News (Updated January 15, 2012)

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FDA says Merck's HIV drug gets generic threat

Jan 10, 2012

(Reuters) - Health regulators said they have received applications from generic drugmakers to make copycat versions of Merck & Co's HIV drug Isentress, GlaxoSmithKline's HIV drug Epivir and Bayer AG's birth control pill Beyaz.

However, the U.S. Food and Drug Administration did not disclose the names of the generic drug applicants.

Isentress was first approved in 2007 for use in adult patients. Last month, the FDA expanded the label on the drug for use in children and adolescents.

Merck shares were trading almost flat at $38.58 on Tuesday on the New York Stock Exchange.

(Reporting by Anand Basu in Bangalore ; Editing by Supriya Kurane)

 

HIV transmitted 1 in 900 times couple has unprotected sex

By Sadie Whitelocks

A study has found a person infected with HIV will transmit the virus to their partner once in every 900 times the couple has unprotected sex

A person infected with HIV will transmit the virus to their partner once in every 900 times they have unprotected sex, say scientists.

And the risk significantly increases if the person infected has a higher concentration of the virus in their bloodstream.

Results, from the largest study of its kind, showed for every tenfold increase in concentration, there was around a threefold increase in the likelihood of HIV transmission.

The findings support the use of anti-retroviral medications that work by lowering the concentration of HIV in the bloodstream.

Lead researcher James Hughes, from the University of Washington in Seattle said: 'Our results underscore the importance of antiretroviral therapy, and, possibly, treatment of co-infections, to reduce plasma HIV-1 viral load in HIV-1 infected partners.'

A study published last year found drugs could reduce HIV transmission of  by 96 percent.

The virus weakens the ability to fight infections and disease, such as cancer. AIDS marks the final stage when the body can no longer battle life-threatening illnesses.

The latest study, published in the Journal of Infectious Diseases, sought to calculate the risk of HIV-1 transmission per act of sexual intercourse.

During research, which included heterosexual 3,297 couples from sub-Saharan Africa , experts determined the amount of virus in the blood as the single most important factor in HIV transmission between sexual partners.

 Hughes said that this makes it difficult to determine an average risk of transmission, as concentration can vary from person to person.

For instance someone newly infected may only need to have sex ten times to transmit the virus.

He added: 'The average can be a little deceptive.'

The new study also confirmed condoms are highly effective in preventing HIV infection, reducing the risk of transmission by 78 per cent. 

Meanwhile male circumcision reduced the risk of HIV transmission by 47 per cent.

A study last year found drugs could reduce HIV transmission by 96 percent

Earlier studies attempted to estimate the rate of HIV transmission, but were typically small scale, and did not consistently measure the concentration of the virus in the blood.

The new study involved couples 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 two years, and the amount of HIV in their blood was measured.

They 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 and researchers used genetic testing of the virus to confirm that if new infections had been acquired.

Eighty-six HIV transmissions occurred during the study period.

Despite the results Hughes warned that self-reporting can lead to errors.

He also stated that while most of the findings can be generalised to other countries, the number of sexual acts needed to transmit the virus is likely specific to the African population studied.

The best way to prevent HIV is to practise safe sex and use a condom.

The virus can affect anybody and The World Health Organization estimates that more than 33 million people around the world are living with HIV.

HIV study offers hope toward vaccine development

1/13/2012

Thomas Warren, wtop.com

WASHINGTON -- An unprecedented new HIV study may change how soon the virus can be detected in a person's system -- which scientists hope could lead to developing an effective vaccine.

Currently, it takes three months after the virus has been contracted before it can be detected by an HIV test. But nearly half of all HIV transmissions occur in the first few weeks after it is contracted.

A new test underway in Kenya has detected the virus within five days of contraction, says Fred Sawe, a doctor who has worked on the trial in Kericho , Kenya .

Researchers do stress that more study and follow-up will be conducted to determine the long-term significance of the trial results. In fact, subjects will be followed for at least two years as progression of the virus is monitored.

Sawe says understanding what happens medically in the first stages as HIV mutates and spreads throughout the body is the determining factor in conducting the trial.

"We need to know how what exactly happens, how does your body respond in the first few hours after acquiring the infection," Dr. Sawe says.

Early results published in March of 2011 showed "acute" HIV infection was found in 26 of 32 cases, although researchers say the numbers, now, are much higher.

The term "acute infection" describes the the first few weeks after a person contracts the virus, and how it imbeds itself in the immune system.

The trial is being conducted in Kenya , Tanzania , Uganda , and Thailand . It's spearheaded by the U.S. Military HIV Research Program, which also published a groundbreaking vaccine trial conducted in Thailand in 2009.

Once a good measure of what happens in the body during the early stages of infection is determined, the results will be used by other research groups in trials to develop an HIV vaccine.

"We think one of the reasons why we've never developed a vaccine against HIV is that we were modeling our vaccines against the status of someone who has had HIV for a long time," Dr. Sawe says.

Currently, more than 34 million people worldwide live with HIV.

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(Copyright 2012 by WTOP. All Rights Reserved.)


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