DiversityNursing Blog

DONALD G. McNEIL Jr.

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

Fifty-one years ago, Arthur Lampitt of Granite City, Illinois, smashed his 1963 Thunderbird into a truck. This week during surgery in suburban St. Louis, a 7-inch turn signal lever from that T-Bird was removed from his left arm.

Dr. Timothy Lang removed the lever Wednesday during a 45-minute operation. Lampitt, now 75, is recovering at home.

The St. Louis Post-Dispatch ( http://bit.ly/1EOtGa6 ) reports that the accident broke Lampitt's hip, drawing attention away from the arm, which healed.

A decade or so ago, his arm set off a metal detector at a courthouse. An X-ray showed a slender object the length of a pencil, but since it caused no pain or hardship, Lampitt was told to let it be.

He was moving concrete blocks a few weeks ago when the arm began to hurt for the first time.

"Everything was fine until it started to get bigger," Lampitt's wife, Betty, said. "The arm started bulging."

Lampitt decided to have surgery. He initially wasn't sure what was in the arm. He wondered if perhaps a medical instrument had been left during the emergency room visit in 1963.

He unearthed a collection of old photos of the mangled Thunderbird taken by a friend at the scene. He noticed the metal blinker lever was missing from the left side of the steering column. He figured that was it, and surgery at City Place Surgery Center in Creve Coeur, Missouri, confirmed it.

"Seven inches long," Lang told Betty.

"Oh, my God," Betty said.

Lang said a protective pocket grew around the lever.

"We see all kinds of foreign objects like nails or pellets, but usually not this large, usually not a turn signal from a 1963 T-Bird," Lang said. "Something this large often gets infected."

Lampitt wasn't sure what he'd do with the lever ? maybe make a key chain out of it.

"We'll figure out something, I am sure," he said.

Source: http://abcnews.go.com

By Meera Senthilingam

Its name means "bending over in pain." It has no treatment or vaccine. Its symptoms resemble Dengue fever. And it has infected more than 1 million people -- 155 of them fatally -- since spreading to the Americas one year ago.

The mosquito-borne Chikungunya virus has long been diagnosed in travelers returning from countries in Asia and Africa, where the disease is widespread. But in December 2013, the first people infected by mosquitoes local to the region were reported on the Caribbean island of Saint Martin.

This was the first outbreak of the debilitating disease in the Western hemisphere, health officials said.

All countries in Central America have now reported local transmission of Chikungunya [pronounced chik-un-GOON-ya], and the United States had 11 confirmed cases of local infection this year as of December 12, all in the state of Florida. There also have been 1,900 imported cases across the U.S. in returning travelers.

"It wasn't until 2013 that unfortunately a traveler resulted in local transmission of Chikungunya," said Erin Staples of the U.S. Centers for Disease Control (CDC), referring to the people infected in Saint Martin.

Those infected carry the virus in their bloodstream; it can then be picked up by mosquitoes as they bite, making them carriers. The virus has since spread rapidly and shows no signs of leaving, as ecological conditions are perfect for the disease to flourish.

"We knew it would spread," said Staples, a medical epidemiologist.

The big question perplexing officials: Why now?

Two mosquito species primed to the temperatures of Central and South America carry Chikungunya. The species -- Aedes aegypti and Aedes albopictus -- also carry the virus behind Dengue fever.

"Given the level of Dengue in the region, we knew there could be the same levels of Chikungunya," Staples said. Both diseases can cause joint pain and inflammation, headaches, rashes and fever, and can lead to death in rare cases.

But this tropical disease with an exotic name (which originates from the African Makonde dialect) causes more intense joint pain and inflammation. For some people the pain can last for months or years, resulting in additional psychological strain.

The lack of immunity among people living in the Americas provided a blank canvas for Chikungunya to spread throughout the population this year. As of December 12, more than 1.03 million people have been infected, in addition to the 155 who died, according to the Pan-American Health Organisation (PAHO). Almost all of the fatalities occurred in the Caribbean island countries of Guadaloupe and Martinique.

"Where we saw the biggest jump was after it reached the Spanish-speaking countries in the region," said Staples, referring to the weakened infrastructures and health systems of countries such as the Dominican Republic, which has reported more than 520,000 cases -- more than half of the overall outbreak and 5% of the island country's population.

As South American countries approach their summer, numbers are expected to rise there as the mosquitoes flourish in the heat.

"Brazil, Peru, Paraguay are coming into their summer months and reporting their first local transmission," Staples said. Already, more than 2,000 people have been infected in Brazil.

Is there cause for concern?

Because infection with Chikungunya is rarely fatal, the issue of most concern to officials is the burden on health services and the impact of the debilitating symptoms on the economy.

"The high number of cases can overload health services," says Dr. Pilar Ramon-Pardo, regional adviser for PAHO, the regional office of the World Health Organization. Until recently, monitoring for Chikungunya was not part of routine surveillance in the region.

"Clinicians have to be ready to diagnose," she said

About 20% to 30% of cases are expected to become chronic, with symptoms such as arthritis and other rheumatic manifestations leading to physical disabilities, Ramon-Pardo said. Further long-term effects are psychological as people become more depressed and tired.

All of this can result in missed work and lower school attendance, she said, hurting local economies.

Is it here to stay?

The warm climate of the region offers potential for Chikungunya levels to be maintained for years to come, just like Dengue fever. But areas of most concern are the tropics.

"The areas which have year-round favorable climate for the mosquito are at the greatest risk," says Dr. Laith Yakob of the London School of Hygiene and Tropical Medicine, which is monitoring the spread of the outbreak.

While the climate and mosquitos have long been present, Ramon-Pardo said, "we don't know why this is happening now." She said globalization is likely to blame, with increased population movement from one country to another. This offers more opportunities for local mosquitos to bite infected humans.

The CDC's Staples said she is temporarily at ease regarding numbers in the U.S. "We're moving into fall and winter periods, which should see activity decrease," she said. Cold temperatures reduce mosquito survival rates.

The rapid spread of Chikungunya this year also could help minimize future infections. "Chikungunya will go through a region quite rapidly and create a level of population immunity which helps mitigate large outbreaks of the disease," Staples said. Unlike Dengue, infection with Chikungunya results in lifelong immunity.

Like many other infections, Chikungunya could, however, remain in the background through animals capable of carrying the virus in their bloodstream and acting as so-called reservoirs of the disease.

"In Asia and Africa there is a transmission cycle in small mammals and monkeys," Ramon-Pardo said, meaning these animals keep the virus present within the population. "In the Americas ... we don't know yet."

Those words -- "we don't know" -- resonate throughout the community of scientists and government officials trying to control the outbreak.

The future risk of spread, levels of future immunity, risk from animal reservoirs, why this is only happening now, and the total economic impact are all unknown.

"Mathematical models are under construction by numerous research groups around the world to improve confidence over projections of future spread," said Yakob, whose team is modeling the disease. As they work, control efforts continue.

Getting it under control

When it comes to controlling Chikungunya, there are two main strategies -- reduce the likelihood of bites and remove the ever-biting mosquito. Prevention is the priority.

Unlike the mosquitoes behind malaria, which bite at night, the species behind Chikungunya bite any time, day or night. Those living in affected areas are asked to use repellent, sleep under bed nets and wear long clothing to avoid getting bitten. The air conditioned and indoor environments of people living in the U.S. mean numbers are likely to stay low there.

But mosquito control is at the heart of it all. Mass spraying of insecticides and removal of any sources of shallow water in which mosquitoes can breed are taking place across the continents. According to the CDC's Staples, Florida has been highly aggressive with its approach to control. "We're only at 11 (cases) due to such proactive measures," Staples said. For now, prevention is all they have as officials wait and see how the outbreak pans out.

"There is no vaccine currently and no good antivirals, so we are trying to control the spread of the disease," Staples said. "There are a lot of questions and only time will tell what we'll see for Chikungunya in the future."

Source: www.cnn.com

By Meera Senthilingam

"It only takes one virus to get through for a person to be infected," explained Dr. John Mascola. This is true of any viral infection, but in this instance, Mascola is referring to HIV and his ongoing efforts to develop a vaccine against the virus. "It's been so difficult to make an HIV/AIDS vaccine."

Those were the words of many working in HIV vaccine development until the results of a 2009 trial in Thailand surprised everyone. "The field is energized," said Mascola, director of the Vaccine Research Center at the U.S. National Institute of Allergy and Infectious Diseases, describing the change in atmosphere in the vaccine community.

The trial included over 16,000 volunteers and was the largest clinical trial ever conducted for a vaccine against HIV. It was also the first to show any protection at all against infection.

Two previously developed vaccines, known as ALVAC-HIV and AIDSVAX, were used in combination, with the first priming an immune response against HIV and the second used as a booster once the immunity waned. The duo reduced the risk of contracting HIV by 31.2% -- a modest reduction, but it was a start.

To date, only four vaccines have made it as far as testing for efficacy to identify their levels of protection against HIV. Only this one showed any protection.

"That trial was pivotal," Mascola said. "Prior to that, it wasn't known whether a vaccine could be possible."

In recent years, there have been parallel findings of an equally pivotal nature in the field of HIV prevention, including the discovery that people regularly taking their antiretroviral treatment reduce their chances of spreading HIV by 96% and that men who are circumcised reduce their risk of becoming infected heterosexually by approximately 60%.

Both improved access to antiretrovirals and campaigns to increase male circumcision in high-risk populations have taken place since the discoveries, and although numbers of new infections are falling, they're not falling fast enough.

In 2013, there were 35 million people estimated to be living with HIV globally. There were still 2.1 million new infections in 2013, and for every person who began treatment for HIV last year, 1.3 people were newly infected with the lifelong virus, according to UNAIDS. A vaccine remains essential to control the epidemic.

A complex beast

Scientists like Mascola have dedicated their careers to finding a vaccine, and their road has been tough due to the inherently complicated nature of the virus, its aptitude for mutating and changing constantly to evade immune attack, and its ability attack the very immune cells that should block it.

There are nine subtypes of HIV circulating in different populations around the world, according to the World Health Organization, and once inside the body, the virus can change continuously.

"Within an individual, you have millions of variants," explained Dr. Wayne Koff, chief scientific officer for the International AIDS Vaccine Alliance.

HIV invades the body by attaching to, and killing, CD4 cells in the immune system. These cells are needed to send signals for other cells to generate antibodies against viruses such as HIV, and destroying those enables HIV to cause chronic lifelong infections in those affected.

Measles, polio, tetanus, whooping cough -- to name a few -- all have vaccines readily available to protect from their potentially fatal infections. But their biology is seemingly simple in comparison with HIV.

"For the older ones, you identify the virus, either inactivate it or weaken it, and inject it," Koff said. "You trick the body into thinking it is infected with the actual virus, and when you're exposed, you mount a robust immune response."

This is the premise of all vaccines, but the changeability of HIV means the target is constantly changing. A new route is needed, and the true biology of the virus needs to be understood. "In the case of HIV, the old empirical approach isn't going to work," Koff said.

Scientists have identified conserved regions of the virus that don't change as readily, making them prime targets for attack by antibodies. When the success of the Thai trial was studied deep down at the molecular level, the protection seemed to come down to attacking some of these conserved regions. Now it's time to step it up.

In January, the mild success in Thailand will be applied in South Africa, where over 19% of the adult population is living with HIV. The country is second only to bordering Swaziland for having the highest rates of HIV in the world.

"The Thai vaccine was made for strains (of HIV) circulating in Thailand," said Dr. Larry Corey, principal investigator for the HIV Vaccine Trials Network, which is leading the next trial in South Africa. The strain, or subtype, in this case was subtype B. "For South Africa, we've formed a strain with common features to (that) circulating in the population." This region of the world has subtype C.

An additional component, known as an adjuvant, is being added to the mix to stimulate a stronger and hopefully longer-lasting level of immunity. "We know durability in the Thai trial waned," Corey said. If safety trials go well in 2015, larger trials for the protective effect will take place the following year. An ideal vaccine would provide lifelong protection, or at least for a decade, as with the yellow fever vaccine.

A broad attack

The excitement now reinvigorating researchers stems not only from a modestly successful trial but from recent successes in the lab and even from HIV patients themselves.

Some people with HIV naturally produce antibodies that are effective in attacking the HIV virus in many of its forms. Given the great variability of HIV, any means of attacking these conserved parts of the virus will be treasured and the new found gold comes in the form of these antibodies -- known as "broadly neutralizing antibodies." Scientists including Koff set out to identify these antibodies and discover whether they bind to the outer coat of the virus.

The outer envelope, or protein coat, of HIV is what the virus uses to attach to, and enter, cells inside the body. These same coat proteins are what vaccine developers would like our antibodies to attack, in order to prevent the virus from entering our cells. "Broadly neutralizing antibodies" could hold the key because, as their name suggests, they have a broad remit and can attack many subtypes of HIV. "We will have found the Achilles heel of HIV," Koff said.

Out of 1,800 people infected with HIV, Koff and his team found that 10% formed any of these antibodies and just 1% had extremely broad and potent antibodies against HIV. "We called them the elite neutralizers," he said of the latter group. The problem, however, is that these antibodies form too late, when people are already infected. In fact, they usually only form a while after infection. The goal for vaccine teams is to get the body making these ahead of infection.

"We want the antibodies in advance of exposure to HIV," explained Koff. The way to do this goes back to basics: tricking the body into thinking it is infected.

"We can start to make vaccines that are very close mimics of the virus itself," Mascola said.

Teams at his research center have gained detailed insight into the structure of HIV in recent years, particularly the outer coat, where all the action takes place. Synthesizing just the outer coat of a virus in the lab and injecting this into humans as a vaccine could "cause enough of an immune response against a range of types of HIV," Mascola said.

The vaccine would not contain the virus itself, or any of its genetic material, meaning those receiving it have no risk of contracting HIV. But for now, this new area remains just that: new. "We need results in humans," Mascola said.

Rounds of development, safety testing and then formal testing in high-risk populations are needed, but if it goes well, "in 10 years, there could be a first-generation vaccine." If improved protection is seen in South Africa, a first-generation vaccine could be with us sooner.

Making an Impact

When creating vaccines, the desired level of protection is usually 80% to 90%. But the high burden of HIV and potentially beneficial impact of lower levels of protection warrant licensing at a lower percentage.

"Over 50% is worth licensing from a public health perspective," Koff said, meaning that despite less shielding from any contact with the HIV virus, even a partially effective vaccine would save many lives over time.

The next generations will incorporate further advancements, such as inducing neutralizing antibodies, to try to increase protection up to the 80% or 90% desired.

"That's the history of vaccine research; you develop it over time," Corey said. He has worked in the field for over 25 years and has felt the struggle. "I didn't think it would be this long or this hard ... but it's been interesting," he ponders.

But there is light at the end of tunnel. Just.

"There has been no virus controlled without a vaccine," he concluded when explaining why, despite antiretrovirals, circumcision and increased awareness, the need for a one-off intervention like a vaccine remains strong.

"Most people that transmit it don't even know they have it," he said. "To get that epidemic, to say you've controlled it, requires vaccination."

Source: www.cnn.com

By Steven Reinberg

Residents of the southern United States may be at risk for a parasitic infection that can lead to severe heart disease and death, three new studies suggest.

Chagas disease, which is transmitted by "kissing bugs" that feed on the faces of humans at night, was once thought limited to Mexico, Central America and South America.

That's no longer the case, the new research shows.

"We are finding new evidence that locally acquired human transmission is occurring in Texas," said Melissa Nolan Garcia, a research associate at Baylor College of Medicine in Houston and the lead author of two of the three studies.

Garcia is concerned that the number of infected people in the United States is growing and far exceeds the U.S. Centers for Disease Control and Prevention's estimate of 300,000.

In one pilot study, her team looked at 17 blood donors in Texas who tested positive for the parasite that causes Chagas disease.

"We were surprised to find that 36 percent had evidence of being a locally acquired case," she said. "Additionally, 41 percent of this presumably healthy blood donor population had heart abnormalities consistent with Chagas cardiac disease."

The CDC, however, still believes most people with the disease in the United States were infected in Mexico, Central and South America, said Dr. Susan Montgomery, of the agency's parasitic diseases branch.

"There have been a few reports of people becoming infected with these bugs here in the United States," she said. "We don't know how often that is happening because there may be cases that are undiagnosed, since many doctors would not think to test their patients for this disease. However, we believe the risk of infection is very low."

Maybe so, but kissing bugs -- blood-sucking insects called triatomine bugs -- are found across the lower half of the United States, according to the CDC. The insects feed on animals and people at night.

The feces of infected bugs contains the parasite Trypanosoma cruzi, which can enter the body through breaks in the skin. Chagas disease can also be transmitted through blood.

It's a silent killer, Garcia said. People don't feel sick, so they don't seek care, but it causes heart disease in about 30 percent of those who get infected, she said.

In another study, Garcia's team collected 40 insects in 11 Texas counties. They found that 73 percent carried the parasite and half of those had bitten humans as well as other animals, such as dogs, rabbits and raccoons.

A third study found that most people infected with Chagas aren't treated.

For that project, Dr. Jennifer Manne-Goehler, a clinical fellow at Harvard Medical School and Beth Israel Deaconess Medical Center in Boston, collected data on nearly 2,000 people whose blood tested positive for Chagas.

Her team found that only 422 doses of medication for the infection were given by the CDC from 2007 to 2013. "This highlights an enormous treatment gap," Manne-Goehler said in a news release.

The findings of all three studies, published recently in the American Journal of Tropical Medicine and Hygiene, were to be presented Tuesday in New Orleans at the annual meeting of the American Society of Tropical Medicine and Hygiene.

Symptoms of Chagas can range from none to severe with fever, fatigue, body aches and serious cardiac and intestinal complications.

"Physicians should consider Chagas when patients have swelling and enlargement of the heart not caused by high blood pressure, diabetes or other causes, even if they do not have a history of travel," Garcia said.

However, the two treatments for this disease are "only available [in the United States] via an investigative drug protocol regulated by the CDC," Garcia said. They are not yet approved by the Food and Drug Administration.

Efforts are under way to develop other treatments for Chagas disease, Montgomery said.

"Several groups have made some exciting progress in drug development," she said, "but none have reached the point where they can be used to treat patients in regular clinical practice."

Source: health.usnews.com

By Reuters

Three more people in Colorado have been diagnosed with the plague after coming in contact with an infected dog whose owner contracted a life-threatening form of the disease, state health officials said on Friday.

In all, four people were infected with the disease from the same source, the Colorado Department of Public Health and Environment said in a statement.

Last week the department said a man in an eastern Colorado county whose dog died of the plague had been diagnosed with pneumonic plague, a rare and serious form of the disease.

The man remains hospitalized, but authorities have not released his condition.

The three people in the latest reported cases had "mild symptoms" and have fully recovered after being treated with antibiotics, the department said, adding that they are no longer contagious.

Two of the patients in the new cases contracted pneumonic plague, the department said.

Pneumonic plague is the only form of the disease that can be transmitted person-to-person, usually through infectious droplets from coughing.

The bacteria that causes plague occurs naturally in the western United States, primarily in California, New Mexico, Arizona and Colorado, according to the U.S. Centers for Disease Control and Prevention.

The infected canine in Colorado likely contracted the disease from prairie dogs or rabbits, which are the primary hosts for fleas that carry the bacteria.

When an infected animal dies, the fleas spread the disease when they find another host.

Colorado has seen a total of 12 cases of humans infected with the plague over the last decade, said Jennifer House, the department's public health veterinarian.

"We usually don't see an outbreak like this related to the same source," House said.

Colorado had not had a confirmed human case of pneumonic plague since 2004, she said.

Source: http://www.foxnews.com/health