Big changes ahead for ASOs

AIDS agencies have to look for ways to branch out if they want to survive and thrive under health care reform

Tammye Nash  |  Senior Editor
nash@dallasvoice.com

An estimated 1.2 million people in the United States are living with HIV infection, and 20 percent of them are not even aware of it, according to the Centers for Disease Control. And a CDC report released in early August suggests that there are about 50,000 new HIV infections each year.

And yet, federal funding for HIV/AIDS services have remained flat for the last five years — from funding for medical services to research dollars to money for support services — according to Raeline Nobles, executive director of AIDS Arms Inc.

And that means, Nobles and Resource Center Dallas Executive Director and CEO Cece Cox agreed this week, that the nonprofit, community-based organizations that have been the backbone have to look ahead and keep their options open to remain viable.

Changes in the way that federal funds through the Ryan White CARE Act are distributed — requiring that 75 cents of every Ryan White dollar be used for core medical services — give an edge to nonprofits that operate clinics. And that means that AIDS Arms, which just opened its second clinic last month — is “more competitive at the national, state and local levels,” Nobles said. “With the number of people who are uninsured and living at poverty levels, access to any kind of medical care is a priority. So if you are providing those kinds of services, it does give you an edge.”

Agencies that don’t provide those kinds of services, she added, can get in on that competitive edge by collaborating with those that do.

“There’s really no new money to sustain new agencies,” Nobles said. “AIDS is definitely off the docket in terms of diseases people seem to be concerned about. In fact, any HIV provider across the country who is not considering all their options is in a great deal of denial, and that may well come back to bite them rather severely.”

There’s also health care reform to consider, with several parts of the law passed in late 2010 still to be implemented. That reform, said Cox, is changing the face of community health clinics, like RCD’s Nelson-Tebedo Clinic, and HIV/AIDS service programs.

“Our nutrition program is a good example,” Cox said. “It has really been hammered in terms of federal funds, so we have focused on supporting the program through the community, foundations and corporations. … It is an amazing puzzle we have pieced together, even with cuts in traditional funding streams. But we have managed. We have done the things we felt we had to do.”

And there are more changes coming. Nobles said that if the Ryan White funds survive beyond 2013 when more health care reform measures go into effect, “it likely won’t include any money for outpatient services like we offer” at the Peabody Clinic and the new Trinity Clinic.

“So we have to take a look at what we do best, and we can use our model and globalize it into different areas. We have to become even more sustainable. Diversification of business is key to survival,” Nobles said. “It can’t just be about HIV and AIDS any more.”

Nobles said “serious discussion has been going on at AIDS Arms for at least two years, at the board and staff levels” about how the agency can expand its focus beyond HIV/AIDS and remain viable.

“We have to diversify our business plan. The situation has been serious for awhile and it is becoming even more serious for our board,” Nobles said. “We hope to have, by early 2012, a final business plan in place to move into the future.

“Health care reform is a great thing for a lot of people, but it poses real challenges for the nonprofit sector. You have to stay ahead of the curve, or health care reform will run right over you. We definitely want to stay ahead of that curve,” she continued. “The HIV nonprofit community has the best model of care and support the U.S. has ever seen. That model can be globalized to include care for other disease — heart disease, cancer, diabetes.”

Cox said that staff and board members at Resource Center Dallas also began planning for the changing future some time ago, and its current capital campaign to build a new facility is part of the plan.

“Nobody seems to have all the answers right now. The feds won’t say what they will and what they won’t fund. So savvy business people are already thinking, ‘If this funding goes away, what can we do instead?’” Cox said.

“Everybody feels like the challenge working in the nonprofit sector is that you are always aware there is so much more that needs to be done,” she added. “But doing more requires more space, more staff, more resources. And to have that, you have to build the business in a way that is sustainable. And you have to remember, nobody can do everything.”

Both Cox and Nobles are quick to remind that even though their agencies are “nonprofits,” they are businesses nonetheless, and have to be operated with an eye toward success.

“There has been, and probably still is, the mindset about nonprofits. People expect the nonprofits to be there to provide all these services without caring about costs,” Cox said. “But the fact is, nonprofit or not, these agencies have to be run like a business. You have to anticipate, plan ahead. You have to put the structures in place and you have to invest. We make large investments in our staff and in technology. For-profit business sell stock and they answer to their stockholders. We get our money from our donors, and we have an obligation to let our donors know what we do with their money and to let them know we use it responsibly.”

This article appeared in the Dallas Voice print edition November 11, 2011.

—  Kevin Thomas

Premature aging an issue for AIDS survivors

30 years after 1st diagnoses, scientists work to pin down cause of complications, while doctors develop treatment guidelines

LISA LEFF | Associated Press

SAN FRANCISCO — Having survived the first and worst years of the AIDS epidemic, when he was losing three friends to the disease in a day and undergoing every primitive, toxic treatment that then existed, Peter Greene is grateful to be alive.

But a quarter-century after his own diagnosis, the former Mr. Gay Colorado, now 56, wrestles with vision impairment, bone density loss and other debilitating health problems he once assumed he wouldn’t grow old enough to see.

“I survived all the big things, but now there is a new host of things. Liver problems. Kidney disease. It’s like you are a 50-year-old in an 80-year-old body,” Greene, a San Francisco travel agent, said. “I’m just afraid that this is not, regardless of what my non-HIV positive friends say, the typical aging process.”

Even when AIDS still was almost always fatal, researchers predicted that people infected with HIV would be more prone to the cancers, neurological disorders and heart conditions that typically afflict the elderly. Thirty years after the first diagnoses, doctors are seeing these and other unanticipated signs of premature or “accelerated” aging in some long-term survivors.

Government-funded scientists are working to tease apart whether the memory loss, arthritis, renal failure and high blood pressure showing up in patients in their 40s and 50s are consequences of HIV, the drugs used to treat it or a cruel combination of both. With people over 50 expected to make up a majority of U.S. residents infected with the virus by 2015, there’s some urgency to unraveling the “complex treatment challenges” HIV poses to older Americans, according to the National Institutes of Health.

“In those with long-term HIV infection, the persistent activation of immune cells by the virus likely increases the susceptibility of these individuals to inflammation-induced diseases and diminishes their capacity to fight certain diseases,” the federal health agency’s chiefs of infectious diseases, aging and AIDS research wrote, summing up the current state of knowledge on last September’s National HIV/AIDS and Aging Awareness Day. “Coupled with the aging process, the extended exposure of these adults to both HIV and antiretroviral drugs appears to increase their risk of illness and death from cardiovascular, bone, kidney, liver and lung disease, as well as many cancers not associated directly with HIV infection.”

In San Francisco, where already more than half of the 9,734 AIDS cases are in people 50 and over, University of California, San Francisco AIDS specialists are collaborating with geriatricians, pharmacists and nutritionists to develop treatment guidelines designed to help veterans of the disease cope with getting frail a decade or two ahead of schedule and to remain independent for as long as possible.

“Wouldn’t it be helpful to be able to say, are you at high risk, low risk or moderate risk for progressing to dependency in the next five, the next 10 years, being less mobile, less able to be functional in the workplace. Are you going to be safe in your home, are you going to remember to take all those medications? How are they going to interact?” explained Dr. Malcolm John, who directs UCSF’s HIV clinic. “All those questions need to be brought into the HIV field at a younger age.”

Research so far suggests that HIV is not directly causing conditions that mimic old age, but hastens patients toward ailments to which they may have been genetically or environmentally predisposed. Plus, their immune systems are being weakened over time even when they are being successfully treated for AIDS, John said.

“That’s probably true for a lot of these things. We aren’t saying HIV’s starting the problem, but it’s added fuel on top,” he said.

Stokes, a patient of John’s who goes by only his last name, is a prime example. At 53, HIV-positive since 1985 and in substance abuse recovery for the last 11 years, he says he is happier than he ever has been. Yet the number of ailments for which he is being treated would be more commonly found in someone 30 years his senior: a condition called Ramsay Hunt syndrome that causes facial paralysis, a rare cartilage disorder for which he has undergone four ear surgeries, bone death in the hip and shoulder, deterioration of his heart muscle, osteoporosis and memory loss.

A specialist recently diagnosed a Kaposi’s sarcoma spot on Stokes’ ankle. Although the cancer is not life-threatening, the sight of young men disfigured by KS lesions was a harbinger of the early AIDS crisis, and its presence on his own body is unsettling.

At his therapy group for men with HIV, aging “comes up frequently,” he said. “I say, ‘Just think what we have come through to have a life today.”’ At the same time, he acknowledges sometimes feeling self-conscious about his physical appearance and worries if “people are not attracted to me and unwilling to go the length of what it means to be with me, no matter how brilliant my mind or my zest for life.”

Loneliness, financial worries and concerns about who will care for them and where can weigh on long-term AIDS survivors in the same way as all adults living in a society that values youth, Charles Emlet, a social work professor at the University of Washington, Tacoma, said.

As they get older and sicker, many feel “doubly stigmatized,” he said. Some people who have lived with the virus for a long time have been getting by on private disability benefits that will run out when they turn 65, forcing them to move to less expensive locations or to consider turning to estranged family members. Like soldiers from a distant war, many lost partners and their closest friends to AIDS.

Such emotional side effects, combined with the physical toll of managing chronic health problems, put older AIDS patients at risk for depression. At the same time, Emlet has uncovered evidence that a majority of long-term survivors also share another trait that typically comes with advanced age: that is, the ability to draw strength from their difficult experiences.

“The older adults I’ve interviewed, many of them talk about how much it means to them to give back, to do something positive with the years they never expected to have,” he said.

Peter Greene can relate to that. At times, like the days he is so exhausted he can’t get out of bed or the pain from his multiple maladies is too intense, he asks himself “the Carrie Bradshaw question — are we really lucky to still be alive?” Carrie Bradshaw was the character played by Sarah Jessica Parker in the Sex and the City TV shows and films.

As frightening and uncertain as this phase of AIDS is, he thinks he knows the answer.

“I’ve tried to make the time I have count, and really, now that I have the body of an 80-year-old, I probably have the wisdom of an 80-year-old as well, which counts for a lot,” Greene said. “Everything becomes clear at the end of your life and in some ways, thinking you’ve been dying all these years, you get moments of clarity that I don’t think everyone gets.”

—  John Wright

Out Youth gets $25K from Sir Elton’s foundation

Out Youth Austin today announced that the organization for LGBT youth has received a $25,000 grant from the Elton John AIDS Foundation for Out Youth’s K.Y.S.S. (Knowing Your Status is Smart) program for HIV prevention, testing and counseling for young people, ages 12-19, in Central Texas.

The group received a $25,000 grant for the same program in March from the London-based Red Hot Organization. The Elton John AIDS Foundation is based in New York.

Out Youth Austin Executive Director Candice Towe called the latest grant “a tremendous Christmas present” for the organization.

Monrovia Van Hoose, Out Youth’s clinical director who oversees K.Y.S.S., said, “It’s critical that GLBTQ youth have regular access to confidential HIV testing and counseling. Staff, clinical interns and volunteers have received intensive training to provide testing and counseling for HIV and other sexually transmitted infections.”

According to a 2009 report from the Centers for Disease Control, 48 percent of Americans ages 13-24 who are infected with HIV are unaware of their HIV status. In 2008, CDC noted that American youth are at “persistent risk” of HIV infection, and that many are “not concerned” about the risks of infection.

—  admin

HIV-positive LA porn actor calls for condom use

Follow-up care was promised but actor says he received none from industry’s clinic

Associated Press

LOS ANGELES — An adult film actor who tested positive for HIV says he now wishes he had known more about the risks of contracting sexually transmitted diseases in the industry and is calling for mandatory condom use in porn films.

Derrick Burts, 24, identified himself to the Los Angeles Times as the performer who tested positive at the Adult Industry Medical Healthcare Foundation in Sherman Oaks in October. He had previously been known as Patient Zeta.

Burts, who performed in straight films as Cameron Reid and gay films as Derek Chambers, described the panicked call he got from clinic staff on Oct. 9 about the infection that sent fears through California’s adult industry.

Clinic staff told him they wanted to perform a follow-up test and begin notifying performers he had worked with since his last negative test result Sept. 3. He was told those performers would be placed on a quarantine list and also would be tested.

When Burts returned to the clinic Oct. 23 to review the second test results, he said he was told that the clinic had traced his HIV infection to someone he had performed a scene with, someone they described as a “known positive.” The clinic would not identity the performer because of patient confidentiality.

Burts said he believed he may have contracted the disease during a gay porn shoot in Florida.

Despite Burts’ account of what he was told, clinic officials released a statement last month that said “Patient Zeta acquired the virus through private, personal activity.”

“That’s completely false,” Burts told the Times. “There is no possible way. The only person I had sex with in my personal life was my girlfriend.”

She tested negative, he said.

An e-mail to the Adult Industry Healthcare Foundation seeking comment this week was not immediately returned.

Burts said the clinic promised to put him in touch with a doctor affiliated with the clinic and promised to arrange for his follow-up care. But he said no one called him back and when he contacted the clinic, he received no response for two months.

In frustration, Burts said he went to an AIDS Healthcare Foundation center in Los Angeles on Nov. 24 but didn’t identify himself as Patient Zeta.

Burts said he was pleased with the care he received there and contacted the head of the organization last week and identified himself as Patient Zeta. He said he wanted to speak out in favor of enforcing mandatory condom use in porn productions.

Burts grew up in Whittier and Hemet and graduated from Hemet High School and a hotel management school in Florida, according to the Times. He worked as a hotel manager and cruise ship magician before becoming a performer in the lucrative porn industry.

“Making $10,000 or $15,000 for porn isn’t worth your life,” he told the Times. “Performers need to be educated.”

© 2010 Keen News Service

This article appeared in the Dallas Voice print edition December 10, 2010.

—  Kevin Thomas

WATCH: Gay porn actor calls for condom use

Associated Press

LOS ANGELES — An adult film actor who tested positive for HIV says he now wishes he had known more about the risks of contracting sexually transmitted diseases in the industry and is calling for mandatory condom use in porn films.

Derrick Burts, 24, identified himself to the Los Angeles Times as the performer who tested positive at the Adult Industry Medical Healthcare Foundation in Sherman Oaks in October. He had previously been known as Patient Zeta.

Burts, who performed in straight films as Cameron Reid and gay films as Derek Chambers, described the panicked call he got from clinic staff on Oct. 9 about the infection that sent fears through California’s adult industry.

Clinic staff told him they wanted to perform a follow-up test and begin notifying performers he had worked with since his last negative test result Sept. 3. He was told those performers would be placed on a quarantine list and also would be tested.

When Burts returned to the clinic Oct. 23 to review the second test results, he said he was told that the clinic had traced his HIV infection to someone he had performed a scene with, someone they described as a “known positive.” The clinic would not identity the performer because of patient confidentiality.

Burts said he believed he may have contracted the disease during a gay porn shoot in Florida.

Despite Burts’ account of what he was told, clinic officials released a statement last month that said “Patient Zeta acquired the virus through private, personal activity.”

“That’s completely false,” Burts told the Times. “There is no possible way. The only person I had sex with in my personal life was my girlfriend.”

She tested negative, he said.

An e-mail to the Adult Industry Healthcare Foundation seeking comment late Tuesday, Dec. 7 was not immediately returned.

Burts said the clinic promised to put him in touch with a doctor affiliated with the clinic and promised to arrange for his follow-up care. But he said no one called him back and when he contacted the clinic, he received no response for two months.

In frustration, Burts said he went to an AIDS Healthcare Foundation center in Los Angeles on Nov. 24 but didn’t identify himself as Patient Zeta.

Burts said he was pleased with the care he received there and contacted the head of the organization last week and identified himself as Patient Zeta. He said he wanted to speak out in favor of enforcing mandatory condom use in porn productions.

The Times reported the foundation had scheduled a news conference with Burt on Wednesday.

Burts grew up in Whittier and Hemet and graduated from Hemet High School and a hotel management school in Florida, according to the Times. He worked as a hotel manager and cruise ship magician before becoming a performer in the lucrative porn industry.

“Making $10,000 or $15,000 for porn isn’t worth your life,” he told the Times. “Performers need to be educated.”

—  John Wright

What to do after bringing Lady Gaga and Kim Kardashian back to life on World AIDS Day

If you decide to join Lady Gaga, Justin Timberlake, Kim Kardashian and other celebrities by giving up Facebook and Twitter on World AIDS Day — and if you aren’t too busy trying to bring them back to life — there will be plenty of other activities to keep you busy Wednesday in North Texas.

In Friday’s Voice we published what we thought was a complete schedule of World AIDS Day doings — from quilt panels to free testing to candlelight vigils — but below is one more that came across this morning. If you know of other events, please feel free to shoot us an e-mail or post them in the comments.

Parkland patients, staff hold educational event about HIV/AIDS

DALLAS – On World AIDS Day, Parkland Health & Hospital System staff and patients who participate in the HIV Consumer Advisory Board will educate the Dallas community about resources available to HIV patients from 6 to 8:45 p.m., Dec. 1 at the Dallas Marriot City Center, 650 North Pearl St. in Dallas.

This free event is the first of its kind, focused on HIV positive members of the community and open to the public. The theme is “Universal Access and Human Rights.”

The event will also offer education and a fair featuring local organizations that specialize in HIV-related services. HIV health care providers from across the community will provide education and materials from local organizations. Light snacks and refreshments will be served.

Keynote speaker Kevin Murphy, MD, will answer questions from guests. Murphy is responsible for formulating the curriculum in AIDS and sexually transmitted diseases at the Dallas County Health Department and organized the early surveillance of AIDS in Dallas.

“One in 376 Texans is HIV-positive. We hope this event can provide support and education to those in our community who are impacted from this complex chronic disease,” said Sylvia Moreno, RN, director of Nursing-HIV at Parkland. “As the premier health care facility in this area for HIV infection, Parkland is able to provide excellent care from the beginning to advanced stages of disease. We want to share that expertise with others by arming them with information and education.”

For more information, please call 214.590.7055 or visit www.parklandhospital.com.

—  John Wright

Truvada breakthrough gets mixed reaction from local docs, advocates

Report that drug could protect HIV-negative men from infection is good news, but concerns remain over long-term effects, some say

David Taffet  |  Staff Writer taffet@dallasvoice.com

REMEMBERING THEIR NAMES | Two unidentified visitors console each other at the NAMES Project AIDS Memorial Quilt display in October 1989 in Washington, D.C. Panels from the Quilt will be on display in the International Peace Chapel at Cathedral of Hope on World AIDS Day 2010, Wednesday, Dec. 1. More coverage of World AIDS Day events in North Texas begins on Page 14. (Doug Mills/Associated Press)

An extensive study released this week indicates that use of the anti-retroviral drug Truvada by HIV-negative men can prevent infection. Use of the drug for prevention is called Pre-Exposure Prophylaxis or PrEP.

Dr. Nick Bellos, a local infectious disease specialist, called the results of the study a step in the right direction. But Bellos also warned that the study only showed 75 percent effectiveness in preventing infection among people who were most compliant. And he said he had concerns about patients developing resistance to the drug and not using other risk-reduction techniques.

Local AIDS activist Bret Camp, associate executive director for health and medical services at Resource Center Dallas, also warned that the side effects and long-term effects of using Truvada can be severe.

Global HIV Vaccine Enterprise executive director Dr. Alan Bernstein, referring to another recent study using a topical microbicide that appears to prevent HIV infection in women and another study that included the first demonstration of efficacy by an HIV vaccine regimen, said, “The announcement [about Truvada] … is a very important addition to what is the most promising 15 months in the field of HIV prevention research since the epidemic began 27 years ago.”

The Centers for Disease Control said the findings in the Truvada study are a major advance in prevention research and a new tool to reduce the risk of infection among gay men and bisexuals.

Dr. Brady Allen, a Dallas internist, was optimistic, but also had some concerns.

“I think we have a lot of issues to consider with PrEP,” he said. “We will certainly need recommendations from the CDC. In addition, I think it is promising work.”

AIDS Arms Executive Director Raeline Nobles was also optimistic.

“This study shows hope and a new way to battle the HIV epidemic,” Nobles said. “Usually we are a little apprehensive when there is a press release about new drugs or vaccines being tested, as we know there will be years of further study and validation — and often failure over time to come to fruition.”

But, she added, the Truvada study has her excited about the future.

Camp stressed that “The anti-retroviral prophylaxis approach is promising but only a piece of the solution.”

He said that the new drug therapy cannot replace traditional prevention methods, and he pointed out that new infections did occur among men who took the medication.

Among the 2,500 enrolled participants, 36 new infections occurred among individuals who received the drug. Among placebo recipients, there were 64 new infections. Researchers estimated that the use of the preventive medication cut new HIV infections by an estimated 44 percent overall when compared to placebo.

“Adherence to taking the pills is key to success,” Camp said.

The study did show that those who took Truvada daily had a much higher rate of protection than those who took the pills only half of the time.

Camp said that “two participants who seroconverted had resistance after” that would have been built by irregular use of the drug, causing it to be at a lower-than-therapeutic level in the blood at the time of infection.

Dr. Nick Bellos
Dr. Nick Bellos

Bellos said that those patients also may have contracted a strain of the virus that is resistant to Truvada.

But Bellos still called the results promising and said that prophylaxis is a good idea.

“In a perfect world, if we could get everyone treated, we could plateau the epidemic,” he said.

While the CDC called “developing guidance on the safe and effective use of PrEP and determining how to most effectively use PrEP in combination with other prevention strategies to reduce new infections in the U.S.” its most urgent priority, Camp warned of the risks.
While he said that compared to some of the other anti-retrovirals on the market, Truvada is fairly well tolerated, it can still cause headaches, nausea and diarrhea.

“It’s known to cause decreases in renal function,” he said. “We could be setting people up for renal issues and the long-term effects are just now coming to our attention. Cardio-vascular disease, diabetes — we don’t know what the next 10 to 20 years on those drugs will be.”

Bellos noted that metabolic bone disease could also be an issue.

He said that anyone taking the drug as a prophylactic measure would need to be medically monitored on a regular basis, just as someone who is HIV-positive.

Despite his concerns, Camp did say he believes the results are a breakthrough that proved a non-intended use or expected finding. Previous studies have shown a benefit of drugs for medical personnel accidentally exposed to the virus but this was the first time prevention was proven through sexual exposure.

“The value is more in post-exposure, when traditional HIV prevention mechanisms fail,” he said.

Camp said he is more excited about the research into anti-microbial topical gels that have recently also proven effective in preventing infection after exposure.

Bellos agreed.

“My preference is for a vaccine,” Bellos said.

“Then we don’t have to worry about it.”

He said that a study has been done in South Africa among couples where one is HIV-positive and the other is negative, showing that when the positive partner’s viral load is undetectable, the risk to the negative partner is about 6 percent.

“On therapy, 94 percent of the negative partners stayed negative,” he said.

Bellos also warned that the Truvada study showed that even for the most compliant participants in the study showed only 75 percent effectiveness in preventing infection.

He said he is concerned that people will ignore traditional prevention methods that have proven effective and instead rely on the less-effective prophylaxis.

Nobles said it has long been known that strict adherence to anti-retroviral treatment among HIV-positive people leads to less transmission of the virus to others.

But she wondered about some of the ethical implications that need to be studied, including the cost and availability of Truvada.

“If we can’t afford to treat all HIV positive people living with the disease today — which we cannot — how will we ever be able to afford paying for preventive medications, too?” Nobles said.

The drug costs about $45 per pill in the United States. Because the manufacturer gave away the patent for production by generic drug makers in other countries, it is available in some countries for under $1.

“One wonders if insurance companies are going to be willing to pay for this,” Allen said.

Bellos said that he has some patients with family members in places like Pakistan and Thailand and they are able to get the drug from overseas.

“We should have two other large PrEP trials reported on in 2011 in other high-risk groups, which will help confirm or refute these results,” said Allen.

President Barack Obama also weighed in on the importance of the study.

“I am encouraged by this announcement of groundbreaking research on HIV prevention,” the president said in a statement released Tuesday, Nov. 23.

“While more work is needed, these kinds of studies could mark the beginning of a new era in HIV prevention,” the president said.

“As this research continues, the importance of using proven HIV prevention methods cannot be overstated.”

……………………..

MORE ON TRUVADA

Truvada is a combination drug therapy known as a nucleoside analog reverse transcriptase inhibitor. Two anti-HIV medications, Emtriva® and Viread®, are combined into one pill that is taken once a day with or without food.

In the United States, the cost of the treatment is more than $1,000 per month.

Manufacturer Gilead has given away the patent for generic manufacturers to produce and sell it in third world countries. There, the cost of the drug averages 45 cents a day or about $15 per month.

Those generic medications are not available in the United States.

Dr. Nick Bellos said that patients of his who have access to the generic medication have family members in those countries that are filling the prescription and sending them the drug.

Truvada has been one of the more successful HIV medications. Fewer people seem to experience side effects on this drug than on some of the others.

Studies show that more people became and stayed undetectable over a three-year period on Truvada than on Combivir or Sustiva, two other popular HIV medications.

Those on Truvada showed a greater increase in the number of CD4 cells than on other medications.

Side effects include nausea, vomiting, unusual muscle pain and/or weakness.

Longterm use could lead to liver damage, renal failure, increased risk of diabetes and metabolic bone disease.

Changes in body fat have been seen in some people taking Truvada.

—David Taffet

This article appeared in the Dallas Voice print edition November 26, 2010.

—  Michael Stephens

Study: Pill helps gay men avoid HIV infection

Experts call Truvada research ‘a major milestone’ but warn that condoms remain the ‘first line of defense’

MARILYNN MARCHIONE  |  Associated Press

MILWAUKEE — Scientists have an exciting breakthrough in the fight against AIDS. A pill already used to treat HIV infection turns out to be a powerful weapon in protecting healthy gay men from catching the virus, a global study found.

Daily doses of Truvada cut the risk of infection by 44 percent when given with condoms, counseling and other prevention services. Men who took their pills most faithfully had even more protection, up to 73 percent.

Researchers had feared the pills might give a false sense of security and make men less likely to use condoms or to limit their partners, but the opposite happened — risky sex declined.

The results are “a major advance” that can help curb the epidemic in gay men, said Dr. Kevin Fenton, AIDS prevention chief at the U.S. Centers for Disease Control and Prevention. But he warned they may not apply to people exposed to HIV through male-female sex, drug use or other ways. Studies in those groups are under way now.

“This is a great day in the fight against AIDS … a major milestone,” said a statment from Mitchell Warren, head of the AIDS Vaccine Advocacy Coalition, a nonprofit group that works on HIV prevention.

Because Truvada is already on the market, the CDC is rushing to develop guidelines for doctors using it for HIV prevention, and urged people to wait until those are ready.

“It’s not time for gay and bisexual men to throw out their condoms,” Fenton said. The pill “should never be seen as a first line of defense against HIV.”

As a practical matter, price could limit use. The pills cost from $5,000 to $14,000 a year in the United States, but only 39 cents a day in some poor countries where they are sold in generic form.

Whether insurers or government health programs should pay for them is one of the tough issues to be sorted out, and cost-effectiveness analyses should help, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

“This is an exciting finding,” but it “is only one study in one specific study population,” so its impact on others is unknown, Fauci said.

His institute sponsored the study with the Bill & Melinda Gates Foundation. Results were reported at a news conference Tuesday and published online by the New England Journal of Medicine.

It is the third AIDS prevention victory in about a year. In September 2009, scientists announced that a vaccine they are now trying to improve had protected one in 3 people from getting HIV in a study in Thailand. In July, research in South Africa showed that a vaginal gel spiked with an AIDS drug could cut nearly in half a woman’s chances of getting HIV from an infected partner.

Gay and bisexual men account for nearly half of the more than 1 million Americans living with HIV. Worldwide, more than 40 million people have the virus, and 7,500 new infections occur each day. Unlike in the U.S., only 5 to 10 percent of global cases involve sex between men.

“The condom is still the first line of defense,” because it also prevents other sexually spread diseases and unwanted pregnancies, said the study leader, Dr. Robert M. Grant of the Gladstone Institutes, a private foundation affliated with the University of California, San Francisco.

But many men don’t or won’t use condoms all the time, so researchers have been testing other prevention tools.

AIDS drugs already are used to prevent infection in health care workers accidentally exposed to HIV, and in babies whose pregnant mothers are on the medication. Taking these drugs before exposure to the virus may keep it from taking hold, just as taking malaria pills in advance can prevent that disease when someone is bitten by an infected mosquito.

The strategy showed great promise in monkey studies using tenofovir (brand name Viread) and emtricitabine, or FTC (Emtriva), sold in combination as Truvada by California-based Gilead Sciences Inc.

The company donated Truvada for the study, which involved about 2,500 men at high risk of HIV infection in Peru, Ecuador, Brazil, South Africa, Thailand and the United States (San Francisco and Boston). The foreign sites were chosen because of high rates of HIV infection and diverse populations.

More than 40 percent of participants had taken money for sex at least once. At the start of the study, they had 18 partners on average; that dropped to around 6 by the end.

The men were given either Truvada or dummy pills. All had monthly visits to get HIV testing, more pills and counseling. Every six months, they were tested for other sexually spread diseases and treated as needed.

After a median followup of just over a year, there were 64 HIV infections among the 1,248 men on dummy pills, and only 36 among the 1,251 on Truvada.

Among men who took their pills at least half the time, determined through interviews and pill counts, the risk of infection fell by 50 percent. For those who took pills on 90 percent or more days, risk fell 73 percent. Tests of drug levels in the blood confirmed that more consistent pill-taking gave better protection.

The treatment was safe. Side effects were similar in both groups except for nausea, which was more common in the drug group for the first month but not after that. Unintended weight loss also was more common in the drug group, but it occurred in very few. Further study is needed on possible long-term risks.

What’s next?

All participants will get a chance to take Truvada in an 18-month extension of the study. Researchers want to see whether men will take the pill more faithfully if they know it helps, and whether that provides better protection. About 20,000 people are enrolled in other studies testing Truvada or its component drugs around the world.

The government also will review all ongoing prevention studies, such as those of vaccines or anti-AIDS gels, and consider whether any people currently assigned to get dummy medicines should now get Truvada since it has proved effective in gay men.

Gilead also will discuss with public health and regulatory agencies the possibility and wisdom of seeking approval to market Truvada for prevention. The company has made no decision on that, said Dr. Howard Jaffe, president of Gilead Foundation, the company’s philanthropic arm. Doctors can prescribe it for this purpose now if patients are willing to pay for it, and some already do.

Some people have speculated that could expose Gilead to new liability concerns, if someone took the pill and then sued if it did not protect against infection.

“The potential for having an intervention like this that has never been broadly available before raises new questions. It is something we would have to discuss internally and externally,” Jaffe said.

Until the CDC’s detailed advice is available, the agency said gay and bisexual men should:

• Use condoms consistently and correctly.

• Get tested to know their HIV status and that of their partners, and get tested and treated for syphilis, gonorrhea and other infections that raise the risk of HIV.

• Get counseling to reduce drug use and risky sex.

• Reduce their number of sexual partners.

—  John Wright

AIDS breakthrough: Gel helps prevent infection

MARILYNN MARCHIONE  |  AP Medical Writer

MILWAUKEE — For the first time, a vaginal gel has proved capable of blocking the AIDS virus: It cut in half a woman’s chances of getting HIV from an infected partner in a study in South Africa. Scientists called it a breakthrough in the long quest for a tool to help women whose partners won’t use condoms.

The results need to be confirmed in another study, and that level of protection is probably not enough to win approval of the microbicide gel in countries like the United States, researchers say. But they are optimistic it can be improved.

“We are giving hope to women,” who account for most new HIV infections, said Michel Sidibe in a statement. He is executive director of the World Health Organization’s UNAIDS program. A gel could “help us break the trajectory of the AIDS epidemic,” he said.

And Dr. Anthony Fauci of the U.S. National Institutes of Health said, “It’s the first time we’ve ever seen any microbicide give a positive result” that scientists agree is true evidence of protection.

The gel, spiked with the AIDS drug tenofovir, cut the risk of HIV infection by 50 percent after one year of use and 39 percent after 2 1/2 years, compared to a gel that contained no medicine.

To be licensed in the U.S., a gel or cream to prevent HIV infection may need to be at least 80 percent effective, Fauci said. That might be achieved by adding more tenofovir or getting women to use it more consistently. In the study, women used the gel only 60 percent of the time; those who used it more often had higher rates of protection.

The gel also cut in half the chances of getting HSV-2, the virus that causes genital herpes. That’s important because other sexually spread diseases raise the risk of catching HIV.

Even partial protection is a huge victory that could be a boon not just in poor countries but for couples anywhere when one partner has HIV and the other does not, said Dr. Salim Abdool Karim, the South African researcher who led the study. In the U.S., nearly a third of new infections each year are among heterosexuals, he noted.

Countries may come to different decisions about whether a gel that offers this amount of protection should be licensed. In South Africa, where one in three girls is infected with HIV by age 20, this gel could prevent 1.3 million infections and 826,000 deaths over the next two decades, he calculated.

He will present results of the study Tuesday at the International AIDS Conference in Vienna. The research was published online Monday by the journal Science.

“We now have a product that potentially can alter the epidemic trends … and save millions of lives,” said Dr. Quarraisha Abdool Karim, the lead researcher’s wife and associate director of the South African program that led the testing.

It’s the second big advance in less than a year on the prevention front. Last fall, scientists reported that an experimental vaccine cut the risk of HIV infection by about 30 percent. Research is under way to try to improve it.

If further study shows the gel to be safe and effective, WHO will work to speed access to it, said its director-general, Dr. Margaret Chan.

The gel is in limited supply; it’s not a commercial product, and was made for this and another ongoing study from drug donated by California-based Gilead Sciences Inc., which sells tenofovir in pill form as Viread. If further study proves the gel effective, a full-scale production system would need to be geared up to make it.

The study tested the gel in 889 heterosexual women in and near Durban, South Africa. Researchers had no information on the women’s partners, but the women were heterosexual and, in general, not in a high-risk group, such as prostitutes.

Half of the women were given the microbicide and the others, a dummy gel. Women were told to use it 12 hours before sex and as soon as possible within 12 hours afterward.

At the study’s end, there were 38 HIV infections among the microbicide group versus 60 in the others.

The gel seemed safe — only mild diarrhea was slightly more common among those using it. Surveys showed that the vast majority of women found it easy to use and said their partners didn’t mind it. And 99 percent of the women said they would use the gel if they knew for sure that it prevented HIV.

This shows that new studies testing the gel’s effectiveness without a placebo group should immediately be launched, said Salim Abdool Karim. The only other study testing the gel now compares it to placebo and will take a couple more years to complete.

The study was sponsored by the Centre for the AIDS Programme of Research in South Africa, or CAPRISA; Family Health International; CONRAD, an AIDS research effort based at Eastern Virginia Medical School; and the U.S. Agency for International Development, or USAID.

Gilead has licensed the rights to produce the gel, royalty-free, to CONRAD and the International Partnership on Microbicides for the 95 poorest countries in the world, said Dr. Howard Jaffe, president of the Gilead Foundation, the company’s philanthropic arm.

The biggest cost of the gel is the plastic applicator — about 32 cents, which hopefully would be lower when mass-produced, researchers said.

Mitchell Warren, head of the AIDS Vaccine Advocacy Coalition, a nonprofit group that works on HIV prevention tools, said the study shows a preventive gel is possible.

“We can now say with great certainty that the concept has been proved. And that in itself is a day for celebration,” he said.

—  John Wright