News (Updated November 14, 2010)

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FACTBOX-Facts about TB from annual WHO report

Nov 11, 2010

Nov 11 (Reuters) - The World Health Organisation (WHO) issued its annual report on Thursday on tuberculosis, a contagious but curable disease that still kills 1.7 million people a year, or 4,700 a day, mainly in Asia and Africa.

Tuberculosis, caused by bacteria, can be cured in six months with antibiotics if detected and treated early. But it can spread rapidly among people suffering from malnutrition or the HIV/AIDS infection.

Here are the main points of the U.N. agency's report:

- There were some 9.4 million news cases of TB in 2009, including 1.1 million cases among people living with the HIV/AIDS virus.

- India , with 2 million TB cases a year, is hardest hit, and half its huge population could be carriers of the virus and therefore at risk of developing the disease. China has 1.3 million cases a year and South Africa some 490,000.

- Globally, rates of TB incidence, prevalence and mortality have fallen steadily since 1995. Some 41 million people have been successfully treated and up to 6 million lives have been saved during the period. - The biggest challenge is posed by multiple drug-resistant strains called MDR-TB, which have emerged because patients do not always take the expensive first-line drugs as directed.

MDR-TB infected an estimated 440,000 people in 2008 and is thought to be most widespread in China, India and Russia, but only a fraction of cases are reported to WHO.

Only 10,000 MDR-TB patients are believed to get the correct but complex treatment which takes from 18 months to 24 months, often with hospitalisation. This is because countries often lack laboratories for diagnosis or fail to test for drug resistance. (For a main story please click on [ID:nLDE6A91S1]) (Compiled by Stephanie Nebehay; Editing by Jonathan Lynn and Jon Boyle)

 

Preventative TB therapy halves risk of death among ARV patients

11 Nov 2010 Source: IRIN

JOHANNESBURG , 11 November 2010  - Preventative tuberculosis (TB) therapy can reduce death among patients on antiretroviral (ARV) treatment by about half, according to new research from South Africa .

Based on an observational study, researchers found that patients newly initiated on ARV treatment who had also been given Isoniazid Preventative TB therapy (IPT) had about a 50 percent lower risk of death after their first year of treatment than patients not given IPT. Isoniazid is a standard first-line TB drug that has more commonly been given as preventative therapy to HIV-infected patients not yet eligible for ARVs.

According to lead author Salome Charalambous, research director with the Aurum Institute, a South African health research NGO, the study provides much-needed evidence to back the effectiveness of IPT use for ARV patients.

"Until now, the use of IPT in combination with ARVs has been thought to reduce mortality but it had not been established," said Charalambous, adding that these assumptions were based largely on the small reductions in mortality found among HIV-positive people who had started IPT but not ARVs.

Charalambous said she expected the findings to be confirmed by early next year when two randomized controlled trials on the use of IPT within ARV programmes report their findings.

The study is one of several IPT-themed papers published in a supplement of the journal AIDS by the Consortium to Respond Effectively to the AIDS/TB Epidemic (CREATE) in anticipation of the expected 1 December 2010 release of new IPT guidelines by the World Health Organization. Much of the research featured in the supplement comes from Aurum's ongoing Thibela TB study involving 80,000 gold miners, which is looking at whether high IPT uptake can help reduce new TB cases at community level.

TB remains one of the leading killers of HIV-positive people. About 70 percent of South African TB patients are co-infected with HIV.

South Africa introduced national IPT guidelines in 2002 that recommended IPT for people living with HIV, but discouraged health workers from giving it to ARV patients. Implementation has been poor and by March 2010, fewer than 1 percent of patients eligible to receive IPT were accessing it.

Myth-busters

According to results of research also published in the AIDS journal supplement, the greatest barriers to IPT uptake in South Africa could be traced to health workers, many of whom were either unaware or unconvinced of IPT's benefits. Many were also deterred by the perceived difficulty of ruling out active TB infection in HIV-positive patients. Patients given IPT who have undetected active TB can develop resistance to Isoniazid, complicating treatment. Health workers also worried that the side-effects and additional pill burden for patients would discourage adherence.

"It's actually quite crazy that most clinicians will routinely prescribe multi-vitamins when there is no evidence [to support their therapeutic effect] but with IPT, where there is so much evidence, there's so much more worry," Charalambous told IRIN/PlusNews.

She added that the mandatory use of X-rays to diagnose TB, according to South Africa's 2002 IPT guidelines, could be a barrier as they may not be available everywhere. In reality, health workers could exclude at least 90 percent of active TB cases through sputum testing and symptom screening – asking patients if they are experiencing night sweats, a persistent cough or weight loss.

Research by Alison Grant from the London School of Hygiene and Tropical Medicine, also included in the supplement, found that serious side-effects related to IPT were rare and largely tied to excessive alcohol consumption.

Charalambous said she hoped the research – and the new guidelines – would be enough to convert the unconverted, some of whom she said ranked among the country's most respected experts.

As part of a new push to scale up the use of IPT by South African Health Minister Aaron Motsoaledi, the government updated its IPT guidelines in June 2010. In response to some of the research produced by Aurum, the new guidelines no longer discourage the use of IPT in ARV patients and have done away with the mandatory chest X-rays and TB skin tests previously needed to start HIV-positive patients on IPT.

llg/ks/mw

 

Tiny variants in protein are key to natural HIV resistance

(AFP) – Nov 4, 2010

WASHINGTON — Tiny variants in a protein that alerts the body to infection could explain how one in 300 HIV-infected people are able to resist the onset of AIDS for years without needing any treatment, researchers said Thursday.

"HIV is slowly revealing its secrets... Knowing how an effective immune response against HIV is generated is an important step toward replicating that response with a vaccine," said Bruce Walker, co-senior author of a study released Thursday.

"We have a long way to go before translating this into a treatment for infected patients and a vaccine to prevent infection, but we are an important step closer," added the director of the Ragon Institute of Massachusetts General Hospital .

For nearly 20 years, doctors have known that a small minority of HIV-infected individuals -- about one in 300 -- are naturally able to suppress viral replication with their immune system, keeping viral load at extremely low levels.

"We found that, of the three billion nucleotides in the human genome, just a handful make the difference between those who can stay healthy in spite of HIV infection and those who, without treatment, will develop AIDS," said Walker .

"Understanding where this difference occurs allows us to sharpen the focus of our efforts to ultimately harness the immune system to defend against HIV," he added in the study published in Friday's issue of Science magazine.

Researchers led by Ragon Institute's Florencia Pereyra enrolled 3,500 individuals in clinics around the world, including 2,500 with progressive HIV infection and 1,000 controllers -- HIV infected people resistant to AIDS.

Through a genome-wide association study, which tests variations at a million points in the human genome, the researchers identified some 300 sites that were statistically associated with immune control of HIV.

The sites were all in regions of chromosome 6 that code for so-called HLA proteins.

Without fully sequencing that genome region, which was unfeasible given the number of participants, the researchers developed a process that pinpointed specific amino acids that have a key role in viral control.

Further testing linked differences in five amino acids in the HLA-B protein to viral control mechanisms.

"Our work demonstrates that these variants could make a crucial difference in the individual's ability to control HIV by changing how HLA-B presents peptides from this virus to the immune system," said Walker .

Copyright © 2010 AFP. All rights reserved.

 

Bone loss more common in HIV

By Alison McCook

Nov 11, 2010

NEW YORK (Reuters Health) - People with HIV are much more likely to develop bone disease, or be on their way to developing it, a new study shows.

In a group of people with HIV, researchers found eight in 10 had either osteoporosis, the brittle-bone disease that raises the risk of fractures, or osteopenia, abnormally low bone mass that could progress to osteoporosis.

It's unclear exactly why people with HIV are more likely to experience bone loss, study author Dr. Anna Bonjoch of the Lluita contra la SIDA Foundation in Barcelona , Spain , told Reuters Health.

HIV-positive people have the same risk factors as anyone else, but the virus itself may affect bones, as may some drugs used to treat it. However, the fact that some drugs may increase the risk does not mean people should opt out of taking them, she cautioned.

"To stop the treatment is not an option," Bonjoch, whose findings appear in the journal AIDS, said in an e-mail.

Some risk factors for bone loss -- such as age -- are impossible to change, Bonjoch added, but there are steps people can take to reduce their risk, or prevent existing problems from worsening.

For instance, HIV-positive people can stop smoking, reduce their intake of alcohol, stay physically active, get enough calcium in their diet, and keep the virus under control.

Osteoporosis is a disease that increases with age, primarily affecting women over 50. According to the International Osteoporosis Foundation, one in three women and one in five men over 50 will experience fractures due to osteoporosis.

The overall rate of low bone density among the general population varies by age and country, Bonjoch explained, but likely falls around five percent.

However, in this study, half of the participants were 42 or younger, suggesting HIV put them at higher risk of bone problems. Indeed, previous research has suggested that people with HIV are three times more likely to develop bone loss than the general population.

From earlier bone scans in 671 HIV-positive patients, Bonjoch and her team found 23 percent had osteoporosis, and another 48 percent had osteopenia.

Among the 105 participants who had received more than one scan and were followed for at least five years, nearly half experienced a worsening of their bone thinning, progressing to osteopenia or osteoporosis.

Even though women are typically at higher risk of developing bone loss, men in this study had double the risk. Other factors linked to bone loss included being underweight, older, and spending more time on the HIV drug tenofovir.

These risk factors match what previous studies have shown, Dr. Todd Brown of Johns Hopkins University , who did not participate in the study, told Reuters Health.

But the rate of bone loss is significantly higher, he said, suggesting the patients were not representative of the overall HIV population.

One explanation could be that patients with bone loss might be more likely to get scans, Brown said.

But the general trend is clear, he added: "The percentage of patients with osteoporosis with HIV infection is probably higher than you would expect in an HIV-negative population."

Brown said HIV patients also appear at higher risk of heart disease, cancer, kidney problems, diabetes, and cognitive decline. "All these big chronic diseases that increase with age do occur earlier in HIV," he said.

SOURCE: link.reuters.com/cyr94q AIDS, October 31, 2010.

 

NTERVIEW-UPDATE 1-Mother-baby HIV box targets transmission

* Colour-coded pack easy to use for mothers who can't read

* Designed as a "one stop shop" to prevent HIV transmission

* UNICEF's $8 mln project to start in four African countries (Adds fresh quotes, global HIV/AIDS numbers)

By Kate Kelland, Health and Science Correspondent

LONDON, Nov 9 (Reuters) - It's no great medical breakthrough, just a simple colour-coded box packed with HIV drugs and pictures, but its backers UNICEF hope it may help finally end transmission of the often deadly virus to babies.

The mother-baby pack, dubbed "innovation for an HIV-free generation" will be distributed to 30,000 pregnant women in Kenya , Cameroon , Lesotho and Zambia starting from this month.

It contains all the medicines and instructions needed to protect an HIV-infected mother and her newborn, even if she never visits a health clinic again until after the baby is born, and even if she can't read properly.

"We don't need any scientific breakthroughs or new technology to tackle this problem," said Jimmy Kolker, head of HIV and AIDS at the United Nations children's fund (UNICEF). "What we need is a way to empower women to take charge of their own care."

Evidence in developed countries, where there is now virtually no transmission of the human immunodeficiency virus (HIV) that causes AIDS from mothers to babies, shows that, as Kolker says, all the medicines and healthcare knowledge are already there to halt it worldwide.

It is the logistics of getting the right drugs to the right people at the right time that is proving the biggest barrier in poorer countries to eliminating mother-to-child HIV transmission -- a goal the United Nations has said it wants to reach by 2015.

"In the developed world, there are now very few babies born HIV positive, but in Africa there are still over 1,000 born every day," Kolker told Reuters in an interview. Eliminating mother-to-child transmission by 2015 was an "ambitious goal", but one that could be reached with some new ideas, he said.

More than 50 percent of HIV-positive women in sub-Saharan Africa in 2008 did not get the drugs they needed to prevent transmission of the virus to their children, according to data from the Joint United Nations Programme on HIV/AIDS (UNAIDS).

The AIDS virus infects about 33.4 million people around the world and 22.4 million of them live in sub-Saharan Africa .

The World Health Organisation says an estimated 430,000 children were newly infected with HIV in 2008, the vast majority of them through mother-to-child transmission. Yet this kind of spread of the disease is preventable if services are available.

Children born with HIV face lifelong disease and, if they're lucky, lifelong medication. In Africa at least half of them will die before their second birthdays without medical intervention.

"We're still missing a lot of mothers because they don't come back to the clinics, or because the clinics are short of drug supplies, or because the mothers don't take the drugs when they're supposed to," said Kolker.

At around $70 per box, the mother-baby pack costs less than half of what it would take to give even a year of drug treatment to an HIV positive baby, UNICEF says.

"It's cost-effective from every point of view," said Kolker. "It's something that can be done at a village level and followed up by a community health worker or mothers group. It doesn't need a nurse or doctor to follow through."

The pack will also simplify the procurement, ordering and distribution of drugs and healthcare since it is a one-stop-shop, with a complete course of medicines and instructions to halt mother-to-child HIV transmission.

The pack is divided into three sections of blue for drugs to be taken during pregnancy, yellow for medicines needed during labour and delivery and pink for drugs needed for mother and baby after delivery.

The colour-coding and a series of simple pictures are designed to help women with low levels of literacy understand when and in what doses to take the medicines.

UNICEF's $8.0 million pilot project in the first four countries is planned in three phases, with around 30,000 packs to be distributed in each phase to reach almost 100,000 women by the middle of 2011.

If it proves successful, Kolker said UNICEF plans to scale the project up in these countries and widen it to include more.

"We don't want to do this without being really sure that it works," he said. "But one of the things that is most promising about this project is that there are already a number of countries who want to be next in line." (Editing by Peter Graff)

 

HIV-related drug won FDA approval

TORONTO , Nov 11 (Reuters) - Shares of Theratechnologies jumped 15 percent on Thursday after the Canadian pharmaceutical company won U.S. regulatory approval of its HIV-related drug.

The U.S. Food and Drug Administration announced late on Wednesday it had approved Egrifta, a drug developed by the Montreal-based company to treat excess abdominal fat in HIV patients.

Theratechnologies' stock rose 75 Canadian cents to C$5.75 on the Toronto Stock Exchange on Thursday shortly after markets opened.

The shares soared 84 percent on May 28 after a U.S. advisory panel unanimously recommend the drug's approval. The FDA typically follows panel recommendation.

The injectable drug treats lipodystrophy, a condition in which excess fat develops in different areas of the body, most notably around the liver, stomach and other abdominal organs.

The condition is associated with many antiretroviral drugs used to treat HIV, the FDA press release said on Wednesday.

"We've all been waiting for this day for many years," Chief Executive Yves Rosconi said during a conference call with analysts on Thursday.

"Marketing approval for Egrifta was granted as the first and only treatment approved to reduce excess abdominal fat in HIV-infected patients with lipodystrophy," said Rosconi, who was making his last conference call before retiring from the company.

He did not give a specific date for when Egrifta will begin selling. The drug will be marketed by Merck KGaA's  EMD Serono division in the United States .

Theratechnologies said during the call that its next objective was to focus on commercializing Egrifta in other markets outside the United States .

 

Glenmark completes phase-III trial for Crofelemer

Nov 8, 2010

MUMBAI (Reuters) - Glenmark Pharmaceuticals said on Monday it has completed phase-III trials for its Crofelemer drug, sending its shares up more than 4 percent in early trades.

The drug, used in the treatment of HIV-associated diarrhoea, would be launched in 140 countries, it said in a statement.

Glenmark has developed Crofelemer with its partners Napo Pharmaceuticals and Salix Pharmaceuticals, it said.

The Mumbai-based drugmaker has exclusive marketing and distribution rights to this compound across 140 countries and is also the sole global supplier of active pharmaceutical ingredients except in China , it added.

Glenmark would invest significant resources to fast-track its development plan to ensure early regulatory approvals for Crofelemer and launch it in most of the markets, Glenn Saldanha, chief executive and managing director, Glenmark, said in a statement.

The firm expects approval for the drug in India in 2012, it said.

At 9:41 a.m., shares of Glenmark Pharmaceuticals were trading at 373.10 rupees, up 2.51 percent in a weak Mumbai market.

(Reporting by Kaustubh Kulkarni; Editing by Sunil Nair)

 


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