Pill-a-Month Hinders Malaria in Kids

Published: Aug 5, 2014

By Michael Smith, North American Correspondent, MedPage Today

A monthly pill appears to protect infants against malaria in regions where the mosquito-borne disease is transmitted year round, researchers reported.

In a randomized open-label trial,dihydroartemisinin-piperaquine  (Duo-Cotecxin) had a protective efficacy of 58% compared with no medication, according to Grant Dorsey, MD,  of the University of California San Francisco, and colleagues.

The drug combination -- known as DP in the trial -- also outperformed other antimalaria drugs in protecting infants, Dorsey and colleagues reported online in PLOS Medicine. 

The DP combination might actually have worked better than the 58% figure would suggest, the researchers reported, since there was evidence of nonadherence in about half of the children diagnosed with malaria who were supposed to be taking the drug.

Chemoprevention "offers a promising strategy" to prevent malaria in African children, the authors noted, but it's not clear exactly how to do that in regions where transmission occurs year round and the disease is resistant to many antimalarial drugs.

To help clarify the issue, Dorsey and colleagues conducted a randomized trial comparing no chemoprevention to three medication arms -- monthly dihydroartemisinin-piperaquine (DP), monthly sulfadoxine-pyrimethamine  (SP), and daily trimethoprim-sulfamethoxazole (TS).

Children were enrolled at 6 months and received study medication until they were 2. The researchers then followed them for another year. The primary endpoint of the study was efficacy in preventing malaria during the intervention period, compared with no chemoprevention.

During the intervention, the incidence of malaria in the no chemoprevention arm was 6.95 episodes per person-year at risk, compared with 6.73 in the SP arm, 5.21 in the TS arm, and 3.02 in the DP arm.

Compared with no prevention, the protective efficacy was 7% for SP, 28% for TS, and 58% for DP, the researchers reported, although only the latter two reached statistical significance.

Protection was better in the first 6 months of the trial and declined in the following 12 months. Specifically:

For the DP combination, malaria incidence in the first 6 months was 1.49 per person-year at risk, compared with 3.88 in the 12 months following. Those rates yielded respective protective efficacies of 78% and 45%, both significant (P<0.001) compared with no chemoprevention.

For the daily TS combination, incidence in the first 6 months was 3.27 per person-year at risk, compared with 6.32 in the following year, yielding efficacy rates of 51% and 11% compared with no chemoprevention. Only the first was statistically significant.

For the monthly SP duo, incidence was 5.51 per person-year at risk in the first 6 months and 7.41 thereafter. Neither was significantly different from no chemoprevention.

Based on diaries completed by primary caregivers, more than 98% of the assigned doses of the study drugs was administered, Dorsey and colleagues reported.

But an analysis of blood among children assigned to the DP combination drug who were diagnosed with malaria told a different story: 52% of them had no detectable piperaquine, suggesting "frequent nonadherence."

All told 2,487 treatments were given for malaria during the intervention period, including 21 for complicated malaria and nine for severe malaria.

There were no significant differences in complicated malaria, hospital admission, diarrhea, or respiratory tract infections between the intervention arms and the control arm.

On the other hand, moderate to severe anemia, defined as hemoglobin less than 8 grams per deciliter, was significantly higher in the SP arm and lower in the DP arm than in the no chemoprevention arm.

As well, the researchers reported, the incidence of elevated temperature, anemia, and thrombocytopenia was significantly lower in the DP arm, but not the other two medication arms, compared with no chemoprevention.

In the year after the intervention, the incidence of malaria in the no chemoprevention arm was 10.85 cases per person-year at risk, not significantly different from any of the chemoprevention arms.

Dorsey and colleagues cautioned that parents or caregivers gave study drugs at home and administration was not directly observed. As well, they noted, multiple comparisons mean that a finding of statistical significance should be interpreted cautiously.

And, they noted, the study took place in an area of high transmission intensity, and widespread resistance to antifolate drugs so the results might not apply elsewhere.

Published: Aug 7, 2014

By Anna Gorman , Kaiser Health News

Now that two of California's biggest health insurers have teamed up on a project to share patients' digitized medical records, they are planning to invite other companies to join.

The project will initially cover about 9 million Californians, making it possible for doctors and hospitals to quickly access patients' medical histories and avoid unnecessary tests and procedures.

Heads of the two rival insurers -- Blue Shield of California and Anthem Blue Cross – said Tuesday that they eventually want to include as many people as possible in the network, dubbed Cal Index.

"Ultimately our goal is to have all payers and all providers participating in Cal Index," said Paul Markovich, president of Blue Shield, during a call with reporters. "We are open to anyone and everyone who can and will contribute data."

Organizers said they plan to reach out to other insurers with the idea of creating a comprehensive, statewide system. The project is set to go live later this year, bringing patients' digitized lab, pharmacy, outpatient and hospital records into one place that can be accessed by both patients and their medical providers.

California's Secretary of Health and Human Services Diana Dooley said she was excited about the project but cautioned that it needs to protect the privacy rights of consumers.

"Patients have expectations that their records will be private – at the same time they want their providers to have access to enhance their medical options and outcomes," she said. "This is the balance we are all striving for."

The electronic network raises concerns about possible data breaches and unauthorized access, said Linda Sherry, spokesman for Consumer Action, a San Francisco-based national consumer advocacy and education organization.

"Health data being so sensitive, we are very concerned when too much of it is available to too many people," she said. "It is even scarier when you think of the sheer number of records in a database like this."

The heads of the two insurance companies said they have done extensive research and planning for the network and will ensure that patients' records are secure.

The federal government has invested heavily in recent years in getting medical providers to switch from paper records to electronic ones. But there has been less focus on connecting those records, meaning that patients often have to start from scratch each time they switch doctors or go to a different hospital.

Anthem Blue Cross and Blue Shield are investing $80 million in the project over the next three years and eventually will charge subscription fees to providers and insurers. Though there are some smaller regional networks, this will be one of the largest exchanges of its kind, said David Feinberg, president of UCLA Health System and chair of Cal Index's board of directors.

Feinberg said the inability to share information results in negative health outcomes, duplication and bad decision-making. "In today's digital age, there is simply no excuse for this waste," he said.

Patients can opt out of the electronic network. But Anthem Blue Cross president Mark Morgan said those who participate will have the peace of mind of knowing that if they move from one doctor to another, their medical information will follow them.