ARVs and HIV Prevention: Controversies, Conflicts and Consensus

An interesting and informative article by AIDSmeds.com writer Tim Horn.

While studies exploring the effectiveness of antiretroviral (ARV) therapy for HIV prevention purposes have generally yielded encouraging results, a group of researchers at the University of North Carolina at Chapel Hill suggest that the way forward is not entirely clear and that additional research is needed, particularly in understanding the combined benefits of biomedical and behavioral interventions in specific at-risk communities.
“Recent research developments in [pre-exposure prophylaxis, or PrEP] and [treatment of people living with HIV to curtail HIV transmission] provide a unique opportunity to highlight areas of advancement that have galvanized changes in HIV treatment and prevention, and to highlight topic areas that remain undecided and controversial,” write Myron Cohen, MD, and his colleagues in an editorial published ahead of print by the journal AIDS.

The paper reviews much of the scientific research that has contributed to our current understanding of ARV treatment as prevention, including pharmacologic and observational studies, ecological evaluations and various modeling and empirical data. And despite the completion of several sound clinical trials—also summarized by Cohen and his colleagues and reviewed here—gaps in knowledge remain.

CLICK HERE to read the full article.

Calif. Gives $11.8M in HIV Grants, Including PrEP Study

Click here to read the Mercury News article

California to test pill
for HIV prevention

Associated Press

LOS ANGELES — California will test an HIV-prevention pill in an attempt to slow the spread of the disease in the state, researchers announced Tuesday.

The pill, which is already used to treat HIV patients, will be prescribed to 700 gay and bisexual men and transgender women in Los Angeles, San Diego and Long Beach who are high-risk but not infected.

“With this new prevention pill, we have another intervention to put in the arsenal to try and impact this epidemic,” said George Lemp, director of the California HIV/AIDS Research Program with the University of California president’s office.

The program awarded $11.8 million in state grants for the prevention pill studies and efforts to get about 3,000 HIV-infected people in Southern California into treatment and keep them there. The grants will go to a group of UC schools, local governments and AIDS organizations.

There are an estimated 140,000 people living with HIV or AIDS in California, including about 30,000 who don’t know they are infected, Lemp said.

The pill, under the brand name of Truvada, is already approved by the Food and Drug Administration for treating HIV but not for prophylactic use. In 2010, a study published in The New England Journal of Medicine said that it reduced the risk of contracting HIV by 44 percent to 73 percent, depending on how often participants took their medication.

The two-drug pill, produced by Gilead Sciences in the Bay Area, hasside effects that include nausea and vomiting, and possible kidney problems when used with other anti-HIV drugs.

 

A recent Stanford University study showed that the pill, which costs about $26 a day, only makes sense economically if prescribed to people at high risk, such as those with multiple partners.

The prevention pill and counseling have “enormous possibilities” for high-risk people, said Phil Curtis of AIDS Project Los Angeles, which will recruit participants. But more research is needed to measure the effects in the real world, he said. “It is unrealistic to expect that a patient without HIV is going to see a doctor every month,” he said.

Critics say there is not enough evidence of the pill’s effectiveness to support its use. In addition, they say the pill could lead to more men not using condoms and result in more new infections.

“Men — gay, straight, bisexual — don’t want to use condoms,” said Michael Weinstein, president of the AIDS Healthcare Foundation. “That’s universal. If they are given another reason, then they won’t.”

 


Bill to Require Health Insurance Plans to Cover Routine HIV Tests

U.S. Representative Maxine Waters (D–Calif.) is sponsoring a bill to require health insurance plans to provide coverage for routine HIV tests, The New York Times reports. The proposed Routine HIV Screening Coverage Act of 2012 is an amendment to the Public Health Service Act and is being cosponsored by Representative Barbara Lee (D–Calif.). This bill was assigned to a congressional committee April 19 and will be considered by the speaker before possibly being sent to the House or Senate as a whole. 

Click here to read the NY Times update
.

CALIFORNIA: "Pill to Block HIV Tested"

CALIFORNIA:   “Pill to Block HIV Tested”
Los Angeles Times     (04.18.12):: Anna Gorman


Researchers announced on April 17 that California will take part in a trial of a pill to slow the spread of HIV in the state. Truvada, already approved to treat HIV infection, will be prescribed to 700 gay and bisexual men and transgender women in Los Angeles, San Diego, and Long Beach who are at high risk of infection.

“With this new prevention pill, we have another intervention to put in the arsenal to try and impact this epidemic,” said George Lemp, director of the California HIV/AIDS Research Program with the University of California president’s office.

The program awarded $11.8 million in state grants for the prevention studies and for an outreach to get about 3,000 HIV-positive Southern Californians to adhere to treatment. University of California schools, local governments, and AIDS service organizations are receiving the grants.

Although a study published in 2010 found that Truvada reduces the risk of contracting HIV by 44 percent to 73 percent, depending on how often patients took their medication, a recent Stanford study showed the drug only makes sense economically if prescribed to people at high risk, such as those with multiple partners.

Phil Curtis of AIDS Project Los Angeles said more research is needed to measure the effects of the approach in the real world. In San Diego, researchers plan to use text messages to remind people to take their pill. In Los Angeles, the level of drugs in participants’ blood will be regularly measured.

Critics say taking Truvada for prevention could lead to more men not using condoms. “Men – gay, straight, bisexual – don’t want to use condoms,” said Michael Weinstein, president of the AIDS Healthcare Foundation. “That’s universal. If they are given another reason, then they won’t.”

N.Y. Advocates Want Condoms Out of Prostitute Cases

CDC National Prevention Information Network

NEW YORK:   “N.Y. Advocates Want Condoms Out of Prostitute Cases” 

(04.17.12):: Michael Virtanen

A Manhattan-based group that advocates for sex workers wants New York to be the first state to ban police officers from confiscating condoms as evidence in prostitution cases. The Sex Workers Project at the Urban Justice Center said Tuesday that fear of police harassment and arrest has led some prostitutes to carry fewer or no condoms and have unprotected sex.

State Sen. Velmanette Montgomery (D-Brooklyn) has sponsored a bill to ban condoms as evidence. “We are not endorsing prostitution,” she said. “It is simply related to the fact that over 100,000 people right now are infected with HIV and AIDS in New York City.”

Although New York City health officials have given out 192 million free condoms since 2007, health department spokesperson Alexandra Waldhorn said the city opposes the pending legislation.

Kate Hogan, a prosecutor, said giving up supporting evidence would be giving pimps and sex traffickers “a lot of leeway we don’t want to give them.”

Surveys of sex workers were done in 2010 and 2011 by the city and the PROS Network, a coalition of workers and advocates. The network survey included 35 sex trade workers; of those, 15 said police had taken or destroyed their condoms with only five arrests. Six said they had sex later, and only half of them used a condom. Of 63 people in the city survey, 36 said their condoms were taken and 26 said they were arrested.

Human Rights Watch researchers Kathleen Todrys and Megan McLemore said preliminary results from their study of sex workers in New York City and other cities raise similar concerns. McLemore said that after San Francisco supervisors directed police to stop confiscating condoms in 1996, officers instead began photographing the condoms to use as evidence.

UCLA/Johnson & Johnson Health Care Executive Program

 

Greetings! 

 

The Anderson School of Management at University of California Los Angeles (UCLA) invites executive directors and leaders of Community Health Centers (CHCs) and AIDS Service Organizations (ASOs) to apply for the:

UCLA/Johnson & Johnson Health Care Executive Program”

Click here for application materials.

Click here for relevant website.

Applications due on May 15th

 

 

 

 

Questions:  Please direct all questions to Diana Hernandez or call her at (310) 794-9559.

 

California Office of AIDS

Resource Identification, Dissemination and Linkage (RIDL) Task Force

With better HIV tests, should FDA end its ban on gay men donating blood?

Raymond Robbins was ready to roll up his sleeve and give blood for the first time when a question asked of potential donors stopped him cold:

“From 1977 to the present, have you had sexual contact with another male, even once?”

“I answered yes, but I was caught off guard by the question,” said Robbins, 28, of Washington.

His answer got him turned away, stopped by a longstanding Food and Drug Administration policy that bans sexually active gay men from ever donating blood. The federal ban, now three decades old, has come under increasing scrutiny in recent years as HIV detection tests and procedures for screening donated blood have improved greatly and blood shortages have become common.

“It makes me feel like I’m placed in a negative category, like they are labeling me as diseased and decrepit,” said Robbins, who because of the ban has never tried to give blood since being rejected 10 years ago during high school. “The policy is very backward.”

But the FDA defends the ban, saying men who have sex with men are at a much higher-than-average risk of HIV and other infections that can be transmitted through transfusions. Although the FDA wouldn’t make officials available for an interview, the agency said in a statement that it’s trying to protect the public and is basing its policy on science, not “any judgment concerning the donor’s sexual orientation.”

The FDA said studies are underway that could lead it to reevaluate the ban, which was most recently upheld after a 2010 review by the Department of Health and Human Services Advisory Committee on Blood Safety and Availability. Meanwhile, a similar ban was lifted last year in England, Scotland and Wales, which now allow men to give blood if they haven’t had sex with another man for at least a year, more than enough time for HIV to be detected in their blood.

 

Time for a change?…..

CLICK HERE to continue reading this article from washingtonpost.com

 

 

Latent HIV Infection

 By Ike Nwankpa

As seen on TheBody.com

 April 9, 2012

 HIV infects cells of the immune system and reprograms them to spew out copies of the virus. But not all of these HIV-infected cells roam freely in the body; some HIV goes into hibernation instead, avoiding the attention of the immune system and of antiretrovirals. This hibernation is called “latent infection.” It results in “reservoirs” of undetected HIV tucked away in various parts of the body, ready to seed the body with more of the virus when triggered.

There is still much we don’t know about how latent HIV infection works, but many experts believe that if a way can be found to find this hidden HIV and eliminate its reservoirs in the body, it may bring us one huge step closer to a cure.

According to Futurity, destroying latent HIV infections may one day be possible:

The strategy involves reactivating the HIV and coaxing it out of hiding, but only after boosting other immune system T cells and preparing them to ambush and eradicate the virus as it emerges.”Our study results strongly suggest that a vaccination to boost the immune response immediately prior to reactivating latent virus may be essential for totally eradicating HIV infection,” says Robert Siliciano, professor at Johns Hopkins University School of Medicine and a Howard Hughes Medical Institute investigator.

Dr. Siliciano is one of the world’s foremost researchers in this area. He was the first who explained that HIV could survive in an inactive state, even after years of antiretroviral treatment. Now, he explains, getting to the stage where the virus can be successfully eradicated depends on finding a successful way to activate this latent HIV. He is one of a number of researchers exploring different ways to do this.

The AIDS Beacon reported that at CROI 2012, a recent HIV research conference, U.S. scientists discussed a new method that may help force out these latent viruses:

The study by researchers at UNC-Chapel Hill included six HIV-positive individuals whose HIV infections were well controlled with antiretroviral therapy. In this study, participants received a single 400 mg dose of Zolinza [vorinostat].In contrast to the Melbourne-based trial, the results from this study suggested that Zolinza treatment resulted in a five-fold increase in the activity of HIV genetic material without serious side effects.

Another drug cited in many studies was disulfiram, which produced conflicting results.

You can read much more about recent research on eliminating latent HIV in this recap from HIV i-Base, which is part of our coverage of CROI 2012 at TheBodyPRO.com.

 

 

CROI 2012: Disulfiram May Not Significantly Reduce Latent HIV Reservoirs

RE: STIMULATION OF HIV-SPECIFIC IMMUNE CELLS IS NECESSARY TO ELIMINATE LATENT HIV 

 

Disulfiram May Not Significantly Reduce Latent HIV Reservoirs In People With HIV (CROI 2012)

Preliminary results from an ongoing small study suggest that disulfiram, a drug used to treat alcoholism that has recently been investigated as a latent HIV activator, is safe and well tolerated. However, the results also showed that disulfiram may not significantly reduce the size of the latent HIV reservoir in HIV-positive adults taking antiretrovirals.

“There was a slight increase in viral load but it does not reach statistical significance,” said Dr. Adam Spivak, from the University of Utah School of Medicine and one of the study investigators.

“We did see a modest 14 percent decline in the size of the latent reservoir…but for the most part it pretty much stayed the same,” he added.

The results were presented earlier this month at the 19th Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.

Latent HIV is HIV that is not actively replicating. Since antiretroviral drugs usually work by blocking replication, they do not work on latent HIV. Many researchers believe that activating latent HIV is the key to curing HIV infection; once HIV is activated and begins replicating, scientists hope it will become susceptible to elimination with antiretroviral therapy.

Research has shown that disulfiram (Antabuse) successfully activates latent HIV in infected cells in the laboratory. However, its efficacy in activating latent HIV in people is still unknown.

In this study, researchers are investigating whether disulfiram is capable of activating latent HIV in adults whose HIV is well-controlled with antiretroviral therapy.

The study includes 14 HIV-positive adults, each of whom received 500 mg disulfiram once a day for two weeks. All participants were on antiretroviral therapy and had had undetectable amounts of HIV in the blood for at least a year.

Researchers measured the amount of HIV RNA, a measure of latent HIV, in participants’ blood before and up to 12 weeks after giving the participants disulfiram.

Results showed that HIV RNA increased 53 percent during treatment and 88 percent after treatment; however, the researchers said neither of these increases are significant.

Overall, disulfiram decreased the size of participants’ latent HIV reservoirs by 14 percent, which was not statistically significant.

Among 57 percent of study participants who had blood sampled at one to two hours after the first dose of disulfiram, HIV RNA increased 4.5-fold, which, according to the researchers, suggests that drugs affecting the latent HIV reservoir may have a rapid onset.

The researchers are planning additional studies that measure HIV RNA levels at multiple time points during the first day participants receive disulfiram to further investigate its efficacy at shorter time intervals.

The researchers reported that disulfiram was well tolerated and that there were no serious side effects.

For more information or the study abstract, visit the CROI2012 website HERE.