 — can make for a longer-acting factor VIII.

The researchers recruited 16 men with severe hemophilia who were already on factor VIII treatment. (The disease primarily affects males.) Each patient was given an injection of factor VIII into a vein, followed by an injection of BIVV001.

Overall, the study found, the fusion protein extended the half-life of factor VIII by three to four times. On day 7, patients’ factor VIII activity was still at a level considered high enough to prevent bleeding episodes.

It all suggests the approach could allow treatment to be weekly — or possibly even every 10 days, said Dr. Pier Mannucci, of IRCCS Maggiore Policlinico Hospital in Milan, Italy.

To Mannucci, who wrote an editorial published with the study, the findings represent “more amazing progress” in treating hemophilia.

He pointed to key developments in recent years — including promising findings on gene therapy, which might provide a cure to at least some people with hemophilia.

And already, patients have options other than factor VIII replacement. In 2017, the U.S. Food and Drug Administration approved a drug called emicizumab — a lab-engineered antibody that mimics the activity of factor VIII.

Emicizumab has the advantage of being taken weekly, or even less often, and it’s injected under the skin rather than into a vein, Mannucci pointed out.

But, he said, the drug lacks some benefits of an “authentic” factor VIII — including the ability to treat sudden bleeding. So a longer-acting factor VIII could be an alternative to emicizumab, Mannucci said.

An ongoing “phase 3” trial is testing the new factor VIII product over the longer term, with patients receiving weekly doses.

Konkle said no safety issues emerged in this early study, published in the Sept. 10 New England Journal of Medicine. But the longer-term trial is needed to see whether any adverse effects, like allergic reactions, turn up.

Drugmakers Sanofi and Sobi, which are funding the research, developed BIVV001 together.

“It’s really an incredible feat of bioengineering,” Konkle said.

Historically, she explained, it’s been difficult to create a longer-acting factor VIII. That’s because the replacement protein interacts with a natural blood protein — called von Willebrand factor — which limits its half-life.

BIVV001, Konkle said, essentially “uncouples” the factor VIII replacement from von Willebrand factor circulating in patients’ blood.

She believes the new therapy, if approved, “will be a really important addition to our treatment options.”

But, Konkle added, “different approaches will be right for different patients.”

No one knows what the new factor VIII therapy could cost. But on the whole, hemophilia treatments are highly expensive, according to the American Society of Hematology — in the range of $300,000 to $500,000 a year.

More information

The U.S. Centers for Disease Control and Prevention has more on hemophilia treatment.

Copyright 2020 HealthDay. All rights reserved.



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Study: Less restrictive reproductive rights reduce birth complications risk by 7%

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Oct. 13 (UPI) — Women living in states with less restrictive reproductive rights policies are 7% less likely have low birth weight babies than those living in states with more stringent laws, according to an analysis published Tuesday by the American Journal of Preventive Medicine.

The risk was 8% lower for Black women living in less-restrictive states, the data showed.

“Our study provides evidence that reproductive rights policies play a critical role in advancing maternal and child health equity,” study co-author May Sudhinaraset, of the UCLA Fielding School of Public Health, said in a statement.

Since the Supreme Court‘s decision in Roe v. Wade in 1973, which effectively legalized abortion, states have had “substantial discretion” in creating policies governing whether Medicaid covers the costs of contraception or reproductive health care.

Some states have taken steps that effectively limit access to abortion services and other reproductive care, Sudhinaraset and her colleagues said.

Black women are more likely to die in pregnancy and childbirth than any other race group, experience more maternal health complications than White women and generally have lower quality maternity care, they said.

In addition, women of color are more likely to experience adverse birth outcomes.

Compared to infants of normal weight, low-birth-weight babies face many potential health complications, including infections early in life and long-term problems, such as delayed motor and social development or learning disabilities.

Sudhinaraset and her colleagues analyzed birth record data for the nearly 4 million births that occurred in the 50 states and Washington, D.C., in 2016, comparing reproductive rights policies and adverse birth outcomes in each state.

They also evaluated if the associations were different for women of color and immigrants.

The findings indicate that expanding reproductive rights may reduce the risk of low-birth weight, particularly for U.S.-born Black women, the researchers said.

“Important policy levers can and should be implemented to improve women’s reproductive health overall, including increasing abortion access and mandatory sex education in schools,” Sudhinaraset said.



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Pandemic-related job cuts have led 14.6M in U.S. to lose insurance

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Up to 7.7 million U.S. workers lost jobs with employer-sponsored health insurance during the coronavirus pandemic, and 6.9 million of their dependents also lost coverage, a new study finds.

Workers in manufacturing, retail, accommodation and food services were especially hard-hit by job losses, but unequally impacted by losses in insurance coverage.

Manufacturing accounted for 12% of unemployed workers in June. But because the sector has one of the highest rates of employer-sponsored coverage at 66%, it accounted for a bigger loss of jobs with insurance — 18% — and 19% of potential coverage loss when dependents are included.

Nearly 3.3 million workers in accommodation and food services had lost their jobs as of June — 30% of the industry’s workforce. But only 25% of workers in the sector had employer-sponsored insurance before the pandemic. Seven percent lost jobs with employer-provided coverage.

The situation was similar in the retail sector. Retail workers represented 10% of pre-pandemic employment and 14% of unemployed workers in June. But only 4 in 10 retail workers had employer-sponsored insurance before the pandemic. They accounted for 12% of lost jobs with employer-sponsored insurance and 11% of potential loss including dependents.

The study was a joint project of the Employee Benefit Research Institute, the W.E. Upjohn Institute for Employment Research and the Commonwealth Fund.

“Demographics also play an important role. Workers ages 35 to 44 and 45 to 54 bore the brunt of [employer insurance]-covered job losses, in large part because workers in these age groups were the most likely to be covering spouses and other dependents,” said Paul Fronstin, director of EBRI’s Health Research and Education Program.

“The adverse effects of the pandemic recession also fell disproportionately on women,” Fronstin added in an EBRI news release. “Although women made up 47% of pre-pandemic employment, they accounted for 55% of total job losses.”

More information

The U.S. Centers for Disease Control and Prevention has more on COVID-19.

Copyright 2020 HealthDay. All rights reserved.



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Study: Medicines, frequent counseling helps cancer patients quit smoking

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Oct. 13 (UPI) — A program that included telephone counseling sessions and one of two smoking cessation drugs was 50% more effective than telephone consultations alone at helping cancer patients quit smoking, a study published Tuesday by JAMA found.

Among cancer patients who underwent treatment with four bi-weekly and three monthly counseling sessions by telephone and either bupropion, marketed as Wellbutrin, or varenicline, marketed as Chantix, for up to six months, 35% were able to successfully quit smoking, the data showed.

But only 22% of the cancer patients who underwent treatment with the telephone counseling sessions had successfully quit after six months, according to the researchers.

“Counseling plus medication is the state-of-the art tobacco treatment for cancer patients,” study co-author Elyse R. Park told UPI.

“Smoking cessation assistance should be an integral part of cancer care and sustained tobacco support can be effective for cancer patients who smoke,” said Park, an associate professor of psychiatry at Harvard Medical School.

More than 34 million adults in the United States smoke, and some 16 million are living with smoking-related diseases, including cancer, according to the Centers for Disease Control and Prevention.

Up to 20% of cancer survivors continue to smoke, despite the fact that quitting improves prognosis with the disease, research suggests.

For their study, Park and her colleagues evaluated smoking cessation treatment programs in 303 adults recently diagnosed with breast, gastrointestinal, genitourinary, gynecological, head and neck, lung, lymphoma or melanoma cancers.

Roughly half — 153 — underwent “intensive” treatment for smoking, with telephone counseling and their choice of bupropion or varenicline, with the rest receiving “standard” care, with telephone counseling only, for up to six months, the researchers said.

Both bupropion and varenicline have been approved for smoking cessation treatment by the U.S. Food and Drug Administration.

The most common adverse events in the two treatment groups were nausea, rash, hiccups, mouth irritation, difficulty sleeping and vivid dreams, and all were more common in the patients who received “intensive” care, the researchers said.

“Nausea is a side effect of varenicline, so [its use] should be monitored for patients who are experiencing nausea from their cancer treatment,” Park said.

In addition, patients on tamoxifen for breast cancer should not take bupropion, or receive a reduced dose, because of interactions between the two drugs, she said.



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