Top 10 HIV Clinical Developments of 2020
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Top 10 HIV Clinical Developments of 2020

HIV test.In any given year, thousands of HIV-related studies and research presentations flood our medical journals and conference halls. (Or, in a year like 2020, our virtual conference halls.) Each of these scientific nuggets furthers our knowledge about HIV and moves the needle on our ongoing efforts to end the epidemic.

Amidst this vast ocean of new HIV-relevant information, how can the HIV workforce best discern the studies and stories that have the greatest potential to impact HIV prevention, care, services, and policy within the forseeable future?

Turns out, one pretty reliable solution is to an expert who really knows their stuff.

As 2020 draws to a close, we asked David Alain Wohl, M.D., a professor of medicine in the Division of Infectious Diseases at the University of North Carolina and a highly respected HIV clinician-researcher, to take stock of the year's most momentous research developments and other critical events. In this exclusive series of articles, Wohl calls attention to 10 such developments that have tremendous short-term implications for our day-to-day efforts to improve HIV prevention, treatment, patient care, and policy in the U.S., and analyzes each development with his trademark wit and clinical savvy.

#1: HIV in the Time of COVID-19

When I called to check in on him, my patient of more than 20 years told me, “I don’t go near anybody but my dog, and haven’t since March.” His commitment to maximum SARS-CoV-2 avoidance was shared by most of the patients living with HIV I spoke with during our COVID-19-proof telemedicine visits. “I have enough going on; all I need is COVID,” another said.

Their caution is understandable, and staying away from other Homo sapiens is a prudent approach we should all emulate. Underlying their self-imposed lockdowns, though, was a concern that their HIV infection placed them at a heightened risk for SARS-CoV-2 infection and severe COVID-19. However, it still remains unclear whether SARS-CoV-2 poses any greater threat to people living with HIV infection than it is to those who are HIV-negative—although the bulk of data we have thus far obtained is more encouraging than not.

#2: HIV PrEP Is About to Get Its Shot

Pre-exposure prophylaxis (PrEP) for HIV is a pill. It has always been a pill. But it will not always be a pill, thanks to two major trials evaluating cabotegravir, an integrase inhibitor formulated for intramuscular injection, as PrEP.

A shot in the butt is not for everyone—and it does not have to be. What injectable cabotegravir offers is a choice, the first of what will likely be many, so that people can select which of multiple options is the best fit for them.

#3: The Nefariousness of Prior Authorization for PrEP

Before you get too excited by visions of injectable PrEP dancing in your head, the here-and-now reality is that we already have highly effective oral PrEP—that is, provided a person is able to gain access to it. Often-cited drags on expanded PrEP uptake include low provider knowledge and willingness to prescribe, stigma, under-appreciation of personal risk, and lack of access to clinics offering PrEP.

An important new analysis offers another barrier to PrEP, one that is almost sinister in its application predominantly in the U.S. South—which is home to more people living with HIV any other region of the U.S., and where the majority of new cases of HIV are diagnosed. That barrier is Prior Authorization.

#4: Mortality Rates Are Way Down Among People With HIV

As we watch deaths from COVID-19 accumulate in the U.S. and elsewhere, it can be useful to reflect that there was a time when it was hard to imagine that mortality from AIDS would plummet and keep decreasing over time. HIV therapies have, of course, been remarkable; they not only flattened the HIV pandemic curve, they trounced it (albeit slowly).

A new report is explicit in associating the positive HIV mortality trends with strong and concerted public health interventions. These have increased the proportion of people aware of their HIV status, shortened the time from diagnosis to viral suppression, and supported the engagement in care and treatment (once known as the “cascade”).

However, the report also undescores that more needs to be done, despite its upbeat headline. In 2017, the final year of the analysis, 16,000 people with HIV died in the U.S.—including approximately 5,500 from HIV-related causes. This risk of death from HIV was much greater for people who are Black and living in the South.

#5: Why Do Some People With HIV Have Lower Life Expectancy?

Given the decline in mortality among people living with HIV in the U.S., it’s no surprise that the difference in life expectancy between those with and without the virus is shrinking. But even in a near-ideal healthcare setting, lower life expectancy for HIV-positive people persists.

When a friend of mine who is living with HIV first brought this article to my attention, he saw the odds stacked against him: He felt the differences in life expectancy between positive people and negative people as the number of precious years he could be robbed of. I understand that. As a healthcare provider, I also see the contours of the existing limits of care.

Some things will take more than what I can offer during an office visit. And, no surprise: Addressing poverty, discrimination, and other stressors would likely also matter.

#6: Fostemsavir, a New Option for Extensive HIV Drug Resistance

The number of people living with HIV who are heavily treatment experienced and have few remaining antiretroviral options is fairly small. Still, for that small percentage, things can be rough: Many are straddled with antiretroviral regimens that include pharmacological boosters, inconvenient dosing, and side effects. Some may even still fail to achieve virologic suppression.

Therefore, U.S. Food and Drug Administration (FDA) approval of fostemsavir (brand name: Rukobia), an HIV attachment inhibitor, in July is welcome news to these patients and their providers.

Most people living with HIV will never need fostemsavir. But for those who do, the drug can be a life-saver—and that is pretty epic.

#7: Lenacapavir May Transform HIV Treatment. But Where's the Data?

Can someone tell me when it became OK to announce clinical trial results in a press release well before presentation at a scientific meeting or publication in a peer-reviewed journal?

Lenacapavir, a long-acting inhibitor of the formation of the HIV capsid, has been found effective in a Phase 2/3 trial at lowering the viral load of patients with multi-drug resistant virus—that is, according to a press release from the company developing it.

The data on lenacapavir we have seen thus far pave a path that can soon lead to an every-six-month, self-administered antiretroviral injection. Such a therapy can be a powerful tool for treating HIV by increasing convenience and reducing stigma.

But before we bite, let’s demand to see full results presented at major conferences and published in reputable, peer-reviewed journals. Let’s refuse to act on press releases alone.

#8: Where You Live in the U.S. Affects Your Baby's Risk for HIV

Black women in the U.S. are three times more likely to die during pregnancy than white women, and maternal mortality for HIV-positive women is than it is for HIV-negative women. While HIV infection itself may contribute to adverse pregnancy outcomes, a team of academic and public health investigators in Philadelphia sought to identify structural and contextual factors that could also influence the well-being of pregnant women living with HIV infection in that city.

Among the host of factors that were explored as potentially being associated with a detectable viral load at delivery, neighborhood education attainment and crime levels were the most significant.

A reasonably understandable initial response to this important study could be “WTF”—a reaction that appropriately mixes the sadness, anger, and sense of injustice that these findings evoke. But the forces that conspire to harm people of color and people living in poverty are persistent and intransigent. The investigators carefully isolated and identified such forces, depicting how they impact the well-being of women and their children.

#9: Weight Gain After Starting HIV Treatment

A top story in HIV medicine in 2019 was the excess weight gain experienced by some during HIV treatment with integrase inhibitors. These antiretrovirals had quickly become the special sauce of HIV therapy: They were potent, had a high resistance barrier, and were very well-tolerated.

Make that: Mostly very well-tolerated.

This year solidified much of what we first heard last year. Dramatic increases in weight following the initiation of integrase inhibitors, especially dolutegravir or bictegravir, is a thorny problem that may prevent the use of these otherwise excellent HIV therapies. Black women seem to be at greatest risk of excess weight gain, but white women and men of all races are not immune.

The etiology of the weight gains shown in the latest research is not clear. But given the differences we’ve seen among disparate subgroups, it is highly likely that there are genetic influences on the amount of weight people gain on certain HIV therapies.

#10: Biden Wins. What's Next for HIV Medicine?

In 2016, I lamented President-elect Trump’s bluntly stated threats to destroy the Affordable Care Act (ACA) and his implied threats to cut funding to Ryan White CARE Act HIV/AIDS programming, as well as the National Institutes of Health (NIH). More than anything, I worried that the four years of his administration would not be good for people living with HIV.

At the end of those four years, some of these worries have been validated.

The incoming Biden administration is already telegraphing a very different, science-first approach—one that has included consistent messaging about COVID-19. Health care will be front and center in many debates over the next few years, even after the worst of the COVID-19 pandemic is past us.


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