Promising News In HIV Partner Study

Via AIDS Map:

The second large study to look at whether people with HIV become non-infectious if they are on antiretroviral therapy (ART) has found no cases where someone with a viral load under 200 copies/ml transmitted HIV, either by anal or vaginal sex. Statistical analysis shows that the maximum likely chance of transmission via anal sex from someone on successful HIV treatment was 1% a year for any anal sex and 4% for anal sex with ejaculation where the HIV-negative partner was receptive; but the true likelihood is probably much nearer to zero than this. When asked what the study tells us about the chance of someone with an undetectable viral load transmitting HIV, presenter Alison Rodger said: "Our best estimate is it's zero."

(Tipped by JMG reader Bill)

White House Announces Gene Therapy Is Safe For Drug-Free Treatment Of HIV

The White House tonight issued a press release declaring that the National Institutes of Health has found that initial studies show gene therapy to be "generally safe" as a drug-free alternative for the treatment of HIV/AIDS. Here is the press release in full.

Scientists today report initial results from humans on the safety and tolerability of a novel strategy to curb HIV disease by removing key cells from HIV-infected individuals, genetically modifying the cells to resist HIV infection and returning them to those people. The basic and pre-clinical research on this strategy, which eventually might help people control the virus without drugs, was funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The Phase I clinical trial was funded by Sangamo BioSciences and was led by NIAID grantee Carl H. June, M.D., with co-investigators Bruce L. Levine, Ph.D., and Pablo Tebas, M.D., all of the Perelman School of Medicine at the University of Pennsylvania, Philadelphia.

The trial built on the observation that people who naturally have a genetic modification in a protein called CCR5 are resistant to HIV infection, and when infected with HIV, progress to AIDS more slowly. CCR5 is a cell-surface molecule, or receptor, that most HIV variants must use to enter their primary target: the CD4+ T cell. In the trial, CD4+ T-cells were collected from each of 12 HIV-infected volunteers whose virus was controlled by anti-HIV therapy. These cells were then treated in the laboratory with molecular tools called zinc-finger nucleases (ZFNs). The ZFNs were designed to snip the DNA within the gene that codes for the CCR5 receptor. This process introduced a genetic mutation rendering CCR5 receptors non-functional. Subsequently, the cells were stimulated to multiply, and each patient received an infusion of 10 billion of their own CD4+ T-cells, with roughly a fifth of the CCR5 genes now mutated.

Four weeks later, in a planned interruption of anti-HIV therapy, half the study participants stopped taking their antiretroviral drugs for 8 to 12 weeks. Investigators found that the experimental treatment was generally safe, and that the genetically modified cells appeared to be protected from HIV infection. In one volunteer who naturally had the desired mutation in half of his CCR5 genes, HIV replication was controlled during the entire 12-week treatment interruption. Future research will include evaluating this experimental treatment in more volunteers, as well as maximizing the frequency of CCR5 disruption by ZFNs and increasing the persistence of the genetically modified cells in the body to achieve a therapeutic effect.

Should further studies demonstrate that the result is long-lasting, it will be interesting to learn how the cost of such a procedure will compare to the cost of traditional drug therapies. My guess is that it will be prohibitive at the start, but cost effective in the long run. It certainly is a better prospect than a lifetime of pill-popping. Experts (and I know you are here) please weigh in.

NEW YORK: State Endorses Truvada For Daily Use As HIV Preventive

The New York state Department of Health has officially endorsed daily use of the Gilead medication Truvada for the prevention of HIV infection.

After months of anticipation, the Health Department's AIDS Institute released thorough clinical guidelines for pre-exposure prophylaxis, commonly known as PrEP, which is a daily dose of HIV medication that people who are HIV-negative but at-risk of contracting the virus can take to drastically reduce their chance of infection. The drug, known by its prescription name Truvada, can reduce the chance of infection by as much as 73 percent, according to studies funded by the Bill and Melinda Gates Foundation. However, the AIDS Institute stressed that PrEP alone was not enough to prevent new infections. "PrEP should not be offered as a sole intervention for HIV prevention. PrEP should only be prescribed as part of a comprehensive prevention plan," the report says.

Preventive use of Truvada, while supported by most HIV/AIDS groups including ACT UP and the San Francisco AIDS Foundation, remains controversial. In particular, the Los Angeles based AIDS Healthcare Foundation has long battled against the preventive use of Truvada. In July 2012, when the drug was first approved for daily preventive use, the AHF accused both Gilead and the FDA of "negligence bordering the equivalence of malpractice which will sadly result in new infections, drug resistance and serious side effects among many, many people." Last August the AHF declared victory in their Freedom of Information Act request which sought proof that Gilead colluded with the FDA on "what to say to get their unfavorable drug trial results spun in such a way that the FDA deemed them sufficient to approve the drug."

Truvada retails at an annual cost of up to $14,000 and its use as a preventive is not yet covered by all insurance plans. Today's guideline from the state recommends that AIDS groups focus on identifying the most high-risk persons who would benefit from its daily use.

Headline Of The Day

Via AIDS Map:

A study from the US has found that some groups of people with HIV, especially those treated before their CD4 count falls below 350 cells/mm3, now have life expectancies equal to or even higher than the US general population. However, it also finds that life expectancy for some other groups – most notably women and non-white people – is still considerably below comparable members of the general population and that for people who inject drugs, life expectancy in the era of antiretroviral therapy (ART) has not improved at all.

(Tipped by JMG reader Bill)

Manhunt Promotes Truvada

The hook-up site Manhunt today announced that they will begin promoting the usage of Truvada, which was recently approved by the FDA as a daily HIV preventive for high-risk populations. Via press release:

Manhunt has partnered with Gladstone Institutes’ Dr. Robert Grant and The Fenway Institute to assure that the information conveyed is accurate and consistent with peer-reviewed published science. This promotion is part of Manhunt’s 2012 Social Responsibility Initiative, and it is entirely self-funded. The promotion is being sent to over 2.5 million Manhunt members on World AIDS Day through Manhunt’s internal email broadcast system with the following tagline: “HIV Prevention Pill for Negative Men (and women too): A choice when condoms are in the way or not enough?” The campaign encourages members to visit Manhunt Cares™ dedicated PrEP page to learn more about this important biomedical intervention.

As we've noted here on JMG many times, the usage of Truvada as an HIV preventive has somewhat fractured the HIV/AIDS advocacy movement. The AIDS Healthcare Foundation, in particular, campaigned against its approval for this usage and called the FDA's decision "reckless." The San Francisco AIDS Foundation and amFAR, however, both support Truvada's usage as a preventive. The long-term effects of Truvada on uninfected (and infected) individuals remains unclear.

BRITAIN: Life Expectancy For HIV+ On Therapy Nears National Average

According to a study out of the UK, the life expectancy for HIV+ people on anti-retroviral therapy is nearing the national average for all.

The latest forecasts of life expectancy in people with HIV in the UK, based on mortality data from the UK Collaborative HIV Cohort (UK CHIC) study, show that the average life expectancy of people on antiretroviral therapy (ART) with a CD4 count over 350 cells/mm3 is now very close to the national average, the eleventh International Congress on Drug Therapy in HIV Infection heard last week.

The UK CHIC study also found that life expectancy, which lags behind the average in younger people, approaches normal as people age. There is starting to be some evidence, though based on very small numbers of patient records, that if people with HIV in the UK reach the age of 60, their life expectancy may actually be starting to exceed the average, possibly because of superior medical monitoring and treatment for people with HIV compared to other older people.

That last sentence is rather striking. (Tipped by JMG reader Bill)

Four-In-One HIV Med News

Gilead has announced the results of Stage 3 clinical trials of "the Quad," which would be the world's first four-in-one daily HIV pill. The Quad contains two new (and not yet FDA approved) drugs: the integrase inhibitor, Elvitegravir, and Cobicistat, which is meant to mitigate the side-effects of Elvitegravir.

Via press release:

“These data show that the Quad is as effective [as Atripla] as a current standard of care in HIV therapy. The safety profile of Quad was also comparable to that of Atripla, and was better tolerated in terms of key neurological side effects,” said Paul Sax, MD, Clinical Director of the HIV Program and Division of Infectious Diseases at Brigham and Women’s Hospital, Boston, and principal investigator of Study 102. “Based on these results, I believe the Quad could represent a potentially important new treatment regimen for a wide range of HIV patients initiating therapy.”

Gilead also produces Atripla. Both Atripla and the Quad contain Truvada, which is under consideration as a daily pre-exposure prophylactic (PReP) for the uninfected.

Reuters has more:

The safety data, presented here on Wednesday at the Conference on Retroviruses and Opportunistic Infections, showed that patients on Atripla had significantly higher rates of dizziness, abnormal dreams, insomnia and rash, compared with the Quad. The experimental pill did result in higher rates of nausea, 21 percent vs 14 percent. The study found that at 48 weeks of treatment, 88 percent of Quad patients, compared with 84 percent of Atripla patients, achieved target levels of HIV virus.

As millions of patients are well into their second decade of daily HIV therapy, we'll see more of this focus on refining the treatments to reduce their immediate and long-term side-effects.

HIV/AIDS Plummets In British Columbia

AIDS deaths and new HIV infections are plummeting in British Columbia. Experts say the decline is due to an aggressive policy of placing the newly infected immediately on a drug regimen and thus reducing their infectiousness.

“We’re particularly pleased to see that our treatment-as-prevention strategy has taken off big-time,” said Dr. Julio S. G. Montaner, director of the British Columbia Center for Excellence in H.I.V./AIDS. His center was a pioneer in the strategy, which involves searching aggressively for people at risk of H.I.V. infection, talking them into being tested and putting those who are infected on antiretroviral drugs immediately, which lowers by 96 percent the chances that they will infect others.

Credit is also being given to Vancouver's "safe-injection" center where IV drug users can get and use clean needles on the premises.

San Francisco and New York City have also adopted "treatment as prevention" policies, but some HIV activists have denounced the idea due to questions about the long-term side effects of taking the medications for decades. Reknowned HIV/AIDS activist Sean Strub:

This is, in essence, a chemical quarantine. People should be given the option to take drugs to reduce their chance of transmitting to others, but to recommend treatment for people in the absence of conclusive science that it will, on average, provide a greater net benefit than harm, is unethical. Why haven't the NYC DOH--and the other promoters of "treat everyone with HIV, no matter their medical need"--been out advocating for the clinical trials to definitively answer the question as to when is the optimal time for a person with HIV to commence treatment? We know that some people with high CD4 counts can go years and years, some even decades, without going on treatment and suffering the cumulative toxicities of treatment. But now NYC DOH, as well as San Francisco's DOH, are advocating putting those people on treatment. This is not healthcare, it is a chemical quarantine.

New AIDS Cases Drop 25% In NYC

New York City continues its long trend of fewer new AIDS cases, thanks in part to the increasing ease of complying with HIV drug regimens.

In a sign of progress against one of the great plagues of the last generation, a dwindling number of New Yorkers have been diagnosed with AIDS over the last eight years, according to new statistics released Friday. The number of adults newly diagnosed with AIDS dropped to 2,225 in the 2011 fiscal year, which ended June 30. That total was 25 percent lower than the total the year before (2,969 cases diagnosed), and 47 percent lower than in the 2003 fiscal year, when there were 4,164 new cases, according to the Mayor’s Management Report, which was released Friday.

At the pandemic's peak in 1993, NYC saw almost 13,000 new cases of AIDS.

UPDATE: In case it's not clear, this story is about the number of HIV-positive people who progress to full-blown AIDS, not the rate of new HIV infections.

FDA Approves New HIV Med

Yesterday the FDA approved the second all-in-one daily combination pill for the treatment of HIV infection. The first such medication, Atripla, has been on the market for several years.

Complera, a complete single-tablet regimen containing Janssen Therapeutics’ Edurant (rilpivirine) and Gilead Sciences’ Viread (tenofovir) and Emtriva (emtricitabine), was approved August 10 by the U.S. Food and Drug Administration (FDA), according to an announcement by Gilead. Complera, the second all-in-one fixed-dose combination tablet for people living with HIV, is approved for those starting antiretroviral (ARV) therapy for the first time.

The new combination pill is not yet available in Europe.

San Francisco: Earlier HAART Treatment Appears To Reduce New HIV Infections

According to a story posted on AIDSmap.com, San Francisco is seeing a decrease in new HIV infections because HIV+ people are going on medication sooner and therefore have a reduced period of infectiousness.

Dr Das presented more evidence from San Francisco to show a strong correlation between reductions in community viral load and the falling number of HIV diagnoses. The most recent CVL, defined as the average viral load of all HIV positive people being seen for care in the city, went down from approximately 25,000 copies/ml in 2004 to 10,000 copies/ml in 2009. Over the same time, new diagnoses of HIV decreased from 820 in 2004 to 500 in 2009. For CVL to decrease, a number of other things have to happen first, in a ‘cascade’ of events. Firstly, the frequency of testing in the at-risk population must increase; this must result in a lower proportion of undiagnosed cases; those diagnosed must be linked to care, and the majority must start treatment; and the time between diagnosis and viral suppression must reduce. Dr Das said all these indicators were strongly correlated. The average time from diagnosis to the start of treatment shrank from twelve months in 2004 to two months in 2009. The time between diagnosis and achieving an undetectable viral load went down from nearly three years in 2004 to eight months in 2009; and the percentage with an undetectable viral load within a year of diagnosis increased from 26% in 2004 to 82% in 2008.

Last April the San Francisco Department of Public Health adopted the controversial position that newly infected patients should immediately begin HAART therapy upon their diagnosis. Some AIDS activists strongly objected to that, citing the prevailing opinion that HAART treatment should be delayed as long as possible due to the long-term side effects of the medications. Many HIV specialists continue to recommend a closely-monitored delay in treatment, but the above result in San Francisco should not be discounted.

(Tipped by JMG reader Bill)

CDC Issues Interim PrEP Guidance

Last last year researchers announced some success in preventing HIV among gay men who were taking a daily dose of the HIV medication Truvada. The concept of warding off infection by pre-dosing with a medication is known as pre-exposure prophylaxis (PrEP.) But alarmed by the prospect for abuse, yesterday the CDC issued some interim PReP guidance as studies continue.

CDC says it wanted to fend off improper use of pre-exposure prophylaxis (or, more catchily, PrEP) as it and other agencies work on more detailed guidelines, which will take “several months.” It says that the drug should only be used in men who have sex with men, since studies in other high-risk groups such as IV drug users are still underway. And it should be used only in high-risk men (with multiple partners or partners from an area with a high prevalence of HIV infection), who are most likely to benefit. Also, the drug isn’t the equivalent of the morning-after pill for HIV; it’s meant to be taken daily. “Support for adherence to the prescribed medication regimen must be a routine component” of PrEP, the CDC says. (In the study, the risk of HIV infection was reduced just 21% in men whose adherence was less than 90%, compared to a 73% lower risk of infection for those with adherence of 90% or better.) And other preventive measures, such as condom use, should continue to be taken.

The wholesale cost of Truvada in the United States is $1000 for a month's supply, a cost unlikely to be covered by insurance when the drug is used as a preventive. In some countries, Truvada costs as little as $12/month.

HIV Drug Effective In PrEP Study

A just-released pre-exposure prophylactics (PreEP) study reveals that taking the HIV drug Truvada once a day reduces the incidence of HIV infection by about 44%. The result was even better among men who were the most compliant about taking the drug every day.

The drugs tenofovir and emtricitabine, packaged as a once-daily pill and sold in drugstores as Truvada, reduced HIV infections by an average of 44% among gay and bisexual men who took the drug, compared with those taking a placebo. Men who reported being the most diligent about taking their pill each day reaped an even bigger benefit, reducing their risk by 73%. "This is a huge step forward," says lead researcher Robert Grant, at the J. David Gladstone Institute at the University of California-San Francisco, a non-profit research foundation that carried out the study. David Paltiel of Yale University says that his research shows that Truvada could be as cost-effective a prevention method as those used to combat heart disease diabetes and cancer, despite its $8,700 annual cost.

The findings have bred new enthusiasm in a field where, for years, optimism was rare. Over 30 years, HIV has infected 40 million people. But this year alone, researchers have demonstrated that a pill and a vaginal gel (containing a component of Truvada) can prevent HIV and shown, at least in concept, that a vaccine can work. This is a very exciting, dynamic time in HIV prevention research," says Alan Bernstein, head of the Global HIV Vaccine Enterprise, a non-profit effort to accelerate vaccine research. "It couldn't come at a better time. There's clearly a growing realization that we're not going to be able to treat our way out of this epidemic.

Read the full details of the study.

Study Claims Using HIV Meds As Preventive To Infection Is Safe For Negative Gay Men

A study released at the AIDS 2010 conference in Vienna claims that using widely-prescribed HIV medications as a preventive for new infections (PrEP) is safe for HIV-negative men who have sex with men. Please note that effectiveness in preventing infection results have not yet been released on this study.

Pre-exposure prophylaxis (PrEP) with tenofovir (found in Viread, Truvada and Atripla) is safe for men who have sex with men (MSM), according to a U.S. study presented Friday, July 23, at the XVIII International AIDS Conference (IAC) in Vienna. PrEP is one of the most promising prevention tools on the immediate horizon. With PrEP, HIV-negative individuals take antiretroviral drugs to prevent becoming infected with the virus. The first PrEP studies are testing tenofovir alone (Viread), while several later studies are testing tenofovir plus emtricitabine (Truvada). Currently, all studies are looking at daily ongoing use of the drugs, but future trials are planned with intermittent dosing. The first efficacy results are expected later this year, but researchers from the Centers for Disease Control and Prevention (CDC) in Atlanta presented findings from a safety study at this year’s IAC.

As always, it's important to look at the size and the methodology of this study before making any decisions about your own health care.

RELATED: An unrelated NYC-based survey released last month indicated that the wide availability of PrEP would cause a high percentage of the most at-risk gay men to abandon safer sex practices.

HIV Researchers Make Immune Cell Breakthrough With Mice

Scientists at the University of Southern California say they succeeded in creating immune cells that ward off HIV in mice.

The researchers tinkered with human stem cells and then inserted them into mice where they multiplied into immune system cells that provided protection against infection with HIV, according to a study released online July 2 in Nature Biotechnology. The results are unlike typical research in animals because the mice have been "humanized": They have human immune systems and resisted a human disease. Still, until research is conducted on humans, there's no way to know if the treatment will work in people. And it may be years until that happens. But there are high hopes. "It's a one-shot treatment if it works," noted study co-author Paula Cannon, associate professor of molecular microbiology at the University of Southern California.

One researcher estimates the cost of this procedure in humans to be around $100,000. Which is still far less than the cost of a lifetime of HAART therapy.

ADAP Waiting Lists Swell

The terrible economy has been especially hard on the ADAP system, the AIDS Drugs Assistance Program that provides life saving medications to the HIV-positive. More people are now on ADAP waiting lists that at any time since the program began.

Eleven states have closed enrollment in the federal program, most recently Florida, which has the nation’s third-largest population of people with H.I.V. Three other states have narrowed eligibility, and two of them — Arkansas and Utah — have dropped scores of people from the program. Last week, because of swelling numbers here in South Florida, the nationwide waiting list surged past record levels set in 2004, to 1,781 people, according to the National Alliance of State and Territorial AIDS Directors. The growth is expected to continue when Georgia starts deferring enrollment in its drug assistance program on July 1. Illinois may soon follow, and New Jersey plans to cut eligibility on Aug. 1, removing 600 of the 7,700 people on its rolls. Louisiana capped enrollment on June 1 but decided against keeping a waiting list. “It implies you’re actually waiting on something,” said DeAnn Gruber, the interim director of the state’s H.I.V./AIDS program. “We don’t want to give anyone false hope.”

In addition to the waiting lists, some states are cutting out drugs that don't directly fight HIV, but treat the many conditions related to the infection. The irony, of course, is that the government will end up paying much more to treat people for opportunistic infections because they don't have access to their meds.

What Would PrEP Mean For Safer Sex?

PrEP stands for Pre-Exposure Prophylaxis, the taking of a medication in advance of a possible exposure to a disease. Commonly used for decades in travelers to exotic locales, multiple PrEP trials are currently underway to examine to effectiveness of taking an HIV medication prior to exposure. Putting aside the worrisome aspect of long-term side effects, the prospect of a daily pill to ward off HIV is thrilling, to say the least, but even at a very high rate of effectiveness, the risk of contracting HIV and the necessity of maintaining consistent safer sex practices would remain.

But according to a troubling new survey of gay men in New York City, a high percentage of those most at risk indicate that they would abandon safer sex practices were HIV PrEP to become available.

A substantial proportion of gay men say they would reduce their condom use if pre-exposure prophylaxis (PrEP) proves to be effective, US investigators report in the online edition of the Journal of Acquired Immune Deficiency Syndromes. The investigators found that the availability of 80% effective PrEP could reduce inhibitions about unprotected sex. Their results also showed that it could lead men to view unprotected sex as having an acceptable level of risk. “A better understanding of the emergent issues inherent in the provision of PrEP will allow for the development of both individual-level interventions supporting PrEP users and community-level interventions designed to increases awareness and acceptability of PrEP”, comment the investigators. [snip]

Little research has been undertaken into the potential impact of PrEP on sexual behaviour. Therefore investigators in New York designed a study involving 180 substance-using HIV-negative gay men who had had at least one recent episode of unprotected anal sex. They completed a questionnaire about their use of club drugs (cocaine, ketamine, ecstasy, methamphetamine, GHB or poppers), sexual risk behaviour, and attitudes towards PrEP. The men also answered questions to assess behavioural disinhibition and risk compensation. Researchers measured risk perception on a five-point scale using seven questions to assess the extent to which condom use was dependent on the participant's perception of risk in each individual sexual encounter. The men had a mean age of 29 and were racially diverse. Only a minority of men (42%) had been to college, and 40% had an annual income below $20,000. The men reported a median of three high-risk sex acts in the previous 30 days, a median of two occurred when using club drugs.

How effective would HIV PrEP have to be before you'd consider raw sex to be an acceptable risk? I think you know what the answer should be, but be as honest with yourself as you can.

The Lazarus Effect

Here is the complete documentary from HBO about the miraculous effect of HAART therapy on Africans suffering from HIV. Clip description:

Executive produced by Spike Jonze, this (RED), HBO & Anonymous Content 30-minute documentary follows the story of HIV positive people in Africa who were at death's door and in as little as 40 days undergo a remarkable transformation to health, when they gain access to the 2 lifesaving pills that cost around 40 cents a day. Directed by Lance Bangs.

San Francisco Endorses New HIV Strategy: Begin HAART Therapy Immediately

Many HIV+ patients delay beginning anti-retroviral therapy for years after they become aware of their infection, waiting for signs that their immune system has begun to falter before starting treatment. San Francisco's Department of Health has just endorsed starting HAART treatment immediately upon diagnosis.

Behind the policy switch is mounting evidence that patients who start early are more likely to live longer, and less likely to suffer a variety of ailments — including heart disease, kidney failure and cancer — that plague long-term survivors. Studies suggest that in the early years of infection, when a patient may show few signs of immune system failure, the virus is in fact causing permanent damage that becomes evident later. For instance, in older patients who finally start taking the drugs, the effects of chronic inflammation take their toll. “The impact on health risk is comparable to that of diabetes,” said Dr. Steven G. Deeks, a researcher at the University of California, San Francisco.

“Their immune system may look like that of someone 30 years older.” Dr. Diane V. Havlir, chief of the H.I.V./AIDS division at San Francisco General Hospital, said the new policy was already in effect for her patients. Although a decision whether or not to take the medicine rests with the patient, all those testing positive for H.I.V. will be offered combination therapy, with advice to pursue it. “The history of H.I.V. disease has always been about change,” she said. “We pride ourselves on working quickly with new data.”

Today's HIV drugs are far, far less toxic than those available when HAART therapy first became available almost 15 years ago, but they are still very tough on some patients and their long-term side effects won't be known for decades. Some San Francisco-based HIV specialists quoted in the above-linked story strongly oppose the city's new directive.

(Tipped by JMG reader Ru)

An Instructive Film About HIV & PEP

Via Pep411.com, here's a short instructive film about Post-Exposure Prophylaxis (PEP). This latest project is targeted to help young men of color, but of course applies to everybody. This clip may be slightly NSFW due to male-on-male making out.

PEP stands for Post Exposure Prophylaxis. It is HIV medications, usually 3 or 4 pills, that you take after you think you may have been exposed to HIV. These medications called antivirals can prevent you from becoming infected with the HIV virus. In order for PEP to work, you have to take the medications every day for 4 weeks (28 days). You may have side effects from the medications like nausea or an upset stomach, but your doctor can help you deal with them.