China to use drug bulk-buy program to close price gap

BEIJING (Reuters) – China will use its national drug bulk-buy scheme to lower the price of drugs currently sold at higher prices compared with other markets, it said in an official statement.

The move could force international drugmakers to further cut prices and enable copycat medicines to replace imported off-patent brands at faster pace.

Many branded versions of drugs are currently more expensive in China than in other major markets. They could now be subjected to a centralized procurement program where manufacturers will have to go through a bidding process to get the right to supply drugs to public hospitals, the National Health Commission said in a document published on late Friday.

The bulk-buy program, which currently covers 25 types of medicines, allows no more than three successful bidders access to China’s public hospitals, where most Chinese people buy their drugs.

The program caused the price of some drugs to plunge more than 90% when it was introduced last year in some cities, state news agency Xinhua said.

Multinational drugmakers usually cut the price of drugs when they go off-patent and face competition from generic versions, but such price drops were slow to happen in China, partially because many local drugmakers were unable to develop high-quality generic drugs to compete with off-patent branded drugs.

In the first round of nationwide implement of the program, in September, multinationals including Sanofi and Eli Lilly managed to cut some prices low enough to levels close to those offered by local generic makers.

Beijing will strengthen its monitoring of overseas drug market and collect global prices for imported medicines, Friday’s guideline said.

The government is leveraging its large patient population to push non-domestic drugs companies to cut prices to their lowest level globally.

Most foreign drugmakers offered Beijing the lowest prices globally in a recent round of negotiations in order to get some of their new products included in national insurance program, a move that will help them gain access to more patients in less-affluent cities, officials said on Thursday.

Reporting by Roxanne Liu and Brenda Goh

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Morphosys CFO says tafasitamab drug sales potential above $1 billion: magazine

FRANKFURT (Reuters) – German biotech company Morphosys’ tafasitamab, the group’s most advanced drug which is currently being tested, has sales potential of significantly more than $1 billion a year, its finance chief said in remarks to a magazine.

“Analysts estimate sales at between half a billion to $1 billion per year. If further indications are added, for example additional forms of leukaemia, they might be significantly higher than that,” Jens Holstein told Germany’s Euro am Sonntag.

Earlier this month, a data monitoring committee recommended an increase in the number of patients to 450 from currently 330 in the ongoing “B-MIND” trial, which tests tafasitamab against relapsed or refractory diffuse large B cell lymphoma.

Holstein said he expected tafasitamab to be approved by mid-2020 in the United States, adding it could take one more year in Europe.

Reporting by Christoph Steitz; Editing by Mark Heinrich

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Diet pills, laxatives may signal eating disorder risk in young women

(Reuters Health) – Teens and young women who use diet pills and laxatives for weight control are five to six times more likely to be diagnosed with an eating disorder in the next three years, a U.S. study suggests.

Using these medications for weight loss can be dangerous and may be a warning sign to consider counseling because there is an increased risk for developing an eating disorder such as anorexia or bulimia, the study authors write in the American Journal of Public Health.

“Advertising for these products is common on social media, and the products are easily accessible at local pharmacies and groceries, which gives young people the mistaken idea that they are safe to use,” said Jordan Levinson of Boston Children’s Hospital’s Division of Adolescent and Young Adult Medicine, the study’s lead author.

“But this could not be further from the truth. These products are not medically recommended for healthy weight management and can even be dangerous,” she told Reuters Health by email. “When young people get their hands on these easily accessible yet harmful products, they are put at risk for disordered weight control behaviors and, as our study suggests, may even put them on a path to develop an eating disorder.”

Levinson and colleagues analyzed data on more than 10,000 U.S. women between ages 14 and 36, who were participating in a long-term study. The women were surveyed annually about whether they had used diet pills or laxatives for weight loss during the past year, and whether they’d received a new diagnosis of an eating disorder.

Researchers excluded young women already diagnosed with an eating disorder from the analysis, and adjusted for overweight status, age, and other factors.

They found that eating disorders developed in just 1% of women who did not report diet pill use for weight control during the past year, and 1.8% of those who did use diet pills.

Similarly, 0.8% of women who did not report laxative use for weight loss were later diagnosed with an eating disorder, compared to 4.6% of those who did use laxatives.

Using these kinds of products may increase the likelihood of eating disorders by creating irregular eating behaviors, physical disruptions to digestion or psychological issues, the study authors speculate.

“Eating disorders have among the highest mortality rate of any mental health condition, so our finding that these products may be gateway drugs to a serious and life-threatening mental health condition is cause for alarm,” Levinson said.

Policymakers and public health professionals should work together to restrict access to diet pills and laxatives for adolescents through bans or taxes, the study authors argue. For instance, Instagram and Facebook recently banned ads targeting minors for over-the-counter weight loss products, and retailers should do the same, the authors note. The research team is working with legislators in Massachusetts to ban the sale of these products to people under 18.

“Dietary supplements claiming all types of health benefits or functional properties – including weight loss, appetite suppression, and muscle building – are virtually unregulated. Most people do not know the extent (to which) these products are not regulated or approved by the FDA,” said Jennifer Pomeranz, a public health lawyer and researcher at New York University in New York City, who wasn’t involved in the study.

“Unfortunately, in the U.S., industry’s interests in selling products is often more valued than government’s responsibility to protect the public from harmful products,” she told Reuters Health by email. “Even if people do not suffer health harms from dietary supplements claiming unachievable benefits, consumers waste money on them and may not take other actions to protect their health, relying on the false promise of over-the-counter products instead.”

SOURCE: bit.ly/2qSaV6g American Journal of Public Health, online November 21, 2019.

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Short sleep after menopause linked to weaker bones

(Reuters Health) – Bones may age faster in older women who get too little sleep, a U.S. study suggests.

Based on data from nearly 11,000 participants in a long-term study, researchers found that postmenopausal women who slept less than five hours a night were more likely to have low bone mass than those who averaged seven hours sleep. Short sleepers were also up to twice as likely to have osteoporosis of the hip and spine, according to the report in the Journal of Bone and Mineral Research.

The bone mass differences between the short sleepers and those who logged seven hours were small, but roughly equivalent to about one year of aging, the study team notes.

“We were building on our previous work, which showed women who slept too little had higher fracture risk,” said epidemiologist Dr. Heather Ochs-Balcom of the school of public health at the State University of New York, Buffalo, who led the study.

“Here, we examined a measure of bone mineral density, to see if that could explain the previous finding,” she told Reuters Health in an email.

Ochs-Balcom and her colleagues analyzed data from the Women’s Health Initiative Study, which originally enrolled 161,808 postmenopausal women aged 50 to 79 at 40 clinical centers and followed them over time.

For the current study, the researchers focused on 11,084 women who had undergone full body scans to assess bone density and had answered sleep questionnaires. This group was 78% non-Hispanic white, with an average age of 63, and nearly one in 10 reported sleeping five hours or less per night. One in three also met criteria for insomnia.

Using seven hours of sleep as the reference point, researchers found that women who slept only five hours or less had lower bone mass in whole-body, hip, neck and spine measurements. They were also twice as likely to have osteoporosis in the whole-body measurement, 63% more likely to have it at the hip and 28% more likely to have osteoporosis in the spine.

Women sleeping six hours a night had slightly increased risk of spine and whole-body osteoporosis as well, the analysis found.

The researchers note that the sleep and bone-density assessments reflect a single point in time, so the study cannot determine whether short sleep causes changes in bone health. It is important, they write, to consider the possibility that lower bone mineral density could also be tied to factors that affect sleep.

A number of things contribute to skeletal health, said Dr. Alana Serota of the Hospital for Special Surgery in New York City, who wasn’t involved in the study. “I feel all our sins are written on our skeletons,” she said in a phone interview.

Serota noted that there is no clear answer on the ideal amount of sleep for postmenopausal women, but it is important to wake up feeling rested.

“We know poor sleep has an impact on cardiovascular health, leads to diabetes, poor sugar control and hypertension. It stands to reason these things can also impact the skeleton,” she added.

“The most important thing is to stay active,” Serota said. “Even if one hasn’t exercised before, it is a good time to start. The diagnosis of any chronic condition, or a transition in any point of life, is a good time for a health reset.”

SOURCE: bit.ly/37kxzVk Journal of Bone and Mineral Research, online November 6, 2019.

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‘An Arm And A Leg’: A La ‘Hamilton,’ Revue Takes On History Of Health Insurance


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“Bills, Bills, Bills” — the 1999 hit from mega-group Destiny’s Child — has gotten a remix of sorts from the New York City musical troupe Heck No Techno. The troupe’s show “Explanation of Benefits” charts the history of the U.S. health care system, borrowing Beyoncé swagger and adding new lyrics:

Can you pay my bills?
Can you pay my medical bills?
Can you pay my deducti-bills?
So maybe I can get my pills?

The musical revue, staged earlier this year, starts with hospital prepayment plans from the 1920s, traces the origins of insurance giant Blue Cross and dances through decades of health policy twists, including a light skewering of the Affordable Care Act.

The show’s creators used their experiences with the health care marketplace as inspiration.

“I just felt so angry about this topic,” said lead songwriter Emily Lowinger. “I just remember being like, ‘We have to do this because, otherwise, I don’t know what I’ll do.”

The show wraps with sketches demonstrating ways patients can work to protect themselves from excessive charges, including tips for confronting physicians.

Stephanie Regina, one of the group’s founders, spent years working in a small medical office.

“One of the doctors I used to work for came to see the show, and he loved it — and he said, ‘Ooh, that was rough,” Regina said. “Because he knows, too, sometimes people have to look at him in a certain light in order to protect themselves.”

The storytellers from Heck No Techno have taken some enraging and depressing personal moments and turned them into art and laughter. This season, the podcast is all about financial self-defense, and art and laughter are nice tools to have in your arsenal.


Season 3 is a co-production of Kaiser Health News and Public Road Productions.

To keep in touch with “An Arm and a Leg,” subscribe to the newsletter. You can also follow the show on Facebook and Twitter. And if you’ve got stories to tell about the health care system, the producers would love to hear from you.

To hear all Kaiser Health News podcasts, click here.

And subscribe to “An Arm and a Leg” on iTunes, Pocket Casts, Google Play or Spotify.

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Four killed in attacks against Ebola response centers in Congo

GOMA, Democratic Republic of Congo (Reuters) – Militia fighters in eastern Congo killed four people and injured several others in attacks on two Ebola response centers on Thursday, in what responders described as a serious setback to efforts to contain the epidemic.

Violence and unrest have hampered the health authorities’ response to the second worst Ebola outbreak on record, which has killed 2,199 people since it was announced in August 2018.

Mai Mai militia fighters and local residents have attacked health facilities, sometimes because they believe Ebola does not exist, in other cases because of resentment that they have not benefited from the influx of donor funding.

In the latest such violence, Mai Mai fighters simultaneously attacked Ebola centers in Mangina in North Kivu and Byakoto in Ituri, according to Jean-Jacques Muyembe, head of Ebola response for the Democratic Republic of Congo.

“It is a blow to the Ebola response because we were eradicating the disease. These attacks are challenging the efforts to date,” Muyembe told Reuters.

The World Health Organization said the dead included a member of a vaccination team, two drivers and a police officer. It said none of its own staff were killed and that most of the five people injured were from Congo’s Ministry of Health.

Health workers have lost access to the remaining strongholds of the virus in recent weeks due to deteriorating security, said Mike Ryan, head of the WHO’s emergencies program, describing the latest attack as the deadliest yet.

“The interruption of outbreak response has led to a decrease in over 50% of alerts, a collapse in vaccination, a decrease in contact tracing,” he told a news conference.

“Ebola was retreating and now it is likely to resurge,” he said.

New infections have been on the decline since August, with just 70 cases identified in all of October, medical charity Medecins Sans Frontieres said on Monday.

Thursday’s attacks came amid a spate of massacres committed by suspected Islamist rebels in the region, who are believed to have killed at least 80 people in the past month, according to U.N. figures.

This week at least four people were also killed during protests fueled by anger at the perceived failure of the army and U.N. peacekeepers to protect civilians from the Islamist Allied Democratic Forces (ADF).

As a result, the WHO and the U.N. Children’s Fund (UNICEF) on Tuesday evacuated dozens of their staff working on the Ebola epidemic from the town of Beni. WHO staff have now been relocated from Byakoto also, Ryan said.

Additional reporting by Hereward Holland in Kinshasa and Stephanie Nebehay in Geneva; Writing by Hereward Holland and Alessandra Prentice; Editing by Juliette Jabkhiro, Nick Tattersall and Hugh Lawson

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Novartis’s $90 million Swiss factory to help solve cell therapy bottleneck

ZURICH (Reuters) – Swiss drugmaker Novartis’s (NOVN.S) new $90 million cell and gene therapy factory in northern Switzerland is on track to begin commercial production of its cell therapy Kymriah for cancer in 2020.

The company’s logo is seen at the new cell and gene therapy factory of Swiss drugmaker Novartis in Stein, Switzerland, November 28, 2019. REUTERS/Arnd Wiegmann

The new factory, expected to employ 450 people, will allow the drugmaker to make its Kymriah treatment for European patients without first having to fly their immune cells across the Atlantic Ocean.

The Swiss factory, as well as a separate French site also being expanded, are central to Novartis’s plans to transform Kymriah from a modest $250 million-per-year seller into a $1 billion blockbuster as European demand rises.

“We have already started to produce clinical batches at both sites and are on track to begin producing commercial product in 2020,” Novartis said.

Basel-based Novartis sees cell and gene therapies eventually contributing about 15% of its revenue.[nL8N2874FU][nL5N25V4JJ]

T cells currently harvested from Europeans getting the $400,000-per-patient Kymriah blood cancer therapy must now be sent to a U.S. laboratory for re-engineering. Analysts have called the lack of manufacturing capacity a “major bottleneck”.

Novartis is investing some $500 million in new facilities around the world to address production bottlenecks and drug companies including Novartis, Pfizer (PFE.N) and others, have plans to spend $2 billion building out gene and cell therapy manufacturing after rapid expansion into these treatments.

Kymriah’s global rollout in 20 countries, plus Novartis’s efforts to expand the therapy’s indications, make adding commercial production a priority, including in China and Japan. [nL8N1WD64W]

Kymriah’s 2018 approval was hailed as a breakthrough as a last-ditch treatment for acute lymphoblastic leukemia and diffuse large B-cell lymphoma. T-cells are extracted from patients, modified to attack their cancer, then re-infused in the hope they work where other treatments failed.

But its complex production, tailor-made for each patient, poses logistical challenges compared to off-the-shelf treatments, especially in Europe where Novartis lacked commercial manufacturing.

“The key factor in bringing local manufacturing to each region is to make Kymriah available as quickly as possible,” Novartis said.

(This story removes reference to Zolgensma, which will not be made at new Swiss factory in 2020.)

Reporting by John Miller; Editing by Elaine Hardcastle

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State-of-the-art expert reviews provide insights into vitamin D research

Vitamin D is essential for human health. Although much is known about its important role in bone metabolism and in certain areas of non-skeletal health, there are many open questions and topics of debate. With the help of guest editor, Terry Aspray, Calcified Tissue International has commissioned seven state-of-the-art expert reviews which provide insights into current consensus and new directions of research in a wide range of topics – including vitamin D’s role in maternal health, rheumatoid arthritis, respiratory disease, and muscle.

Dr Aspray stated:

I am very impressed with the breadth of coverage of this topic, evident from these reviews, which cover a range of clinically relevant science relating to vitamin D from true experts in the field.”

The reviews include:

Vitamin D Measurement, the Debates Continue, New Analytes Have Emerged, Developments Have Variable Outcomes

William D. Fraser, Jonathan C. Y. Tang, John J. Dutton, Inez Schoenmakers

This review describes developments in the measurement of the commonly analyzed vitamin D metabolites in clinical and research practice. It describes current analytical approaches, discusses differences between assays, their origin, and how these may be influenced by physiological and experimental conditions. An overview of the value and application of the measurement of 1,25 dihydroxyvitamin D, 24,25 dihydroxyvitamin D and free 25OHD in the diagnosis of patients with abnormalities in vitamin D metabolism and for research purposes is provided.

Vitamin D Deficiency: Defining, Prevalence, Causes, and Strategies of Addressing

Kevin D. Cashman

Vitamin D deficiency, even assessed at the most conservative thresholds, is widespread in both low- and high-income country settings. This review addresses environmental factors and personal characteristics which prevent or impede dermal synthesis of vitamin D and looks at a number of strategies for addressing low dietary vitamin D intake and consequently lowering the risk of vitamin D deficiency.

Vitamin D, and Maternal and Child Health

Rebecca J. Moon, Justin H. Davies, Cyrus Cooper, Nicholas C. Harvey

Vitamin D has important roles in calcium metabolism and in the prevention of rickets and osteomalacia. Low levels of 25-hydroxyvitamin D are common in the general population and amongst pregnant women. This paper reviews the evidence to support routine vitamin D supplementation in childhood and pregnancy and points to the need for future research to focus on individual characteristics and genetic factors which may influence the response to supplementation.

Vitamin D, Autoimmune Disease and Rheumatoid Arthritis

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Stephanie R. Harrison, Danyang Li, Louisa E. Jeffery, Karim Raza, Martin Hewison

The overall aim of this review is to provide a fresh perspective on the potential role of vitamin D in Rheumatoid Arthritis (RA) pathogenesis and treatment. It explores the immune activities of vitamin D that impact autoimmune disease, with specific reference to RA. As well as outlining the mechanisms linking vitamin D with autoimmune disease, the review also looks at the different studies that have linked vitamin D status to RA, and the current supplementation studies that have explored the potential benefits of vitamin D for its prevention or treatment.

Targeting Vitamin D Deficiency to Limit Exacerbations in Respiratory Diseases: Utopia or Strategy With Potential?

Karen Maes, Jef Serré, Carolien Mathyssen, Wim Janssens, Ghislaine Gayan-Ramirez

This review focuses on vitamin D as a potential candidate to treat or prevent exacerbations in Cystic Fibrosis, COPD, and asthma. Patients with such respiratory diseases often experience an acute worsening of respiratory symptoms (termed exacerbations), mostly triggered by a respiratory infection. Exacerbations often require hospitalization and are an important cause of mortality. Many patients do not benefit from existing therapies and suffer from recurrent events, and vitamin D deficiency is extremely prevalent in these patients.

The Latest Evidence from Vitamin D Intervention Trials for Skeletal and Non-skeletal Outcomes

Arvind Sami, Bo Abrahamsen

Vitamin D has long been considered a central part of the treatment paradigm for osteoporosis. Initial studies in high-risk populations with widespread vitamin D deficiency found a reduction of both vertebral and non-vertebral fractures. Subsequent studies in the general population have yielded mixed but mostly disappointing results both for skeletal and especially non-skeletal outcomes. Recent sequential trial meta-analyses suggest that future studies are likely to be futile given the overall disappointing result. However, mega-trials are still in progress, and additional results have been released. This narrative review aims to evaluate new literature to determine if there has been any substantial change in the message.

Vitamin D and Skeletal Muscle: Emerging Roles in Development, Anabolism and Repair

Christian M. Girgis

This review focuses on morphologic and functional roles of vitamin D in muscle, from strength to contraction, to development and ageing, and will characterise the controversy of the vitamin D receptor’s (VDR) expression in skeletal muscle, central to our understanding of vitamin D’s effects on this tissue.

Source:

International Osteoporosis Foundation

Journal reference:

Fraser, W.D., et al. (2019) Vitamin D Measurement, the Debates Continue, New Analytes Have Emerged, Developments Have Variable Outcomes. Calcified Tissue International. doi.org/10.1007/s00223-019-00620-2.

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Coping With (Power) Loss: California’s Hospitals, Clinics, Patients Face New Reality

We all know that when the power goes out, refrigerators, heaters and air conditioners stop running. Homes go dark, and desktop computers shut down.

But those are mere inconveniences. If you need regular dialysis or chemotherapy at a clinic, or you have an infant in a neonatal intensive care unit or a loved one on a hospital ventilator, a loss of power carries far more dire implications.

California’s recurrent power outages this year by Pacific Gas & Electric Co. and Southern California Edison, in response to wildfire threats up and down the state, have forced patients to think about how they get care when the power is cut at hospitals and clinics.

Hospitals that provide critical care are required by state and federal law to have backup generators on-site. In California, hospitals, outpatient clinics and treatment centers have long-standing disaster plans in place, which cover the possibility of temporary power outages.

“But continuous power shut-offs, sometimes lasting for days and then happening again within a week or two, were never what those plans were intended for,” said Jan Emerson-Shea, vice president for external affairs at the California Hospital Association. “This is all very new to everybody.”

Communities in Northern and Southern California have been subjected this year to numerous outages, often with no assurance of when their power would be restored. The utilities’ estimates sometimes miss the mark. The outages are likely to be a long-term problem, given PG&E’s 10-year timetable for fixing power transmission risks.

And the fires are not necessarily finished for this season: The Camp Fire, the most deadly in California history, started in the second week of November last year. And the Thomas Fire, a huge blaze that ravaged swaths of Ventura and Santa Barbara counties, erupted in early December 2017 and burned well into January.

The bottom line: Hospitals and clinics must be prepared for this new reality. And so must patients. The following answers to some critical questions will help readers understand what patients’ options will be the next time a vital treatment is threatened by a loss of power.

Q: We have a family member on a ventilator in the hospital. What happens to her if the power goes out?

She will likely not be affected. All California hospitals must have backup generators and enough diesel fuel on hand to run for 72 hours without electricity. The generators kick in within 10 seconds of a power shut-off, Emerson-Shea said, so all critical functions — ventilators, heart monitors, surgical procedures — can continue without interruption.

Q: Some recent outages have lasted longer than 72 hours. What happens then?

As long as the hospital has access to diesel fuel, it can run on its generators for as long as it needs to (although air quality issues arise from their prolonged use). But even with generators, hospital administrators must decide which services are absolutely critical and which ones are temporarily dispensable.

Q: What are some examples of both?

If you have elective surgery like a knee replacement scheduled, and power is expected to be cut off that day, there’s a chance the hospital will reschedule the operation. The generators are intended primarily to power the critical-care functions of a hospital — operating and emergency rooms; labor centers; the monitoring of patients’ heart rates, breathing and blood pressure — and officials will keep those functions going even if it means turning off the building’s air conditioning or heat.

Q: I have a chemotherapy treatment scheduled on a day when a power shut-off may occur. Should I still go?

That depends on your provider. Many oncology practices are located within or next to hospitals, so they would retain access to power even in a shut-off. The situation changes, though, if your treatments are normally provided at a free-standing health clinic or private care center, where such backup may not exist. A survey by the disaster-preparedness nonprofit Direct Relief found that only 44% of California’s community health centers have a backup energy source in case of electrical failure.

Q: What do clinics without backup energy do, then, if the power goes out?

Phone calls by California Healthline to several such clinics found that most of them had a similar plan: Staffers use their cellphones to contact each patient and cancel his or her session. So be aware that you may see an unfamiliar incoming number that turns out to be your provider. If someone from your treatment team doesn’t call you, call them. And if your treatment is canceled, make sure it is rescheduled for immediately after power is restored. A few of the facilities noted that their doctors have privileges at local hospitals, so in cases where the treatment is indispensable, they can send patients there. Emerson-Shea said several hospitals have reported receiving patients who had been directed there by clinics.

Q: How bad is it if I miss a chemo or radiation treatment?

In many cases, a delay of a few days won’t hurt you. But missing a session altogether is not good. A study published by the National Institutes of Health showed that missed chemotherapy doses correlated with worse prognoses and higher mortality rates among cancer patients. Missed radiation treatments, likewise, have been linked to a greater risk of cancer recurrence. So it’s important to stay on track.

Q: What about dialysis? If my clinic has no power, can I get treatment elsewhere?

Yes. During mandatory fire-related evacuations in Sonoma County last month, some clinics with no formal affiliation functioned as ad hoc cooperatives, cross-referring their patients depending upon which facilities were up and running, said Monica Hannaman, a dialysis social worker at Fresenius Medical Care in Santa Rosa. The goal was to treat patients without having to send them to a hospital, she said, “because the hospitals are already so burdened during emergencies like that.”

Also, keep in mind that if your dialysis center is part of a bigger chain, you can go to one of its other locations. Some Sonoma County dialysis patients of San Jose-based Satellite Healthcare, which has multiple locations in California, went as far as Sacramento for treatment last month, said Lanie Borja, manager of the Satellite clinic in Windsor, Calif.

Q: What else can health care providers do to ensure my well-being in the likely case of future power outages?

Hospitals may start rethinking ways to store backup energy, Emerson-Shea said, especially given the long time PG&E has said it will take before it can stop the precautionary outages. Some free-standing medical clinics in areas with high fire and wind risk are considering buying generators large enough to power their operations, despite the big expense. Hannaman said Fresenius is thinking of putting generators in its two Santa Rosa-area clinics, because “this will be happening more often, we’re afraid.”

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

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Treating HIV-infected infants very early substantially improves health: study

CHICAGO (Reuters) – A small study of African infants infected with HIV found that treating them with powerful drugs within the first hours and days of birth helped preserve their immune systems, improving their chances of better long-term health, U.S. researchers said on Wednesday.

HIV infections in newborns pose a huge health burden in developing countries. One study estimated that 300 to 500 infants are infected every day in sub-Saharan Africa.

“Without treatment, 50% of HIV-infected children progress to death within two years,” study co-author Dr. Roger Shapiro of the Harvard T.H. Chan School of Public Health said in a telephone briefing with reporters.

The study, published in the journal Science Translational Medicine, builds on discoveries of infants whose HIV was thought to have been cured after receiving antiretroviral therapy (ART) within weeks of birth. The first such case involved a Mississippi infant born in 2010 who was treated within 30 hours of birth and was able to control her virus for several months after treatment was stopped.

In the new study, a team of Harvard and MIT researchers tested this early treatment approach on a group of 40 HIV-infected infants in Botswana, where 24% of pregnant women are living with the virus that causes AIDS.

The researchers reported results of the first 10 infants who were given ART within hours and days of birth, 10 infected infants who began treatment four months after birth and compared those with 54 infants without HIV.

The earliest-treated infants showed a much smaller viral reservoir – the pool of virus that persists through life even during treatment – than the second infant group after 96 weeks, researchers reported.

Babies in the earliest treatment group also had more robust immune systems than even the infants without HIV, researchers found.

Current World Health Organization guidelines recommend infected newborns receive ART within weeks of birth to suppress the virus, which can otherwise quickly lead to rapid and fatal immune deficiency.

Shapiro said the earlier treatment strategy is not a cure, but could be combined with other interventions as part of research toward an HIV cure.

The research team said that some of the children may be enrolled in a trial testing the use of protective antibodies specifically engineered to neutralize HIV to see if the approach could help the infants control the disease without the need for lifelong treatment. That trial is set to start in 2020.

Reporting by Julie Steenhuysen; Editing by Bill Berkrot

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