This drug will change the equation completely, says Dr Julio Montaner, of the American Food and Drug Administration’s (FDA) recent decision to approve a new, single-pill HIV treatment.
“This really is the ultimate step of simplification,” he declares. “It’s going to be a long time before things get any easier than this. It opens the door for a large number of people who had difficulties thinking about treatment because of lifestyle issues, or concerns regarding ability to adhere to complex regimens, people with depression, mental illness or whatever.
“I view this as a great, positive development for the patients that I deal with.”
Montaner is already talking to one of the companies involved in creating the new treatment, Gilead Sciences, to bring the pill to BC in the new year. The pill will combine three different HIV drugs in one.
“I have big plans for one pill, triple therapy. I will be unveiling some of those at the Toronto [International AIDS] Conference.”
Already the director of the BC Centre for Excellence in HIV/AIDS, and the physician program director for HIV/AIDS at St Paul’s Hospital, in February Montaner was voted president-elect of the International AIDS Society (IAS), the world’s leading independent association of HIV/AIDS professionals based in Geneva, Switzerland.
“I view it as more of the same,” he says humbly about this new position. “I can’t do more than I am doing already,” he laughs. He assumes his new role at the International AIDS Conference in Toronto, Aug 13-18, and will begin his two-year term as president at the closing of the next International AIDS Conference in Mexico City in 2008.
Montaner has been involved in the IAS for years. He helped organize the International AIDS Conference in Vancouver in 1996, where he reported on experiments that the Centre for Excellence had completed using highly active anti-retroviral therapy (HAART). HAART is the potent cocktail of revolutionary protease inhibitors, which has since saved countless lives and greatly changed the course of treatment and prognoses for patients living with HIV/AIDS.
“I see [the presidency of the IAS] as the normal evolution of everything that I have been doing all these years,” Montaner says. “It will give me the opportunity to give the organization further leadership in the expansion of retroviral therapy worldwide. We really have an opportunity to tackle HIV more aggressively. The world has accepted the fact that HIV is an exceptional problem that needs to be addressed with exceptional measures.
“Having said that,” he notes, “the rhetoric has not been matched with effort.
“We’re a bit saddened that the federal government is not showing the kind of leadership that we feel Canada should be playing in the AIDS field,” he asserts. “I don’t want to be too critical too soon, but our honourable prime minister has to make up his mind as to what his position is going to be and what he’s going to do about it. We are either going to be happy with what he’s doing, or not, and we are going to let him know.”
Although dozens of global figures in the fight against HIV/AIDS agreed to attend the Toronto conference, Conservative Prime Minister Stephen Harper refused to go.
Last year, Montaner made headlines when he confronted Health Canada and the then-Liberal government over access to experimental AIDS drugs.
The conflict arose after he applied under Health Canada’s Special Access Program (SAP) for approval to use two new drugs in combination, TMC 114 and TMC 125, for six of his patients who had exhausted all other treatment options.
SAP was originally designed to allow medical practitioners access to drugs that are not approved for use in Canada. It is supposed to be limited to patients with serious or life-threatening conditions on a compassionate or emergency basis when conventional therapies have failed, are unsuitable or unavailable.
Although Montaner’s patients seemed to meet those criteria, Health Canada refused his request, saying the drugs had not been proven completely safe.
Montaner agrees he didn’t know how safe the drugs would be but, given his patients’ limited options, they chose the treatment knowing the risks.
Health Canada eventually approved a tiny clinical trial, but not before one of Montaner’s six patients died.
Since starting the experimental therapy, Montaner’s remaining five patients have seen their health improve substantially. “To be honest with you, we have been very gratified that the drugs, so far, have been extremely well tolerated, and in every case they have been associated with significant improvements.”
Even though he succeeded in helping these patients, he is still frustrated by the process.
“The concerns that were put forward by the Special Access Program [were] that the drugs could be toxic,” Montaner recalls. “Therefore, they were not going to allow me to use them together. I felt that those concerns were inappropriate at the time, but now I can tell you they were also unfounded.”
“I don’t consider myself God,” he continues, “and I am not here to claim that everyone has to live until the end of the day, but I was able to access the drugs for free, so there was no cost to anybody. The patient was willing to take them. He knew that his life was in danger and was willing to take this last desperate step to make things better, or if not, to die fighting, which is a right that I think we should all have. This was denied to him for reasons that I still don’t understand.”
In June, the FDA approved TMC 114 for use in the United States.
“The other one [TMC 125] is a little behind in development,” Montaner explains, “but the way things are evolving one would hope that within a matter of months both of them could be available. Until [they are] widely available, people are not able to benefit from them; not because the manufacturers are not willing to make them available but because the bureaucracy that is involved in accessing [them] is insurmountable. That’s the sad part of all of this.”
Montaner believes that the theme of the Toronto Conference, Time To Deliver, is very appropriate.
“We’re meeting at a time in which we’re facing 40 or 50 million people infected with HIV and AIDS in the world and the time to deliver is now. We want to start here, set examples for Canada that we can take to the rest of the world, and armed with that, echo it for similar responses elsewhere.
“My concern is that I just don’t see the Canadian wheels turning at the speeds they should be to ensure that this is going to happen,” he says.
“[What] we need to do is work very hard at trying to engage the international community, mostly the political leadership, in some sort of action that is commensurate with the magnitude of the challenge that we have ahead,” he continues.
“It’s unacceptable, and generations to come are going to judge us very harshly for not having done what could have been done to stop what is otherwise very problematic. Ultimately, we tax many generations to come because of [the] inaction of our political leadership.
“It’s really criminal negligence not to do whatever is needed to curb the spread of the epidemic,” he says, “to slow down and quite possibly stop what is currently very rapidly growing in much of the world, including our own backyard.”
Though he concedes that government spending on HIV and AIDS has increased, he says “the magnitude of the effort pales by comparison in relationship to the magnitude of the threat.
“This is not like you increase roads [spending] by 20 percent, 30 percent and then you’re happy. No, you have an epidemic that is out of control. It continues to grow. We know how to stop it. Through education [or] HIV treatment. Either you do it, or you don’t. So far, we haven’t done it because the effects have not been measured.
“Maybe I [am] being very drastic,” he concludes, “but saying that the expenditure [on] AIDS has globally increased really doesn’t help anybody. The virus obviously has been growing faster than the expenditure. That’s the bottom line.
“Am I optimistic that the global response is going to be there, and that the national leadership is actually going to follow through?” he ponders. “You know what, I don’t know, but we’re going to find out, and we won’t give up, that’s for sure.”
Though much of Montaner’s work at the BC Centre for Excellence is primarily focused on HIV and AIDS in the community at large, he has led a number of studies specifically on gay men’s health, including an attempt to develop an AIDS vaccine a few years ago.
“Currently,” he says, “we have the only operating anal dysplasia clinic for gay men. If you look at our publications over the years, I would be surprised if a good third of [them] are not addressing issues specific to the gay community,” he adds. “We are currently looking at opening another gay cohort. We’ve had several, [but] the most recent one has matured and become less clinically relevant.”
Despite facing imposing challenges, Montaner is still able to joke about himself. When asked about how he maintains his energy and keeps focused, he laughs, “Some people call it a personality defect.”
He continues more seriously, “Although you probably perceive that I am always pretty upbeat and optimistic, I am able to turn my frustration into energy to move [to] the next level; rise above the obstacles, and keep fighting. It gets to be a little bit tiring at times, particularly when you get people, for example bureaucrats or elected politicians, who plainly ignore you and give lip service for what you are trying to do.
“I have a tremendous advantage,” he figures, because, “I remain clinically active dealing with patients, people infected with HIV, basically 50 percent of my time. They are the source of my inspiration and energy. I learn from them what their needs are, what the weaknesses of the systems are, and I try to build, based on their learning. When you see the kind of energy that they put into fighting against HIV themselves, the kind of stuff that I’m doing is modest by comparison.”