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Innovation

How Advances in HIV Treatment Could Help Young People Living With HIV

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We spoke to a scientist behind a treatment for the disease that was recently FDA-approved for adolescents ages 12 to 18 to learn how it could give them new hope.
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A few decades ago, human immunodeficiency virus (HIV), the viral precursor to acquired immunodeficiency syndrome (AIDS), was considered a fatal condition. In the 1980s, AIDS-related illnesses killed more than 100,000 people in the U.S. alone.

Today, thanks to the tireless efforts of researchers and advocates and remarkable advancements in treatments, people with HIV can live long, healthy lives with the help of consistent antiretroviral therapy.

That said, young people and other high-risk populations continue to contract HIV. For example, approximately 75% of Black/African-American gay or bisexual men with HIV received their diagnosis between the ages of 13 and 34. But recent longer-acting treatments are providing patients with new therapeutic options—and more choices that might better fit their individual needs.

One such treatment option, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson in collaboration with ViiV Healthcare, was approved earlier this year by the U.S. Food and Drug Administration (FDA) for use in adolescents between the ages of 12 and 18.

"This longer-acting treatment regimen could be potentially game-changing for young people with HIV, particularly since it's not pill-based," says Kati Vandermeulen, Senior Director and Compound Development Team Leader, Infectious Diseases & Vaccines, Janssen R&D.

For World AIDS Day, we spoke to Vandermeulen about what it took to bring this new therapy to market and its potential to help improve the lives of adolescents living with HIV.


Q:

Can you tell us a bit about your work?

A:

I’m a scientist. I have a master’s degree in biology-biotechnology and started in pharma in 1990. Now I’m a compound development team leader at Janssen, which means I'm leading the team that focuses on the development of new medicines for young people and adults living with HIV.

Q:

Around the globe, HIV in infants and young people is a major concern—especially in sub-Saharan Africa, where 90% of all HIV-positive children live. In the U.S., young people 13 to 24 years of age accounted for 21% of all new HIV diagnoses in 2018. Can you share your thoughts on why these cases persist?

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A:

Unfortunately, in resource-limited settings such as sub-Saharan Africa and some countries in Asia, access to treatment can be challenging. Treatment access can also be an issue for some groups in higher-income countries as well, particularly for minority populations and people who don't have health insurance.

Adolescents are considered a vulnerable population. Once they become sexually active, they risk contracting HIV themselves. For these young people, the daily reminders of their disease, including the need to take pills every day, can be difficult, not to mention the potential stigma they face due to their HIV-positive status. Dealing with a chronic disease condition is an extra burden on top of all the normal challenges of growing up.

Q:

From your experience, how is HIV generally medically treated?

A:

All HIV drugs available today stop viral replication through a variety of mechanisms of action. It’s not a cure, so if you stop taking the treatment, the virus will start replicating again.

HIV cannot be treated with one drug alone. Because it is a chronic disease, patients need to take their pills daily, preferably even at the same time of the day. It might only be one pill a day, but it can still be a challenge to remember to take it and without anyone else noticing it.

As you can imagine, having to tell adolescents to take their pills can cause clashes. Adolescents don’t always want parents telling them what to do.

Q:

In your opinion, are there different considerations to keep in mind when adjusting an HIV treatment for use in adolescents and children?

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A:

Often HIV drug development starts in the adult population. Then we adjust formulas by weight and age. Adolescents can be close to adults in weight and/or age, so it is often possible to extrapolate from the adult data.

Formulating dosages for children under the age of 12, however, is a bit more challenging. Their metabolism might be different from that of adults, which can impact drug absorption, the distribution of the drug into the body and the way the drug gets eliminated. The trick is to have a balance; we cannot give a child too much medicine, because if we do, that could affect safety. At the same time, we should not under-dose, because if we do not give enough of the treatment, the virus can start replicating again.

Q:

Do you believe the treatment will ultimately become available outside of the U.S.?

A:

Yes, the plan is to make this long-acting regimen broadly available.

Q:

How long have you been researching this medication?

A:

Our collaboration with ViiV on this long-acting HIV regimen project started in 2015, and the adult trials started shortly after that. In March 2020, the long-acting regimen received its first regulatory approval.

Q:

What excites you about working on potential HIV treatments?

A:

Definitely being able to make a difference for patients. When I was in my last year of studying, and that was a long time ago, I was already working on HIV. The fact that it’s gone from a really terrible deadly illness to a chronic treatable disease in a couple of decades is truly remarkable—and I’m really proud to have been a small part of that.

Q:

In your words, this approval marks the culmination of years of hard work. How does it feel to see this treatment out in the world?

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A:

It’s a great feeling. In the absence of a cure—which of course would be the best outcome—long-acting treatments are a significant step forward in HIV care. We hope that treatments like this will help redefine how HIV can be managed moving forward.

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