News (Updated April 19, 2009)

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HIV may be increasing in virulence

Wed Apr 15, 2009 11:48am EDT

NEW YORK (Reuters Health) - From 1985 to 2007, the CD4+ cell counts seen at diagnosis in HIV-infected patients in the US have fallen, suggesting that the virus may be adapting to the host and becoming more virulent, according to a report in Clinical Infectious Diseases.

These findings agree with those of other researchers, who have reported that patients starting treatment for HIV infection in recent years may have lower CD4+ cell counts at diagnosis and require antiretroviral therapy earlier in the course of disease, Dr. Nancy Crum-Cianflone, from the Naval Medical Center , San Diego , California , and colleagues report.

The study results stem from an analysis of data for 2174 patients who tested positive for HIV antibodies and were enrolled in the TriService AIDS Clinical Consortium HIV Natural History Study. None of the subjects had received antiretroviral treatment and had their CD4+ counts measured within 6 months of their HIV diagnosis. CD4+ cells are immune cells that are used to assess the severity of the infection. As HIV infection progresses, CD4+ cell counts decrease.

The average initial CD4+ cell counts during the periods 1985-1990, 1991-1995, 1996-2001, and 2002-2007 were 632, 553, 493, and 514 cells per microliter, respectively. During the same periods, the percentage of subjects with initial CD4+ cell counts below 350 cells per microliter were 12 percent, 21 percent, 26 percent, and 25 percent.

The reduction in initial CD4+ cell counts was similar in African American and in white patients, the report indicates. Similar trends were also noted for the CD4+ cell count percentage and the total count of lymphocytes, a type of white blood cell involved in the immune response.

In an accompanying editorial, Dr. Maria Dorrucci, from Istituto Superiore di Sanita, Rome , and Dr. Andrew Phillips, from University College Medical School , London , comment that while some studies, such as the current one, have suggested that HIV virulence is increasing, others have found that it is either stable or decreasing.

This, they note, may relate to how virulence is assessed, adding that "it is unclear whether simple immunological or virological proxies for virulence can be expected to adequately capture the whole complexity of HIV virulence" and the susceptibility of the patient to HIV infection.

SOURCE: Clinical Infectious Diseases, May 2009.

 

GSK, Pfizer pool HIV drugs businesses

Thu Apr 16, 7:52 PM

The GlaxoSmithKline (GSK) headquarters compund in west London. ...LONDON (AFP) - GlaxoSmithKline and Pfizer, two of the world's largest pharmaceutical groups, are planning to combine their HIV drugs businesses into a new company, GSK said Thursday.

The new combined company will sell 11 existing drugs produced by the two firms, holding a 19 percent share of the market and generating annual sales of about 1.6 billion pounds (1.8 billion euros, 2.4 billion dollars), Britain-based GSK said.

Initially controlled 85 percent by GSK and 15 percent by Pfizer, it will also focus on research and development of new HIV treatments and formulations, including developing six new drugs already in the pipeline.

"We are creating a new global leader in HIV and reaffirming our ongoing commitment to the treatment of the disease," said Pfizer chief Jeff Kindler.

GSK chief executive Andrew Witty said the agreement marked a "definitive step" to deliver more medicines, more efficiently.

"At the core of this specialist business is a broad portfolio of products and pipeline assets, which can be more effectively leveraged through the new company's strong revenue base and dedicated research capability," he said.

"HIV remains a global threat with increasing incidence and viral resistance. This new company will be better placed to meet these challenges and improve access to treatments."

 

US Government statistics on syphilis, HIV

By The Associated Press The Associated Press Sat Apr 18, 2009

A summary of US federal government figures on syphilis and HIV:

• The rate of primary and secondary syphilis — the most infectious stages of the disease — reached an all-time low in 2000 then started a climb over the next seven years, the most recent time period available from the Centers for Disease Control and Prevention.

• The rate increased 15.2 percent between 2006 and 2007 — from 3.3 cases per 100,000 people to 3.8 cases. The actual number increased from 9,756 to 11,466.

• Men who have sex with men represented 65 percent of the primary and secondary syphilis cases in 2007.

• More than 1 million people in the U.S. have HIV, the virus that can lead to AIDS. One in five is unaware of the infection.

• About 56,300 Americans become infected with HIV each year.

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Source: Centers for Disease Control and Prevention

 

Health advocates tout new model of female condom

By DAVID CRARY, AP National Writer  Thu Apr 16, 2009

NEW YORK – Advocates of the female condom are promoting a less costly, more user-friendly version that they hope will vastly expand its role in the global fight against AIDS and other sexually transmitted diseases. An early version of the female condom was introduced in 1993, and it remains the only available woman-initiated form of protection against both STDs and unintended pregnancy.

Yet despite global promotion by the United Nations and other organizations, its usage is still minuscule, even as women bear an ever-growing share of the AIDS epidemic.

Advocates hope the dynamics will change following last month's approval by the Food and Drug Administration of the FC2, a new version of the female condom produced by the Chicago-based Female Health Co.

About 35 million female condoms were distributed worldwide last year, but that compares to more than 10 billion male condoms, which are far cheaper and, at least initially, easier to use. However, in some nations with high HIV rates, many men refuse to wear condoms, putting women at risk.

Though it looks similar to its predecessor — a soft, transparent sheath with flexible inner and outer rings — the FC2 is made from synthetic rubber rather than polyurethane, making it cheaper to produce.

Mary Ann Leeper, former president of Female Health Co. and now its strategic adviser, said the FC2 also is less noisy during use. Complaints about squeaky noises were among the factors that slowed acceptance of the original version.

The cost of the FC2 is one-third less than its predecessor, and may go lower, enabling health organizations to distribute many millions more than at present. For now, the price is about 60 cents compared to less than 4 cents for mass-distributed male condoms — a difference that's an issue in the developing world.

The FC2 had been accepted previously by some international organizations, and the Female Health Co. distributed 14 million of them abroad last year along with 21 million of the older version. Advocates of the female condom praised the FDA announcement because it opens the door for the U.S. Agency for International Development (USAID), one of the largest global providers of condoms, to distribute the FC2 overseas.

"This is a tremendous victory," said Susie Hoffman, an assistant professor of clinical epidemiology at Columbia University who contends the female condom has suffered from misconceptions.

"In the United States , there has been strong bias against it," Hoffman said. "Some people involved in AIDS and family planning would say, 'Why do we need these? ... It's so weird that women are not going to pick it up.'"

"But if presented in the right way, many women do like it," Hoffman said. "To find these people and help them and train them, you need systematic programming, which costs money."

Resistance is less of a problem in some developing nations. The U.N. Population Fund, government agencies and nonprofits are aggressively promoting female condoms in places such as Brazil , Ghana , Zimbabwe and South Africa .

Women's groups in Zimbabwe collected more than 30,000 signatures demanding access to the female condom. In Ghana, nonprofits say more than 10,000 people have attended training programs that teach women how to insert female condoms — they require careful instruction to be used properly — and how to negotiate with their male partners.

"The mindset is changing, but there are still a lot of challenges," said Bidia Deperthes, the Population Fund's HIV technical adviser for condoms. "Accessibility is still minimal. There's a huge demand, and we're not meeting it."

Deperthes hopes that with FDA approval of the FC2, the number of female condoms distributed globally could climb to 50 million this year. If the numbers keep rising, she said, the cost to public-sector distributors for each FC2 could drop as low as 25 cents.

Jeff Spieler, a science adviser with USAID's Office of Population and Reproductive Health, said the female condom's future may depend on whether its promoters can develop a private-sector market. Its commercial price in the United States generally has been more than $2.

Another challenge is a stigma associated with the female condom in some places because prostitutes are among those deemed to benefit most from using it. On the other hand, advocates of the female condom say it has invaluable safe-sex potential for married women whose husbands are unfaithful and shun male condoms.

Serra Sippel, executive director of the Center for Health and Gender Equity in Washington , said FDA approval of the FC2 is a key step toward "putting the power of prevention in women's hands." But she bemoaned the product's limited over-the-counter availability.

"We'd love to see the profile raised, to have commercials about it and normalize it so people aren't embarrassed," she said.

Mary Ann Leeper said the Female Health Co. is seeking a corporate partner to help market the FC2. She suggested that concern about HIV/AIDS may generate interest among women in communities with high infection rates.

The female condom's advocates stress that it will never be the "magic bullet" that by itself turns the tide in fighting AIDS. But, they say, it should be a bigger part of the arsenal.

"It's not going to be the one answer," Hoffman said. "But it's got a lot more to contribute than it has to date."

 

Generics deal cuts cost of AIDS drugs further

Thu Apr 16, 2009 8:03pm EDT

LONDON (Reuters) - The cost of AIDS medicines in poor countries is to come down further, following a new bulk purchase arrangement negotiated with a group of generic drug manufacturers.

The Clinton Foundation HIV/AIDS Initiative and the international drug-purchasing consortium Unitaid said Friday they had struck deals offering steeper discounts on a range of life-saving treatments.

The price of most affordable generic second-line drug regimen -- needed when patients develop resistance to initial treatment -- falls to $590 annually, from more than $700 a year ago.

And a one-pill, once-daily first-line regimen based on the drug tenofovir is now available for $210 annually, down 30 percent from 2008.

In total, new price agreements have been struck for 41 adult and paediatric formulations at an average reduction of 16 percent compared to 2008.

There is no cure for the human immunodeficiency virus (HIV) that causes AIDS, but combinations of drugs can keep the virus from replicating and damaging the immune system.

An estimated 33 million people globally are infected with the AIDS virus, most of them living in Africa and other developing countries.

(Reporting by Ben Hirschler; Editing by Erica Billingham)


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