A test to determine if you are infected with HIV should be made available over-the-counter, a federal advisory panel to the Food and Drug Administration has recommended. 

Having a home test kit available would seem to be a good idea for cutting down on new cases. About 1 in 5 people with HIV don't know they are infected, according to the Centers for Disease Control, and could be passing the virus on to others.

And early treatment seems to help diminish the virulence of HIV so a home test kits sounds like a better idea.  And given that it was just recently announced by another FDA advisory panel that the drug Truvada ought to get the FDA’s blessing as a way to prevent HIV transmission, would seem to be a great idea.

But is an HIV home test kit really a great idea? On the whole yes, but, there are some big ethical holes facing home testing.

First, there is no mandatory counseling to go along with the test. You can get some counseling by phone if you want it but you do not have to do so. Shouldn’t counseling be mandatory? After all, if you test positive don’t you need to hear some information about getting medicine fast, telling sexual partners, changing any risky behavior you are engaged in and what to do if you are pregnant or have a serious disease?  When you test at home shouldn’t you have to contact someone who can tell you the facts you need to know?

Having a home test kit for HIV is a bit like relying on a bathroom scale in the battle against obesity. Both tests can tell you important information. That information may well save your life. But, unless someone discusses the significance of the test result with you telling you what can be done to battle the problem, there is a pretty good chance you will either say “Thank goodness I did not test positive” and keep doing whatever it is you are doing even if it is bad for you --  or test positive and say “I have a problem and I am so ashamed or frightened I won’t do anything at all about it.”

There is another problem facing the home HIV test kit.  It is not 100 percent accurate. A negative result can occur by error, misusing the test or because the infection is too recent to register. A positive result needs reconfirmation by a blood test.

Another concern is that a home test kit can be used surreptitiously. The screening test relies on a simple swab of the gums. Someone could get your DNA while you are sleeping or under false pretense or even from a toothbrush.  You might get tested without your knowledge or consent.

It is still true that finding ways to let people know they are infected is better than doing nothing. Home testing will cut the rate of infection and that is good. Still, to get the most out of home testing it is important that someone from outside the home be involved in discussing the results.

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By David Morgan
Reuters

WASHINGTON - A U.S. Food and Drug Administration panel of outside experts concluded that OraSure Technologies Inc's over-the-counter, in-home HIV test is reasonably safe and effective for determining whether someone has the AIDS virus.

The 17-member FDA advisory committee voted unanimously that the drug's ability to prevent new HIV infections and provide HIV-positive people with access to medical care and social services outweighed the risks of false results.

Tuesday's recommendations will now be considered by agency regulators as they determine whether the product, known as the OraQuick In-Home HIV Test, should be approved as the first-ever over-the-counter, completely in-home HIV test.

Advocates say the in-home test would provide a new and potentially powerful strategy for attacking an U.S. HIV epidemic that has infected nearly 1.2 million people and increases by 50,000 new cases each year.

Trading in OraSure's shares was halted for the FDA meeting after closing on Monday at $9.10.

The company said it would expect the product to retail for less than $60, if approved and marketed over the next the several months.

Panel members urged OraSure to undertake post-marketing studies to ensure that the test is available to under-served populations in a manner that would link those who use the kit to the healthcare services including confirmatory tests at professional settings.

A home version of the professionally administered OraQuick Advance test, the new product is an oral swab rapid test that produces results within 20 minutes. The test should not be taken until 90 days after an individual last had an risky behavior.

FDA officials said the OraQuick In-Home test showed a high degree of effectiveness in detecting HIV infection. But some research data suggested the test lacked sufficient sensitivity to avoid false negative results.

False negatives are of particular concern because they could lead HIV-positive individuals to take fewer precautions, raising the danger that they will engage in unprotected sex.

Some panel members argued for strongly worded labeling about false results and procedures to link those who telephone a company hotline with questions with healthcare professionals.

U.S. health officials told the panel that home-testing could help get needed healthcare to HIV-positive individuals earlier. At present, only 62 percent of those with HIV are linked to the healthcare services and just 28 percent have access to drugs capable of suppressing the infection.

The panel heard overwhelmingly supportive public testimony from more than two-dozen witnesses including HIV activists, black community representatives and public health experts, some of whom received money and other assistance from OraSure.

The witnesses urged the panel to back the test as a means of eliminating HIV's public stigma, a main barrier to testing, by making the home test just another item that can be purchased at a local pharmacy along with aspirin or condoms.

Whitney Engeran of the AIDS Healthcare Foundation, a Los Angeles-based group that provides care for nearly 170,000 HIV patients, said the potential ability to break down the stigma outweighed the product's shortcomings. "The perfect cannot be the enemy of the good," he said.

One witness, who represented healthcare providers, urged the FDA to withhold approval until further study can raise the test's accuracy to a level more in line with those administered in clinics and other professional settings.

Last week, another FDA panel recommended regulatory approval for Gilead Sciences Inc's HIV drug, Truvada, as the first pill treatment for protecting uninfected individuals. 

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One step closer to a cure for AIDS – that is the implication of results out Wednesday from from several leading research centers.

It should be noted that many people involved in AIDS research, including several who carried out the latest research, avoid the “c” word. Their goal is to allow people infected with HIV to live without daily doses of the medications that usually keep the virus under control-- at a large financial cost --and a risk of side effects.

The latest work, published in Science Translational Medicine, details 43 HIV-infected volunteers who had experimental genes inserted into their disease-fighting white blood cells 11 years ago. All patients are doing fine. After more than a decade with this gene therapy, there are no side effects. In almost every one the inserted genes are still working properly. 

While these experiments were never intended to treat or cure anything, they lay the groundwork for gene therapy that could have a substantial impact on HIV disease.

A cure for AIDS became an obvious goal as soon as the disease was discovered 30 years ago. But it became “the dirty four letter word,” as Jon Cohen of Science magazine put it, after some spectacular failures. Soon after the powerful cocktail of anti-AIDS drugs came on the market in 1996, some scientists speculated they could use the drugs to knock out all the infection in the body. But that idea crashed as repeated experiments showed that pockets of infected cells hid in various parts of the body, emerging quickly as soon as the drugs were withdrawn.

HIV has infected some 50 million people in the world and none has been cured -- except perhaps Timothy Ray Brown.

It was the case of Brown, also known as “the Berlin patient,” that energized the new search for a cure. Infected with HIV, Brown was dying not of that disease, but of leukemia. His only hope was a bone marrow transplant – first killing, then replacing all the cells in his body that make blood cells with those from a donor. Brown’s doctor Gero Hütter was not an AIDS specialist, but he knew that about 1 percent of people of European decent have a mutation in a receptor called CCR5 on certain white blood cells that make HIV infection very difficult. So the doctor sought a donor with that mutation.

The transplant took place in 2007. In 2010 Hütter published his results. Not only had the transplant eliminated Brown’s leukemia, he no longer needed to take his HIV medications and the most sophisticated tests find no trace of HIV in his body.

A transplant with a serious risk of death, costing more than $250,000, will not be a treatment for a disease contained by medications. But the case raised the possibility that modifying the white blood cells with gene therapy might do the trick. Several experiments are underway in both animals and humans and more are planned.

The latest research shows the gene therapy can be safe in the long term. Whatever we call it, we may be at the beginning of the end of AIDS.

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By Rachael Rettner
MyHealthNewsDaily

A heterosexual person infected with HIV will transmit the virus to their partner once in every 900 times the couple has unprotected sex, according to a new study conducted in Africa.

However, the exact number of sexual acts that are needed to transmit the virus can vary tremendously depending on the amount of the virus in the infected person's blood, said study researcher James Hughes, of the University of Washington in Seattle.

In fact, the amount of virus in the blood is the single most important factor in determining whether HIV is passed between sexual partners, the study found. For every tenfold increase in the concentration, there is about a threefold increase in the risk of transmission during a single sexual act.

People with very high blood concentrations of the virus (such as those who very recently acquired the infection) may need to have sex only 10 times to transmit the virus, Hughes said. "The average can be a little deceptive," Hughes said.

The new findings reinforce the idea that the best methods for reducing HIV transmission are those that decrease the concentration of the virus in the blood, as can be done with antiretroviral drugs, Hughes said. A study published last year found the drugs could reduce the transmission of HIV between partners by 96 percent.

The new study also confirmed condoms are highly effective in preventing HIV infection, reducing the risk of transmission by 78 percent. Male circumcision reduced the risk of HIV transmission by 47 percent.

HIV transmission

Earlier studies attempted to estimate the rate of HIV transmission, but were typically quite small, and did not measure the concentration of the virus in the blood throughout the entire study period.

The new study included 3,297 couples from sub-Saharan Africa that were "HIV-discordant," meaning one partner had HIV while the other did not. The HIV-infected partners in the study were tested periodically over the two-year study for the amount of HIV in their blood. Infected partners were also interviewed every month and asked how many times they had sex, and whether they used protection.

The uninfected partners were tested periodically to see whether they had acquired HIV. The researchers used genetic testing of the virus to confirm that any new HIV infections had been acquired from the study partner designated at the study's start.

Eighty-six HIV transmissions occurred during the study period.

Men were about twice as likely to transmit HIV to women as women were to men. This increased risk of transmission could be attributed to higher virus concentrations in the blood of men compared with women, according to the study. In addition, women were more likely to have genital herpes, which increases susceptibility to HIV.

Condoms were reported to be used in 93 percent of sexual acts, but the researchers suspect their  use was overreported. Therefore, condoms actually may be even more effective at preventing HIV transmission than the 78 percent reduction that the researchers estimated, Hughes said.

The AIDS epidemic

The study relied on self-reports, which might be wrong. However, errors in reports of the number of sexual acts would be unlikely to affect most of the study results, Hughes said.

The average risk of HIV infection per sexual act estimated in the study is consistent with what has been found by previous research, but there are many situations in which that number may not apply," said Dr. Myron Cohen, a professor of medicine, microbiology, immunology and public health at the University of North Carolina at Chapel Hill, who was not involved in the work.

That's because the participants included in the study are couples that have remained together and discordant over a long period of time. This indicates the couples might have some biological protection against transmission, Cohen said.

"The true estimation might be higher if you were studying different kinds of people," Cohen said.

While most of the findings are likely generalizable to other countries, the number of sexual acts needed to transmit the virus is likely specific to the African population studied, Hughes said. Previous studies in the United States have found a lower transmission rate.

In addition, the findings only apply to heterosexual couples, and not men who have sex with men, a group that is likely to have a much higher transmission rate, Hughes said.

Pass it on: The best way to reduce the risk of HIV transmission is to lower the amount of the virus in the blood.

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A clinical trial involving AIDS this year is rightly being called by Science magazine the most important scientific breakthrough of the year.

When the study on the benefits of antiretroviral therapy ran last August in the New England Journal of Medicine, it did not really get the attention it deserved, possibly because news headlines are too often drawn to human failure, evil and the miserable.  However, researchers convincingly showed that people who take antiretrovirals  -- medicine that weakens the HIV virus -- not only benefit from treatment but are far less likely to sexually infect their non-HIV positive wife or partner. 

How much less? Try 95 percent!

Myron Cohen of the University of North Carolina's School of Medicine, and an international team of colleagues, started looking at the impact of medicine on disease transmission back in 2007. They studied more than 1,700 heterosexual couples from nine different countries: Brazil, India, Thailand, the United States, Botswana, Kenya, Malawi, South Africa and Zimbabwe. Each couple included one partner with an HIV infection, one not.

They found that AIDS medicine reduced the amount of virus in an infected person’s body -- not news there. But the meds reduced the amount of virus in the infected person to the point where giving it to others through sexual activity was greatly diminished.

So, at last, after taking a terrible toll on us for decades, we now know how to get the HIV virus on the run. Get anti-retroviral medications to all 7.6 million people who need them, continue aggressive efforts to promote the use of condoms and the avoidance of risky sexual and injection drug behavior, give out clean needles to addicts and we can have our revenge on the virus that causes AIDS.

Art Caplan, Ph.D., is the director for the Center for Bioethics at the University of Pennsylvania.  Follow him on Twitter @ArthurCaplan. 

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Chip Somodevilla / Getty Images

Workers hang a huge red ribbon on the North Portico of the White House ahead to commemorate World AIDS Day.

World AIDS Day is about recognizing how far we’ve come -- and how far we still have to go -- in the fight against a plague that has infected 60 million people and killed half of them. 

But today, now 30 years into the epidemic, a series of setbacks threatens to dash hopes for the goal of an “AIDS-free generation.”

“Just when we were beginning to make the most progress, the rug was pulled from under us,” says David Barr, a leading activist with the International Treatment Preparedness Coalition.

Through the efforts of activists and government leaders, 6.6 million infected people around the world are now getting the drugs that stave off death.  But just as important as the health effect for individuals is the discovery that the drugs drop the amount of HIV in a person’s blood to near zero so they seldom infect others. As a result of the widespread treatment, the worldwide infection rate dropped 25 percent in the past decade, according to UNAIDS.

In response to the heartening news, the UN pledged in June to raise the number treated to 15 million by 2015. 

But that won’t happen. In fact, far fewer people will soon be getting the lifesaving medication.

The Global Fund to Fight AIDS, Tuberculosis and Malaria, an international agency that pays for about half of HIV treatment around the world, announced last week that its last pledge round had fallen so far short of expectations that it will give no new grants until at least 2014.  It will also scale back on many of its current commitments. 

And here at home, the U.S. Centers for Disease Control and Prevention just announced that its latest numbers reveal that only 28 percent of this nation’s1.2 million infected individuals are getting the medications they need.  Twenty percent of the infected have never been tested so neither they nor their sex partners know of the danger.  The CDC called for more testing.

But even if people in the U.S. know they are infected, will they get treatment? More than 50 million Americans lack access to health insurance.  The U.S. does have the AIDS Drug Assistance Program (ADAP) to get medications to those who cannot afford them.  But it is not clear whether or at what level Congress will re-authorize the program.

Even at current funding levels, the Kaiser Family Foundation counts more than 6,400 people in 12 states who are the waiting list for medications from ADAP.  Though financed by the federal government, ADAP is administered by states, and 25 states are considering cutbacks to these programs.

These major blows to the war on AIDS require more than a day of red ribbons to set right.

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Robert Bazell is Chief Science and Medical Correspondent for NBC News.