Promising new drug suffers major setback
NYC health clinics stop use of oral HIV tests due to false positives
NAPWA and OraSure launch Mayors Campaign Against HIV
Abbott responds to recently unsealed documents regarding Norvir price hike
Analysis finds AIDS-related deaths in Washington, D.C. underreported by more than half
Northern California colleges ban campus blood drives due to FDA’s policies on MSM
Promising new drug suffers major setback
The only ongoing study of novel anti-HIV agent KP-1461 was recently halted by its developer, Koronis Pharmaceuticals, when it failed to demonstrate measurable activity against the virus.
Through a process known as terminal mutagenesis, this experimental agent was expected to become the first HIV drug to work by speeding up the mutation rate of HIV, mutating it so severely that it becomes unable to infect cells and replicate. Laboratory experiments, in fact, showed that the virus eventually mutated itself out of existence when exposed to KP-1461.
A series of lab tests required by the U.S. Food and Drug Administration (FDA), however, showed that the drug failed to force resistance in the virus, a finding that is in direct conflict with initial results observed in similar tests conducted by the developer.
Only two people were actually taking the drug at the time of this discovery, both of which have been informed of the findings, discontinued use of the drug, and recommended to start on a full HIV regimen.
In a statement to Project Inform, Koronis lead investigator Stephen Becker, MD said that the company is “committed to understanding these discordant results and will attempt to validate the original 2002 research.” It is expected to take at least a couple of months to investigate this setback, according to Becker.
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NYC health clinics stop use of oral HIV tests due to false positives
An increase in false positives has prompted New York City public health clinics to stop using OraSure Technologies’ OraQuick Advance Rapid HIV 1/2 Antibody Test. City health officials report that over the past eight months, the number of inaccurate tests rose as high as 1.1% -- a rate that is roughly five times higher than the kit’s label claims.
Though the oral test, which uses a swab to collect tissue from the inside of a person’s mouth in order to detect antibodies against HIV, continues to meet U.S. standards and is currently still available on the market, NYC clinics have discontinued using it and have switched to alternative methods of testing which require finger-prick blood screening instead.
According to Susan Blank, city commissioner for STI prevention and control, health officials began noticing problems with the test in October 2007, which continued through April 2008. “So far, the false positives have not been linked to handling, storage conditions, lot numbers, clinic sites, and test operators,” she added. It should also be noted that health clinics in NYC and in other cities have had problems with false positives in the past as a result of the OraQuick test.
OraSure spokesperson Ron Ticho contends that the tests have performed better in other cities, with a false positive rate of 0.2% in more than 250,000 tests used over the past 17 months at 200 sites across the country. “What’s happening in New York City appears to be a slight aberration,” said Ticho. “Performance results may fall slightly outside the expected range for a short period of time. That’s expected.”
According to Ticho, Orasure is following standard company protocol for investigating product performance, and is cooperating with the U.S. Centers for Disease Control and Prevention (CDC) and NYC health officials to try to get an understanding of what went wrong. The CDC is also investigating whether health officials in other cities are experiencing similar problems with the test.
Issues regarding the accuracy of rapid testing underscore the importance of confirming all reactive HIV tests. To read the CDC article published in the Mortality and Morbidity Weekly Report (MMWR), visit CDC.gov.
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NAPWA and OraSure launch Mayors Campaign Against HIV
In observance of National HIV Testing Day, June 27th, several mayors from major cities across the U.S. have joined the National Association of People with AIDS (NAPWA) and OraSure Technologies in a campaign designed to help disseminate the critical messages regarding early detection of HIV at a local level and nationwide.
The initiative urges mayors across the country to lead by example by taking an HIV test and encouraging their constituents to do the same. Mayors from 68 U.S. cities, including Chicago, Newark, Phoenix, Baltimore, Boston, Seattle, and Dallas have signed onto the campaign.
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Abbott responds to recently unsealed documents regarding Norvir price hike
In a statement to Positively Aware editor Jeff Berry regarding documents that were recently ordered unsealed by a judge in an on-going class action lawsuit against Abbott Laboratories, Inc., a spokesperson for the pharma giant contends that “the re-pricing of Norvir was legal and captured the value of this important medicine based on its new role in the marketplace."
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Analysis finds AIDS-related deaths in Washington, D.C. underreported by more than half
A recent analysis conducted by Washington D.C.’s Department of Health and the U.S. Centers for Disease Control and Prevention (CDC), which indicates that more than half of the AIDS-related deaths that occurred in the district from 2000 to 2005 were overlooked by the city’s system for reporting such deaths, has been published in the CDC’s MMWR.
The initial investigation was launched when boxes of unexamined paper records were discovered, prompting concern from D.C. health officials that the number of people living with HIV and dying of complications with AIDS in the district might have been significantly underreported. The analysis found that of the 2,460 deaths resulting from AIDS-related illnesses that occurred in the district between 2000 and 2005, 1,337 had not been reported.
“[This] tells us our surveillance system wasn’t complete enough,” said Shannon Hader, senior deputy of the health department’s HIV/AIDS Administration. “We’re clearly underreporting.”
Hader added that, in response to these findings, the district is initiating several efforts to improve its reporting system. Efforts include a mass mailing in January to roughly 4,000 physicians and laboratories, with hopes of increasing the number of diagnoses reported. Routine reviews of death records are also being conducted, in addition to the launch of a new campaign that is designed to get more people tested and into treatment.
“What we need to do is get more people who don’t know they have HIV diagnosed and into care and treatment,” said Hader.
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Northern California colleges ban campus blood drives due to FDA’s policies on MSM
Some colleges in Northern California are banning campus blood drives, citing the U.S. Food and Drug Administration’s (FDA) lifetime ban on blood donated by men who have (or have had) sex with men (MSM) a violation of the schools’ nondiscrimination policies.
Some healthcare advocates maintain that the FDA’s policy is justified because, as the FDA suggests, lifting the ban on donations from MSM could increase the risk of HIV transmission through blood donations because of the increased potential for the presence of the virus in this population. Blood bank officials, however, have said that the decrease in campus blood dives could severely impact the blood banks’ ability to maintain adequate blood supplies.
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