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Thursday, April 28, 2011

FDA Panel Backs Experimental Merck Hepatitis Drug

A Food and Drug Administration panel on Wednesday unanimously approved the first of two hepatitis C treatments being considered during a two-day meeting on antiviral drugs. By an 18-0 vote, FDA's expert National Viral Hepatitis Roundtable (NVHR) agreed that the benefits of Merck & Co.'s boceprevir outweigh its risks.

Boceprevir, a protease inhibitor, is a tablet designed to be taken in combination with the standard hepatitis C virus drugs ribavirin and interferon-alpha. Studies show combination treatment with boceprevir boosts HCV sustained viral response rates to 60 percent-65 percent, compared with just 40 percent for standard therapy alone. Boceprevir also can cut HCV treatment time in half, to six months.

Panelists noted boceprevir's side effects include anemia and lower blood cell counts, and some expressed concern about patients' ability to adhere to the drug's three-times-a-day dosing regimen. Some patient populations have not shown a strong response to boceprevir and will need longer treatment, the panel said. These include African Americans, those with liver disease, and patients who have failed standard HCV treatment.

The panel will consider Vertex Pharmaceutical Inc.'s telaprevir, also a protease inhibitor, on Thursday. Like boceprevir, telaprevir is taken in a drug cocktail. The two medications represent more than 15 years of research to find more effective treatments for HCV, which infects approximately 3.2 million Americans.

"There are a lot of patients out there who have been waiting for this drug before seeking treatment," Martha Saly, director of NVHR, said of boceprevir. "But they're probably not going to be as excited when they realize it isn't replacing the older drugs."

FDA typically follows the recommendations of its panels; a final decision on boceprevir is expected next month.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


TOGETHER WE REMAIN STRONG!

Symptoms of Primary HIV Infection Often Mistaken for Malaria

Almost two-thirds of a cohort of Kenyans newly infected with HIV had sought treatment for fever, and 40% of these received presumptive treatment for malaria, but only 12% were tested for HIV, highlighting important missed opportunities for diagnosis and prevention of onward transmission, Eduard J Sanders and colleagues report in a prospective cohort study published in the advance online edition of AIDS.

Half of those treated were tested for malaria parasites; all were negative. Only six percent were suspected of having acute HIV infection; in spite of 25% having had a symptomatic sexually transmitted disease in the three months before an HIV diagnosis.

Many people within the first few weeks of HIV-infection (also known as acute HIV-1 infection or AHI) will experience a sudden onset of illness including: fevers, joint pains, headache, tiredness and rash. Many will seek care.

Identification of people with AHI presents an important public health opportunity.

Newly infected people are highly infectious and may account for a large number of new infections. Early diagnosis presents an opportunity for improved treatment and care as well as potential behavior change.

It is common in resource-rich settings to seek urgent healthcare for these symptoms. However, the authors note that little is known about health care seeking behaviors in sub-Saharan Africa around the time of AHI.

Given the interest in using point-of-care tests for early diagnosis of AHI, the authors chose to look at healthcare seeking in patients diagnosed with AHI in Kenya.

In July 2005 a prospective open cohort of men and women at risk for HIV began in two research clinics in Kilifi district in Kenya. Men and women aged 18-49 years of age who reported transactional sex work or men having sex with men (MSM) were enrolled voluntarily. Volunteers were given either three-monthly or monthly (when receptive anal intercourse was reported) appointments.

Records covering clinical, counselling, treatment and laboratory work of all previously HIV-negative at-risk individuals who had seroconverted between July 2005 and October 2010 and had agreed to be a part of the AHI cohort were reviewed.

The cohort comprised a total of 72 volunteers (60 men and 12 women); 60% of whom had either p24-positive or RNA-positive or HIV-I discordant rapid test before seroconversion.

Median age at seroconversion was 25 (IQR: 22-28) for men and 24 (IQR: 23-27) for women. Over half had secondary or higher education. 93% of men were bisexual or homosexual; 77% (55) of men and 17% (2) of women reported receptive anal intercourse.

Before diagnosis 75% (54) reported fever. 69% (50) sought urgent care for symptomatic illness; 84% of whom had symptoms within a month of the estimated date of HIV infection. 32% first sought care in a non-research facility.

Over a quarter sought urgent care more than once before HIV diagnosis.

Only one in four patients with fever was tested for malaria parasites, yet in spite of negative results was treated for malaria.

Malaria treatment was strongly associated with fever (aOR: 46, 95% CI: 3-725) and a non-research setting (aOR: 5, 95% CI: 3-64).

However the World Health Organization’s (WHO) revised malaria treatment guidelines state that treatment be given upon a confirmed diagnosis. Treatment based on clinical symptoms can be considered only when “parasitological diagnosis is not accessible.”

The authors stress the urgent need for continued education for front line health care workers as well as for researchers working in a research setting.

The identification of people with acute HIV infection at point-of-care services will facilitate treatment and care as well as HIV prevention interventions.

The authors propose that, together with improved clinician training, a risk score algorithm is developed to evaluate acute HIV infection in resource-poor settings where previously malaria was the most common cause of fever.

The authors note that among research staff there was low recognition of AHI in spite of patients presenting with known predictors of HIV infection: symptomatic sexually transmitted infections and discordant rapid HIV test results before seroconversion.

While HIV is only one of many causes of fever in sub-Saharan Africa, the authors note they couldn’t determine whether testing for HIV was done at non research facilities but suspect it was not.

Limitations include the selection of a high-risk group; bias in recall; and differences in follow-up may have influenced estimated differences in illnesses in men compared to women.

The authors conclude the majority of adults with AHI in malaria-endemic areas seek urgent health care and most are treated presumptively for malaria. Improved recognition of AHI presents a public health opportunity for early diagnosis, treatment and care as well as improving HIV prevention strategies.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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Needle Exchange Helps Cut HIV Rate: University Study Shows Changes Are Working

A new study finds Montreal's needle-exchange programs (NEPs) have helped reduce HIV incidence rates among injecting drug users (IDUs).

The city was one of the first in North America to adopt harm-reduction strategies in the 1990s. However, a 1995 study showed that HIV incidence was higher among IDUs who used NEPs than among those who did not. Acting on that knowledge, the Montreal Public Health Department (MPHD) began making improvements to the programs, including doubling the number of syringes available. The new study suggests those enhancements are working.

In the prospective cohort study of the period 1992 to 2008, researchers at the Université de Montréal followed 2,137 IDUs who had tested HIV-negative at enrollment.

Annual HIV incidence rates declined four times faster after 2000, when IDUs started obtaining clean syringes from NEPs or supervised injection sites. In 2000, HIV incidence among IDUs was 5.1 per 100 person-years. By 2007, it had dropped to 0.4, before
rising to 1.8 in 2008.

"The evolution of the policies has led to a reduction in HIV incidence," said lead author Dr. Julie Bruneau. "Our study really shows that adapting services and opening new ways of reaching out to drug users that are at risk of HIV infection is the way to go."

However, much more work is needed, said MPHD Director Dr. Richard Lessard. "The significant reduction of HIV transmission among [IDUs] constitutes a real, though insufficient step forward," he said. "Since the early 2000s ... hepatitis C infection has taken on alarming proportions. During this period, the distribution of injection material has not attained the expected deployment, and for this reason, we have to increase our efforts."

The study, "Trends in Human Immunodeficiency Virus Incidence and Risk Behavior Among Injection Drug Users in Montreal, Canada: A 16-Year Longitudinal Study," was published in the American Journal of Epidemiology (2011;173(9):1049-1058).

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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Early Exposure to Parents' Relationship Instability: Implications for Sexual Behavior and Depression in Adolescence

The current study examined the effects of the timing of parents' relationship instability on adolescent sexual and mental health.

A total of 585 participants were assessed annually from age five through young adulthood as part of a multisite community sample. The timing of parents' relationship instability and whether it was predictive of adolescents' history of sexual partnerships (SP) and major depressive episodes was examined. Multivariate logistic regression analyses controlled for potential mediators related to parenting and the family, including parental knowledge of activities, parent-child relationship quality, number of parents' post-separation relationship transitions, and number of on-hand caregivers.

Participants who experienced parents' relationship instability before age five were more likely to report SP at age 16 (adjusted odds ratio=1.58) or an adolescent episode of major depression (AOR=2.61). Greater parental knowledge at age 12 decreased the likelihood of SP at age 16, "but none of the hypothesized parenting and family variables statistically mediated the association between early instability and SP or major depressive episode," according to the study.

"These results suggest that experiencing parents' relationship instability in early childhood is associated with sexual behavior and major depression in adolescence, but these associations are not explained by the parenting and family variables included in our analyses," the authors concluded.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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US Confab in Chicago This Year

Chicago will play host to the country's largest AIDS conference for the first time this fall. More than 3,500 attendees and 150 vendors are expected at the CDC- and National Minority AIDS Council-sponsored United States Conference on AIDS (USCA), Nov. 10-13 at the Sheraton Chicago Hotel & Towers.

Cynthia Tucker, director of prevention and community partnerships at AIDS Foundation of Chicago (AFC) and chair of the USCA host committee, said the event will give the city an opportunity to showcase the work of local service providers. USCA's focus this year is men who have sex with men, and Chicago has led the way in developing innovative responses to the epidemic among MSM, she said.

"We are very organized in Chicago when it comes to care and prevention," said Tucker. Through the AFC Service Providers Council, AIDS service organizations in the city collaborate and share resources, she noted.

Though Chicago is a model for service providers, they are being challenged by increasing demand for services and flat or reduced HIV/AIDS funding. USCA will help spotlight those hardships, advocates hope.

For more information on the conference, visit http://www.nmac.org/index/2011-usca.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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Vertex's Hepatitis C Drug Aces Review

Vertex Pharmaceuticals Inc.'s hepatitis C virus treatment results in a sustained virologic response in more patients and in less time than traditional treatment alone, according to a briefing document filed Tuesday by Food and Drug Administration staff members. Using FDA criteria, the regimen including Vertex's telaprevir had a 79 percent SVR for patients. The HCV protease inhibitor is up for review by an FDA advisory committee on Thursday.

The brief notes two side effects reported by Vertex: anemia and skin rashes in some patients taking the three-drug combination regimen - telaprevir plus standard HCV drugs. The telaprevir-based drug cocktail proved more effective than the older drugs alone, which had a 46 percent SVR rate, the paper says.

The committee's daylong hearing on Thursday will center on whether to recommend approval of telaprevir, whose prospective brand name has not been disclosed. Founded in 1989, Vertex has been hiring hundreds of sales and marketing reps in anticipation of a launch.

Today the same FDA committee considers Merck & Co.'s HCV treatment boceprevir, which also inhibits the protease enzyme the virus needs for replication. Taken with other HCV drugs, boceprevir yielded an SVR for 66 percent of patients, according to an FDA briefing paper. Boceprevir also caused side effects in some patients, including anemia and blood disorders. If the drug is approved, Merck plans to market it as Victrelis.

For more information, visit: http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm252750.htm.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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FY2011 HOPWA Formula Allocation Estimates Announced

The Office of Community Planning and Development (CPD) released its FY2011 estimates for its formula programs, including HOPWA, CDBG, HOME, and ESG. To view the estimates, visit:
http://www.hud.gov/offices/cpd/about/budget/budget11/index.cfm

CPD will update its website with its final full-year allocations once FY2011 apportionments are received from OMB.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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Tuesday, April 26, 2011

New Erection-boosting Condom Awaits Approval

A new erection-enhancing condom product, dubbed "Viagra for condoms," is nearing regulatory approval and could be on sale in Europe by the end of the year.

Analysts say the condoms, which contain a gel that helps men maintain a firmer erection for a longer time, could have a significant impact on the condom market, where innovation is rare and patent-protected inventions are infrequent.

The product could also provide a boost to Durex, the world's top-selling condom brand, not least in the U.S., where Durex has struggled to gain a sizable market share.

European regulatory approval for the product, developed by U.K. biotechnology firm Futura Medical PLC and licensed to Durex's owner, SSL International, was held up during SSL's takeover last year by consumer-goods giant Reckitt Benckiser Group PLC. Futura now expects the green light in this year's first half, meaning the condom, named CSD500, could be on the shelves of pharmacies and supermarkets by the end of the year.

Futura's condoms contain a gel with an agent that boosts blood flow—a so-called vasodilator—which is absorbed through the skin, enhancing erections. Finding an active ingredient was straightforward—it's a generic compound for the treatment of angina, a severe chest pain caused by lack of blood flow to the heart. However, "immobilizing" the gel in the condom, so the vasodilator only touches the wearer during sexual intercourse, was the clever part.

"The challenge is having a stable product in a condom—a gel that doesn't do anything detrimental to the condom," Futura Chief Executive James Barder said.

"Some products can degrade the latex very quickly," said Mr. Barder, noting that adding the vasodilator to the lubricant is complicated. "It has to be immobilized in the condom." Most of the patents protecting CSD500 are associated with this immobilization, Mr. Barder said.

Unlike the drug Viagra, with which Futura's product has been compared, the condom isn't being scrutinized by regulators as a treatment for erectile dysfunction. Rather, it's specifically targeted at men who struggle to maintain an erection while wearing a condom. If European regulators give CSD500 the green light, it will be because it encourages these men to use protection, and therefore help to curb the spread of sexually transmitted diseases.

The commercial benefit of this distinction is twofold. First, as Mr. Barder points out, erectile dysfunction is generally found in older men, whereas the inability to maintain an erection while wearing a condom is "much less age specific," meaning a wider potential market. In addition, as a medical device rather than a drug, the condoms will be available off the shelf, avoiding the need for a potentially embarrassing trip to the doctor for a prescription.

Reckitt has so far remained quiet about the product, and declined to comment prior to regulatory approval. Reckitt boss Bart Becht has played down the potential of new Durex products. "In terms of SSL innovation, there are some interesting projects in the pipeline, but I would say, most of them are relatively small," he told analysts last November.

Still, experts say a clinically proven, patented innovation should help the consumer-goods firm take market share from major competitors, which include U.S. manufacturer Church & Dwight Co. and Australia's Ansell Ltd.

"If competitors can't come out with a 'me too' in a relatively short period of time—and let's face it, they've known about this as long as anyone else—these clinical claims are going to help Durex's market position," said Chas Manso de Zuniga, a consumer-goods analyst at Evolution Securities who has closely followed CSD500's progress under both SSL and Reckitt.

According to research from stockbroker Taylor Collison, Durex accounted for 42% of the $3.9 billion condom market in 2010, with Ansell holding a 15% share and Church & Dwight 11%. However, SSL found life tougher in the U.S., by far the largest single market, where Church & Dwight's Trojan brand dominates with a 76% market share.

Once Reckitt has secured European approval, it may be tempted to pursue the U.S. market, according to analyst Navid Malik of Matrix Group, although approval from the Food and Drug Administration would require further clinical data from U.S. patients.

"The reason why Durex hasn't been successful in the U.S. is [SSL] didn't want to go into a war with the incumbents. Reckitt will be less shy on that," said Malik.

"CSD500 will give them a really good jumping off point to marketing Durex [in the U.S.]. In my view, it's the perfect opportunity to highlight the brand."

Nomura, Futura's broker, says a "modest" estimate is that the new product could capture 3% to 5% of the global branded condom market, while priced at a 50% premium to standard condoms.

That's not to say Reckitt's competitors are running scared. Church & Dwight boss James Craigie told analysts a slight decline in Trojan's market share for its most recent quarter—to 75%—was "no big deal," given the overall growth in the condom market.

Mr. Manso de Zuniga points out that the U.S. firm has "pushed the button on innovation" in recent years. In 2009, the firm launched its Ecstasy condom, designed to offer greater sensitivity to the wearer, and last year began selling Fire and Ice, a condom with lubricants offering hot and cold sensations. According to Mr. Manso de Zuniga, these developments aren't dissimilar to products in Durex's "play" range.

Still, CSD500's patents may mean it's more difficult for competitors to match. The condom market has recently been devoid of "real innovation," Mr. Malik said. With its clinically proven claims, Futura's condom has the potential to bring about "a big change in the way condom products have been used," he added.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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Gold Drug Shows HIV Eradication Potential

Using a compound containing gold to treat six monkeys infected with an HIV-like virus, a team of researchers has been able to shrink the reservoir of virus-infected CD4 cells impervious to modern-day antiretroviral (ARV) drugs. These early stage results, to be published in a forthcoming issue of AIDS, contribute to a growing body of research exploring the possibility of curing HIV, this time using a drug already approved for the treatment of rheumatoid arthritis: Ridaura (auranofin).
Current antiretroviral (ARV) therapy is quite potent. When it works well, it completely shuts down HIV reproduction. Unfortunately, a small reservoir of long-lived HIV-infected cells remains in the body, and when people stop taking their HIV medication, the virus quickly reseeds newly produced CD4 cells and resumes replication.

Traditional ARVs can’t target HIV genetic material (HIV DNA) inside this reservoir of infected cells, notably long-lived “memory” CD4 cells. This is because the cells are inactive; most ARVs only work in cells that are actively reproducing. Researchers are now exploring compounds that wake up these resting cells to help purge their HIV DNA payload or, more controversially, that kill the cells harboring dormant virus.

The rheumatoid arthritis drug Ridaura falls into the second category. According to the paper published by Andrea Savarino, MD, of the Istituto Superiore di Sanità in Rome and his colleagues, Ridaura works by killing off memory CD4 cells while also shortening the lifespan of new CD4 cells produced by the immune system. In effect, Ridaura shows HIV eradication potential on two levels: It can help wipe out the existing reservoir while at the same time prevent new long-lived reservoirs from developing.

To explore Ridaura’s potential, Savarino’s group conducted a study involving six macaques infected with simian immunodeficiency virus (SIV), HIV’s primate equivalent. After maintaining undetectable SIV levels in the macaques for at least eight weeks using a typical ARV regimen, the researchers added twice-daily Ridaura treatment.

According to the researchers’ report, the addition of Ridaura significantly shorted both the lifespan and size of the long-lived CD4 cells. What’s more, there was no significant effect on the size of the new CD4 cell population and the monkeys’ CD4 counts remained stable throughout treatment. Marked reductions in SIV DNA levels were also documented.

When ARV therapy was stopped in the six monkeys, SIV viral loads rebounded, but to levels that were significantly lower than those seen before ARV treatment was initiated. Conversely, in six monkeys who underwent therapy with ARVs alone, viral loads rebounded to pre-treatment levels in less than two weeks.

“Our [Ridaura-treated] monkeys showed, upon suspension of all therapies, an improved capacity to keep the infection under control; one of them maintained a low viral load and high CD4 counts for one year,” Savarino is quoted as saying in a press release.

The researchers have decided to wait before moving Ridaura into trials involving people living with HIV. “We prefer not to involve people in a trial of the drug immediately,” said Enrico Garaci, MD, president of the Italian Institute of Health, and coauthor of the study. “That’s because in this phase the trial could only be a proof-of-concept study, and we have already this proof in monkeys. We prefer to put all our effort in the intensification of the attack on the virus reservoir in monkeys by using a combined approach.

“This will also allow,” he added, “a more thorough evaluation of the safety of the approach.”

The authors also caution against using Ridaura outside of clinical trial settings. “[T]he side effects of this approach in the presence of HIV are as yet largely unexplored,” Savarino notes. “I strongly recommend that people living with HIV/AIDS do not buy the drug from uncontrolled sources such as eBay and start self-treatment outside highly medicalized settings.”

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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More Money Needed for HIV Fight in Jamaica

Activists are warning that Jamaica's HIV/AIDS fight is dangerously dependent upon foreign funds, and they are calling for a 50 percent hike in government spending by 2015.

"Although there has been increased spending over the past few years, the Planning Institute of Jamaica notes that there is still a 67 percent shortfall in funding available to achieve the targets set out in the National HIV Strategic Plan 2007-2012," said Civil Society Forum, a coalition of more than 50 AIDS groups.

According to Pat Watson, executive director of the organization Eve for Life, "Too much of the current funding comes from external sources such as the Global Fund, and there is a real risk that when this is no longer available, the sustained impact on the epidemic will decline unless more local resources are dedicated to the response." Addressing a recent CSF meeting, UNAIDS Country Representative Dr. Pierre Somse said that "without the full and active involvement of a strong civil society in leading the HIV response, the gains made so far could be undermined." The Ministry of Health's budget this year for HIV prevention and treatment, $1.3 billion (US $15.3 million), comes largely from the International Bank for Reconstruction and Development.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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University Shares $10 Million in Pursuit of New Weapon Against HIV

University of Minnesota researchers will receive half of a $10 million National Institutes of Health grant to study innate antiviral proteins that, if boosted, may prevent HIV from replicating in human cells.

"Everyone has [these proteins], and several have the capacity to destroy HIV," explained Rueben Harris, an associate professor of biochemistry, molecular biology, and biophysics. "The problem is that HIV and other viruses that are susceptible to [these proteins] have figured out ways to neutralize our innate immune responses."

In 2008, Harris and colleagues discovered the APOBEC3G protein, one of several "APOBECs" that human cells produce naturally. That research showed how HIV binds to and destroys one of the proteins, suggesting that a relatively simple change to the chemical structure of APOBECs could boost their virus-fighting capabilities.

The researchers will use the grant to produce atomic resolution images of the proteins to better understand how they interact with HIV and other proteins in human cells. The goal is to find a way to prevent HIV from attaching to and entering cells, said Harris.

"People are just starting to come around to the fact that we have really powerful innate immune defenses that can kill the virus," said Harris. "Now we need to understand how we can boost those defenses."

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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FDA Says Merck Drug Successfully Fights Hepatitis

A Food and Drug Administration review found Merck & Co.'s new hepatitis C drug cures more patients in less time than current therapies, though some safety questions remain. FDA's analysis was posted Monday ahead of a public meeting Wednesday on whether to approve boceprevir.

And on Thursday, a similar drug made by Vertex Pharmaceuticals Inc. will be considered by FDA's panel. Both medicines are protease inhibitors, blocking an enzyme that allows hepatitis C virus to replicate. The tablets differ from the standard HCV treatments, ribavirin and interferon-alpha, which are designed to boost the immune system.

The two studies submitted by Merck show boceprevir patients had undetectable HCV levels six months post-treatment. Boceprevir plus standard treatment boosted cure rates to 60 percent-65 percent, compared with 40 percent for traditional HCV drugs alone. In addition, the studies indicate that adding boceprevir to standard HCV therapy helped cut treatment time in half, reducing exposure to the older drugs' side effects.

But FDA scientists said some late-responding patients may need to take the boceprevir combination for eight months. In addition, African Americans were among other groups who should receive longer therapy. Blacks, who comprise 20 percent of persons with HCV, had a cure rate 15 percent-25 percent lower than other racial groups. FDA also questioned boceprevir's efficacy in patients who have failed standard treatment.

Boceprevir was associated with an "increased frequency and severity of anemia," FDA said, requiring further review. And though the agency found an increased number of reported symptoms of "suicidal and homicidal ideation" with boceprevir, FDA noted "it is difficult to make any meaningful clinical conclusion from this observation."

FDA is scheduled to make a final decision on boceprevir in May. To access the agency briefing, visit: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252341.pdf.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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Policy May Cut HIV for Gay Men by 60 Percent

San Francisco's policy of recommending HIV treatment to all infected patients upon diagnosis, without waiting for CD4 cell counts to fall, could cut the number of new infections among men who have sex with men by 59 percent in five years, a new study suggests. In addition, combining early treatment with annual testing for all MSM would reduce new infections among them by 76 percent.

When to initiate antiretroviral therapy has long been debated. Early HIV medications carried the risk of such severe side effects that public health officials recommended patients not begin treatment until they were symptomatic. The drugs have since improved, and studies have shown more favorable outcomes under earlier ART initiation. Last year, San Francisco Department of Public Health (DPH) recommended treatment for all HIV patients as soon as they are diagnosed.

"There's a growing recognition that the virus is more toxic than the meds," said study co-author Dr. Moupali Das, DPH's HIV prevention research director. "The meds are not without side effects, but they're so much improved." DPH developed the study's mathematical model with the University of California-San Francisco (UCSF).

"We could have a really significant impact on the number of new cases by taking everyone with a diagnosis and encouraging them to start treatment. And those effects could actually begin quite quickly," said study leader Edwin Charlebois of UCSF.

Three scenarios were tested: ART initiated when CD4 counts fall below 500 (the current US standard of care); offering treatment to all HIV patients currently in care; and intensified annual HIV testing for MSM, with treatment offered to all.

"In conclusion, our projections suggest that ensuring HIV-infected patients in San Francisco already receiving care are offered ART would significantly reduce the incidence of HIV infection in San Francisco. These predictions are supported by recent surveillance data from San Francisco and Vancouver that show decreasing rates of new HIV infections that correlate with ART expansion and lower community viral load. With new national guidelines supporting treatment for most HIV-infected persons for their individual health, secondary benefits of reducing HIV transmission could be realized if adequate support for care delivery are in place."

The full study, "The Effect of Expanded Antiretroviral Treatment Strategies on the HIV Epidemic Among Men Who Have Sex with Men in San Francisco," was published in Clinical Infectious Diseases (2011;52(8):1046-1049).

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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US Monitoring AIDS Growth Rate in Philippines, Says USAID

The number of HIV cases is still small in the Philippines, but the growth rate of new infections is problematic, the mission director of US Agency for International Development said recently. USAID is closely monitoring the situation and working with the government to prevent HIV's further spread, said Gloria D. Steele.

Generally, HIV infections in the Philippines are concentrated among injection drug users and men who have sex with men, Steele said. USAID is coordinating with the Philippines' Department of Health (DOH) to contain the virus. Between 2008 and 2010, USAID allocated $85.8 million for health projects in the Philippines, including for HIV/AIDS.

The Philippines continues to lag behind the Millennium Development Goal of halting and reversing the spread of HIV by 2015, said Teresita Marie Bagasao, the UNAIDS country coordinator. Data confirmed by DOH show new infections are increasing. And UNAIDS says the Philippines is one of just seven countries reporting a 25 percent or greater rise in new HIV cases from 2001 to 2009. In Asia, only the Philippines and Bangladesh saw an increase in new HIV infections.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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More Families Are Adopting HIV-Positive Children

The number of US parents who have adopted or are considering adopting a child with HIV has surged in recent years.

Throughout most of the epidemic, strict US immigration policies limited entry for people living with HIV. But that restriction was lifted in January 2010, enabling HIV-positive children to enter as easily as other adoptive children.

Most adoptions involve orphans from the developing countries that are home to some 2.5 million children living with HIV. In many of these nations, HIV-positive children face stigma, neglect, and early death.

Chicagoan Margaret Fleming, 74, has nine adopted children, including three HIV-positive first-graders. "These kids were, in many ways, the modern-day lepers," she said of the situations they came from. Fleming runs Chances by Choice, a support service that recruits and advises parents interested in HIV adoptions.

A key challenge for many families is deciding when and to whom they should disclose the adoptive child's HIV status. In February, the largest US adoption agency, Bethany Christian Services, issued an educational package about HIV adoptions to help the growing number of interested parents make informed decisions. "Once your child's status is disclosed, you cannot 'take it back,' so careful consideration and thought should be given to this important issue," advises the agency.

Dr. Jane Aronson, a New York City pediatrician who specializes in caring for children adopted abroad, believes HIV-positive children have a right to keep their status private until they are ready and old enough to understand the consequences. "Some parents have made a decision to define their children's identity, now it's more about them than about the kids," she noted. "That could be very challenging when the children grow up. They didn't have a choice."

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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Thursday, April 21, 2011

Minnesota GOP: Let Parents Know When Kids Seek Care

If a new Republican-backed proposal passes the Legislature, Minnesota would become the only state to prevent minors from seeking STD services without parental approval, according to the Guttmacher Institute.

Sen. David Hann (R-Eden Prairie) is sponsoring the measure, which would require parental consent for minors seeking treatment for STDs, pregnancy, or drug or alcohol abuse. The state's current, 40-year-old law prevents doctors from disclosing medical information to parents unless the patient agrees or the condition is life-threatening. Under the proposal, parents could also access their children's medical records.

"It seems if you talk to any parent, most would assume they have the right to know about the medical condition of their child," said Hann. "I think it's a surprise to find out that we don't."

Guttmacher, which tracks sexual and reproductive health issues and opposes parental notification requirements, said no state currently blocks minors from seeking contraceptives without consent, though some have minimum age requirements. Thirty-seven states plus the District of Columbia allow confidential prenatal care or place slight conditions on it, the institute said. Thirteen states have no laws regarding minor care; in these states, doctors typically rely on recommendations from their respective medical associations, most of which support minors' right to consent to treatment, said Elizabeth Nash, a Guttmacher public policy associate.

Aggie Leitheiser, assistant commissioner for the Minnesota Department of Health, said the bill could lead to higher rates of STDs, unintended pregnancies, drug and alcohol abuse, premature births or other complications, and long-term health problems from untreated conditions - thereby driving up health care costs.

The bill was approved by a Senate committee but lacks a companion House measure, making passage unlikely.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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'Surprising and Disappointing' Results in a New Truvada PrEP Study for Women

A clinical trial testing the HIV-prevention potential of Truvada (tenofovir plus emtricitabine) in HIV-negative African women has been stopped early because of concerns about effectiveness, according to an announcement by the trial sponsor, Family Health International (FHI). This result stands in stark contrast to another study reported in late 2010, which found that Truvada cut new HIV infections by at least 44 percent in men who have sex with men (MSM) and transgender women.

Truvada is an antiretroviral (ARV) drug currently approved to treat people living with HIV. Several years ago, scientists suggested that the drug’s HIV-fighting power could also be used as prevention. Early studies in monkeys suggested that if the drug were given to HIV-negative people every day, it might keep them from becoming infected with HIV. Subsequent small studies in people found that it was likely to be safe, and so larger studies were launched in MSMs, transgender women, heterosexual women and heterosexual men.

The first of the large efficacy studies, called iPrEx, was reported in the late fall of 2010. That study—largely based in South America—found that in 2,500 MSM and transgendered women, those randomized to receive Truvada were 44 percent less likely to become infected with HIV. In those who reported taking the pill at least 90 percent of the time, new infections were cut by 73 percent, and in a small subgroup whose blood levels were monitored, Truvada appeared to cut infections by more than 90 percent in those who had measurable levels of Truvada in their blood.

The new study, FEM-PrEP, enrolled 1,951 heterosexual HIV-negative women who were at high risk for contracting HIV. The study was carried out in Kenya, Tanzania and South Africa by FHI and African academic partners. Women were randomized to receive either daily Truvada or a placebo. During a planned interim check of the data, the study monitors found that there were an equal number of new HIV infections in both the Truvada and placebo groups, making it highly unlikely that the study could determine whether or not Truvada was effective.

FHI, in its release, calls this finding “surprising and disappointing,” given the promise of Truvada in previous studies. Researchers state that follow-up with the HIV-negative study participants will be conducted over the next few months, but then an in-depth analysis of the data will occur—including Truvada blood-level monitoring data—to help understand the study’s results. Though the women in the study reported taking 95 percent of their doses, blood-level monitoring in the iPrEx revealed that fewer than 50 percent of those study participants were actually taking the drug, despite their claims otherwise.

According to FHI, “There are a number of possible reasons for the study findings, including low adherence to study regimen, a true lack of effect of the product among women (versus men who have sex with men), or other factors still to be determined.”

In fact, one especially surprising result—which also suggests poor adherence could be at least part of the explanation—is that women taking Truvada were also more likely to become pregnant, despite the use of hormonal contraceptives, than women taking a placebo. “That’s both a surprising finding and one that we can’t readily explain,” Timothy Mastro, MD, from FHI, told The New York Times.

No study conducted in the past decade has ever suggested that tenofovir could interfere with the blood levels of hormonal contraceptives. The researchers will be looking very closely to determine the reason for the additional pregnancies in the Truvada group.

It will take time to understand exactly what happened in the FEM-PrEP study. In the meantime, said Mitchell Warren, the executive director of the AIDS Vaccine Advocacy Coalition in New York City, “[FEM-PrEP] must be seen as what it is—the closure of a single trial in a field that has generated exciting results in the recent past.”

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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Deported HIV-Positive Stripper Denied Return to Canada

Suwalee Iamkhong, a former stripper and sex worker, was denied the chance to return to Canada after being deported to Thailand for transmitting HIV to her ex-husband, the Toronto Sun reports.

Iamkhong was deported after serving more than two years of a three-year prison sentence for HIV transmission. The court determined the possibility of rehabilitation in this case wasn’t enough to allow her return to Canada. Her lawyer said Iamkhong was devastated by the decision because she is having problems obtaining HIV medications and dealing with the stigma associated with being HIV positive.

To read the Toronto Sun article, visit: http://www.torontosun.com/news/torontoandgta/2011/04/05/17885546.html

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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HIV Cases Up 32% Among Tennesseans Ages 15 to 24

Newly diagnosed HIV cases increased 32 percent between 2005 and 2009 among Tennesseans ages 15 to 24, The Tennessean reports.

Other age groups during that time had a slight decline in HIV cases. Health officials are attributing the rise to the fact that successful antiretroviral drugs have removed the fear of HIV among young people. Officials added that the spread of drug-resistant virus also contributes to the increase in cases.

To read the Tennessean article, visit: http://www.tennessean.com/article/20110419/NEWS07/304190025/HIV-surges-among-young-Tennesseans?odyssey=tab|topnews|text|FRONTPAGE

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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Abbott to Pay $52M in Settlement With Direct Drug Buyers

Abbott Laboratories agreed to pay $52 million to resolve claims by direct drug buyers that it tried to harm competition when it quadrupled the price of its HIV medicine Norvir in 2003.

The settlement, which is subject to court approval, would resolve a class-action lawsuit filed on behalf of Abbott customers that purchased Norvir, a boosting agent for other HIV drugs, and a second medicine Kaletra, which includes Norvir, according to an April 8 filing in federal court in Oakland, California. Abbott denied wrongdoing, according to the accord.

Abbott increased the wholesale price of a Norvir capsule containing 100 milligrams to $8.57 from $1.71, the Abbott Park, Illinois-based company said in court documents. GlaxoSmithKline Plc and drug retailers and distributors sued, claiming other drugmakers that used Norvir in their medicines couldn’t compete on price with Kaletra, and the price increase penalized drug customers that wanted to buy medicines that competed with Kaletra.

Abbott said it increased Norvir’s prices for legitimate business purposes and Kaletra lost market share after the price increase.

CVS Caremark Corp., Walgreen Co., Rite Aid Corp. and retailers that sued opted out of the settlement, according to court documents.

The case is Meijer v. Abbott Laboratories, 07-5985, U.S. District Court, Northern District of California (Oakland).

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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Illinois ADAP to Restrict Access to New Applicants

On April 15, the Illinois Department of Public Health ( IDPH ) announced plans to restrict access to the AIDS Drug Assistance Program ( ADAP ) to new applicants with incomes at or below 300 percent of the federal poverty level ( $32,670 for a single individual ) beginning in July. The current limit to qualify for Illinois ADAP is 500 percent of federal poverty ( $54,450 for a single individual ) .
"This is a sad day for the fight against HIV/AIDS in Illinois," said David Ernesto Munar, President/CEO of the AIDS Foundation of Chicago ( AFC ) . "The new policy will keep ADAP out-of-reach for hundreds of individuals who have nowhere else to turn for help. Many will simply forgo treatment, at great risk to themselves and their partners."

Jointly funded by the federal and state governments, ADAP provides HIV medications each month to more than 4,200 Illinoisans who have no other means to afford their lifesaving medications, which can cost $18,000 or more per year.

All current program recipients, including those with incomes between 300-500 percent of poverty, will continue to receive ADAP services, provided they meet other eligibility criteria and reapply for the program every six months. Stemming spiraling costs that threaten continuity of care for existing program clients motivated the changes, state officials said.

The announcement comes on the heels of two years of financial pressure on the program. Record numbers of people with HIV became eligible and joined ADAP as a result of the economic downturn, high unemployment, and losses of private health insurance. Illinois has struggled to keep its program solvent in the face of inadequate federal funding. Nationally, nearly 8,000 people with HIV in 11 states are on ADAP waiting lists.

In 2009, Gov. Quinn redirected an additional $7 million, including portions of the state's HIV prevention, housing and care budgets, toward ADAP to avoid financial collapse. With pressure from state lawmakers to achieve even greater savings in government services to close the historic budget gap, public health officials forecast a $1.8 million shortfall for ADAP in 2012 without cost-containment measures. In addition, Illinois received nearly $5 million this year in one-time supplemental federal funding because the state's caseload grew so significantly. However, slower growth to date means Illinois may not receive this funding next year.

"We're fully committed to continuing to work closely with the General Assembly, Governor Quinn, IDPH, and federal lawmakers to identify additional funds that will allow unrestricted ADAP access for Illinoisans who desperately need HIV medications to survive and thrive," said John Peller, AFC Vice President of Policy.

While unsupportive of the service reductions, AFC recognizes that absent additional state and federal funding, ADAP officials were left with few options to safeguard services for existing ADAP clients.

However, one aspect of the cost-cutting plan that is particularly concerning to AFC is the decision to redefine eligibility criteria rather than institute a waiting list.

"No one wants to see an ADAP wait list in Illinois but if service cuts are unavoidable, a waiting list is preferred to new eligibility criteria," Munar said. "A waiting list keeps alive hope that the program can be stabilized and that full access can be restored. In addition, a wait list allows the state to closely monitor the health of those denied medications and affords these individuals greater opportunities to seek assistance directly from pharmaceutical companies. A wait list could also make Illinois eligible for emergency federal funding assistance. Finally, the wait list becomes a powerful reminder to public officials about the persistent, unmet needs for HIV medication access."

Based on past enrollment data, the new eligibility criteria will likely affect 100 or more individuals annually who might otherwise become eligible for ADAP. Many clients in this income bracket are working but uninsured and unable to afford the high cost of HIV medications without assistance. IDPH expects the change in eligibility to save $1.3 million, or just under 3 percent of program costs.

"Denying access to HIV medications will cost taxpayers in the long-run," Munar noted. "Without medication access, HIV-positive people are at high risk of dangerous opportunistic infections, costly hospital stays, and irreversible damage to their health. Just as important, HIV-positive people can dramatically reduce chances of transmitting the virus to others by adhering to a regular medication treatments. Illinois might save $1.3 million now, but the state will likely foot the bill later in increased hospital care and more cases of HIV transmission."

As part of a responsible budget response, AFC urges Illinois officials to consider creative solutions, such as pursuing a waiver application with the federal government to expand Medicaid coverage for non-disabled low-income people with HIV. The Obama Administration directed the federal Medicaid program to create a streamlined application process for expanded HIV care as part of the National HIV/AIDS Strategy. Illinois should explore this option as a way to match its state HIV investments with federal Medicaid funds. Doing so will effectively decrease the need for ADAP.

In addition, AFC urges the Illinois House to abandon its artificially low revenue estimate for the next state fiscal year. This overly conservative estimate will force $1.3 billion in needless funding cuts to vital programs such as ADAP. The General Assembly and Governor Quinn should also consider other measures to prevent loss of state revenue, such as requiring businesses to follow current depreciation rules instead of newly enacted federal rules. This change would retain several hundred million dollars in state revenue that would otherwise be lost.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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Anti-CMV Drug Reduces HIV-Related Inflammation

Adding the anti-cytomegalovirus (CMV) drug Valcyte (valgancyclovir) to an antiretroviral (ARV) regimen calms down immune system inflammation in people with HIV, according to a study published in the May 15 issue of The Journal of Infectious Diseases.

Even when HIV is well controlled, the presence of residual virus causes the immune system to remain in a state of high alert, a syndrome called inflammation. Inflammation has been tied to serious health problems such as cardiovascular disease, diabetes and kidney disease in both HIV-positive and HIV-negative people. In HIV-positive people, inflammation is also thought to blunt the recovery of the immune system after a person starts taking ARVs.

Scientists are eagerly looking for ways to eradicate the residual amount of HIV that ARV therapy can’t contain. In the meantime, they are also seeking ways to reduce inflammation in people who are otherwise doing well on medication. Such methods, if found, could be particularly helpful for people who waited to start ARV therapy until their CD4s dropped below 200 and who haven’t seen their CD4 levels return to normal despite successful treatment.

One avenue to reduce inflammation that researchers are exploring is treating other chronic viral infections known to rev up the immune system. One of these viruses—a virus that more than 90 percent of HIV-positive people carry—is CMV. The theory proposed by researchers at the University of California in San Francisco (UCSF) is that treating underlying CMV might actually reduce HIV-specific inflammation as well.

To test this proposal, Peter Hunt, MD, from UCSF, and his colleagues compared the drug Valcyte with a placebo in 30 HIV-positive people who tested positive for CMV, were on ARV therapy and who had low CD4 counts. The aim was to determine whether adding Valcyte to an ARV regimen for eight weeks would further reduce inflammation on HIV-specific immune cells called CD8 cells.

The 14 people who received Valcyte were similar in most respects to the 16 who received a placebo. Almost all were male, and the average age was 49. The average length of time on ARV drugs was just over two years, most had undetectable HIV levels, and the majority had a CD4 count under 200 at the time of the study. Hunt’s team measured HIV levels, CD4 counts and various aspects of immune inflammation every two weeks during the eight weeks on either Valcyte or placebo, plus an additional four weeks after that.

Hunt and his colleagues found that adding eight weeks of Valcyte reduced the number of activated CD8 cells by 20 percent and it remained at this reduced level during the four weeks of observation after people stopped taking the drug. By comparison, inflammation remained the same for the entire 12 week period in those receiving a placebo.

The authors are quick to point out that Valcyte can have serious side effects, including the suppression of bone marrow. For this reason, people should definitely not be adding Valcyte to their HIV regimens. What’s more, the study was so small and so short that there is no way to tell whether the reduction in CD8 cell activation will actually result in a meaningful improvement in CD4 counts or other health benefits. Nevertheless, the authors state that the result is large enough and strong enough to warrant a longer and larger study, especially in those with poor CD4 recovery despite effective ARV therapy.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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Moving Can Be Hazardous to Health for HIV Positive People

HIV-positive people who moved to a new location outside the range of their HIV clinic had poorer health than those who stayed in care within the clinic, according to a study published in the May 1 issue of the Journal of Acquired Immune Deficiency Syndromes.

In real-world HIV care, one of the most troubling situations for health care providers is losing touch with their patients. In some clinics, substantial proportions (sometimes exceeding 30 percent) of people leave care without explanation and without giving providers a way to track their future health, what health care experts call “lost to follow-up.”

Studies have demonstrated that when such individuals return to care at a particular clinic or are located later at another clinic, they are often in much poorer shape than people who remain in care. There are often characteristics of people who are lost to follow-up, however, that exacerbate poor health. These include more frequent drug use, incarceration, mental illness and homelessness.

One group of people who’ve been studied less thoroughly are those who make a planned move and whose care can be tracked in some way. To better understand how such individuals fare after a move, Hartmut Krentz, PhD, and his colleagues from the University of Calgary, in Canada, studied the medical records of 836 people receiving care in the Southern Alberta region of Canada. One benefit of studying people with HIV in Canada is that the country had universal health care and universal access to HIV care, thus eliminating one of the biggest barriers to continuous care for people in the United States.

Krentz and his team compared those who stayed in care within the Southern Alberta system, those who were lost to follow-up and returned, and those who made a planned move and who later returned to care. The characteristics of those who remained in care was similar to those who left care at some point, except that those who left care tended to be younger and healthier when they entered HIV care: on average they had higher CD4 count and fewer AIDS diagnoses.

Overall, those who left care fared much more poorly than those who remained in care, no matter their reason for leaving. People who stayed in care saw their CD4 cells increase from an average of 288 to 460. By contrast, those who were lost to follow-up and then returned saw their CD4s drop from 405 to 270. Of concern, however, was the fact that even those who planned a move suffered negative health consequences—their CD4s also fell, from 424 to 339. People who left care and then returned also had twice the rate of new AIDS diagnoses as those who stayed in care.

The authors acknowledge that their study size is small and that there might be factors associated with those who moved that would predispose them to poorer health outcomes than those who stayed in care. Nevertheless, the fact that those with a planned move did almost as poorly as those who were simply lost to follow-up does indicate that even a planned move can be detrimental.

The authors state that they suspect that the primary reason for poorer health outcomes in those who moved was either discontinuing their antiretroviral (ARV) medication or failing to get on medication later if their CD4 cells dropped.

In any respect, Hertz and his colleagues strongly recommend that people with HIV and their providers try hard to seek out care in advance for those who may be moving and to make the transition to a new clinic as seamless as possible.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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Low Vitamin D Levels Are Common in Both HIV-Positive and HIV-Negative Women

Though nearly two thirds of women in a large study had low vitamin D levels—a risk factor for bone and heart problems—the HIV-positive women were actually slightly less likely than HIV-negative women to be vitamin D deficient. These data were published online April 5 in the Journal of Acquired Immune Deficiency Syndromes.

Researchers have long known that low vitamin D levels can contribute to poor bone health, but in recent decades we’ve also learned that low vitamin D can lead to high blood pressure, cardiovascular disease, diabetes and even certain cancers. Some of the strongest risk factors for being vitamin D deficient include getting too little exposure to the sun—as can happen especially in winter months—consuming too little vitamin D, having dark skin and being overweight.

Vitamin D deficiency is common. In a recent study of the adult U.S. population, only 23 percent of those tested had sufficient blood levels of vitamin D. Inadequate vitamin D is also a growing concern in people with HIV. This is because some studies have found the condition to be more common in HIV-positive people, while others have found that the commonly used antiretroviral (ARV) drug efavirenz (found in Sustiva and Atripla) contributes to low vitamin D levels. What’s more, many of the diseases that are cropping up at younger ages in people with HIV—such as cardiovascular disease, diabetes and metabolic syndrome—are all tied to vitamin D deficiency.

To better understand how HIV may contribute to vitamin D deficiency, Oluwatoyin Adeyemi, MD, from the CORE Center at Rush University Medical Center in Chicago, and her colleagues tested stored blood samples from 1,268 HIV-positive and 510 HIV-negative women enrolled in the Women’s Interagency HIV Study (WIHS). The majority of the women were African American or Latino, and they were distributed equally in cities at lower and higher latitudes. Most of the women in the study were in their early 40s.

Adeyemi and her colleagues found that vitamin D deficiency was quite common among all the women in the study, with 63 percent deficient and 22 percent with severe deficiency. In fact, only 13 percent had sufficient blood levels of vitamin D.

What was interesting is that HIV-positive women, on average, had higher vitamin D levels. Also, the proportion of HIV-positive women with vitamin D deficiency was lower compared with HIV-negative women, 60 percent versus 72 percent. The difference was small enough, however, that it could have occurred by chance. Adeyemi and her colleagues explained that this unexpected result could be due to the HIV-positive women enrolled in their study receiving better and more consistent health care than the HIV-negative women.

In most regards, the factors associated with higher odds for having low vitamin D levels were similar to those found in studies conducted solely in HIV-negative people. The two primary factors associated with low vitamin D levels in this study were being black or Latino and being overweight

In HIV-positive women, additional factors for having low vitamin D levels included having a lower CD4 count. Conversely, having an undetectable viral load or being on a protease inhibitor–based ARV regimen were protective.

In contrast to most studies, Adeyemi and her team found that older women were actually less likely than younger women to have low vitamin D levels. The authors offer two potential explanations: first, that the vast majority of older women in the WIHS study are still below the age categorized as “elderly” in the general population; and second, that the blood levels of vitamin D found in the older women suggested that many were using vitamin D supplements.

“While there are no formal guidelines on testing for and supplementation of vitamin D in HIV-infected women, it will be important to explore the response to vitamin D supplementation in these women and the impact on a myriad of health outcomes including insulin resistance, cardiovascular disease, bone health and a variety of mental health outcomes,” the authors write.

“An understanding of the role that vitamin D deficiency plays in non-AIDS-related morbidities reported in excess among HIV-infected individuals is planned for investigation in WIHS,” they conclude.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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Wednesday, April 20, 2011

Predictors of Unrecognized HIV Infection Among Poor and Ethnic MSM in Los Angeles

The authors aimed to evaluate "associations between unrecognized HIV infection and demographic factors, internalized homonegativity [homophobia], drug use, and sexual behaviors among HIV-positive men who have sex with men (MSM)" who are poor, urban, and of ethnic descent. Understanding these associations may help guide interventions to boost HIV testing and potentially reduce transmission, they explained.

Data from 347 HIV-positive participants from the Los Angeles site for National Institute on Drug Abuse's Sexual Acquisition and Transmission of HIV-Cooperative Agreement Program were used. Participants were MSM and men who have sex with men and women (MSM/W), and predominantly African-American (36.0 percent) or Latino (38.7 percent) and unemployed (82.8 percent).

Multivariate logistic regression indicated that unrecognized HIV infection was associated with being African American (OR: 9.81, CI: 1.2-77.9) or Latino (OR: 10.92, CI: 1.3-88.4), MSM/W rather than MSM (OR: 3.24, CI: 1.09-9.62), and having higher homonegativity scores (OR: 1.22, CI: 1.02-1.4), controlling for age, education, and homelessness.

"Building on past studies of predictors of unrecognized infection, results of this analysis suggest that high homonegativity is a strong predictor of lack of knowledge of HIV status," the authors concluded. "Understanding and addressing associations between homonegativity scores and stigma may improve the design of interventions to facilitate regular HIV testing for MSM communities of color in urban areas. Targeting interventions toward MSM/W, populations of color and populations with high levels of HIV-related stigma may help to increase testing and treatment and reduce rates of unrecognized HIV."

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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Russia Makes Little Progress Against Drugs

President Dmitry Medvedev on Monday acknowledged that a growing epidemic of drug abuse threatens Russia's future.

Drug use is contributing to up to a 3 percent economic decline per year in Russia, home to the world's third-highest rate of heroin use and one-third of all heroin-related deaths. According to the World Health Organization, heroin use is driving the country's fast-growing HIV/AIDS epidemic.

Health experts have been critical of the government's refusal to consider harm-reduction approaches such as methadone replacement therapy or needle exchanges. The Geneva-based International AIDS Society predicts HIV infections in Russia could grow between 5 percent and 10 percent annually unless the government takes appropriate action.

Medvedev said Russian children as young as 11 are using drugs. "In spite of the fact that heightened attention is given to this topic ... changes for better have been very, very few," he said in a meeting with high-level federal and regional officials in the Siberian city of Irkutsk. "There may be reason to think about introducing separate courses in educational programs, especially in disadvantaged areas and those where there is a tendency toward drug use."

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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New Condom Nears Approval

European regulators are considering whether to approve a condom containing a gel that helps men maintain a firmer erection. Developed by Futura Medical PLC, a UK-based biotechnology firm, CSD500 is noteworthy in a market where innovation is rare and patent protections are uncommon.

The gel in CSD500 is absorbed by the skin, boosting blood flow and enhancing erection. It is based on a generic compound for the treatment of angina, severe chest pain caused by lack of blood flow to the heart. The hurdle for Futura was immobilizing the gel so that the vasodilator maintains its integrity and only makes contact with the wearer during intercourse.

"Some products can degrade the latex very quickly," explained Futura CEO James Barder. "The challenge is having a stable product in a condom, a gel that doesn't do anything detrimental to the condom." Most of the patents involving CSD500 center on this immobilization, he said.

Though considered "Viagra for condoms," CSD500 is not classified as an erectile dysfunction treatment. Instead, it targets men who struggle to maintain an erection while wearing a condom. Designation as a medical device, rather than a drug, means CSD500 would be sold over-the-counter. The hope is that CSD500 will encourage men to use protection, thus helping prevent the spread of STDs.

Regulators in Europe are expected to rule on CSD500 during the first half of 2011, meaning the condom could be on pharmacy and supermarket shelves by year's end. If marketers decide to seek US approval, the Food and Drug Administration would require additional clinical data from US patients, said Matrix Group analyst Navid Malik.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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Porn Firms Faulted for Not Aiding HIV Probe

Pornographic film producers in California were uncooperative in assisting a recent HIV contact investigation involving an adult-film performer, a new report reveals. Los Angeles County public health officials undertook the investigation to quickly identify those infected and prevent onward HIV transmission; instead, barriers slowed its progress.

"Limited cooperation from many adult-film industry companies restricted this contact investigation. Rarely did industry legal counsel give information for investigation," Francisco Meza, a physician with CDC, wrote in a report analyzing the 2010 HIV scare. The case led local porn producers to temporarily shut down productions.

On Oct. 6, performer Derrick Burts tested HIV-positive at an adult-film industry-supported clinic that regularly screens performers for STDs. Considering his previous negative tests, health officials concluded Burts likely was infected between mid-August and mid-September. He had performed with two men he later learned had HIV; one was not being treated.

Of Burts' 16 sex partners two months prior to the HIV-positive diagnosis - six men and 10 women - 15 were industry performers, the report says. Following customary practice, Burts used condoms during scenes involving anal sex with male partners, but not during vaginal or oral sex scenes. Since his disclosure, Burts has advocated expanded condom use on porn sets.

Two key barriers to the county health investigation were the adult-film companies' refusal to cooperate and the performers' use of pseudonyms, the report says. Health officials were able to contact just five of the 16 partners, and all refused to cooperate with the investigation. Under federal law, porn producers must keep performers' real names on file to prove they are not minors.

The report urges the companies to give health officials the names of relevant actors and use condoms during the filming of any sex act.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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Veterans Affairs Increases HIV Screening

Streamlined testing procedures have helped more than double the number of vets getting screened for HIV in the Veterans Health Administration (VHA) system, according to a report presented at the recent American Conference on Treatment for HIV in Denver. The data and conclusions are considered preliminary until publication after peer review.

In 2009, federal law was amended to eliminate the requirement that the Department of Veterans Affairs document written informed consent to HIV testing, as well as mandatory pre- and post-test counseling. In addition, the VA incorporated electronic medical records HIV testing prompts, created new testing promotional materials, and held the first VHA HIV Testing Week in the summer of 2010, reported James Halloran, a researcher with the VA's Public Health Strategic Healthcare Group.

Before the law was changed, in 2009 only 2.5 percent of VA outpatients were tested for HIV by agency physicians, and just 9.2 percent of outpatients had ever been screened for HIV. After the law was changed, the number of VA outpatients being tested for HIV more than doubled, and 13.6 percent of outpatients reported having ever been tested.

HIV testing rose in all regions, though not uniformly. The rate of positivity declined, probably because more tests were administered, but remained above 0.1 percent in all regions, Halloran said.

Requiring written informed consent and pre- and post-testing "takes a lot of time," so many health care providers skip screening altogether, said CDC's John Brooks, MD, a conference co-chair. HIV tests should be offered as a routine part of health care and omitted only if the patient declines, he said.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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The Effect of Early Maltreatment, Victimization, and Partner Violence on HIV Risk Behavior Among Homeless Young Adults

The authors sought to "examine the relationship between child maltreatment, physical and sexual victimization, and partner violence victimization with [HIV] risk behaviors among a sample of homeless young adults from the midwestern United States."

Using data from the Homeless Young Adult Project, investigators interviewed 199 people ages 19-26 over 14 months, employing a systematic sampling strategy. The final sample included 172 young adults who were homeless or had a history of running away and being homeless.

Path analysis results showed that sexual abuse is directly linked with street sexual victimization, which was positively associated with a greater number of HIV risk behaviors. "Experiencing more types of physical abuse and neglect were positively correlated with partner violence victimization, which was, in turn, associated with more HIV risk behaviors," results showed. Youths who reported more types of neglect also experienced more forms of sexual and physical victimization.

Noting the implications for service providers, the investigators concluded, "Clinicians who serve homeless youth should recognize the potential effect that experiencing a variety of forms of victimization may have on health risk behaviors."

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


TOGETHER WE REMAIN STRONG!