HIV Update, Vol 7 No 5
October 2006In the Headlines...
OraSure Begins Studies For Its Home HIV TestOraSure Technologies Inc. said it has begun studies on its rapid test for HIV for use at home.
The Bethlehem company said it will seek Food and Drug Administration approval to sell the 20-minute HIV test over the counter. If approved, the OraQuick test would be the first at-home diagnostics test for HIV, similar to a home pregnancy test. OraSure shares were up 3.70 percent, or 30 cents, to $8.30 in trading on the Nasdaq. The company is conducting laboratory-based studies, and plans additional clinical studies under an investigational device exemption filed with the FDA to use its device in safety and effectiveness studies to support regulatory approval. OraSure president and chief executive officer Douglas A. Michels said, "We look forward to continuing our work with the FDA and other members of the health-care community to make a home-use rapid HIV test available in the United States." In November 2005, an FDA advisory panel met in Gaithersburg, Md., to discuss HIV home tests. The FDA has discussed home HIV tests since 1986. But with newer technology that makes the tests easier to use, more accurate and with quicker results, the FDA agreed to consider OraSure's proposal. Last week, the Centers for Disease Control and Prevention recommended that all Americans between the ages of 13 and 64 be routinely tested for HIV, the virus that causes AIDS. Previously, the CDC had recommended routine testing only in high-risk groups. OraSure has been selling a rapid HIV test for clinical settings since 2002. OraSure's test can detect with more than 99 percent accuracy whether a person has HIV-1 or HIV-2, using a swab to collect cells in saliva in the mouth. The swab is placed in a vial of testing fluid, and 20 minutes later the result is known. The test can also screen HIV in blood. An AIDS funding bill that has stalled on the Senate floor has put Sen. Hillary Rodham Clinton (D-N.Y.) in a difficult position — forcing her to choose between the interests of her home state and those of battleground states in the 2008 presidential election.
Elected officials and AIDS activists from Iowa, South Carolina, and Ohio are urging senators to pass the Ryan White Comprehensive AIDS Resources Emergency Act, which would increase their state’s funding for people infected with HIV, the virus that causes AIDS. A group of activists and officials are focusing their efforts on Clinton because she has the highest profile among the bill’s opponents. They may also be calculating that they have most leverage with her because she is expected to run for president. Iowa and South Carolina will host two of the earliest contests of the 2008 Democratic presidential primary, and Ohio is expected to be a crucial battleground. The bill, also known as the Ryan White Care Act, reauthorizes federal funding to fight AIDS. It would steer money away from major urban areas in New York, New Jersey and California to smaller, more rural states that have seen a dramatic increase in HIV infections in recent years. The bill, which was originally passed in 1990, expires at the end of this week, the end of the 2006 fiscal year. Without a reauthorization, federal funding will continue at current levels. Clinton and her New York colleague, Sen. Charles Schumer (D), outlined their objections to the new funding formula in a recent letter to Senate Minority Leader Harry Reid (D-N.Y.). “New York State stands to lose more than $78 million in Ryan White Title II funds over four years,” they wrote. “Without modifications to address our concerns, we stand united on behalf of New Yorkers living with HIV/AIDS in objecting to this bill.” Clinton and Schumer also wrote that the bill would reduces grants to Buffalo and Albany and could cost New York City as much as $17 million in lost federal funds next year. They stated that they support providing funds needed by other areas of the country, but not at the cost of established programs in their state. That position puts Clinton at odds with Iowa Gov. Tom Vilsack (D), who urged for AIDS funding to be restructured in a letter to Sens. Mike Enzi (R-Wyo.), the chairman of the Senate health committee, and Edward Kennedy (Mass.), the panel’s ranking Democrat. “Iowa is one of many rural states that receive no Title I funding at all,” Vilsack wrote. “[M]any states, including Iowa, have been forced to institute waiting lists for treatment or other cost-containment measures. This is unacceptable. The CARE Act should fully fund all 50 states’ [AIDS Drug Assistance Programs].” If Vilsack does not run for president himself, he could help one of the Democratic presidential contenders gain an edge in the January 2008 Iowa Caucuses. Even if he does run, Vilsack would still be influential in the outcome of the contest. Enzi attempted and failed to get agreement to bring up the bill on the Senate floor Tuesday and will try again, said an aide. Three prominent Democratic public officials from Ohio, a state that narrowly decided the 2004 presidential race, have pressured Clinton recently. Donald Plusquellic, mayor of Akron, Rhine McLin, mayor of Dayton, and Mark Mallory, mayor of Cincinnati, have each written letters to Clinton since mid-August urging her to support the revised formulas in the reauthorization bill. “The current act disproportionately rewards larger cities at the expense of medium sized cities such as Cincinnati,” wrote Mallory. “This is especially important in states like Ohio with multiple urban centers. The reformed act would go a long way to address these funding deficiencies and greatly increase funding for many medium sized cities, including a potential increase of $79,000 to Cincinnati.” McLin highlighted the effect on African Americans, a substantial Democratic constituency in Ohio as well as in South Carolina. “Here in Ohio, African Americans were 45 percent of new AIDS cases in 2004, according to the Centers for Disease Control. Nationally, African Americans were 48 percent of new AIDS cases that year, while in some Southern states the percentage reaches as high as 75 percent,” wrote McLin. Clinton is one of a small group of Democrats holding up the bill, said Craig Orfield, a spokesman for Enzi. He said that in addition to Clinton and Schumer, New Jersey Sens. Frank Lautenberg (D), Robert Menendez (D) and Sen. Barbara Boxer (D-Calif.) are thought to oppose the bill. Dr. Kent Stock, an infectious disease physician from Charleston, South Carolina, who has helped lobby local state legislators on the economic costs of not stopping the spread of HIV, said Clinton has emerged as the most prominent opponent in the eyes of local AIDS activists. “Hillary has taken a lot of heat because a lot of people are saying that it’s Hillary who’s putting her foot down on this act. In reality, it’s not just Hillary. “She has become the figurehead. There are a lot of people saying that Hillary has the ability to move it forward or hold it up in Congress…She’s protecting her turf as any good senator would do.” But Clinton’s position may require her to answer tough questions if she campaigns in the South Carolina next year or in early 2008. “I think its going to hurt persons with HIV first and foremost where African Americans in my state represent 73 percent of the people affected,” said Dr. Bambi Gaddist, executive director of the South Carolina HIV/AIDS Council. African Americans are estimated to make up a third or more of the Democratic electorate in the state. State Rep. Joe Neal, an African-American Democrat from South Carolina, said about 300 people in his state diagnosed with HIV are on a waiting list to receive medical treatment. Passage of the Ryan White Care bill would eliminate the list, he said. “The AIDS crisis is now shifting to the south fairly dramatically,” said Neal, who has advocated for more funds. “I understand that the political reality that the senator faces in protecting her own state and her interest but this is a larger interest than just New York and I hope she would think about it in that context.” Clinton’s staff did not respond to several requests for comment. Many Americans don't know that they are infected with the AIDS-causing HIV virus, or don't even realize they are at risk. Many are unwittingly infecting and being infected by sexual partners. And they aren't getting treatments that can slow the onset of AIDS and extend the productive lives of those who have contracted this fatal disease.
These new facts of HIV life make a recent shift of federal health policy a no-brainer: All teenagers and most adults should be tested for the virus as a part of routine care. And physicians no longer should have to obtain signed consent forms from patients that aren't required for other medical tests. The recommendations by the federal Centers for Disease Control and Prevention do not have the force of law. But all states, including New York, would be wise to embrace them, as most medical authorities have suggested. The State Legislature should make whatever changes are necessary to state law, including assuring that the tests will be covered by public or private insurance. The only exception we take to the CDC recommendations is the elimination of a requirement to offer counseling to patients who test positive, not only to help them cope with the powerful emotional blow of such news, but to suggest a course of care. New therapies, if administered early and regularly, can add decades to the lives of AIDS victims. About 250,000 people have the virus and don't know it. They should -- the next time they go to the doctor. A protein being developed by Sangamo BioSciences Inc. appeared in laboratory testing to make human immune system cells permanently resistant to HIV infection, the company said.
Previously, the company had demonstrated only short-term resistance, said company spokeswoman Elizabeth Wolffe. Sangamo said cells modified with its protein, a zinc finger DNA-binding protein nuclease, survived continuous exposure to HIV, the virus that causes AIDS, and expanded to the point that they represented the vast majority of cells at the end of the 70-day experiment. Shares of Sangamo, which rose 5.1 percent to close at $5.38 on Nasdaq, were up another 17 percent at $6.30 in after-hours trading. "We have now shown that we can get permanent modification and permanent HIV resistance," Wolffe said. She also said the company has not changed its goal of launching a human clinical trial this year, but did say that "there are more experiments that have to be done." The Sangamo compound is part of a newly evolving class of drugs known as CCR5 receptor antagonists, which are designed to block a key receptor needed by a strain of HIV called R5 to enter and infect the cell. Current treatments work by preventing the virus from replicating once it is inside the cell. GlaxoSmithKline Plc terminated a CCR5 program because of liver toxicity, while Schering-Plough Corp. discontinued a trial after patients experienced sharp spikes in the amount of the HIV virus in their blood. Measuring the amount of AIDS virus circulating in the blood of HIV-positive patients is not a good indicator of the health of their immune systems, researchers said.
Physicians often assess the amount of HIV particles in the blood -- known as the viral load -- along with the decline in CD4 cells that help the body fight infections to measure the disease's progress and decide when to prescribe drug therapy. But a study of 2,800 untreated HIV-positive individuals found only about 5 percent of the variations in viral load corresponded to variations in immune system damage. Depletion of CD4 cells is therefore not a simple consequence of the amount of virus circulating, said the study published in this week's Journal of the American Medical Association. "The results of this nationwide study may have profound implications in our understanding of how HIV causes disease and in our approach to the management of HIV-infected patients," said lead investigator Dr. Benigno Rodriguez of Case Western Reserve University in Cleveland. Estimating damage to the immune system is critical in deciding when it is best to start antiretroviral therapy, the AIDS-fighting drugs credited with allowing millions of infected people to live with the disease. Because of issues of drug resistance and the potent side effects of the drugs, doctors and patients often defer starting medications until medically necessary. The study challenges the current belief that the degree to which the virus replicates itself is the trigger for the loss of CD4 cells, white blood cells that are a key component of the body's immune system. An accompanying editorial in the journal said the findings were exciting because they suggested that researchers should look for and target non-viral factors that set off the eventual decline in the immune system. More than a quarter of New Yorkers infected with the AIDS virus are now dying of other causes, researchers said.
An analysis of 68,669 New York City residents infected with HIV, the virus that causes AIDS, found that of those who died between 1999 and 2004, 26.3 percent died of something other than HIV. That is a 32 percent increase from 1999, when just under 20 percent of HIV patients died of other causes. Cocktails of drugs that suppress the virus have been credited with allowing HIV patients to lead near-normal lives, and once- or twice-a-day dosing now makes them more manageable. Nonetheless, AIDS remains incurable and is always fatal in places where the drugs are not available -- notably much of Africa. Writing in the Annals of Internal Medicine, Judith Sackoff and colleagues at the New York Department of Health and Mental Hygiene said they found that 31 percent of HIV patients died because of substance abuse, close to 24 percent died of cardiovascular disease and 20 percent died of cancer unrelated to the virus. "Physicians everywhere must remember that most of their HIV-infected patients will survive to develop the diseases that plague the rest of us," Dr. Judith Aberg of New York University wrote in a commentary. Another study published in the same journal found that nearly 10 percent of men interviewed in New York who identified themselves as heterosexual reported having sex with at least one man during the previous year. The survey of 4,193 men conducted by the New York City Department of Health and Mental Hygiene found that 70 percent of the men who had sex with other men were married. Many admitted they had not used a condom and had not been tested for HIV. "Doctors need to ask patients about specific sexual practices instead of relying on self-reported sexual orientation to assess risk for unsafe sexual practices and risk for sexually transmitted diseases," said Preeti Pathela, who led the study. "Public health prevention messages should target risky sexual activities, such as unprotected receptive anal sex, and should not be framed to appeal solely to gay-identified men." Uncircumcised men who have wetness around the head of the penis, beneath the foreskin, have a significantly higher HIV prevalence rate than men with a dry penis, according to a study conducted amongst men attending a sexual health clinic and published in the September edition of Journal of Acquired Immune Deficiency Syndromes. HIV prevalence was 44% higher amongst men with wetness around the glans penis and coronal sulcus than amongst men with a dry penis.
Evidence suggests that male circumcision may be a way of significantly reducing HIV incidence. But it involves a traumatic surgical procedure and is culturally unacceptable to many men. The role of penile hygiene in preventing sexually transmitted infections has received little attention since the First World War, despite there being evidence that wetness under and around the head of the penis can cause inflammation increasing susceptibility to some infections. Frequent wetness beneath the foreskin may be caused by retention of droplets of urine beneath the foreskin, by failure to wash and dry the penis after sexual intercourse or masturbation, or by the presence of a persistent infection. What is unclear is the role that the environment beneath the foreskin plays in increasing the risk of HIV acquisition. Investigators therefore conducted a cross-sectional study involving 386 uncircumcised men who attended a sexual health clinic in Durban, South Africa to determine the association between penile wetness and HIV prevalence. Two weeks after their sexual health assessment and treatment, the men returned to the clinic and were assessed for penile wetness. They also answered questions about their demographic background and personal hygiene. Just under half (49%) of the men were assessed as having some penile wetness, and this was significantly associated with younger age (p = 0.018), low educational attainment (p = 0.009), low income (p = 0.029), higher numbers of lifetime sexual partners (p = 0.031), and not washing after sex (p = 0.05). Overall HIV prevalence was 56%. However, amongst men with penile wetness, HIV prevalence was 66% compared to 46% HIV prevalence amongst men with no penile wetness (p < 0.001). After adjusting for potential confounding factors, such as infection with herpes simplex virus-2, the investigators calculated that the risk ratio of HIV infection was 44% higher for men with penile wetness compared to men with a dry penis (p < 0.001). Although circumcised men were not included in the main analysis, 35 for initially screened for inclusion in the study. HIV prevalence amongst these men was 43%, similar, the investigators emphasise, “to that of uncircumcised men without penile wetness.” Four possible reasons for the association between penile wetness and increased HIV prevalence are advanced by the investigators: Providing education about the importance of genital hygiene and greater access to clean water with which to wash could, the investigators suggest, help reduce the prevalence of penile wetness and be an adjunct to more conventional HIV prevention methods. Short-term highly active antiretroviral therapy (HAART) started soon after HIV seroconversion appears to provide longer lasting virologic and immunologic benefits than starting HAART later or not at all, new research suggests.
However, findings from a related study, suggest that the benefits of acute HAART initiation are short-lived. As reported in the Journal of Infectious Diseases, Dr. Frederick M. Hecht, from the University of California at San Francisco, and colleagues assessed HIV RNA levels and CD4+ T cell counts in 395 subjects with HIV seroconversion within the last 6 months. The subjects included 13 who elected to begin HAART within 2 weeks of seroconversion (acute treatment group), 45 who started therapy within 2 to 6 months of seroconversion (early treatment group), and 337 who declined therapy. Patients in both treatment groups received HAART for at least 12 weeks and then stopped therapy. At 24 weeks after treatment discontinuation, both treatment groups had lower viral loads and higher CD4+ cell counts than the untreated group. By 72 weeks, the acute treatment group still had lower viral loads and higher CD4+ cell counts than did the untreated group, whereas the early treatment group had higher CD4+ cell counts, but no longer had lower viral loads. Further research is needed "to determine whether the benefit that we observed in association with treatment initiated during acute HIV infection can be corroborated and to assess the optimal duration of HAART for persons with acute HIV infection," the authors state. In a related study, appearing in the same journal issue, Dr. Marcus Altfeld, from the Massachusetts General Hospital in Boston, and colleagues assessed virologic and immunologic changes in 8 subjects who began HAART during acute HIV infection and 12 similar subjects who did not receive HAART. The treatment group received HAART for 24 weeks before stopping therapy. The estimated median duration from HIV infection to HAART initiation was 25 days. Compared with non-treatment, HAART was associated with a drop in viral load, an increase in CD4+ T cell count, and other beneficial immunologic effects. However, at 6 months after HAART discontinuation, no significant differences were noted between the groups in viremia or CD4+ cell count. "The present study shows that short-term HAART initiated during acute HIV-1 infection has no major impact on the control of HIV-1 viremia 6 months after HAART is discontinued," the authors conclude. Although peripheral fat loss and central fat gain have been reported in women with HIV, peripheral lipoatrophy appears to be more common, according to researchers.
"Contrary to prior reports," researches Dr. Phyllis C. Tien told Reuters Health, "where lipohypertrophy was thought to predominate in women, we found that lipoatrophy -- or fat loss -- especially in peripheral body sites, appears to predominate." Dr. Tien of the University of California, San Francisco and colleagues studied 183 HIV-positive and 142 control women aged between 33 and 45 years. The HIV group reported more fat loss than controls and peripheral lipoatrophy was more common in this group than in controls (28% versus 4%). The extent of central lipohypertrophy was similar in both groups (62% versus 63%), the researchers report in the August 15th issue of the Journal of Acquired Immune Deficiency Syndromes. In the HIV group, women with central lipohypertrophy were significantly less likely to have peripheral lipoatrophy than those without central lipohypertrophy (odds ratio, 0.39). Thus, the researchers conclude that peripheral lipoatrophy is common in HIV-infected women, "but is not associated with reciprocally increased visceral adipose tissue or trunk fat."
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Author: CAF
Release Date: 10/15/2006
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