US nod for once-a-day pill to cut HIV risk

PTI Jul 18, 2012, 05.18AM IST
WASHINGTON: For the first time, a once-a-day pill which reduces the chance of contracting HIV among high risk groups "significantly" has got green signal in the US, where 1.2 million people are infected by the deadly disease. The drug,'Truvada' can now be used by those at high risk of the infection and anyone who may engage in sexual activity with HIV-infected partners, the Food and Drug Administration (FDA) announced.
"In two large clinical trials, daily use of the drug was shown to significantly reduce the risk of HIV infection," it said on Monday. However, some health workers and groups active in the HIV community opposed the approval for the once-a-day pill.
There are concerns that circulation of such a drug could engender a false sense of security and mean people will take more risks. There have also been fears that a drug-resistant strain of HIV could develop. People diagnosed with HIV that without treatment develops into AIDS take antiviral medications to control the infection that attacks their immune system.
In a statement, the FDA stressed that the drug should be used as part of a "comprehensive HIV prevention plan", including condom use and regular HIV testing. Studies show that Truvada reduced the risk of HIV in healthy gay men - and among HIV-negative heterosexual partners of HIV-positive people - by between 44% and 73%.
"In the 80s and early 90s, HIV was viewed as a life-threatening disease; in some parts of the world it still is. Medical advances, along with the availability of close to 30 approved individual HIV drugs, have enabled us to treat it as a chronic disease most of the time," Debra Birnkrant, director of the Division of Antiviral Products at FDA, said.
GM bacteria prevents malaria transmission
In a breakthrough, US scientists have genetically modified a bacterium to kill the parasite that causes malaria before it infects humans. Researchers at Johns Hopkins Malaria Research Institute said their breakthrough could help prevent mosquitoes from transmitting malaria to humans. Malaria kills over 800,000 people worldwide every year, most of them are children.
In the new study, published in the journal Proceedings of the National Academy of Sciences, the researchers modified the bacterium, called Pantoea agglomerans, to secrete proteins that are toxic to the malaria parasite, but not harmful to the mosquito or humans. The bacterium is commonly found in the mosquito's midgut. It was found that the modified bacteria were 98 per cent effective in reducing the malaria parasite burden in the insects, the researchers said.

Scientists develop ‘roller’ to keep your back flexible

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Jul 18, 2012 at 8:45 AM
BackacheScientists might have found a revolutionary way to cure back pain. Tiny, artificial rollers, which mimics the flexibility of the spine! Developed by a team at Brigham Young University in the U.S., the “roller” when inserted in the spine replaces damaged discs and provides the same range of movement as the real one.
The replacement disc has a rolling action to allow the spine to move in different directions. It’s intended as an alternative to fusion, where bones either side of the damaged disc area are welded together to reduce pain, the Daily Mail reported. Spinal discs, which contain a gel-like substance, help, cushion the vertebrae during movement. While they are critical for movement, the discs can become the source of back pain when they degenerate. Treatment ranges from painkillers and physiotherapy, to different types of surgery.
One of the most common forms is spinal fusion, in which the vertebrae on either side of the damaged disc are welded together to make one solid bone. However, the operation can limit the flexibility of the spine and restrict movement. To overcome this problem, the Brigham team designed and developed the artificial roller that can move forwards and backwards, as well as side to side.
The device is inserted between the vertebra and disc — tiny spikes in the plates anchor it in place, leaving the roller unimpeded. Early tests on animals and human spines suggest that the device does provide significantly more flexibility than standard disc replacement.
The researchers are now using the device in larger clinical trials. If they are successful, they hope to launch the technology in the next three years. Commenting on the technology, Jane Tadman of Arthritis Research U.K. said: “We welcome news of this new implant. Disc replacement allows a close approximation to the normal spine by allowing it to remain flexible, however new designs need adequate testing.” 

FDA approves first pill to help prevent HIV

The Food and Drug Administration on Monday approved the first drug shown to reduce the risk of HIV infection, a milestone in the 30-year battle against the virus that causes AIDS.
The agency approved Gilead Sciences' pill Truvada as a preventive measure for people who are at high risk of acquiring HIV through sexual activity, such as those who have HIV-infected partners.
Public health advocates say the approval could help slow the spread of HIV, which has held steady at about 50,000 new infections per year for the last 15 years. An estimated 1.2 million Americans have HIV, which develops into AIDS unless treated with antiviral drugs. With an estimated 240,000 HIV carriers unaware of their status, doctors and patients say new methods are needed to fight the spread of the virus.
Gilead Sciences Inc. has marketed Truvada since 2004 as a treatment for people who are already infected with the virus.
But starting in 2010, studies showed that the drug could actually prevent people from contracting HIV when used as a precautionary measure. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 42 percent, when accompanied by condoms and counseling.
Last year another study found that Truvada reduced infection by 75 percent in heterosexual couples in which one partner was infected with HIV and the other was not.
Because Truvada is on the market to manage HIV, some doctors already prescribe it as a preventive measure. FDA approval will allow Gilead Sciences to formally market the drug for that use, which could dramatically increase prescribing.
Truvada's groundbreaking preventive ability has exposed disagreements about managing the disease among those in the HIV community. Groups including the AIDS Healthcare Foundation asked the FDA to reject the new indication, saying it could give patients a false sense of security and reduce the use of condoms, the most reliable preventive measure against HIV.
But FDA scientists said Monday said there was no indication from clinical trials that Truvada users were more likely to engage in risky sexual behavior.
"What we found was that condom use increased over time and sexually transmitted infections either remained at baseline levels or decreased," said Dr. Debra Birnkrant, FDA's director of antiviral products. "So in essence, we don't have any strong evidence that condoms were not used or there was a decrease in condom use."