DiversityNursing Blog

Study That Paid Patients to Take H.I.V. Drugs Fails

Posted by Erica Bettencourt

Wed, Feb 25, 2015 @ 11:51 AM

DONALD G. McNEIL Jr.

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A major study testing whether Americans would take their H.I.V. drugs every day if they were paid to do so has essentially failed, the scientists running it announced Tuesday at an AIDS conference here.

Paying patients in the Bronx and in Washington — where infection rates are high among poor blacks and Hispanics — up to $280 a year to take their pills daily improved overall adherence rates very little, the study’s authors said.

The hope was that the drugs would not only improve the health of the people taking them, but help slow the spread of H.I.V. infections. H.I.V. patients who take their medicine regularly are about 95 percent less likely to infect others than patients who do not. The Centers for Disease Control and Prevention estimates that only a quarter of all 1.1 million Americans with H.I.V. are taking their drugs regularly enough to not be infectious.

Paying patients $25 to take H.I.V. tests, and then $100 to return for the results and meet a doctor, also failed, the study found.

“We did not see a significant effect of financial incentives,” said Dr. Wafaa M. El-Sadr, an AIDS expert at Columbia University and the lead investigator. But, she said, there is “promise for using such incentives in a targeted manner.”

Cash payments might still work for some patients and some poor-performing clinics, she said.

Other H.I.V.-prevention research released here Tuesday offered good news for gay men but disappointing results for African women.

Two studies — both of gay men, one in Britain and the other in France — confirmed earlier research showing that pills to prevent infection can be extremely effective if taken daily or before and after sex. Both were stopped early because they were working so well that it would have been unethical to let them continue with men in control groups who were not given the medicine.

But a large trial involving African women of a vaginal gel containing an antiviral drug failed — apparently because 87 percent of the women in the trial were unable to use the gel regularly.

The failure of the cash-incentives trial was a surprise and a disappointment to scientists and advocates. It had paid out $2.8 million to 9,000 patients in 39 clinics over three years, but the clinics where money was distributed did only 5 percent better than those that did not — a statistically insignificant difference.

Some small clinics and those where patients had been doing poorly at the start of the study did improve as much as 13 percent, however.

People in other countries have been successfully paid to stop smoking while pregnant and to get their children to school. In Africa, paying poor teenage girls to attend school lowered their H.I.V. rates; scientists concluded that it eased the pressure on them to succumb to “sugar daddies” — older men who gave them money for food, clothes and school fees in return for sex.

One study presented here at the annual Conference on Retroviruses and Opportunistic Infections estimated that every prevented H.I.V. infection saved $230,000 to $338,000. Much of that cost is borne by taxpayers.

Mathematical modeling suggested that paying people up to $5,000 a year could be cost effective, Dr. El-Sadr said, but $280 was settled on after a long, difficult debate.

Paying more than $280 at some clinics was not an option, she said; achieving statistical relevance would have meant signing up even more clinics. The study had already involved almost every H.I.V. patient in the Bronx and Washington.

“I don’t think anyone has an answer to what amount would be sufficient without being excessive,” Dr. El-Sadr said.

One advocate suggested that more money could work — in the right setting.

“In South Africa, $280 is a lot of money,” said Mitchell Warren, the executive director of AVAC, an organization that lobbies for AIDS prevention. “For that much, you’d definitely get some behavior change.”

The two studies among gay men looked at different ways to take pills. A 2010 American study, known as iPrEx, showed that taking Truvada — a combination of two antiretroviral drugs — worked if taken daily.

The British study, known as PROUD, used that dosing schedule, and men who took the pill daily were protected 86 percent of the time.

In the French trial, known as Ipergay, men were advised to take two pills in the two days before they anticipated having sex and two in the 24 hours afterward.

Those who took them correctly also got 86 percent protection.

“The problem,” Dr. Susan P. Buchbinder, director of H.I.V. prevention research for the San Francisco health department, said in a speech here commenting on the study, “is that studies have shown that men are very good at predicting when they will not have sex and not good at predicting when they will.”

The African study, known as FACTS 001, was a follow-up to the smaller trial from 2010, which showed that South African women who used a vaginal gel containing tenofovir, an antiviral drug, before and after sex were 39 percent better protected than women who did not.

But it also found that many women failed to use the gel because it was messy or inconvenient or because partners objected.

In this trial, there was virtually no effect.

One problem, said Dr. Helen Rees, the chief investigator, was that the women were very young — the median age was 23, and most lived with their parents or siblings.

“They had no privacy for sex,” she said. “They had to go outside to use the product.”

Mr. Warren, of AVAC, said: “The women wanted a product they could use. But this particular product didn’t fit into the realities of their daily lives.”

The development means that advocates are hoping even more that other interventions for women now in trials will work. They include long-lasting injections of antiretroviral drugs and vaginal rings that can be inserted once a month and leach the drugs slowly into the vaginal wall.

Another trial in Africa, the Partners Demonstration Project, conducted among couples in which one partner had H.I.V. and the other did not, found it was extremely effective to simultaneously offer treatment to the infected partner and preventive drugs to the uninfected one until the other’s drugs took full effect.

In the group getting the treatment, there were zero infections that could be traced to partners who were in the study.

Source: www.nytimes.com

Topics: drugs, virus, AIDS, study, health, research, health care, patients, medicine, treatment, infection, Money, HIV, cure

Microneedles For Easy Delivery Of Drugs Into Eye

Posted by Erica Bettencourt

Mon, Nov 17, 2014 @ 11:52 AM

microneedles

A number of eye conditions can be treated by administering drugs directly into the eye. Yet, conventional needles have a bunch of drawbacks, including the patients’ fear of needles entering such fragile parts of the body and the difficulty of accurately administering medication into a targeted region of the eye. For glaucoma, for example, eye drops are prescribed which have a shorter active lifetime and are often skipped by the patients. An easy injection that works for months at a time would help control the disease considerably better.

Researchers at Georgia Tech and Emory University have been working on microneedles and formulations to safely and effectively deliver drugs into the eye. The microneedles are designed to only penetrate to the correct depth and the formulations need to be viscous enough to stay in place and release their therapeutic compounds in a controlled fashion. The researchers have already tested the microneedles on laboratory animals and showed that they can place drugs within the targeted sections of the eye.

More from Georgia Tech:

The microneedle therapy would inject drugs into space between two layers of the eye near the ciliary body, which produces the aqueous humor. The drug is retained near the injection side because it is formulated for increased viscosity. In studies with an animal model, the researchers were able to reduce intraocular pressure through the injections, showing that their drug got to the proper location in the eye.

Because the injection narrowly targets delivery of the drug, researchers were able to bring about a pressure reduction by using just one percent of the amount of drug required to produce a similar decline with eye drops.

To treat corneal neovascularization, the researchers took a different approach, coating solid microneedles with an antibody-based drug that prevents the growth of blood vessels. They inserted the coated needles near the point of an injury, keeping them in place for approximately one minute until the drug dissolved into the cornea.

In an animal model, placement of the drug halted the growth of unwanted blood vessels for about two weeks after a single application.

Source: www.medgadget.com

Topics: needles, drugs, microneedles, eyes, technology, health, healthcare, medical, patients, medicine

An Ingestible Pill With Needles Could Be The New Form Of Injection

Posted by Erica Bettencourt

Mon, Oct 06, 2014 @ 11:25 AM

By Marie Ellis

needle pill

Imagine swallowing a pill with tiny needles instead of getting an injection. Then again, imagine swallowing a pill with tiny needles. It may sound painful, but according to the researchers who developed the novel capsule - which could replace painful injections - there are no harmful side effects.

The researchers, from the Massachusetts Institute of Technology (MIT) and Massachusetts General Hospital (MGH), have published the results of their study - which tested the microneedle pill in the gastrointestinal (GI) tracts of pigs - in the Journal of Pharmaceutical Sciences.

Though most of us would probably prefer swallowing a pill over having an injection, many drugs cannot be given in pill form because they are broken down in the stomach before being absorbed.

Biopharmaceuticals made from large proteins, such as antibodies - known as "biologics" - are used to treat cancer, arthritis and Crohn's disease, and also include vaccines, recombinant DNA and RNA.

"The large size of these biologic drugs makes them nonabsorbable," explains lead author MIT graduate student Carl Schoellhammer. "And before they even would be absorbed, they're degraded in your GI tract by acids and enzymes that just eat up the molecules and make them inactive."

In an effort to design a capsule that is capable of delivering a wide range of drugs - while preventing degradation and effectively injecting the medicine into the GI tract - Schoellhammer and colleagues constructed the capsule from acrylic, including a reservoir for the drug that is coated with hollow, 5 mm long needles made of stainless steel.

The capsule measures 2 cm long and 1 cm in diameter.

Needle capsule worked safely and effectively in pigs

The team notes that previous studies involving humans who have accidentally swallowed sharp objects have suggested swallowing a capsule coated with short needles could be safe. They explain that there are no pain receptors in the GI tract and that, as a result, patients would not feel any pain.

But to assess whether their capsule could safely and effectively deliver the drugs, the researchers tested the pill in pigs, using insulin in the drug reservoir.

The capsules took more than a week to move through the whole digestive tract, and there were no traces of tissue damage, the researchers say. Additionally, the microneedles effectively injected insulin into the lining of the pigs' stomachs, small intestines and colons, which resulted in their blood glucose levels dropping.

Co-lead author Giovanni Traverso, a research fellow at MIT's Koch Institute for Integrative Cancer Research and gastroenterologist at MGH, notes that the pigs' reduction in blood glucose was faster and larger than the drop observed from insulin injection.

"The kinetics are much better and much faster-onset than those seen with traditional under-the-skin administration," he says. "For molecules that are particularly difficult to absorb, this would be a way of actually administering them at much higher efficiency."

'Oral delivery of drugs is a major challenge'

Though they used insulin for their tests in pigs, the researchers say they envision their capsule being used to deliver biologics to humans.

"This could be a way that the patient can circumvent the need to have an infusion or subcutaneous administration of a drug," says Traverso.

Prof. Samir Mitragotri, a professor at the University of California-Santa Barbara - who was not involved in the research - says:


"This is a very interesting approach. Oral delivery of drugs is a major challenge, especially for protein drugs. There is tremendous motivation on various fronts for finding other ways to deliver drugs without using the standard needle and syringe."

In terms of future modifications, the team plans to alter the capsule so that contractions of the digestive tract slowly squeeze the drug out of the capsule as it travels through the body, and they also want to make the needles out of degradable polymers and sugar that break off, becoming embedded in the gut lining and slowly disintegrating.

Source: http://www.medicalnewstoday.com

Topics: drugs, researchers, innovation, injections, pills, health, healthcare, medicine

College students developing nail polish to detect date rape drugs

Posted by Erica Bettencourt

Fri, Aug 29, 2014 @ 01:33 PM

By Eun Kyung Kim

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Four students at North Carolina State University hope to tackle a problem on many campuses by developing a nail polish that can detect so-called date rape drugs by changing colors when it comes into contact with them.

Women who wear the polish can simply swirl their fingers in a drink to test it for any colorless, odorless compound that may have been slipped in.

The four male entrepreneurs behind the product, which they call Undercover Colors, have received mainly positive responses. They won an $11,000 prize from a contest on campus, where they also have met with a potential investor. 

A White House report estimates one in five women has been sexually assaulted while at college, but only 12 percent of those student victims ever report the crime.

“As a rape victim, and a mother of 3 daughters, I can not thank you enough,” one fan said in a post on the group's Facebook page, which has been “liked” by more than 26,000 users.

But some have expressed skepticism about the product, however well-intentioned it may be.

"I think it reflects the cultural reality where we actually put the blame on women,” often when they are the victims of rape,” said Elizabeth Plank, a senior editor at Mic. “We put the onus on them, to prevent rape, when we very well know that this is not an effective way of actually reducing sexual assault."

North Carolina State has encouraged the students to continue pursuing their project, providing them with lab space to experiment. It’s not clear when the nail polish will be available on the market.

Source: http://www.today.com

 

Topics: drugs, prevention, college, nail polish, date rape

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