There was a palpably upbeat mood at the 25th International AIDS Conference, held last month in Munich, Germany. Organized by the International AIDS Society, the event brought together more than 10,000 delegates, speakers, researchers and guests representing scientists, industry, caregivers, policy makers and field advocates from around the world.
The conference was buzzing with anticipation of the announcement of surprising results from a recent trial of the twice-yearly PrEP injection lenacapavir.
Also causing a stir was the encouraging news that a patient in Berlin had been cured, joining a small circle of other former HIV patients who had undergone high-risk stem cell transplants designed to fight aggressive cancer and similar diseases.
The conference was attended by three cured patients who shared their heart-warming stories of how they underwent a dual-effect procedure to eradicate HIV while fighting the disease, and are now living HIV-free and cancer-free.
Over the course of the week, I attended several key sessions at AIDS 2024, including a pre-conference panel on HIV prevention hosted by Global Black Gay Men Connect, and the conference’s opening session, highlighted by a welcoming address from German Chancellor Olaf Scholz.
Scholz reaffirmed his country’s commitment to funding HIV/AIDS treatment and research, and reiterated the need for continued support around the world. “One person dies from AIDS every minute,” Scholz said. “One person every minute! This has to change. Our common goal is to end the AIDS epidemic by 2030. We are making progress, but there is still a long way to go.”
Scholz noted that Germany, along with the United States, France and the United Kingdom, is one of the largest donors to the Global Fund to Fight AIDS, Tuberculosis and Malaria, and stated that “we will continue to support the fund in the future.”
The prime minister’s remarks were a fitting response to an earlier opening speech by Winnie Byanyima, Executive Director of the Joint United Nations Programme on HIV/AIDS (UNAIDS), in which she called on world leaders – “political leaders and business leaders” – to ensure that adequate funding is dedicated to the fight against AIDS.
“Fund the frontline heroes here today and all the HIV activists in their communities,” Byanyima said. “And free developing countries from debt bondage. Free them.”
Byanyima noted that in many African countries, debt repayments account for more than 50 percent of total government revenues. “Suffocating debt must be restructured immediately to enable governments to fund the health of their people.”
In fact, the theme of this year’s International AIDS Conference was Putting People First – focusing on recognizing the human beings behind the numbers and statistics, and recognizing that amazing advances in treatment are meaningless if people cannot access or afford treatment.
Lenacapavir, made by Gilead, the drug maker behind the once-daily PrEP pill Truvada, is very expensive, costing thousands of dollars, but that did not dampen the excitement surrounding the release of Gilead’s clinical trial data.
Results from the PURPOSE 1 trial, which enrolled young women in South Africa and Uganda, “confirm that lenacapavir is 100% effective in preventing HIV in cisgender women,” Linda Gayle Becker, director of the Desmond Tutu HIV Centre at the University of Cape Town, said during the conference. One year after two doses of the shot, none of the women in the trial had contracted HIV.
“Twice-yearly lenacapavir for HIV prevention is a groundbreaking advance with great potential for public health. If approved and delivered quickly, cheaply and equitably to those who need and want it, this long-acting tool could help accelerate global progress in HIV prevention,” outgoing IAS President Dr. Sharon Lewin said in a statement about the results.
“We now look forward to the results of PURPOSE 2, which will evaluate twice-yearly lenacapavir for HIV prevention in other populations and countries,” Lewin added.
According to a Gilead press release, the company’s PURPOSE 2 trial is evaluating lenacapavir for PrEP in cisgender men who have sex with men, transgender men, transgender women, and non-binary individuals who have sex with partners assigned male at birth in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States.
The company plans to include results from both PURPOSE 1 and PURPOSE 2 in its regulatory submissions. But what will Gilead do about pricing?
Drug manufacturers are notoriously cautious on the subject, and as I personally witnessed at a GBGMC-sponsored session, a representative from ViiV Healthcare made a clumsy attempt to deflect the discussion from the issue of pricing by simply suggesting something else the panel could consider instead.
But at nearly every session, participants wanted to discuss price. “Gilead, we call you. We know you’re in this room,” UNAIDS Executive Director Byanyima teased in her opening remarks.
“Gilead has a long-acting injectable called lenacapavir that I call a miracle prevention tool,” Byanyima continued. “This could transform access for gay men, transgender people, sex workers, young women in Africa, freeing them from the stigma and fear of being attacked for even being seen taking a pill. But right now, Gilead, lenacapavir, is priced for people in wealthy countries. This inequity has never worked for good in the response to HIV. Not at all!”
Byanyima urged the company to quickly license lenacapavir to generic drug manufacturers through the United Nations-backed Medicines Patent Pool, concluding that “this miracle product should not be limited to a few manufacturers, as prices will remain high and millions will be excluded.”
Access, affordability, financing and providing adequate resources to key populations remain major challenges in the fight against HIV/AIDS – and all of these challenges are exacerbated by the stigma faced by people living with HIV and AIDS, which fuels fear and hatred, discrimination and criminalization.
Combating stigma with facts, such as U=U and the fact that an undetectable HIV viral load means the virus is not contagious, was a major motivator for many of the attendees. Cured patient Marc Franke, also known as the “Düsseldorf patient,” revealed at the conference that this was part of his motivation to go public with his story in order to combat stigma.
“HIV is not the worst disease because what’s more exciting than finding a cure is fighting the stigma,” Franke explained to me. “Emotionally it’s the worst, because you can’t tell anyone. If this were easier, fighting HIV would be a lot easier.”
Franke, along with London patient Adam Castillejo and City of Hope patient Paul Edmonds (three of the seven people cured so far), featured in a pre-conference panel discussion about what an HIV cure looks like.
All of the Frankes were infected with HIV and had severe cancer (in Franke’s case, acute myeloid leukemia) and received stem cell transplants from donors who carried a rare genetic mutation that protects the cells from HIV. Patients eligible for such treatment are extremely rare, and these incredibly good outcomes are jeopardized by a seemingly limitless number of potential complications.
In a separate session, Dr. Bjorn-Erik-Ole Jensen, head of Dr. Franke’s team at University Hospital Duesseldorf, warned that stem cell transplantation is not a scalable treatment strategy.
Still, cured patients are living proof that something works. Castillejo told the panel audience, “For me, being cured of HIV is very humbling and gives me hope to give hope to people all over the world.”
“When you compare the cured patients, there are small differences in each case,” Franke told me, “and I hope that scientists will come together and find the right puzzle pieces. What makes a treatment really effective? I don’t think anyone knows exactly right now.”
Still, hope abounds everywhere. “I believe a cure for HIV is possible, and I believe it will come, although I don’t know when,” Edmonds, the cured patient, told me. “We had stem cell transplants because we had leukemia, and we didn’t have many options, and then we found a donor with a mutation that protects against HIV.”
But the procedure is again very risky, Edmonds noted. “This isn’t for everyone,” he said. “But it could be for genetic reasons. [advances] Is there anywhere we can replicate what happened to us without a stem cell transplant?”
A universal treatment or vaccine? Edmonds believes so. “I have a vision of a day when HIV is no longer just a piece of writing, but a footnote in history,” he said.
Source: Metro Weekly – www.metroweekly.com