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Kaiser Daily HIV/AIDS Report


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Monday, May 12, 2008

Politics and Policy

Drug Access

Global Challenges

Science & Medicine




Politics and Policy
 

    CDC Director Gerberding Calls for Increase in HIV Prevention Efforts for Black Community
    [May 12, 2008]

      CDC Director Julie Gerberding on Friday at a forum in Oakland, Calif., said that more money is needed to fight HIV/AIDS in the black community, particularly among black men who have sex with men, the San Francisco Chronicle reports.

"We have not succeeded in our prevention efforts," Gerberding said at the meeting, which was hosted by Rep. Barbara Lee (D-Calif.). She added, "You have to scale the money to the scope of the problem. The pie is only so big right now. What we need is a bigger pie."

Although 13% of the U.S. population is black, the group makes up about 50% of people living with HIV, the Chronicle reports. Among young people newly diagnosed between 2001 and 2005, 61% were black, and 48% of cases among black men were linked to sex with other men. HIV/AIDS rates among black men were seven times higher than those among white men in 2005, according to CDC.

The Bush administration has proposed reducing CDC's budget request for HIV prevention and surveillance funding by $1 million to $691 million in the upcoming fiscal year. According to the Chronicle, Gerberding often testified before Congress that she wanted more money for CDC than was requested by her superiors in the administration. She requested $7.2 billion for the agency last year, but the budget was reduced to $5.9 billion.

In response to HIV/AIDS in the black community, Lee said that she is again calling on the federal government to declare a "national public health emergency." She added, "We need to make sure not only that resources are increased, but are targeted to where they are needed most."

George Lemp, director of the Universitywide AIDS Research Program at the University of California, said studies from the early 1990s repeatedly found that HIV was spreading twice as fast among black MSM than among white MSM but that prevention programs were not reaching young black men. "Our interventions are targeting the wrong people, in the wrong places and at the wrong time of day," he said (Russell, San Francisco Chronicle, 5/10).

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Drug Access
 

    Canadian Drug Company Awarded Rwandan Contract To Provide Combination Antiretroviral
    [May 12, 2008]

      Rwanda recently accepted a bid from the Toronto-based generic drug company Apotex to supply its fixed-dose combination antiretroviral drug Apo-triAvir to the country, the Toronto Star reports (Toronto Star, 5/9). According to the CP/Google.com, securing the contract was the final legal step the company had to take in the process of receiving approval from Canada's Access to Medicines Regime. Apotex is the first company to complete CAMR's approval process, which has been criticized by some HIV/AIDS advocates and generic drug manufacturers, the CP/Google.com reports (CP/Google.com, 5/8).

The World Trade Organization in October 2007 announced it had received notification from the Canadian Intellectual Property Office authorizing Apotex to manufacture the drug. GlaxoSmithKline in August 2007 announced that it had given consent to Apotex to use two of GSK's patented antiretroviral drugs, lamivudine and zidovudine, to manufacture Apo-triAvir -- a combination of lamivudine, zidovudine and nevirapine. Boehringer Ingelheim agreed in July 2007 to allow Apotex to use nevirapine in the combination.

Under an August 2003 waiver to WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights, known as the "paragraph 6 system," developing countries with a public health crisis are allowed to import generic drugs when they cannot manufacture the drugs themselves. According to WTO, Rwanda is the first country to use the waiver, which would allow it to import generic drugs that are manufactured under compulsory licenses in other countries. The TRIPS waiver submission was made in September 2007 by the Treatment and Research AIDS Centre (Kaiser Daily HIV/AIDS Report, 8/10/07). According to the Star, Apotex plans to send 15.6 million tablets of the drug beginning in October (Toronto Star, 5/9). Apotex will sell the drug for about 19.5 cents per dose, but if purchased separately and from their patent holders, the drugs will total about $6 per dose, the CP/Google.com reports.

Comments
"We're almost there," Elie Betito, director of public and government affairs for Apotex, said, adding, "By October sometime we're hoping that the product will be on a plane on delivery to Rwanda." Betito said that nothing will be final until the drugs are delivered, adding that the patent-holding companies can still withdraw permission for the sale to take place "even on the day we are shipping" (CP/Google.com, 5/8). Betito said that Apotex essentially developed the drug as a goodwill gesture and will not see a return on its development costs at the selling price. He added that the company likely will not go through the CAMR process again unless it is changed (Gandhi, Globe and Mail, 5/8).

Richard Elliott, executive director of the Canadian HIV/AIDS Legal Network, said Apotex's accomplishment is bittersweet. If Apotex is unwilling to go through the process again, other drug companies are unlikely to attempt to try, Elliott said. He added, "I don't think the experience of Apotex is going to inspire [drug companies] to say, 'OK, yeah, now we'll step up to the plate and do it,' unless of course we fix the system and make it much smoother and easier" (CP/Google.com, 5/8). Jeff Connell, spokesperson for the Canadian Generic Pharmaceutical Association, said none of the group's members is willing to go through the CAMR process in its current form (Globe and Mail, 5/8).

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    No-Cost Antiretrovirals at Clinic in Rural Malawi Reduces AIDS-Related Deaths, Study Says
    [May 12, 2008]

      No-cost antiretroviral drugs have significantly decreased HIV/AIDS-related deaths in rural areas of Malawi, according to a study recently published in the journal Lancet, Health-e reports. Researchers from the London School of Hygiene and Tropical Medicine examined mortality rates in a population of 32,000 people in northern Malawi between August 2002 and February 2006. An HIV/AIDS clinic opened in the area in June 2005. The researchers found that overall adult mortality rates declined by 10% eight months after the clinic opened. Mortality also decreased by 35% among adults living near the area's only main road, where deaths were highest before the clinic opened (Health-e, 5/9).

Researcher Judith Glynn said, "I think people didn't expect to see an effect that quickly," adding, "Previous clinical studies have shown improved survival, but we have now shown this translates into a clearly measurable effect, even in a rural area, and surprisingly early."

Mattias Egger and Andrew Boulle of the University of Cape Town, who were not involved in the study, said the rapid results seen with the clinic are a result of the fact that the sickest people received antiretrovirals first. They added that less-ill patients would experience fewer benefits as treatment continued. In addition, differences in mortality reductions between people near and far away from the main road show the potential for disparities in treatment access, they said.

About 59% of deaths among people between ages 15 and 59 are attributed to HIV/AIDS in Malawi. However, it has been one of the more successful countries in terms of providing no-cost treatment to HIV-positive people, according to Reuters. Since 2004, Malawi has been able to offer access to no-cost antiretrovirals with funding from the Global Fund To Fight, AIDS, Tuberculosis and Malaria (Hirschler, Reuters, 5/8). According to Health-e, access to antiretrovirals continues to grow throughout Malawi, which researchers believe will result in continued decreasing mortality rates (Health-e, 5/9).

Online The study is available online.

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Global Challenges
 

    IRIN/PlusNews Examines Efforts To Increase Access to Safe Drinking Water Among HIV-Positive People in Sudan
    [May 12, 2008]

      IRIN/PlusNews on Monday examined efforts to increase access to safe drinking water among HIV-positive people living in Sudan. According to IRIN/PlusNews, people living with HIV are especially vulnerable to diseases that can be spread through unsafe drinking water because of their weakened immune systems. Although conflict in Sudan officially ended in 2005, government officials in the south of the country have said that they do not have the resources necessary to rebuild the region and deliver services, such as safe water.

Since the end of the conflict, water treatment tablets have become available in some stores, and HIV-positive people who can afford the tablets protect themselves from cholera and other diarrheal diseases common in the region, IRIN/PlusNews reports. PSI this year, with funding from CDC, began including water treatment tablets, called Water Guard, in care packets the group distributes to HIV-positive people every three months. The packets include 90 Water Guard tablets, each of which treats 25 liters of water. The packets also contain cans with taps on the bottom, water containers, condoms, two insecticide-treated nets, and educational materials about malaria and HIV.

According to IRIN/PlusNews, the decision to include Water Guard in the packets in part was a response to pressure from HIV-positive people in the region. "It's a major concern for us: we feel that they must have access to clean water," Angok Kueol, executive director of the Southern Sudan AIDS Commission, said, adding that if HIV-positive people "don't have safe water, they are always prone to infections, such as watery diarrhea." Erin Stuckey, HIV/AIDS technical adviser to PSI in southern Sudan, said that the care-packet program will be expanded to other parts of the region in the future. In addition, other organization, such as UNICEF and Solidarites, are making efforts to raise awareness about hygiene and sanitation (IRIN/PlusNews, 5/12).

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    HIV/AIDS Cases Increasing Among Commercial Sex Workers in Uganda
    [May 12, 2008]

      HIV/AIDS cases are increasing among women and girls involved in commercial sex work in Kampala, Uganda, HIV/AIDS advocates said recently, Uganda's Monitor reports.

Robert Kanwagi -- coordinator of the Breaking the Ice Project, which is being implemented by the group Reproductive Health Uganda in Kampala -- said a recent survey found that HIV prevalence among the sex workers in the city was as high as 47.2%, compared with the national prevalence of 6.7%. The survey also found that HIV prevalence is as high as 60% among sex workers ages 25 to 29 and that 59.6% of sex workers were found to have other sexually transmitted infections, such as syphilis and gonorrhea.

Kanwagi, who was speaking at a training workshop on HIV and gender issues, said poverty is the primary reason that women become commercial sex workers. He also said that sex workers lack the authority to negotiate safer sex and that those who offer unprotected sex are paid more money than those who use condoms. The Breaking the Ice Project was launched in July 2007 to expand access to HIV/AIDS services among sex workers in Kampala.

RHU National Program Manager Peter Ibembe said HIV/AIDS is spreading among women and girls because of social, economic and cultural factors that deny them access to HIV prevention and treatment services. "A poor woman or girl may not be able to deny a man sex because she needs money," he said, adding, "Because of their lack of decision-making power in matters of sex, as well as other factors like poverty, they become more exposed to the risk of becoming infected than men" (Nafula, Monitor, 5/9).

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Science & Medicine
 

    Increased Research, Determination Needed in HIV/AIDS Vaccine Efforts, HIV Vaccine Enterprise Head Says
    [May 12, 2008]

      The disappointment that followed the cancellation of a Merck vaccine trial in September 2007 has been replaced by a renewed determination among the scientific community, Alan Bernstein, executive director of the Global HIV Vaccine Enterprise, said ahead of the 25th anniversary of the scientific paper announcing the discovery of HIV, the CP/Yahoo! News reports. "I could not guarantee that one day we'll have a vaccine," Bernstein said, adding, "But not to try is to say to all the 33 million people" who are living with HIV worldwide, as well as the 2.3 million people who contract the virus "every year," that researchers are "giving up."

May 20 is the 25th anniversary of the paper -- published in the journal Science by Luc Montagnier and colleagues at La Pitie-Salpetriere Hospital and the Institut Pasteur -- announcing the discovery of HIV. Science in its current issue has published an editorial by Bernstein, as well as additional articles about HIV/AIDS vaccine and prevention efforts, to mark the anniversary.

Bernstein in the editorial writes that people who use recent vaccine candidate setbacks to argue that such research is misplaced and that a vaccine cannot be developed are "misguided." He added, "The development of new drugs and new vaccines always take time and is never a straight line, and it's always marked by failures."

According to Bernstein, the result of a number of recent conferences to address HIV/AIDS vaccine research is a consensus to focus on more basic and early-stage clinical research. Such research will allow scientists to examine what happens when people contract HIV, as well as how the immune system functions, Bernstein said. "If we do the kinds of research that's needed to understand how we react to HIV, that ultimately will inform a lot of research on other pathogens," he said (Branswell, CP/Yahoo! News, 5/8).

Online A summary of Bernstein's editorial is available online.

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Jill Braden Balderas, managing editor, kaisernetwork.org
Vince Blaser, associate editor, Kaiser Daily HIV/AIDS Report
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Kimberley Lufkin, editor, Kaiser Daily HIV/AIDS Report
Kate Steadman, web writer, kaisernetwork.org
Simone Vozzolo, senior web producer, HealthCast
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Amanda Wolfe, editor-in-chief, Kaiser Daily Reports
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Sarah Mann, Mandy McAnally, Christopher Rottler, staff writers, Kaiser Daily HIV/AIDS Report
Alyssa Mitchell, Emily Picillo, copy editors, Kaiser Daily Reports
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