From The Associated Press via CTV News 

WASHINGTON —  U.S. drug regulators on Tuesday affirmed landmark study results showing that a popular HIV-fighting pill can also help healthy people avoid contracting the virus that causes AIDS in the first place. While the pill appears safe and effective for prevention, scientists stressed that it only works when taken on a daily basis.

The Food and Drug Administration will hold a meeting Thursday to discuss whether Truvada should be approved for people who are at risks of contracting HIV through sexual intercourse. The agency's positive review posted Tuesday suggests the daily pill will become the first drug approved to prevent HIV infection in high-risk patients.

FDA reviewers conclude that taking Truvada pre-emptively could spare patients "infection with a serious and life-threatening illness that requires lifelong treatment."

Despite the positive results, reviewers said that patients must be diligent about taking the pill every day. Adherence to the medication was less than perfect in clinical trials, and reviewers said that patients in the real world may forget to take their medication even more than those in clinical studies.

First announced in 2010, Truvada's preventive ability was hailed as a breakthrough in the 30-year campaign against the AIDS epidemic. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 44 per cent, when accompanied by condoms and counselling. Another study found that Truvada reduced infection by 75 per cent in heterosexual couples in which one partner was HIV infected and the other was not.The FDA's panel of advisers will take separate votes on whether Truvada should be approved for:

• gay and bisexual men
• men or women in relationships with HIV-positive partners
• other people at risk of acquiring HIV through sexual activity

The FDA is not required to follow the advice of its panels, though it usually does.

An estimated 1.2 million Americans have HIV, which overwhelmingly affects men who have sex with other men, according to the Centers for Disease Control and Prevention. HIV attacks the immune system and, unless treated with antiviral drugs, develops into AIDS, a fatal condition in which the body cannot fight off foreign infections.

Because Truvada is already on the market to manage HIV, some doctors currently prescribe it as a preventive measure. FDA approval would allow the U.S. drugmaker Gilead Sciences to formally market its drug for the new use.

But support for FDA approval is not unanimous. Some researchers stress that condoms remain the best weapon against AIDS, and a prevention pill is not the chemical equivalent.

"We know that if the person doesn't take the medication every day they will not be protected," said Dr. Rodney Wright, director of HIV programs at Montefiore Medical Center in New York. "So the concern is that there may not be adequate adherence to provide protection in the general population."

Wright, who is also chairman of the AIDS Health Foundation, added that some upcoming medications may be more effective at preventing infection than Truvada.

Researchers also worry about Truvada's mixed success rate in preventing infection among women. Last year a study in women was stopped early after researchers found that women taking the drug were more likely to become infected than those taking placebo. Researchers speculated that women may need a higher dose of the drug to prevent infection. They also said the disappointing results may have resulted from women not taking the pills consistently.

Still, many HIV patient advocacy groups say the drug should be a prescribing option to prevent HIV, alongside condoms, counselling and other measures.

"If we're going to reduce the more than 50,000 new HIV infections in this country each year, we need to increase the available options for people," said Ronald Johnson, vice-president of AIDS United. He added that more studies are needed to determine the drug's effectiveness in women and other patient subgroups.

"The current state of the data warrants going forward, but we believe additional clinical trials should also go forward to broaden the use of Truvada."

Last month, AIDS United and more than a dozen other advocacy groups sent a letter to the FDA, urging approval of Truvada.

California-based Gilead Sciences Inc. has marketed Truvada since 2004. The drug is a combination of two older HIV drugs, Emtriva and Viread. Doctors usually prescribe the medications as part of a drug cocktail that makes it harder for the virus to reproduce. Patients with low viral levels are far less likely to develop AIDS. Side effects with Truvada include diarrhea, dizziness, nausea and vomiting. More serious problems can include liver toxicity, kidney problems and bone thinning. 

This article by Jeff Sheehy was first posted on the website of University of California, San Francisco (UCSF) here.  Published with permission.  

In a groundbreaking study published last year, scientists reported that effective treatment with HIV medications not only restores health and prolongs life in many HIV-infected patients, but also curtails transmission to sexual partners up to ninety-seven percent. However, a new study by UCSF scientists shows that lack of basic living needs severely undercuts these advances in impoverished men.

The new research builds on a 2010 finding by the Centers for Disease Control and Prevention showing that poverty is the single biggest factor linked to HIV infection in heterosexuals living in inner-city neighborhoods.

In the new study published in the April 25 issue of PLoS ONE, UCSF researchers found that for HIV-infected homeless and unstably housed individuals, a failure to address unmet subsistence needs such as housing, food, clothing and hygiene, undermines these very real individual and public health benefits of HIV medication delivery.

“In this study, we followed a group of homeless and unstably housed HIV-infected people living in San Francisco and found that only about a fifth of those for whom antiretroviral therapy was medically indicated were actually on the medications. More importantly, while viral load was one of the most important predictors of overall health, we found that an inability to meet basic subsistence needs had an even larger influence on health status in this population,” said the study’s principal investigator, Elise Riley, PhD, (below, right) Associate Professor in the UCSF HIV/AIDS Division at San Francisco General Hospital and Trauma Center. 

“This study shows that a simple focus on providing medications will neither effectively treat nor end HIV in inner cities.  A person’s ability to get needed care and take medications becomes less of a priority when they don’t have food or a place to sleep.  If we could improve opportunities for people to meet their basic subsistence needs, in tandem with providing antiretroviral therapy, we could improve patients’ health and better realize the potential gains to public health,” added Riley.

For six years, the researchers followed a group of 288 HIV-infected men who were recruited from homeless shelters, free meal programs and single room occupancy (SRO) hotels that primarily serve individuals with very low or no income.  Twenty percent had reported being homeless recently.  Over one-third of participants reported current symptoms of chronic illness.

At the study onset, participants had an average of 349 CD4 T-cells (the immune cells targeted and killed by HIV), which is not much higher than the cutoff of 200 often used to diagnose AIDS. While current treatment guidelines in the City and County of San Francisco indicate treatment upon HIV diagnosis, the policy active during the study period specified that individuals with less than 350 CD4 T-cells should start antiretroviral medications.

Results indicating that subsistence needs are the strongest predictor of overall health status among homeless men were consistent with findings from a recent homeless women’s study conducted by the same group and published earlier this year in the American Journal of Epidemiology.

“Previous cost effectiveness studies show that homelessness is more expensive to society than the cost of housing. This is due to situations that are strongly linked to homelessness like emergency room use and incarceration.  Our study suggests that the social barriers inherent in poverty are also likely to continue fueling the American HIV epidemic, which may further add to societal costs,” concluded Riley.

Study co-investigators include Torsten B. Neilands, Kelly Moore, Jennifer Cohen, David R. Bangsberg and Diane Havlir.  In addition to UCSF, authors of this study are affiliated with the Harvard School of Medicine and the University of California, Berkeley.

The study, funded by the National Institutes of Health, is online in PLoS ONE.

The UCSF HIV/AIDS Division at San Francisco General Hospital and Trauma Center is affiliated with the AIDS Research Institute (ARI) at UCSF.  UCSF ARI houses hundreds of scientists and dozens of programs throughout UCSF and affiliated labs and institutions, making ARI one of the largest AIDS research entities in the world.

UCSF is a leading university dedicated to defining health worldwide through advanced biomedical research, graduate level education in the life sciences and health professions, and excellence in patient care.

 

As the warmer weather approaches, so does the HIV research conference season. Yes, we get excited about HIV research conferences here at CATIE. In late April, the Canadian HIV research community gathered for the annual conference put on by the Canadian Association of HIV Research —known to us HIV geeks as the CAHR conference. And of course, the big biennial International AIDS Conference is being held in July in Washington, DC.

It becomes very evident during an HIV research conference that the true stars of HIV research are not the eminent scientists with their big pronouncements, but rather the people with HIV who partake in clinical trials and make all of the work possible. Without them, HIV research would be all microcentrifuge tubes and mathematical models. And while that sounds positively intergalactic, the people who participate certainly are not. They’re people with HIV from across this country. Heck, they might even be you.

Have you ever thought about participating in a clinical trial? Or perhaps you’ve been approached by one of your healthcare providers to participate? CATIE wants you to be informed as you make your decision, so here are a few links to other resources we think might be useful. Our partners the CIHR Canadian HIV Trials Network (CTN) and Canadian AIDS Society have produced a new edition of Clinical Trials: What you need to know. The handbook lives up to its name, giving lots of info on key issues, all in an easy Q&A format.  Hard copies of the book will be available from the CATIE Ordering Centre. “Treatments on Trial” from the Spring/Summer 2005 issue of The Positive Side provides some personal perspective.

Finally, if you’re ready to take the plunge, check out the CTN’s list of HIV clinical trials that are enrolling participants. 

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Traitements à l'essai 

CATIE met en avant les ressources sur les essais cliniques pour les PVVIH qui pensent y participer.

L'arrivée du beau temps coïncide avec le début de la saison des congrès de recherche sur le VIH. Et oui, chez CATIE, nous nous réjouissons de l'arrivée de ces congrès. À la fin avril, les chercheurs canadiens se consacrant au VIH se sont rassemblés à l’occasion du congrès annuel organisé par l'Association canadienne de recherche sur le VIH — que nous, les maniaques du VIH, connaissons sous le nom d’ACRV. Et bien sûr, le grand Congrès biennal international sur le sida  aura lieu en juillet à Washington D.C.

Lors d'un congrès scientifique sur le VIH, il devient vite évident que les vraies vedettes de la recherche ne sont pas les éminents scientifiques avec leurs grandes déclarations, mais bien les personnes vivant avec le VIH qui prennent part aux essais cliniques, rendant ainsi tout ce travail possible. Sans elles, les recherches sur le VIH ne seraient que des tubes à microcentrifuge et des modèles mathématiques. Et même si tout cela nous semble intergalactique, ce n'est évidemment pas le cas des participants. Ce sont des personnes de partout au pays qui vivent avec le VIH. Hé, vous en faites peut-être même partie.

Avez-vous déjà songé à participer à un essai clinique? Ou peut-être que l’un de vos professionnels de la santé vous a déjà abordé afin d'y prendre part? Chez CATIE, nous souhaitons que vous preniez votre décision en toute connaissance de cause. Voici donc quelques liens vers d'autres ressources qui peuvent vous être utiles. Nos partenaires, le Réseau canadien pour les essais VIH des IRSC (RCEV) et la Société canadienne du sida ont produit une nouvelle édition du livret Les essais cliniques : Ce qu'il vous faut savoir.  Celui-ci porte bien son nom puisqu'il fournit quantité de renseignements sur les points essentiels sous la forme conviviale de questions-réponses.  Vous serez bientôt en mesure d’en commander des exemplaires à couverture rigide auprès du Centre de distribution de CATIE.  L'article « Les essais cliniques »  paru dans le numéro printemps/été 2005 de Vision positive propose quelques points de vue personnels.

Enfin, si vous êtes prêt à faire le grand saut, visitez la liste des essais cliniques sur le VIH qui recrutent des participants du Réseau canadien pour les essais VIH. 

I entered a rather stark room, its white walls were bare. A gigantic pill the size of a coffin was laid diagonally across the floor. Under the track lights, the pill’s red and green plastic glowed like a siren. It was hauntingly familiar. No, this was not a nightmare but an exhibition at the Art Gallery of Ontario by the three artists collectively known as General Idea. This work resonated for me because my Atripla pills are also larger than life and equally intimidating. HIV/AIDS may have come a long way from the days when this exhibition was first conceived during the Eighties, but some things remain unchanged.

I have gone through periods when taking the pill each night was emotionally difficult, if not physically. The pill is a horse pill and sometimes gets stuck inside my throat. When that happens, I drink water like a fish, and when it does slide down, it burns the lining of my gullet as it dissolves. I wake in the night from the corrosive sensations. In the morning I feel groggy, with a sore throat and difficulty in swallowing food. Apart from its intimidating size, I wonder if there is some Freudian resistance to putting my lips around this phallic pill. Does my throat’s sphincter muscle clamp up because it reminds me that I am daily being screwed by HIV?

My GP was initially unconvinced. HIV does make one into a bit of a hypochondriac. What made the condition worse for me was that in addition to Atripla, I also take a number of heart pills. I work hard to maintain overall good health and hence also take vitamin supplements (calcium pills are notorious for making guys gag). All this casual pill popping made me feel like a pill slut (the cheap street-corner kind). After complaining once too often about my gag-reflex, my GP, like a disgruntled pimp, finally referred me for an endoscopy.

Anyone living with HIV can hardly avoid swallowing multiple pills. Not taking them can have serious consequences. It turned out that I had developed a pocket in the lining of my throat, called a Zenkers Diverticulum. I was told emphatically that these pockets never shrink of their own accord and that they only worsen over time. I was at risk of pneumonia from food bacteria entering the respiratory system  (something no HIV person can take lightly). I was then referred to a thoracic surgeon who informed me that the only way to loosen the sphincter muscle was to cut it. (Kind of the reverse from what a size-queen might endure). 

I had to wonder, if the pill was too large to swallow, why is there no liquid version of this pill? Why do I need to surgically alter my throat to suit this ‘one-size-fits-all’ pill? Left with no choice, reluctantly I went under the knife. My surgeon was named Dr. Darling, and her assistant (no joke) was Dr. Daddi. There I was, lying passed-out on the bed, with my throat slit by a Darling and a Daddi. (This is probably how my poor mother feared I might end up!)

For a day after the surgery I was not allowed food or water. Not even my essential pills. Missing the odd dose of Atripla is considered okay, so I did not panic. Yet.

Early morning on the day after surgery, my surgeon assured me that I was scheduled for barium swallow imaging. If all were well with the incision, I would be put on a liquid diet, and hence could take my Atripla. Little did I realize what a mess of red tape large hospitals actually are. It seems that Radiology had no request for barium imaging. The surgical team was not reachable (they were busy slicing up others) and anyways, the hospital pharmacist had neglected to supply the nurses my requisite medications.

In the absence of authority, the radiologist adhered strictly to the rules: I would have to wait five to seven days for the barium x-rays which meant I must refrain from water, food, pills during the duration (apparently that is standard procedure). Here I was, tethered to a bed, my voice choked and unable to speak, having to fight for my life. It was left to me to point out that five to seven days without Atripla would wreck havoc with my CD4 count.

My GP told me afterward that this is a common problem for persons with HIV. There are no alternative ways to give us our meds when we cannot medically swallow a pill. Some patients lie in hospital for a month with cardiac infractions or throat cancer, unable to swallow, and hence unable to take their life-saving meds. While other drugs have injectable versions, most anti-retrovirals do not. The pharmaceuticals have not bothered to develop versions that can be administered through IV because, apparently, it is not profitable to do so.

Luckily for me, after nearly a day of pushing up against pointless bureaucracy, they finally performed the barium imaging in the evening. A liquid supper and an Atripla were brought to my bed. But what bothers me the most about this incident is that there is no dialogue with pharmaceuticals about creating non-tablet versions of common anti-retrovirals. Many of us have or will undergo serious medical procedures for secondary life-threatening complications.  Come on pharmaceuticals! Do the right thing, ‘cause this is a tough pill to swallow.

You can read more from Philip on his own blog here. 

My best friend and I just came back from a vacation from Manila a few days ago. It was supposed to be a quick five-day unwinding involving the beach, the mountains, the shopping and of course nightlife. We covered those bases as planned; the unexpected was the three extended days of personal hell. At least that’s what the agony of not having access to anti-retroviral medication felt like. It isn’t so much what non-medication in the moment does at that moment in time, but its implications in the long-run replaying in my mind.

The mantra is instilled in me well enough. Do not miss a dose - or else. Things like drug resistance have long become one of my biggest fears. The thought of my virus resisting my current regimen and having to switch to a stronger, probably more expensive type of cocktail, scares me.

That’s beside the point though. The point is the situation I found myself in. Stranded for three days, without additional pills. Why? I missed the flight back.

We were stuck in a traffic jam that persisted longer than the flight from Manila to Singapore would have taken (three hours!). I blame the culmination of on-going road works that had several lanes of vehicles converge into a bottleneck at several stretches of road, and the supposedly normal peak-hour traffic for this. We did somewhat prepare; we actually made our way to the airport with hours to spare before our flight, but only got to the less-than-memorable Ninoy Aquino International Airport (by international surveys, but also, in my own opinion after the staff was incredibly nonchalantly passive to the urgency of my situation) with only 45 minutes to spare. Not surprisingly, we missed our flight.

The predicament could be trivial to some people. A missed flight? So what, take the next one out. Not for me. Not when I didn’t bring extra pills, not anticipating any possibility that I might stay for longer than planned. Besides that, flights for my airline were fully booked for the next two days, and alternative airlines cost three times as much. A costly price, which could have had a less expensive price tag: preparedness.

The traveller’s checklist is a more-or-less standard affair. Us HIV-positive individuals only have to keep in mind the few extra things -  our supplements, prescriptions and of course, anti-retrovirals. Of course, I had all that checked. What did not make it to the list were the “just-in-cases”. Like just in case I had to stay for a few extra days, as I did.

If only I had been ready for this, I could have afforded to be nonchalant about it all. Money is no big issue, it’s always waiting to be earned somewhere, or extended to you, in my case, by my credit card company. My health, I cannot as easily trivialise.

So lesson learned. From now on, always bring extra medication to tide you over just in case. If you’re like me, worried about your embarkation country’s strict or unclear immigration practices when it comes to bringing along medication (inbound travel of HIV-positive individuals is after all, banned in Singapore – and I don’t want to have to answer the obvious as to why I have with me HIV medications with me if I get searched), you can always throw the extra few unused pills away before hopping on the plane. Either way, it’ll still probably be cheaper than having to forfeit and rebook your return flight and pay for that few extra days out of your wallet, and health.

Follow the links to Richard T.’s previous posts for PositiveLite.com under "Related Articles" below.

I woke up early and felt like a teenager who had to ring up for their examination results. I normally email my nurse for the results of my blood tests but this time, as I hadn't spoken with her for a while, felt that phoning would be better and a bit more social. So six weeks after treatment began, I have updated my graph with my latest results from the clinic. (see below)

A picture does say a thousand words. For a moment I had to check I input my viral load figure into the correct box as having it as three figures could easily be confused with a CD4 figure. It has fallen from 41,000 to 357. Three hundred and fifty-seven.

My CD4 which measures the strength of my immune system has gone up from 430 to 530. For people who do not have HiV, anything between 500-1200 is 'normal'.

My CD4% which can be a more stable reflection of the state of the immune system has also leapt to an amazing 20%. I've never been 20% before in my HIV life. I have tottered along at 15% or less since diagnosis in October. Whilst I was expecting my viral load to decline, I am amazed at the speed of it and the recovery of my CD4. It's not until I had first-hand experience of the results that I can say the medication works, and fast.

Prior to starting my regime I remember being a bit concerned with the possible side effects. These have been few but now have largely subsided. Taking two tablets a night is becoming part of my life that doesn't dominate my world 24 hours a day.

Having seen these results, to say I was pleased is an understatement. I'm absolutely bloody delighted. As well as these results, I feel better, the aches and pains I had (not helped by winter) have gone and I'm feeling more motivated to get cycling properly again. I'm now starting to think a bit about what lies ahead, and hopefully can start to plan things a bit more for the future.

Finally I wanted to share a quotation I read and noted from one of my many waiting room visits recently which still resonates with me:

"A high tide lifts all boats."

Find Richard T. on twitter at @livingmyposlife