FDA Approves Abbott’s New HIV Test
Dr. Daniel Berger Continues On
CDC Launches “HIV Screening. Standard Care.”
ADAP Funding Threatened By Tea Party Pressure?
Leading HIV/AIDS Research Organization Joins with University of California, Berkeley
FDA Approves Abbott’s New HIV Test
On June 21, Abbott Laboratories announced that the U.S. Food and Drug Administration (FDA) has approved “an innovative new diagnostic tool, which will allow patients to be diagnosed earlier than ever before.” This marks the fastest approval by the FDA of an automated HIV test to date.
According to the release, “Abbott's ARCHITECT HIV Ag/Ab Combo assay is the first test approved in the United States that can simultaneously detect both HIV antigen and antibodies. HIV antigen is a protein produced by the virus immediately after infection, whereas antibodies are developed days later as the body works to fight off the infection. Studies have demonstrated that Abbott’s new test may detect HIV days earlier than antibody-only tests, which is important in controlling the spread of the virus.”
“Since individuals are most infectious to others shortly after infection, detecting HIV earlier is critical and life-saving,” said Peter Leone, M.D., medical director, North Carolina HIV/STD Prevention and Control Branch, University of North Carolina, Chapel Hill. “A significant percentage of new HIV infections are transmitted by someone with an undetected acute infection, so identifying more people earlier offers a significant opportunity for counseling, which can reduce high-risk behaviors and also initiate antiretroviral treatment for early-stage infection, if appropriate.”
Studies conducted by the Centers for Disease Control and Prevention (CDC) show that current antibody-only tests miss up to 10% of HIV infections in some high-risk populations because they do not detect antigens. However, Abbott’s new assay detects the HIV p24 antigen, or the direct presence of HIV, allowing for diagnosis of early infections days before antibodies emerge.
The Abbott ARCHITECT HIV Ag/Ab Combo assay will be available to consumers in the U.S. later this year.
In the latest issue of the online edition of the Journal of Acquired Immune Deficiency Syndromes, U.S. investigators report that they’ve found that “a substantial proportion of gay men say they would reduce their condom use if pre-exposure prophylaxis (PrEP) proves to be effective.” Results of their study showed that the availability of 80% effective PrEP could reduce inhibitions about unprotected sex, leading men to view unprotected sex as having “an acceptable level of risk.”
“A better understanding of the emergent issues inherent in the provision of PrEP will allow for the development of both individual-level interventions supporting PrEP users and community-level interventions designed to increase awareness and acceptability of PrEP,” commented the investigators.
PrEP involves the treatment of HIV-negative individuals with anti-HIV drugs to prevent infection with the virus. Laboratory and animal tests have had promising results. A number of clinical trials using PrEP are currently underway and some results are expected shortly.
There is considerable optimism about the impact PrEP could have on the transmission of HIV. However, it has been suggested that an increase in risky sexual behavior could undermine the potential benefits of PrEP.
Little research has been undertaken into the potential impact of PrEP on sexual behavior. Therefore investigators in New York designed a study involving 180 substance-using HIV-negative gay men who had had at least one recent episode of unprotected anal sex.
They completed a questionnaire about their use of club drugs (cocaine, ketamine, ecstasy, methamphetamine, GHB, or poppers), sexual risk behavior, and attitudes towards PrEP.
Only 23% of the men had ever heard of PrEP. Three men reported ever having used PrEP. Two men said that they used it before having unprotected sex with a man of unknown HIV status; the third man indicated that he took PrEP because he knew his partner was HIV-positive. A clear majority of men (69%) said that they would be likely to use PrEP if it was shown to be at least 80% effective. Of the men who said that they would be willing to use PrEP, 36% reported that its availability was likely to reduce their use of condoms.
The study investigators concluded, “PrEP has the potential to make an extraordinary contribution to the fight against HIV, but its implications for risk perception and behavior must be fully acknowledged and understood.”
Dr. Daniel Berger Continues On
On June 16, Dr. Daniel Berger of Northstar Medical Center notified Positively Aware that the FDA had decided not to disqualify him from future trials, accepting his proposal to have an independent investigator monitor future research.
The Chicago Tribune reported on June 15 that Dr. Berger could be disqualified by the FDA from conducting further clinical trials after an investigation begun in March 2009 revealed that his supervision of a clinical trial of a drug that treats chronic diarrhea in HIV patients had been “inadequate” and that fraudulent information about participants had been submitted.
Without Dr. Berger’s knowledge as the study’s principal investigator, his study coordinator fictitiously created records of participants’ names, lab tests, physical exams, and electrocardiograms, as well as forging their signatures on medical forms. It was also discovered that more than 200 tablets of the drug were missing.
The study coordinator turned out to be a convicted felon who’d been sentenced to seven years in prison for embezzling $364,000 from the DePaul University Alumni Relations Department. Unfortunately, no background check was conducted when he was hired at Northstar.
Berger cooperated fully with the FDA investigation and has admitted that falsified information had been provided because he failed to adequately monitor the coordinator’s work on the study. He has also taken steps to prevent such a situation in the future, hiring a firm led by a former FDA official to scrutinize records of all 12 studies involving the former coordinator, as well as going through training with his staff on how to spot fraud.
Dr. Berger is well known and respected in Chicago’s HIV community for the decades of work he’s done, not only with clinical trials, but in treating his patients, and publishing and lecturing about HIV around the country. As Derek Worley, Treatment Education Manager at Test Positive Aware Network vehemently put it, “He’s saved lives!”
CDC Launches “HIV Screening. Standard Care.”
It was announced on June 16 that the U.S. Centers for Disease Control and Prevention’s (CDC) Division of HIV/AIDS Prevention will launch a new phase of its Act Against AIDS campaign, “HIV Screening. Standard Care.” (HSSC), to assist physicians in making HIV testing a standard part of medical care.
The CDC’s 2006 HIV screening recommendations advise that all patients between the ages of 13 and 64 be tested for HIV as a routine part of medical care at least once— regardless of perceived risk for the disease—and that individuals at high risk (e.g., those with multiple or HIV-infected partners) be tested at least once annually. HSSC is designed to help medical providers comply with the recommendations.
HSSC resources and materials will be available to providers, including a quick annotated guide to the recommendations and patient education materials that will help answer patients’ questions about HIV testing. The materials will be available free of charge to providers at www.cdc.gov/HIVStandardCare.
ADAP Funding Threatened By Tea Party Pressure?
According to an article in The Washington Blade on June 9, some Democrats and Republicans in Congress who have long supported funding for the AIDS Drug Assistance Program (ADAP) may be reluctant to voice their support for an emergency supplemental appropriation bill because they’re afraid the additional spending will jeopardize their chances of being re-elected.
William Arnold, executive director of the National ADAP Working Group (NAWG), said intense pressure on members of Congress to curtail spending by the so-called Tea Party movement has made it difficult to line up support for the measure.
In the Senate, two Republicans (Richard Burr of North Carolina and Tom Coburn of Oklahoma) have co-sponsored a bill that would take the $126 million needed for ADAP this year from unobligated funds in the federal stimulus program. Senators Michael Enzi of Wyoming and George LeMieux of Florida, also Republicans, signed onto the bill, but no other Republicans have signed on and no Democrats have agreed to become co-sponsors so far.
Arnold and NAWG support the Burr-Coburn bill on grounds that it could provide immediate help for ADAP and the funds are already incorporated into the federal budget, preventing the need for “more spending” to appropriate the funds. He also noted that the Tea Party movement appears to have frightened both Republicans and Democrats from supporting new spending, even when it’s needed to help save lives.
“The Blue Dog Democrats have been very opposed to spending money, period, because they’re worried about getting re-elected and they’re from swing districts where Tea Partiers might be challenging them,” Arnold said.
A bill like the Burr-Coburn bill has yet to be introduced in the House, though nearly 80 members of the House, including gay Representatives Barney Frank of Massachusetts and Tammy Baldwin of Wisconsin, both Democrats, signed a petition urging the president to back an emergency funding measure. Baldwin told the Blade that she was certain that congressional Democrats would take steps to support the $126 million emergency appropriation. She said, however, that Republicans in the House have followed a policy of opposing nearly all spending bills proposed by Democrats.
Leading HIV/AIDS Research Organization Joins with University of California, Berkeley
In a press release issued on June 24, the Forum for Collaborative HIV Research announced that it is joining forces with the University of California, Berkeley, School of Public Health “to accelerate the nation’s progress in fighting HIV/AIDS, hepatitis C and tuberculosis in Washington.”
The Forum is now part of the University of California (UC), Berkeley School of Public Health and has set up new facilities at the UC campus in Washington, D.C. “While not changing the Forum’s mission, this new affiliation allows the Forum to take advantage of existing partnerships with faculty and researchers at the UC Berkeley School of Public Health to frame the issues and help set the research strategy in HIV/AIDS, co-infection and advancing universal HIV testing,” the release noted.
“We anticipate our affiliation with the UC Berkeley School of Public Health will be mutually enriching across many dimensions,” said Dr. Veronica Miller, executive director of the Forum. “The School has expressed full support for our research, policy and educational missions concerning HIV, hepatitis C and tuberculosis, which bring an extra dimension to the school’s own research and educational mission.” Dr. Miller will be a visiting professor at the School during the transition.
Dr. Stephen Shortell, dean of the UC Berkeley School of Public Health, stated “The Forum strengthens our programs in infectious disease, epidemiology and health policy and will provide our students with new and exciting opportunities in the nation’s capital.”
According to the release, the Forum is planning a number of major initiatives, including hosting the 2010 National Summit on HIV Diagnosis, Prevention, and Access to Care in Washington and issuing a series of reports on the risk of coronary artery disease in patients on antiretroviral treatment; designing effective treatments for hepatitis C; and pre-exposure HIV prophylaxis.