News (Updated December 12, 2010)

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WHO says Cepheid rapid test will transform TB care

Dec 8 2010

By Kate Kelland

LONDON (Reuters) - The World Health Organization (WHO) gave its backing on Wednesday to a new molecular test for tuberculosis made by Cepheid which can rapidly diagnose TB, one of the world's biggest killer diseases.

The Geneva-based WHO said in a statement it was endorsing the test because it could "revolutionize" TB care and control by accurately diagnosing patients in about 100 minutes, compared to current tests that can take up to three months to give results.

Cepheid said it would offer a 75 percent price discount for poorer nations on the tests and the table top computer system used to analyze them, meaning the tests will cost $16.86 and the machine will cost around $17,000.

The firm's chief executive John Bishop told Reuters this preferential price would be granted to 116 low and middle-income countries where TB is endemic, and prices would be discounted further as the volume of demand rises in coming years.

The test, called Xpert MTB/RIF, was developed by Cepheid and the Foundation for Innovative and New Diagnostics (FIND), a non-profit group funded by the Bill & Melinda Gates Foundation, the European Union and national donors. It detects many TB cases missed by current technology, which is more than a century old.

"There has been a strong commitment to remove any obstacles, including financial barriers, that could prevent the successful roll-out of this new technology," said Giorgio Roscigno, FIND's chief executive. "For the first time in TB control, we are enabling access to state-of-the-art technology simultaneously in low, middle and high income countries."

GROWING GLOBAL PROBLEM

TB hits mostly poor people in developing regions such as sub-Saharan Africa, India and China , but also occurs in poor regions of developed nations and is common in patients with the human immunodeficiency virus (HIV) that causes AIDS.

It is among the world's top 10 leading causes of death. The WHO estimates that 9.4 million people developed active TB in 2009 and the disease killed 1.7 million in that year. The emergence of drug-resistant and extensively drug-resistant forms of TB is also a growing global problem.

Many countries still rely largely on sputum smear microscopy for testing for TB, a diagnostic method developed more than 100 years ago. The new Xpert MTB/RIF is a "while-you-wait" test that can be used outside of conventional laboratories by general health workers and does not require a specialist operator.

In a study published in September, researchers said that when used on 1,730 patients with suspected TB and suspected drug-resistant TB, the Xpert test successfully identified 98 percent of all cases.

It also identified 98 percent of patients with a form of TB resistant to rifampin, or rifampicin -- one of the most powerful TB drugs -- and achieved these results in less than two hours.

The WHO said implementation of this test could result in a three-fold increase in the diagnosis of patients with drug-resistant TB and a doubling in the number of HIV-associated TB cases diagnosed in areas with high rates of TB and HIV.

Mario Raviglione, director of the WHO's Stop TB department said the test represented "a major milestone" for TB care.

The Xpert system, which Cepheid expects to sell to wealthy nations too at full price, can also be used to diagnose a number of other illnesses, including flu, leukemia, sexually transmitted infections, and the so-called "superbug" MRSA.

 

Circumcision may not curb gay HIV transmission

Dec 7 2010

NEW YORK (Reuters Health) - While circumcision has been shown to lower a man's risk of contracting HIV through heterosexual sex, a new study indicates that the value of circumcision for gay and bisexual men remains questionable.

In a study of more than 1,800 men from the U.S. and Peru , researchers found that overall, the risk of contracting HIV over 18 months did not significantly differ between circumcised and uncircumcised men.

Over the study period, 5 percent of the 1,365 uncircumcised men became HIV-positive, as did 4 percent of the 457 circumcised men, according to findings published in the journal AIDS.

All of the men in the study reported having sex with other men and were considered to be at increased risk of HIV infection because they were already infected with the genital herpes virus (herpes simplex type 2), which can make people more susceptible to HIV.

Male circumcision is far more common in the U.S. than in most other countries, and 82 percent of the 462 American men in the study were circumcised, compared with just 6 percent of the 1,360 Peruvian men.

The researchers did find some hints that circumcision could be protective among men who primarily had insertive sex with other men. Among men who said they'd had insertive sex with their last three male partners at least 60 percent of the time, circumcision was linked to a 69 percent lower HIV risk.

That difference, however, was not statistically significant, which means the finding could be due to chance.

Taken together, the results "indicate no overall protective benefit from male circumcision" when it comes to male-to-male HIV transmission, write the researchers, led by Dr. Jorge Sanchez of the research organization Impacta Peru, in Lima.

They add that studies should continue to look at whether circumcision affects HIV risk from insertive sex and do so in larger, more diverse study groups.

In general, the researchers write, public-health messages for gay and bisexual men should "reinforce the importance of condom use for HIV prevention."

The findings may help inform debate over whether circumcision could stand as a weapon against HIV transmission among men who have sex with men.

In 2005 and 2006, three clinical trials in Uganda , South Africa and Kenya showed that circumcision can reduce a man's risk of HIV infection through heterosexual sex by up to 60 percent.

The World Health Organization now recommends medically supervised circumcision as one way to lower men's risk of HIV in countries where heterosexual transmission is common.

But the public-health value of circumcision in other countries, including the U.S. , is a contentious issue. Most HIV infections in the U.S. are related to homosexual sex or IV drug use and studies have yet to find strong evidence that circumcision lowers HIV transmission among men who have sex with men.

Circumcision is thought to lower the heterosexual transmission of HIV and other sexually transmitted diseases through several mechanisms. One is by reducing the amount of mucosal tissue exposed during sex, which limits the viruses' access to the body cells they target. Another theory is that the thickened skin that forms around the circumcision scar helps block the viruses' entry.

One reason circumcision might have little effect on homosexual HIV transmission is that it would have no impact on the risk from receptive anal sex. Experts have also pointed out that in wealthier countries, many HIV-positive people are on powerful anti-viral drugs that reduce the risk of transmission, and any added effect of circumcision might be small.

Currently, the American Academy of Pediatrics does not recommend routine circumcision for newborns, citing insufficient evidence of overall health benefits. The U.S. Centers for Disease Control and Prevention, meanwhile, is in the process of developing recommendations on adult and infant circumcision for lowering HIV risk.

SOURCE: link.reuters.com/qaz88q AIDS, online November 19, 2010.

 

GeoVax Announces Expansion of Phase 2a Human HIV/AIDS Vaccine Trial 

ATLANTA , Dec. 6, 2010 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc., announced today the expansion of the Phase 2a clinical trial testing of its HIV/AIDS vaccine products. The expanded Phase 2a trial will test the administration of three doses of the recombinant poxvirus vaccine MVA62B without the use of the recombinant DNA-vectored vaccine, which was used to prime immune responses in the first part of this trial. At the completion of the trial, 150 participants will have received the vaccine products using two DNA inoculations followed by two MVA inoculations, 75 participants will have received the vaccine using three MVA inoculations and 75 participants will have received placebo. Enrollment into the expanded Phase 2a trial opened December 6th.

GeoVax is developing two vaccine components: a recombinant DNA-vectored vaccine and a recombinant MVA-vectored vaccine. Both produce non-infectious virus-like particles in the body of a vaccine recipient. These non-infectious particles are designed to "train" the immune system of the vaccinated person to recognize HIV should the vaccinated person be exposed to the real virus. Both the DNA and MVA vaccines induce humoral (antibody) and cellular (cytotoxic T cell) responses. Antibodies have the potential to block virus before it infects cells. The cytotoxic T cells have the potential to recognize and kill virus-infected cells. The vaccine is designed to control clade B HIV infections. Clade B HIV is found in North, Central and parts of South America, Western Europe , Australia and Japan .

"I like the simplicity of using the MVA-vectored vaccine alone because it is a regimen that could easily be taken forward for the world. The data from our Phase 1 clinical trial and recent preclinical data obtained using a non-human primate model support the use of this simplified vaccine regimen," said Harriet Robinson, the GeoVax Chief Scientific Officer.

The expanded Phase 2a trial is sponsored by the National Institute of Allergy and Infectious Diseases, part of the US National Institutes of Health, and is conducted by the HIV Vaccine Trials Network (HVTN). The HVTN is the largest worldwide clinical trials network dedicated to the development and testing of HIV/AIDS vaccines. The trial bears the same HVTN 205 designation as the original Phase 2a trial.

 

 


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