As the world eagerly awaits the latest COVID-19 drug and vaccine developments, the public has become steeped in a new scientific vocabulary: Efficacy and effectiveness, placebos, and Phase 3 trials. In many ways, 2020 has become a banner year for biomedical research and development (R&D). We’re already seeing exciting developments from R&D to stop the coronavirus—and we're also making great progress against another global disease, HIV/AIDS.
HIV was first discovered in the 1980s, and the R&D journey has certainly taken longer than what we are seeing with COVID-19. As a physician and researcher, I’ve seen the ups and downs of this process firsthand, but I’ve also seen how scientific perseverance pays off for people living with HIV. Today, we stand on the cusp of a transformation in the field, one in HIV prevention.
The history of pre-exposure prophylaxis—drugs used to prevent HIV infection, called PrEP—begins in 2010, when a clinical trial showed for the first time that a daily oral pill for PrEP was safe and effective. Daily oral PrEP pioneered an entirely new type of HIV prevention, but it quickly became apparent that it isn’t feasible for everyone.
In sub-Saharan Africa today, women and adolescent girls are more than twice as likely to acquire HIV as men. Deeply entrenched social inequities such as poverty, lack of access to higher education, and gender-based violence have left them particularly vulnerable. These same inequities make it extremely difficult for some women to take daily pills without risking judgment or even retribution.
What if we could develop a product that women only had to use once a month, or even less often? And what if we could develop multiple products to choose from, the same way that women can now choose between contraceptive pills, patches, and implants?
Now, a vaccine and multiple long-acting prevention methods—injectables, pills, and even a vaginal ring—are in advanced development. In 2020, years of research on an injectable drug, cabotegravir, culminated in two clinical trials: HPTN 083 and 084, both of which showed that cabotegravir can protect against HIV with just six injections per year.
These trials also showed that cabotegravir could work for everyone. HPTN 083 enrolled men and transgender women across the world—North America, South America, and South Africa—while HPTN 084 focused on women living in sub-Saharan Africa.
Regulatory agencies still need to review the data on cabotegravir before it can be used widely. But if it is approved, it will be for men as well as transgender and cisgender women—which is a major step toward ensuring that every person who needs PrEP can access it.
Then, just last month, Merck announced plans to launch a global clinical trial program studying a new drug called islatravir as a once-monthly oral pill for PrEP. These trials will tell us whether a single dose per month can prevent HIV, and though we won’t know the results for a couple of years, islatravir is the first long-acting oral option in development. In 2010, we never imagined that 30 pills a month could eventually become one.
These advances have been driven by sharp science and collaboration between the private sector, governments, research institutes, advocates, and people living with HIV everywhere. But what makes long-acting PrEP so exciting isn’t just the science. It’s what these prevention methods could offer: Options.
The convenience of long-acting PrEP increases the likelihood that these methods will be easier for countries to roll out. For example, PrEP could be offered at the same time as contraception, streamlining the process for women interested in both. Biomedical prevention will also become an important complement to initiatives such as the DREAMS Partnership that breaks down the structural barriers putting women at risk.
I know what new HIV R&D developments can mean for people because I lived through one of the first major breakthroughs: Triple therapy in the 1990s. This combination of antiretroviral drugs was the first truly effective treatment for HIV/AIDS, and as a medical resident I watched inpatient wards empty out as people with HIV began living healthy lives outside the hospital. I’m optimistic that once more options become available for women, long-acting PrEP will also change millions of lives.
While 2020 has been a year of incredible hardship, it has also been a period of unparalleled innovation—for both HIV and COVID-19. I hope we will look back on this time as a powerful example of how global collaboration and support for R&D can improve health and well-being for all.
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