PARIS – Imagine if rather than taking a daily pill to protect you from HIV, you could get an injection or an implant that could work for months, or even years.
For women and girls around the world, this could be transformative, especially for those who want to be discreet about protecting themselves from the disease or who have difficulty regularly accessing a health facility. This is not a far-off dream: Injections and implants are currently being developed and the trials are promising.
Pre-exposure prophylaxis (PrEP) – an anti-HIV medication that keeps HIV-negative people from getting infected – has been on the market for the past few years in oral form, but implementation has been limited and adherence has been a challenge. The pill, called Truvada, contains two antiretrovirals that work to keep the virus from establishing a permanent infection in someone exposed to HIV.
The first randomized control trial of PrEP, which began in 2007 in six countries, found that while the drug offered high protection against HIV if the person took the pill every day, only about half took the pill correctly.
“The only stumbling block of PrEP is adherence: that people don’t take the drug,” said Dr. Anthony Fauci, a leading HIV specialist and the director of the National Institute of Allergy and Infectious Diseases in the United States. “It works [but] you’ve just got to get it in a form so people will use it.”
On July 25, a new study into a long-acting injectable drug for HIV prevention was presented at the International AIDS Society Conference on HIV Science, held in Paris. The authors say the study, which involved low-risk men and women in Brazil, South Africa and Malawi, proved that the injectable, when administered every eight weeks, is safe.
Participants were injected with cabotegravir – a drug that belongs to a group of HIV drugs called integrase inhibitors – which works over time by preventing HIV from multiplying in the body, just like the oral tablet does.
The study has moved to phase III trials, which are needed to prove the treatment is effective in high-risk groups, before it moves on to be approved by the U.S. Food and Drug Administration and then other countries’ regulatory bodies. The phase III trials, which began at the end of 2016, involve 4,500 people, including gay men, trans women and trans men.
An HIV-prevention implant – which is the size of a matchstick and biodegradable so it would dissolve in a person’s arm over time – is further behind on development. However, studies show promising results, said Leah Johnson, a research chemist at RTI International, a nonprofit institute in North Carolina. It’s hoped an implant could last as long as two years in the body.
Researchers envision that either the implant or the injectable could be coordinated with family planning so that when at-risk women and girls go to healthcare centers for contraception, they could also be offered an HIV-prevention option.
Jacqueline Wambui, a Kenyan HIV/AIDS activist, was diagnosed with HIV in 2004. She’s excited about the potential these new tools could have for women and girls, who, in sub-Saharan Africa, face the greatest risk of acquiring HIV.
“An injectable or an implant would be fantastic,” she said. “Girls could just go to the health clinic, get it put in and forget about it.”
However, she raises important questions that she hopes researchers will consider moving forward: Will these tools be available at local clinics? How far will a woman have to travel to get them? Is this something that a woman can get discreetly, without her partner knowing?
Elizabeth Montgomery, an infectious disease epidemiologist at RTI who focuses on preventing HIV infection among women in southern Africa, believes discretion and convenience are the key benefits for young girls compared with the daily pill.
Montgomery believes an implant has huge potential to transform HIV prevention.
“It’s very empowering,” she said. “Especially for young girls who are living at home and they don’t want to get caught with pills and have to explain to their parents, or for girls who can’t successfully negotiate condom use with their partners so they need to protect themselves secretly.”
Giving Women Choice
Looking ahead, there are still a lot of unanswered questions. When will these products be brought to market? Who will pay for them? Who will benefit from them? How much will they cost?
“Do you target certain high-risk populations? Gay men? Sex workers?” said Montgomery, who warns that targeting only certain populations could introduce stigma.
Dr. Raphael Landovitz, associate director of the University of California’s Center for Clinical AIDS Research and Education, led the research into the proposed injectable drug. He says in the future, HIV prevention could be like a family planning regime.
“Some women want pills, some women want a shot, some women want an IUD, some women want to just use condoms, some women don’t want any of that,” he said.
“I think the more choices [there are], the more likely it is we will have something that will be useful for a given individual.”