News (Updated December 6, 2009)

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New WHO guidelines urge phase-out of major HIV drug

By Stephanie Nebehay Stephanie Nebehay Mon Nov 30, 12:14 pm ET

GENEVA (Reuters) – Countries should phase out the use of Stavudine, the most widespread antiretroviral, because of "long-term, irreversible" side-effects in HIV patients including wasting and a nerve disorder, the World Health Organization said on Monday.

In sweeping changes to its guidelines, the WHO also recommended that people with HIV, including pregnant women, should start taking antiretroviral drugs earlier to live a longer and healthier life.

For the first time it advised HIV-positive women and their babies to take the drugs while breastfeeding to prevent mother-to-child transmission of the virus that causes AIDS.

Stavudine, also known as d4T, is marketed as Zerit by U.S. drugmaker Bristol-Myers Squibb Co. Generic versions are made by Cipla Ltd, Aurobindo Pharma Ltd and Strides Arcolab Ltd, all of India .

Stavudine, widely available in developing countries as a first-line therapy, is relatively cheap and easy to use, according to the United Nations agency.

But it causes a nerve disorder leading to numbness and burning pain in the hands and feet, and loss of body fat known as lipoatrophy or wasting, it said, conditions that are "disabling and disfiguring."

LESS TOXIC ALTERNATIVES

The WHO recommended "that countries progressively phase out the use of Stavudine as a preferred first-line therapy option and move to less toxic alternatives such as Zidovudine (AZT) or Tenofovir (TDF)." These are "equally effective alternatives."

Zidovudine was first manufactured by GlaxoSmithKline Plc whose patent expired in 2005. Aurobindo and Ranbaxy Laboratories, also of India , are among makers of the generic version. Tenofovir is marketed by Gilead Sciences under the name of Viread.

Of over 4 million people globally who take antiretrovirals, about half are on a regimen containing stavudine, down from 80 percent in 2006 when the WHO first said countries should envisage moving away from it because of its long-term effects, according to Dr. Siobhan Crowley of WHO's HIV/AIDS Department.

"It is the most widely used. There is a trend moving away from it. We think it will take some time," she told Reuters.

An earlier start to treatment of HIV-infected adults and adolescents with antiretrovirals reduces their viral load much sooner and therefore also lowers the risk of them spreading the virus, according to the WHO.

"The new recommendations are based on a solid body of evidence indicating that rates of death, morbidity and HIV and tuberculosis transmissions are all reduced by starting treatment earlier. This prolongs and improves quality of life," it said.

An estimated 33.4 million people worldwide, two thirds of them in sub-Saharan Africa , are infected with the AIDS virus, an annual United Nations report said last week.

 

More funds needed for TB tests, drugs, vaccines

Dec 3 2009

By Tan Ee Lyn, Asia Health and Science Correspondent

CANCUN, Mexico (Reuters) - Health experts on Thursday called for more research funding to develop better diagnostic tests, vaccines and drugs for tuberculosis, which killed 1.8 million people around the world last year.

While diseases like AIDS and malaria can be diagnosed in minutes by applying a drop of blood to a rapid test kit, confirming active tuberculosis, or TB, is a laborious procedure.

It requires a patient to cough up sputum, which is smeared on a slide, stained and examined under a microscope.

And the 100-year-old test misses up to 70 percent of otherwise positive cases in some places, experts say.

In Africa , where the scourge of TB is most keenly felt, many people delay follow-up testing because of cost.

"A lot of people die before a TB diagnosis is even made," Dr Jeremiah Chakaya of the Kenya Medical Research Institute told reporters at an international conference on lung health in Cancun , Mexico .

Chakaya and other experts believe that a highly sensitive blood or urine test for TB could become a reality. But given the lack of funding, it is unlikely such a test will reach the market before 2015.

Between 2006 and 2007, investment in TB research rose by $56 million -- to a total of $474 million. But between 2007 and 2008, investment rose by just $36 million to $510 million.

"With current investment rates, millions of people will continue to suffer and die unnecessarily of TB because the world stood by and refused to revitalize desperately needed TB research funding," said Mark Harrington, executive director of the Treatment Action Group, an HIV and TB advocacy group.

BETTER DRUGS, BETTER VACCINES NEEDED

There were 9.4 million new cases of active TB in 2008, up from 9.27 million in 2007, according to new data released by the World Health Organization's Stop TB Department on Thursday.

While one in every three people in the world is infected with TB, only 10 percent will develop active TB, due mostly to a weakened immune system caused by diseases such as AIDS.

With the exception of Pfizer Inc's rifabutin, a drug used to treat tuberculosis for those with drug-resistant HIV/AIDS, there have been no newly licensed drugs for TB in 40 years.

And the effectiveness of the Bacille Calmette-Guerin (BCG) TB vaccine, which has been around since 1919, is in doubt.

"Wouldn't one think that the largest killer of any single infection deserves better, newer tools?" said Lee Reichman of the Global Tuberculosis Institute at the New Jersey Medical School .

In the pipeline are two experimental drugs and nine vaccines for TB, which the experts said would need funding to push into clinical trials.

"The need for new TB tests, drugs and vaccines is obvious," Chakaya said.

(Reporting by Tan Ee Lyn; Editing by Julie Steenhuysen and Eric Beech)

 

Researchers develop new hepatitis C treatment

Thursday, December 3, 2009

An experimental treatment targeting hepatitis C was able to inhibit replication of the virus in the bloodstream of chimpanzees and could treat chronic infections in humans, a new study said Thursday.

The treatment works by inhibiting a molecule that helps hepatitis C virus replicate, according to scientists at the Southwest Foundation for Biomedical Research (SFBR), who said the drug continued to work up to several months after it was used.

The treatment is already undergoing "human clinical trials and is currently undergoing Phase 1 clinical studies in healthy volunteers," the researchers said in a press release.

It is the first medication of its type to be tested on humans, according to the researchers, whose work was published in the December 3 issue of the journal Science Express.

The medication, dubbed SPC3649, was developed by the biopharmaceutical firm Santaris Pharma A/S, a Danish company.

It uses Santaris' proprietary nucleic acid called "locked nucleic acid," which captures the microRNA122 molecule that the hepatitis C virus (HCV) would otherwise use to replicate.

"Our collaboration with Santaris Pharma proved that the drug worked exceptionally well in treating HCV infections in chimpanzees," said SFBR's Robert Lanford, the lead author of the research.

The study also showed the technology could prove useful in the treatment of other diseases, including HIV, cancer and inflammatory diseases.

According to the World Health Organization (WHO), 170 million people worldwide are infected with hepatitis C, which is transmitted via blood and can progress over years into cirrhosis and liver cancer.

There are an estimated four million carriers of the virus in Europe, and between three and four million people in the United States are chronically infected, according to the WHO.

At present, the only hepatitis treatment approved by the US Food and Drug Administration is a cocktail of interferon and ribavirin, which is toxic, must be administered in a 48-week course and is effective in less than half of patients.

The researchers said SPC3649 could in the future be used to replace interferon in some treatments, and combined with interferon and ribavirin in a cocktail in other instances.

"This antiviral could be used alone to treat disease progression and there are indications that it can convert interferon non-responders to responders, so that non-responders to the current therapy could be treated with the combination of this drug with interferon," Lanford said.

In the test carried out on four HCV chronically infected chimpanzees, the two animals that received a higher dose of the new medication registered a 350 fold drop in the virus levels in their blood and liver.

 


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