ViiV Healthcare long-acting HIV treatment secures FDA approval

07-Feb-2022 - Last updated on 07-Feb-2022 at 15:07 GMT

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The HIV-focused pharma company announced the agency has approved Cabenuva for administration as few as six times a year for adults living with the virus.

ViiV Healthcare, the HIV specialist company majority-owned by GlaxoSmithKline (with Pfizer and Shionogi as shareholders), has announced the US Food and Drug Administration (FDA) has granted approval of Cabenuva (cabotegravir and rilpivirine) for use every two months. The treatment is now approved for administration as infrequently as six times a year to virologically suppressed adults diagnosed with HIV, without prior treatment failure or resistance to cabotegravir or rilpivirine.

In January 2021, Cabenuva became the first and only long-acting HIV regimen when the FDA approved it as a once-monthly treatment for HIV-1 in virologically suppressed adults. It contains ViiV’s cabotegravir extended-release injectable suspension in a single-dose vial and rilpivirine extended-release injectable suspension in a single-dose vial, a product of Janssen Sciences Ireland (one of the Janssen Pharmaceutical Companies of Johnson & Johnson); FDA approval now allows Cabenuva to be dosed monthly or every two months.

Outsourcing-Pharma recently checked in with John Peller, president and CEO of AIDS Foundation of Chicago, a non-profit offering advocacy and resources for people living with HIV/AIDS. He explained how the approval might be good news for HIV patients and discussed some of the primary concerns about HIV treatment and care access.

OSP: Could you please share some of the reasons why going from a monthly regimen to every other month might benefit HIV patients?

OSP_ViiVregimen_JP — John Peller, president and CEO, AIDS Foundation of Chicago

JP: ViiV’s new medication, Cabenuva, was the first longer-acting HIV treatment when it was approved about a year ago. All other HIV treatments are daily pills.

We welcome news that people living with HIV can now get injections every two months, which will make Cabenuva a much more attractive option. Cabenuva must be given as a shot in the buttocks in a medical office and having to go to the doctor monthly can be challenging.

It’s critical that people living with HIV have a wide range of treatment options. The bi-monthly, longer-acting injectable is an important addition to the landscape. The bi-monthly shot is likely to be a great option for people living with HIV who have challenges taking a daily pill, such as people who are unhoused, adolescents, or people who use drugs. One-third of people living with HIV in Illinois are not engaged in HIV treatment; providing a suite of medication delivery choices is critical.

Taking Cabenuva every other month will be much less expensive (wholesale acquisition cost of $48,708/month for 12 injections vs. $36,531 six times a year). The cost for six injections a year is competitive with other commonly-used HIV pills. This lower cost may increase Medicaid, Medicare, and private insurance coverage of Cabenuva and reduce prior authorization requirements, which will streamline access for people living with HIV and reduce the administrative burden for providers.

We can’t talk about HIV without talking about racial health disparities. Black Americans make up 46% of Illinoisians living with HIV but 14% of the state’s population, and Latino/a/e/x people are 17.5% of people living with HIV but 20% of the state’s population.

Medical mistrust runs deep among Black and Latine people, as we’ve seen from disparities in COVID vaccine uptake. Substantial investments are needed to educate people living with HIV about longer-acting treatment options, with a focus on the most marginalized communities to ensure equitable uptake.

OSP: Might there be any other HIV treatments in development your organization is keeping a hopeful eye on?

JP: There are other long-acting medications in development from other companies, including Gilead and Merck. At least one drug in the pipeline is a monthly pill, which would be a game-changer. We are optimistic that one of these will pan out.

We are excited that the FDA in December 2021 approved Apretude, an every-other-month injectable for HIV prevention also made by ViiV. The drug includes one of the components of Cabenuva. Apretude is incredibly effective at preventing people from becoming infected with HIV and gives us great hope.

However, insurance coverage may be challenging because there’s a widely available generic pill for HIV prevention that’s just $30 a month, compared to the wholesale acquisition cost of $3,700 per dose for Apretude.

The US has the opportunity to end the HIV epidemic – a goal that President Biden has embraced and that we have put into action in Illinois with the Getting to Zero Illinois strategy. New, longer-acting forms of HIV treatment and prevention have the potential to accelerate our progress towards those goals, but only if combined with substantial investments in the supports people living with HIV need to consistently engage in health care. This includes safe and affordable housing, culturally competent on-demand behavior health services, social marketing campaigns to decrease HIV stigma and homophobia, and initiatives to increase trust in the health care system.