Gel Found to Reduce HIV Risk in Women
Canadian Study Confirms HAART as "Fundamental Prevention Strategy"
Heinz Family Philanthropies, Welvista, Abbott, and Merck Join to Help Solve ADAP Crisis
Study Reveals Promise for NAT HIV Test
Gel Found to Reduce HIV Risk in Women
The Washington Post published a report on July 20 of the results of a study conducted in South Africa which tested a vaginal microbicide gel containing the antiretroviral drug tenofovir (Viread, also found in Truvada and Atripla). The research was presented at the 18th International AIDS Conference in Vienna.
According to the report, “In Africa, 60 percent of people with HIV infection are women, nearly all of whom acquired the virus through sex. For many, the proven methods of preventing infection, such as abstinence, being faithful, and using condoms, are either not an option or out of their control. A vaginal microbicide that could be used with or without a man's knowledge is considered essential, missing until now.”
"It's groundbreaking," said Catherine Hankins, chief scientific officer of the United Nations' AIDS agency, UNAIDS. "This in combination with [male] circumcision in places where the epidemic is generalized could really turn the tide."
In the study, a group of HIV-negative women were randomly assigned to use a gel that was either 1% tenofovir or a placebo. The gel came packed in syringe-like applicators. A woman was instructed to inject the gel into her vagina no more than 12 hours before intercourse and again within 12 hours afterward (with no more than two applications in a 24-hour period). Each woman got a monthly HIV test, and the researchers collected used and unused applicators to verify the women's reports of whether they were using them.
At the end of two and a half years, there were 98 infections in the 889 women. The HIV incidence, measured as the number of new infections for every 100 "women years" in the study, was 5.6 in the volunteers using the tenofovir gel and 9.1 in those with the placebo gel.
That amounted to a prevention effectiveness of 39%. Among women who said they used the gel for at least 80% of the times they had intercourse, the effectiveness was 54%.
Researchers would need to show that the microbicide is effective in at least one other group of women before it could be licensed for commercial use. That effort, which will take several years, is now at the top of the international research agenda.
A larger study, underway in four African countries and not expected to yield results until 2013, is testing tenofovir gel and antiretroviral drugs in pill form as a way to protect women against sexual transmission of HIV. Several other experiments, including ones in which the drug is in a long-acting vaginal ring, are in earlier stages. A microbicide might also be useful in protecting people who are at risk of acquiring the virus through anal sex.
The report concludes, “The net impact seen in the study reflects the combined effect of many variables, only one of them the action of tenofovir. Other variables include the prevalence of HIV infection in the male population; the number of sexual partners a woman had; the amount of virus ("viral load") in an infected man's semen; concurrent use of condoms; and, most important, the consistency with which a woman used the gel.”
Speaking of how much protection this microbicide might afford any woman, Salim Abdool Karim of the University of KwaZulu-Natal in Durban, South Africa, who helped lead the study, said, "We can only approximate it. What you see is a mixture of the efficacy of the product mixed with the ability to use the product. It is fundamentally dependent on human behavior."
Canadian Study Confirms HAART as "Fundamental Prevention Strategy"
British Columbia researchers have become the first in the world to confirm that an anti-HIV treatment has led to a significant decrease in diagnoses of the virus, according to a groundbreaking study released at the International AIDS Society conference in Vienna on July 18.
The United Nations HIV/AIDS (UNAIDS) program director, Michel Sidibe, told the conference the UN is embracing highly active antiretroviral therapy (HAART) as the fundamental prevention strategy to fight the pandemic, based on results from the Canadian study.
For every 100 patients using HAART, scientists recorded a three percent decrease in HIV diagnoses in British Columbia, said Julio Montaner, lead researcher and director of the B.C. Centre for Excellence in HIV/AIDS.
“Today is a big day for us in B.C. and Canada. I don’t remember the last time a made-in-Canada strategy to address a global epidemic has taken this kind of initiative,” Montaner told Postmedia News.
HAART, a combination of antiretroviral drugs, was first implemented in 1996 to stop HIV from progressing to AIDS. What has emerged with the new research is that the treatment also seems to have a secondary benefit— a reduction in the emergence of new cases, due to the cocktail lowering the viral load of those who are HIV-positive to the point where they are less likely to transmit the virus to their partners.
The study investigators gathered data on the number of HIV tests done and new HIV diagnoses from the B.C. Centre for Disease Control while figures on viral loads, cell counts, and HAART use from the Centre were also collected.
Results showed that between 1996 and 2009, the number of patients receiving HIV treatment increased from 837 people to 5,413, while the number of new HIV diagnoses in that same period fell drastically from 702 to 338 people, a 52% decrease.
The study, funded by the U.S. National Institute on Drug Abuse, appeared in the latest issue of the medical journal Lancet.
Heinz Family Philanthropies, Welvista, Abbott, and Merck Join to Help Solve ADAP Crisis
In a press release on July 14, it was announced that Merck has joined with the Heinz Family Philanthropies (HFP), Welvista, and Abbott Labs in an initiative that begins to address the needs of patients waiting for access to HIV medications through the AIDS Drug Assistance Program (ADAP).
“In collaboration with Heinz Family Philanthropies, Merck and Abbott will be providing Welvista— a non-profit organization that fills prescriptions for patients who are uninsured and underinsured— with the HIV/AIDS medications that will help patients maintain their independence. They will also be providing a grant to Welvista for the operation of the overall effort. No single entity in the partnership will shoulder all of the costs.”
This initiative was created in response to a call for help from NASTAD (the National Alliance of State and Territorial AIDS Directors) to find ways to clear the waiting lists that are growing across the country and to make enrollment simple for patients.
According to the release, “Enrollment in the program is virtually automatic for anyone currently certified on an ADAP waiting list and the program will provide direct access to no-cost HIV medications through Welvista. Patients who are on ADAP waiting lists can request that their state ADAP program contact Welvista on their behalf. If need exists after one year, the program may be extended.”
William Arnold, executive director of the Community Access National Network (CANN), applauded the initiative. “At a time when wait lists continue to spiral out of control and President Obama is calling on the pharmaceutical industry to shoulder more of the responsibility for ensuring these patients have access to treatment, Merck, Abbott, Welvista, and HFP have taken up the call. While accessing individual drugs from individual companies can be a cumbersome process for patients, this partnership is aimed at streamlining the process and will undoubtedly have a profoundly positive impact on a number of HIV patients who are currently waiting for treatment.”
Study Reveals Promise for NAT HIV Test
A program that integrated nucleic acid testing (NAT) with rapid-result HIV antibody screening helped increase the HIV case detection yield - especially in settings that cater to high-risk individuals, a new study from San Diego County shows.
Of 3,151 people screened, 79 were newly diagnosed with HIV. Sixty-four were diagnosed via rapid HIV test; however, 15 additional infections were found only by NAT. Thus, NAT increased the HIV detection yield by 23%.
"If people got an antibody test alone and were told they weren't infected when they were, they could be a strong infection risk until they get tested again, which according to guidelines could be six to 12 months later," said study leader Dr. Sheldon Morris, of the University of California-San Diego's Antiviral Research Center.
Study participants could receive their NAT results in person with clinic staff or through an automated system accessible by telephone or website. About 65 percent chose an automated option. All NAT-positive patients received their results within a week.
The NAT can detect HIV within 10 days of infection, Morris said, pointing out that it can take months before a newly infected person's body produces enough antibodies to register as HIV-positive on antibody test.
"I think the time is coming when we will have to adopt a strategy for earlier [HIV] detection," said Morris. "If you have a testing site with a high-risk prevalence, then you probably should be running this test on all of their samples that are antibody-negative,” he said.
The study, "Evaluation of an HIV Nucleic Acid Testing Program with Automated Internet and Voicemail Systems to Deliver Results," was published in the June 15 issue of Annals of Internal Medicine.