Kaisernetwork.org (Washington, DC)
25 March 2008
Science & Medicine
Trials of NIH HIV Vaccine Candidate Scaled Down After Failure of Merck Vaccine
[Mar 25, 2008]
Trials of NIH's Vaccine Research Center's HIV vaccine candidate will be scaled down after the recent failure of a Merck HIV vaccine candidate, Bloomberg reports (Lauerman, Bloomberg, 3/24). Merck in September 2007 announced it had halted a large-scale clinical trial of its experimental HIV vaccine after the drug failed to prevent HIV infection in participants or prove effective in delaying the progression of the virus to AIDS. The vaccine candidate also might have put some trial participants at an increased risk of HIV (Kaiser Daily HIV/AIDS Report, 3/21).
The VRC candidate, called PAVE-100, is similar to the Merck vaccine in that both stimulate CD4+ T cells against HIV and both contain the cold virus adenovirus-5. Researchers in the Merck trial found that men who received that vaccine were at an increased risk of contracting HIV if they had a high immunity to adenovirus-5 when they enrolled in the trial. Anthony Fauci, director of NIH's National Institute of Allergy and Infectious Diseases, said that the VRC trial will not enroll anyone with high immunity to the cold virus. According to Bloomberg, this could rule out nine in every 10 potential study participants in Africa. In addition, the trial will require that men be circumcised, according to Wayne Koff, senior vice president for research and development at the International AIDS Vaccine Initiative.
VRC initially planned to enroll 8,500 people in the U.S. and Africa in the trial but now plans to enroll only 2,000. In addition, IAVI on Monday announced plans to pull out of the VRC trial. Koff said the group had planned to enroll 1,000 people in Africa in the new trial but pulled out because it believes that human trials of HIV vaccine candidates should be small and aim to design better vaccine candidates than those currently in development. Koff said that there is not a "clear understanding of why" the Merck trial failed, adding that IAVI believes there is "a safety unknown" in the new VRC trial.
The new vaccine has features that could make it more effective than the Merck vaccine, according to Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition. PAVE-100 uses DNA that researchers hope will induce cells to produce vaccine-like proteins to generate a protective immune response against HIV. Researchers also are hoping that the cold virus in PAVE-100 will cause a stronger immune response than the cold virus in the Merck vaccine. According to Warren, HIV vaccine trials in the immediate future should focus on answering questions about how such vaccines work as opposed to whether they can prevent HIV transmission. He added that there is "certainly something to learn by advancing PAVE-100."
According to Bloomberg, some researchers have said that the failure of the Merck vaccine has set back HIV vaccine research for years, and many researchers are questioning new trials. The AIDS Healthcare Foundation recently called for all HIV vaccine research to be stopped. NIAID on Tuesday is expected to hold a meeting with HIV/AIDS researchers to discuss its $497 million HIV vaccine research program. Bruce Walker, a researcher at Harvard Medical School, said the NIAID meeting will aim "to stop and take stock" of HIV vaccine development following the "unanticipated result" of the Merck trials (Bloomberg, 3/24).
Link to this story.
Genetic Variations Might Be Causing Mutations to HIV, Making It Less Potent, Study Says
[Mar 25, 2008]
Genetic variations that might help people newly diagnosed with HIV control their viral loads also could be causing a mutation in the virus that makes it less potent, according to a study published Friday in PLoS Pathogens, Reuters reports.
Some people have versions of an immune system gene, called HLA, that are "known to force HIV to tolerate mutations that damage its ability to reproduce," according to Carolyn Williamson of the Centre for the AIDS Programme of Research in South Africa and colleagues. The weakened virus also means lower viral loads and slower disease progression in people with beneficial versions of HLA, according to Reuters. The researchers found that the weakened virus might be transmitted to and act in the same way in other people, even if they do not have the HLA variation, Williamson said.
The researchers followed 21 women in South Africa who recently contracted a weakened strain of HIV. The women did not have the beneficial HLA variation, according to Reuters. The researchers followed the women for between one to three years, Reuters reports. The researchers found the women had much lower viral loads, compared with people carrying a strain of HIV that had not mutated to a weakened state. The researchers also found that while the women's viral loads decreased, their CD4+ T cell counts increased. "It is pretty well established if you have certain HLA genes, you are better off," Williamson said, adding, "It is very likely that the virus in the people who did not have the HLA gene came from individuals who did."
According to Williamson, the "significant difference to other studies is that this is showing the actual benefit is due to the genetic composition of the virus." She added that the findings show "a survival advantage with a virus containing specific genetic signatures associated with lower replication."
The researchers have not studied the women to see how much slower they progress to AIDS but noted the findings could help researchers looking for an effective vaccine through an improved understanding of why some people living with the virus survive longer (Kahn, Reuters, 3/20).
The study is available online.
Link to this story.
Politics and Policy
Houston Chronicle Examines U.S. HIV/AIDS-Related Travel Restrictions
[Mar 25, 2008]
The Houston Chronicle on Sunday examined U.S. HIV/AIDS-related travel restrictions for visitors and immigrants. According to the Chronicle, the U.S. is one of 13 countries -- including Armenia, Iraq and Qatar -- that has such restrictions (Carroll, Houston Chronicle, 3/23). A regulation included in a 1993 amendment to the Immigration and Nationality Act only permits HIV-positive foreigners to obtain visas to enter the U.S. under limited circumstances. The regulation also requires HIV-positive foreigners to obtain waivers from the Department of Homeland Security before they can receive visas.
Draft rules proposed by the Homeland Security Department that would change U.S. HIV-related travel rules have not been finalized. Some advocates and Democrats have objected to the proposed rules, saying that the rules do not improve the situation (Kaiser Daily HIV/AIDS Report, 3/12).
The Senate Foreign Relations Committee earlier this month approved a President's Emergency Plan for AIDS Relief reauthorization bill (S 2731), which includes a provision that would lift some of the travel restrictions, the Chronicle reports. Rep. Barbara Lee (D-Calif.) has sponsored a House version of the amendment.
Although the provision is attached to the PEPFAR reauthorization bill, supporters are cautiously optimistic, the Chronicle reports. If the provision is approved, HHS will then need to decide whether HIV/AIDS should remain on a list of diseases preventing entry into the country, according to the Chronicle. HHS officials did not return calls seeking comment on the issue.
According to the State Department, 938 immigration applicants were denied admission to the U.S. in 2007 because of a communicable disease; however, 478 of the applicants later received waivers and were permitted entry. A breakdown of the applicants' diseases was not available, according to Steven Royster, a State Department spokesperson. According to the Chronicle, the U.S. requires HIV tests only for people who plan to immigrate permanently, but short-term visitors are asked whether they have a communicable disease during the visa application process.
Supporters of the amendment have said a repeal of the travel ban is overdue. "There is no scientific basis whatsoever for the travel ban, and there never has been," Mark Kline, head of retrovirology at Baylor College of Medicine and director of the school's AIDS International Training and Research Program, said. He added that the travel ban was a "political decision." In addition, the ban has led to a U.S. boycott by some HIV/AIDS advocacy and research groups, and International AIDS Society conferences have not been held in the U.S. since Congress passed the travel restrictions.
Kline said that the travel restrictions could indirectly lead to the spread of the virus through increased stigma, adding that the restrictions could cause people living with the virus to avoid seeking treatment. "We know that treatment can suppress the virus in the body and actually contribute to prevention by making people with HIV less likely to transmit the virus," Kline said, adding that if a country has laws or policies that prevent people from "testing, from acknowledgement of the infection and treatment, you actually help to perpetuate and promote the spread of the disease" (Houston Chronicle, 3/23).
Link to this story.
Across The Nation
Alabama Advocates Urge Officials To Remove Work Release Restrictions for HIV-Positive Inmates
[Mar 25, 2008]
Advocates in Alabama are calling on prison officials to remove work release restrictions for HIV-positive inmates, the AP/Alabama Live reports. According to the AP/Alabama Live, HIV-positive inmates in Alabama are eligible to participate in the Supervised Early Release Program, which allows them to live away from prisons near the end of their sentences. However, advocates say that Alabama is the only state with a prison system that bans HIV-positive people from participating in work release programs.
Work release programs allow select inmates to hold jobs, earn money and spend the day without supervision of corrections staff outside of prison. In Alabama, inmates must meet several criteria before being allowed to participate in the program, including testing HIV-negative. State corrections officials attribute the rule in part to medical requirements that were established in a 2004 settlement of a lawsuit over inadequate health care for inmates living with HIV/AIDS. Medical requirements for inmates living with the disease include special diets and monitoring of inmates who take antiretroviral drugs by a nurse, the AP/Alabama Live reports. According to prison officials, the work release program allows inmates to be free of staff supervision, making the medical monitoring provision of the settlement impossible to meet.
Prison officials in other states -- including Florida, Louisiana, North Carolina and Tennessee -- said they have work release programs similar to Alabama, and none bans HIV-positive inmates from being eligible. Keith Acree, a spokesperson for the North Carolina Department of Correction, said he is "surprised" to hear of the rule. He added that in North Carolina, "as long as the inmate is physically able to work, they can do work release. If their medical condition gets to a point where they can't do the job, then they have to put them on some other program." David Fathi, director of Human Rights Watch's U.S. program, said, "If 49 other states can allow HIV-positive prisoners" to participate in work release programs, "Alabama could do it too."
Margaret Winter, associate director of the American Civil Liberties Union's National Prison Project, said, "I think we're dealing with a long custom here in Alabama. There's fear here." She added, "Certainly, we have no reason to think anything the commissioner is doing is based on malice -- far from it -- but there needs to be a rational look at the facts." Alabama Corrections Commissioner Richard Allen said that the situation is under review and that the issue is not very widespread. "We're talking about a very small number of inmates -- a handful of women and maybe a score of men when you consider who's eligible with the other criteria," Allen said.
Edward Harrison, president of the National Commission on Correctional Health Care, said the medical monitoring cited by Alabama prison officials can be a valid concern. He added that he assumes officials are open to alternate approaches "if it can be done without compromising security and health." Fathi said Alabama ultimately has to decide if it is in the state's best interest to keep HIV-positive inmates from participating in work release programs. "It's really about public safety," Fathi said, adding, "That means less crime, fewer people returning to prison and, ultimately, it means a safer society for everybody. So by denying work release to inmates with HIV who would otherwise be eligible, Alabama is shooting itself in the foot" (Hunter, AP/Alabama Live, 3/23).
Link to this story.
Global Challenges
Central Asian Governments Should Work Quickly To Address HIV/AIDS in Region, Official Says
[Mar 25, 2008]
Central Asian governments should act quickly to address the spread of HIV/AIDS in the region or face serious consequences, Kyrgyzstan's Deputy Prime Minister Nur uulu Dosbol said during a recent conference in Bishkek, Kyrgyzstan, the Times of Central Asia reports.
Dosbol said that people living with HIV/AIDS in Central Asia lack reliable access to treatment and that the virus is spreading uncontrollably among high-risk groups. He also noted that Central Asian nations have shortages of qualified medical workers and lack effective HIV testing strategies. Central Asia AIDS Control Project Executive Director Tilek Meimanaliev warned that the region could be on the verge of an epidemic. A U.S.-sponsored survey in 2006 found that 5% of the population was HIV-positive in some areas, the Times reports.
To better understand the HIV/AIDS situation in the region, USAID, CAAP and CDC have helped introduce a new surveillance technique in Central Asia that studies how HIV is spread, the Times reports. The technique -- which has been launched in Kazakhstan, Kyrgyzstan, Tajikistan and Uzbekistan -- investigates the dynamics of the disease and assesses the effectiveness of various prevention programs.
U.S. Ambassador to Kyrgyzstan Marie Yovanovitch said that USAID, CDC and the Global Fund To Fight AIDS, Tuberculosis and Malaria are planning to fund three HIV/AIDS programs in Central Asia to help local governments monitor the spread of the virus. Thirteen CAAP pilot projects are under way in four Central Asian states. The CAAP projects, funded by the World Bank and the United Kingdom Department for International Development, are working to strengthen partnerships between public, nongovernmental and private sectors. Dosbol said data from projects worldwide have shown that HIV prevention and treatment programs can be effective when civil society participates (Levina, Times of Central Asia, 3/21).
Link to this story.
Opinion
Letters to Editor Respond to Opinion Piece Addressing Debate Over PEPFAR, Family Planning Services
[Mar 25, 2008]
The Washington Post on Friday published two letters to the editor written in response to a March 12 Post opinion piece by columnist Michael Gerson, senior fellow at the Council on Foreign Relations. Gerson in the opinion piece wrote that the original legislation authorizing the President's Emergency Plan for AIDS Relief included a compromise that "separated AIDS relief from the partisan debate over abortion." He added that the original PEPFAR bill focused funding on the ABC approach -- which stands for practice abstinence, be faithful and use condoms. Earlier this year during PEPFAR reauthorization hearings, the compromise "seemed to be unraveling" as some congressional Democrats called for more family planning within HIV/AIDS programs, which a "number of conservatives interpreted as a push for abortion rights," Gerson wrote.
He added that instead, lawmakers had a "last-minute, late-night outbreak of sanity" and "chose ... to skirt the abortion issue. Republicans kept a provision" that requires PEPFAR recipients to pledge opposition to commercial sex work, and Democrats "achieved an $11 billion increase in AIDS funding," as well as an "end" to the requirement that at least one-third of HIV prevention funds that focus countries receive through PEPFAR be used for abstinence-until-marriage programs, according to Gerson. Gerson noted that some conservatives oppose the increase in PEPFAR funding and that some liberal advocates want to address the abortion issue on the "theory that aggressive" family planning is necessary to prevent the spread of HIV (Kaiser Daily HIV/AIDS Report, 3/12). Summaries of the letters appear below.
Linda Bales: Although it is "heartening" that Gerson addressed PEPFAR reauthorization, his "equating 'aggressive family planning' with abortion is appalling, if not dangerous" to people who "want to prevent the spread of AIDS and plan their families responsibly," Bales, director of United Methodist General Board of Church & Society's Louise and Hugh Moore Population Project, writes. Bales adds that any "notion that family planning is really just abortion is false" (Bales, Washington Post, 3/21).
Kate Bourne: The "idea" that the U.S. does not "need to redouble" its HIV prevention efforts "divorces logic from reality," Bourne, vice president of international policy and regional programs at the International Women's Health Coalition, writes. Bourne writes that some government agencies have estimated that the "addition of family planning services" to PEPFAR programs "could double the effectiveness" of programs aimed at preventing mother-to-child HIV transmission. She concludes that family planning services for HIV-positive women were "sacrificed on the altar of political expediency" during the PEPFAR reauthorization hearings (Bourne, Washington Post, 3/21).
Link to this story.
U.S. Should Fund HIV/AIDS Strategies 'That Work,' Not 'Expensive Vaccine Research,' Opinion Piece Says
[Mar 25, 2008]
The U.S. should invest in proven HIV/AIDS treatment, testing and prevention strategies and not in "expensive vaccine research that over 20 years has yielded little of promise other than discovering how not to make an AIDS vaccine," Homayoon Khanlou and Michael Weinstein of the AIDS Healthcare Foundation write in a Baltimore Sun opinion piece.
According to the writers, the "fact remains" that after 20 years of research, a "vaccine against a retrovirus, the family of viruses HIV belongs to, has never been successfully developed." They add that it is "highly unlikely that there will be an AIDS vaccine -- certainly not by any current definition of the word." Despite "this record of failure," the U.S. has more than doubled its budget for HIV/AIDS vaccine research from $327 million in 2000 to $854 million in 2006, according to the authors. "Meanwhile, funding for HIV/AIDS care in the U.S. has flatlined," and "millions are dying" worldwide because they lack access to effective prevention, treatment and testing strategies, the authors write. It is "time to stop the waste" and end government funding for HIV/AIDS vaccine research, they write, adding that "much could be achieved" if funds "being poured" into vaccine research were applied to other successful strategies. For example, routine HIV testing is "still far from reality in the U.S. or abroad," the authors write, adding that allocating $1 billion to the "rapid scale-up of HIV testing worldwide would likely prevent millions of new infections." In addition, providing universal access to treatment would "make the most significant contribution to" a decrease in AIDS-related deaths and in the spread of HIV worldwide, according to the authors.
"Suspending U.S. funding for an HIV vaccine and investing in strategies that save lives and stop new infections is the wisest and most effective use of limited public resources," the authors write, concluding, "And with thousands of lives lost daily because people around the world lack access to proven, effective and relatively inexpensive prevention and treatment options, it is also the only moral choice" (Khanlou/Weinstein, Baltimore Sun, 3/23).
Link to this story.
Be the first to Write a Comment!
Copyright © 2008 Kaisernetwork.org. All rights reserved. Distributed by AllAfrica Global Media (allAfrica.com). To contact the copyright holder directly for corrections — or for permission to republish or make other authorized use of this material, click here.
AllAfrica aggregates and indexes content from over 125 African news organizations, plus more than 200 other sources, who are responsible for their own reporting and views. Articles and commentaries that identify allAfrica.com as the publisher are produced or commissioned by AllAfrica.
