Editor’s note: This article first appeared on the blog of the Positive Women’s Network here.  We had published the Xtra article referred to below, without comment on our part, here. That's not to say we didn't recognize the controversial nature of some of Salerno's remarks relating to funding of women’s programming. So we welcomed this opportunity for a representative of the HIV women’s community to present her views. (Thank you, Janet.)

*Sigh.*

It was disheartening to read a piece on HIV funding that appeared in Xtra a couple of weeks ago. I could understand author Rob Salerno’s take on the challenging process that many HIV service organizations in Ontario faced recently in applying for funding under a tight deadline. Here in BC we faced it too, and there were supportive phone calls and emails back and forth between groups as we all wrote feverishly to meet said deadline. 

What I found disheartening was Salerno’s comment on one successful funding application. Instead of applauding it, he wrote, “ I’m unconvinced that a province-wide wellness retreat for HIV-positive women …. (is) the best use of limited public funding to fight HIV.”

You know, I’ve heard that before.

Positive Women’s Network has been around for over twenty years, and in that time we’ve had people bluntly ask us why we deserve funding. Why should services for women with HIV get money when so many more men are infected? The answer is this - women get HIV, and are doing so in increasing numbers. Their needs, experiences and lives are different than men’s. A sampling could list gender roles, biological vulnerability, women’s roles in their specific cultures, histories of gender-based violence and sexual assault. Women express the need for women-only services, as we heard over and over when we did a retrospective of our work. One type of organization doesn’t fit all.

We offer a range of services that include weekend retreats for women. These retreats provide health education on HIV, treatments and disease progression; leadership development, and peer support. Women tell us we’ve changed their lives and made a death sentence manageable. Some aren’t sure how they would have gone on if it weren’t for our retreats. If that can be offered to women in other parts of the country, bravo, I say.

Salerno despairs the lack of funding that compromises the work of support organizations, and I get that - there isn’t enough money to go around to everyone. Yet he also recognizes that the organization that successfully received funding has a client base that’s over one third women.

We are fortunate at PWN that many organizations and individuals we’ve worked with over two decades have abandoned their skepticism as they’ve seen the women we work with and the work we do.

HIV funding isn’t endless, as anyone who applies for it knows. But are we in this fight together or what? I’ve believed through the work of many that we are, but obviously there are folks who hold a different opinion.

- Janet

This article by Roger Pebody first  appeared on aidsmap. 

The First Study

Pre-exposure prophylaxis (PrEP) would be an acceptable HIV prevention strategy for large numbers of gay, bisexual and other men who have sex with men in major UK cities, according to two studies presented to the British HIV Association (BHIVA) conference in Birmingham this week.

The conference also heard details of a small pilot PrEP study, likely to start recruiting later this year.

A cross-sectional survey of 842 HIV-negative gay and bisexual men, recruited at bars, clubs and saunas in London, suggested that half the respondents would be interested in taking PrEP.

Respondents were given information about pre-exposure prophylaxis and asked: “If PrEP were available, how likely is it that you would take a pill (oral dose) on a daily basis to prevent HIV infection?”.

Half said yes, with 16% saying they were likely to take PrEP and 34% saying they were very likely to. Men interested in PrEP were slightly more likely to be under the age of 35 (AOR adjusted odds ratio 1.58), have attended a sexual health clinic in the past year (AOR 1.59) and to have previously taken post-exposure prophylaxis (PEP) (AOR 1.96). After statistical adjustment, various measures of risky sex were no longer associated with interest in PrEP.

In this survey, 17 men (2.1% of those answering the question) said that they had previously taken antiretroviral drugs to reduce their risk of HIV infection.

Secondly, clinicians at the Manchester Centre for Sexual Health surveyed HIV-negative men attending their service who reported unprotected receptive anal intercourse. Of the 121 men who responded, 36% said they would be “very willing” to take PrEP while only 14% said they would not take the treatment. Daily dosing was perceived as a better option by four fifths of respondents – just one fifth would prefer taking a dose before sexual activity.

These data confirm and reinforce findings from a study reported in November 2011, which found that half the gay men surveyed would consider taking PrEP. Once again, daily dosing was preferred to taking a dose before sex. In the qualitative data, men commented that sex is often spontaneous and that they felt daily dosing would facilitate adherence.

However these data are all based on giving men a few key facts about PrEP and presenting it as a hypothetical option. In real-life circumstances, where men think more seriously about PrEP as an option and hear friends’ experience of taking it, actual uptake and sustainability may be very different.

While the Manchester respondents largely assured the researchers that they would take all their doses of PrEP and wouldn’t have more risky sex, real-life experience needs to be tested in research.

To this end, the Medical Research Council are seeking funding for a 5000-participant, two-year study which would randomise HIV-negative gay men who report unprotected anal intercourse to either take PrEP (Truvada) and attend motivational interviewing (intervention group) or to be put on a one-year waiting list for PrEP and to have motivational interviewing in the meantime (control group).

For the researchers, it is crucial that this is an open label but randomised study, in which participants know whether they are receiving the actual drug. This unusual research design would, they argue, tell us more about the real-world effectiveness of PrEP than a blinded study as it would take into account the possible impact of participants taking more sexual risks because they felt that PrEP afforded some protection. (Researchers call this ‘risk compensation’ or ‘behavioural disinhibition’).

Rather than test efficacy in artificial conditions, the study would therefore test effectiveness in more realistic UK conditions.

So far, however, the potential funders of this costly study have not been persuaded by this argument and it is unclear whether the study will be able to go ahead.

What will, however, start recruiting later this year is a pilot version of the same study, aiming to include 500 men who attend one of around twelve sexual health clinics.

As well as allowing the researchers to have a dry run of the main trial and identify teething problems with its strategy, it should also provide valuable information on the number of men who actually follow through on a clinician’s offer of PrEP. Data on the characteristics of men who seek PrEP, drop-out rates and risk compensation will also be collected.

The researchers intend to take some of these data back to the main study’s potential funders, in order to support a revised application.

Acceptability of taking HIV treatment for prevention purposes

As well as asking people hypothetical questions about PrEP, researchers have also been asking people waiting for an HIV test result hypothetical questions about treatment as prevention.

Individuals from high-risk groups attending the Jefferiss Wing at St Mary’s Hospital for HIV testing were given an explanatory paragraph about treatment, infectiousness and safer sex. They were then asked: “If you were diagnosed with HIV would you consider taking treatment to reduce the risk of passing on infection (even if you did not need to take treatment for your own health)?”.

Four out of five respondents said ‘yes’. Encouragingly, gay men who reported unprotected anal intercourse in the past three months were more likely than others to be interested in the idea. Less encouragingly, people who had had a sexually transmitted infection or who had previously taken PEP were slightly less likely to say that they would take treatment for prevention.

The researchers suggested that the latter factor may be associated with PEP users’ experience of side-effects. It contrasts with the findings of the London PrEP attitudes study described above which found people who had previously taken PEP more likely to be interested in PrEP.

References

Aghaizu A et al. Who would use PrEP? Predictors of use among MSM in London. 18th Annual Conference of the British HIV Association, Birmingham, abstract O23, 2012. See abstract here.  

Thng C et al. Acceptability of HIV pre-exposure prophylaxis (PrEP) and associated risk compensation in men who have sex with men (MSM) accessing GU services. 18th Annual Conference of the British HIV Association, Birmingham, abstract P233, 2012. See abstract here.

Jones C et al. Treatment as prevention: the views of high risk patients attending an outpatient GUM clinic. 18th Annual Conference of the British HIV Association, Birmingham, abstract P234, 2012. See abstract here.

This article is copyright © NAM Publications, 2012. All rights reserved

This article  by Ruthann Richter first appeared in the journal of Stanford School of Medicine.

The end of the AIDS epidemic — one of worst pandemics the world has known — is now in sight, given the myriad scientific tools available today, from drug prevention to circumcision and methods to stop transmission from mother to child, Anthony Fauci, MD, the country’s top AIDS scientist, said today at the Stanford University School of Medicine.

Fauci, director of the National Institute of Allergy and Infectious Diseases, said the 30 years of the epidemic, which first came to light in 1981 in a seemingly innocuous report about a rare pneumonia among gay men, represents one of the “unprecedented success stories of investments in biomedical research.”

Where he once expected his newly diagnosed patients not to live beyond six to eight months, today he can look a 25-year-old, HIV-positive patient in the eye and tell him, “If you start on one pill a day, you will live 50-plus years. There are few successes that can match that,” Fauci told an overflow crowd of 400 at the school’s Li Ka Shing Center for Learning and Knowledge.

And that has all turned on the stunning progress in both the basic and applied sciences, which in the past two decades has produced more than two dozen approved antiretroviral drugs as well as a wide array of prevention tools that Fauci predicted ultimately will lead to an AIDS-free generation.

“It’s a convergence of scientific accomplishments that have become breathtaking, together with implementation that is unprecedented in U.S. history,” said Fauci, who oversaw vast investments in AIDS research and treatment both through the National Institutes of Health and the President’s Emergency Plan for AIDS Relief, the five-year, $15 billion initiative begun under the Bush administration in 2003.

Today, some 34 million people are infected with HIV worldwide, with 2.7 million becoming newly infected in 2010 alone. In the United States, the federal Centers for Disease Control and Prevention estimates some 1.2 million people are living with HIV, with 50,000 new cases diagnosed every year — an “embarrassing number,” Fauci said. Some 20 percent of infected individuals in the United States don’t even realize they are carrying the virus, he said.

Identifying those individuals and getting them into treatment, as well as keeping up with the pace of new infections, are among the major challenges of the campaign to stop the spread of AIDS, he said. For every person who received life-saving, antiretroviral treatment in 2010, two more became infected with the virus. “So you’re losing that game,” he said.

However, a landmark clinical trial, sponsored by the NIH and published in May 2011, could dramatically change that equation. The study, which involved 1,763 couples in nine countries, showed antiretroviral treatment could reduce the risk of heterosexual transmission by 96 percent. Fauci called the results, which Science magazine singled out as the scientific breakthrough of the year, a “real showstopper.”

“Treatment as prevention has a one-two knockout punch,” he said. “It saves the life of the person already affected and has a 96 percent chance of preventing transmission to another person…. We believe this is going to be a major tool for getting the whole level of the virus in the population down.”

Preventing transmission from HIV-positive pregnant women to their newborns is another area in which there has been major progress, Fauci said. With the use of drug intervention, the rate of mother-to-child transmission in the United States has fallen from 10.9 percent in 1997 to near zero today, he said.

The U.S. government and nongovernmental organizations now are aggressively rolling out treatment among pregnant women in sub-Saharan Africa, where hundreds of thousands of infants are born HIV-positive every year. Now, Fauci said, “It looks like we can turn off mother-to-child transmission if implemented properly.”

Circumcision, now recommended by the World Health Organization, also is beginning to have an impact on transmission rates, Fauci said. More men have been stepping up to have the procedure following studies in South Africa, Kenya and Uganda, which found it could reduce a man’s risk of HIV infection by up to 60 percent. Since then, male circumcision has been shown to have a 73 percent effectiveness rate in preventing viral acquisition over a five-year period, Fauci said.

“If we had this (result) with a vaccine, I would be in the Rose Garden announcing it,” he said.

Women, too, could benefit from emerging technologies that can block the virus during sexual activity. At the International AIDS Conference in Vienna in 2010, South African researchers announced a stunning result with a vaginal gel, containing an antiretroviral drug, which could be used before sex to reduce a woman’s risk of infection by 39 percent. Since then, researchers have announced the development and large-scale testing of a vaginal ring that could be used just once a month, making it even more appealing to women, Fauci said.

He said effective implementation of new technologies in the real world is always a challenge. People first have to know they are HIV-infected; then they have to be linked to care and stay in treatment. At each step, the numbers drop, so that fewer than one-third of infected people consistently remain in treatment — a phenomenon he called “the implementation gap.”

However, he said experience in some countries, such as Rwanda, have shown that it can be done, as the government’s aggressive program to identify patients and provide free treatment has led to a patient retention rate of 92 percent.

Combining these approaches, he said, will change the path of the epidemic, with a steady decline over the next few decades in the population of those who are infected. And while acknowledging that the virus still at times appears to defy the hopes for a cure and may not be fully eradicated in our lifetimes, Fauci said such measures will bring us closer to his vision of an AIDS-free generation.

This editorial by Rob Salerno first appeared in Xtra, Canada’s Gay and Lesbian News source, here.

Two weeks ago, I found myself at the Newmarket Health Centre, where Conservative MP Lois Brown was making an announcement of new funding for the AIDS Committee of York Region (ACYR).

It was a tastefully subdued affair. ACYR’s executive director, Radha Bhardwaj, gave a speech outlining the accomplishments of her organization and some of the unique challenges of providing services for HIV-positive people in the sprawling region north of Toronto that’s home to more than one million people.

Brown spoke eloquently of her own relationship with HIV, forged when her mother, a retired nurse, saw the virus emerging in the region and decided to volunteer with patients many other health professionals refused to treat.

Brown then announced that the agency was receiving $162,400 over two years from the Public Health Agency of Canada’s (PHAC) AIDS Community Action Program (ACAP) to fund a “Community HIV Engagement Program,” which will “increase awareness and visibility of the impact of HIV/AIDS in the region and will improve individual, organizational and community-wide knowledge about HIV prevention and transmission,” according to a government press release.

The announcement noted that a big part of the new program will focus on engaging at-risk populations, including the homeless, drug users, youth and immigrant women. Notably absent from the press conference and briefings was any mention of gay men, who still make up the largest cohort of new HIV diagnoses.

But perhaps that’s not surprising. The epidemic is different in York Region than it is in Toronto, ACYR board chair Marnie Sigmar explained to me. More gay men live in the city or would feel more comfortable accessing services there. In York Region, which has the third-highest number of HIV cases in the GTA after Toronto and Peel, the clientele is noticeably more female and immigrant or ethnic minority.

Sigmar seemed very interested in attempting more outreach to gay men but confessed that she isn’t sure how to do that given there aren’t any gay bars or gay neighbourhoods in the region. She said ACYR would try to reach out on social networking sites and the internet.

Shortly before ACYR received its funding, the AIDS Committee of Toronto (ACT) found out it was losing the funding it had received for years from ACAP to run services for women and Portuguese-speakers.

PHAC had reworked the ACAP funding criteria to limit the number of programs a single agency could receive funding for, specifically to spread the money further outside of Toronto, where many older AIDS service organizations have run multiple programs for years.

Again, that shouldn’t be surprising. Toronto is home to 75 percent of Ontario’s 26,000 estimated HIV patients – almost 20,000 people. For comparison, ACYR estimates its client base in the low hundreds.

This isn’t to denigrate the good work ACYR does. Nor do I think it’s as simple as the Conservatives punishing gay downtown Torontonians for not voting Conservative and rewarding the tiny organizations in Tory-friendly suburban ridings — really, do you think HIV workers are a target Tory demo? Besides, the Tories have a third of Toronto’s ridings now, too.

The changing nature of the epidemic requires flexible and dynamic responses from our government and our service providers, and that can be provided only with stable and predictable long-term funding.

Instead, PHAC left agencies across Ontario dangling for months, then hastily issued a call for funding over the Christmas holidays, leaving organizations with little time to table serious new proposals.

I’m unconvinced that a province-wide wellness retreat for HIV-positive women or services for lusophones are the best use of limited public funding to fight HIV, but by keeping ASOs in the dark and limiting their number of applications, the government hobbled their ability to respond to the epidemic in new and better ways.

The result will likely be increased stresses on AIDS services in Toronto, decreased awareness in the epicentre of the crisis, and a resulting increase in the HIV caseload in Toronto.

PHAC and Health Minister Leona Aglukkaq should be ashamed.

See also Xtra’s other articles on this topic

• Federal cuts force ACT to cancel programs 

• Federal HIV/AIDS funding falls short 

(PositiveLite.com Editor’s note; This article mentions the cuts to ACT’s programming. The full extent of cuts to funding of other ASO’s in Toronto and across the country resulting from this last round of PHAC funding requests is not yet known. PHAC will not provide this information. This information is currently being gathered by the HIV community. PositiveLite.com will report this information as soon as it becomes available to us.) 

Newly updated US treatment guidelines are recommending antiretroviral treatment for all people with HIV infection, rather than starting at a particular CD4 range. But for those about to start treatment and their doctors, it’s not quite that simple; the strength of the recommendations varies by category of patient. Here is how a simplified scale looks:

• CD4 count less than 350 – strong recommendation
• CD4 count 350 to 500 - strong recommendation
• CD4 count over 500 – moderate recommendation

Regardless of CD4 count, initiation of ART is strongly recommended for individuals with the following conditions: pregnancy, a history that includes an AIDS-defining illness, HIV-related kidney disease and HIV/hepatitis B virus (HBV) co-infection. The guidelines also include an early treatment recommendation for anyone at risk of transmitting HIV to partners.

You can read a summary of the recommendations, including changes to existing guidelines, here or read the  full guidelines here.  

In contrast, recently issued draft British HIV Association treatment guidelines continue to recommend treatment when the CD4 cell count falls below 350, although treatment may be started earlier in people with hepatitis B or by people concerned about the risk of transmitting HIV to partners.

Canada has no national guidelines at present, a reflection of our provincially administered healthcare system, but our practice tends to follow the US guidelines.   BC and Quebec have their own guidelines.  But it’s likely that these new US guidelines will be influential in affecting treatment decisions here and around the world.

In Ontario, the advice you will receive currently depends, at least to some extent, on who is your doctor.  Some (many?) doctors are now suggesting treatment immediately on diagnosis, with the consent of the patient, of course. Others are suggesting holding off.  But clearly there has been a move towards earlier treatment for some time, driven in part by the evidence of better clinical outcomes   for those who start earlier, and in part perhaps by concerns about the perceived need to curb secondary infections that the treatment as prevention advocates frequently cite.  More on that later.

The issue of when to start treatment has been controversial. Previously, for instance, the panel that decided on the US guidelines was divided.

There has been little reaction to the new US guidelines from the Canadian HIV community to date.  But HIVers from Australia, in the form of NAPWA (National Association of People Living with HIV/AIDS) were quick to state their position.  In a March 28 statement, NAPWA president Robert Mitchell said “It is increasingly clear that untreated infection is bad for the health of people living with HIV, whether their infection is recent or long-term. We also think that people with HIV will value the added benefit of being on treatment in helping reduce the risk of transmitting HIV to others, when used with other proven prevention measures like correct and consistent condom use.”

This two-pronged rationale for earlier treatment contains elements which have been troublesome for people living with HIV in the past.  Over the years, there have for instance been issues raised about the potential side effects from long(er) term exposure to HIV drugs - longer term at least than if treatment were delayed.  Informed consent has also been an issue for some HIVers – nobody wants to be persuaded to start treatment when they are not ready for making that decision. But on this latter point the new guidelines are clear; “patients (who start) ART should be willing and able to commit to treatment and should understand the benefits and risks of therapy and the importance of adherence. Patients may choose to postpone therapy, and providers, on a case-by-case basis, may elect to defer therapy on the basis of clinical and/or psychosocial factors.”

The longer-term exposure to side effects concerns?  I raised this issue with Dr Julio Montaner, a long-time early-treatment proponent, when I interviewed him for PositiveLite.com earlier this year.  Here’s what he had to say about that. “There is no doubt that antiretroviral therapies have improved dramatically. They are simpler, safer and better tolerated. No doubt about it.  Are they perfect? No they are not….However, if we are having a discussion here on whether starting treatment immediately or on a deferred basis, the gap between those two decisions is somewhere in the order of months to a couple of years. It varies from person to person but when we’ve done studies, the rate of CD4 decline in an untreated person is somewhere between 60 and 120 cells per year. If somebody today says ‘no, I’m going to wait,’ what I say is ‘sure, you can defer antiretroviral therapy, no problem, we are not forcing anybody to start treatment.’ What we are saying is let’s have a discussion."

For an expert narrative on the new US guidelines, I interviewed CATIE’s Sean Hosein last week.  He’s an acknowledged expert on treatment issues and I wanted to gauge his feelings on the impact of the new guidelines for Canada.

Sean cautions against interpreting the guidelines as saying that once people are diagnosed they should start treatment then and there. “What this means” he says ”is that there is an opportunity for doctors and people living with HIV to start the discussion about therapy. Given the therapy that we have today, people are going to be taking it every day for the rest of their lives,  and so people have to be prepared for this – ready, willing and able.”

Do the new treatment guidelines represent a major change? Sean thinks so. ”It’s a major change compared to ten years ago, even five years ago, when they were saying ‘let’s wait ‘til the CD4 counts fall’. But what’s happened is that they’re finding that HIV just doesn’t affect CD4 counts. It causes inflammation inside the body that affects major organs like the brain, the heart, the lungs, the kidneys, the liver, the bones  - and so that’s why there is a push to start treatment earlier.”

I asked Sean to what extent the treatment as prevention arguments – which revolve around, in part, reducing the possibility of secondary infections by suppressing viral load to undetectable levels – might have had on the US decision to recommend starting  treatment earlier.  “I think it’s a mix of two things”, says Sean of the new guidelines. “It’s a mix of trying to do the right thing for the individual person living with HIV and also trying to do something for the rest of society in order to reduce the risk of transmissions.” But  of treatment as prevention, Sean cites the cautions in the guidelines about interpreting HPTN 052 results (the much-publicized study released last year which saw a 96% reduction in the risk of HIV transmission in heterosexual sero-discordant couples) too broadly, noting in particular the lack of data relating to MSM (men whoi have sex with men) , an issue discussed in my interview with CATIE’s James Wilton that you can read here.

On the side effects issue, Sean says the environment has changed. ”That argument, I think was important in the 1990’s and maybe ten years ago when the drugs that were used were much less tolerable.  With the drugs that are commonly prescribed today, the regimes are simpler.  There are side effects but they are generally mild and they tend to go away.  It’s true that people haven’t been on the latest drugs for fifty years so in theory there may be problems in years to come. . . . We need long-term studies to monitor people and those studies are underway.”

I asked Sean if the new guidelines are big news for the HIV community.  Sean thinks so. “It’s about strengthening doctor/patient relationships. I would encourage people who have recently been tested to see this as an opportunity to speak to their doctor about starting treatment early.”

Does he think the US guidelines will shift the Canadian response to HIV infection?  Says Sean “I think it will, because it’s good for people living with HIV. It will keep them alive longer.  It’s a good thing.”

I think so too.  Starting treatment earlier is likely a good thing for many people.  Whether the new US guidelines are driven by a desire for better clinical outcomes for people living with HIV or reflect treatment as prevention policies, or both, is almost immaterial.  I say almost because many of us have been vocal about our concerns surrounding treatment as prevention and we are cautious when some of its key tenets appear to go main-stream. But things have changed. Our knowledge of disease progression has changed. Treatments have changed. My own opinions have changed. So yes, I’m with the US on this one.

Let’s hope that Canada follows suit.