The Challenges and Potential of Long-Acting Injectable HIV Treatment

The Challenges and Potential of Long-Acting Injectable HIV Treatment

The arrival of long-acting injectable antiretroviral therapy (ART) has brought a new option for providers and patients with HIV. This innovative treatment offers an alternative to daily oral pills, which can be burdensome for some individuals. Long-acting ART provides convenience, reduces pill burdens, and may help prevent stigmatization. However, while this treatment option has shown promise, there are challenges and limitations that need to be addressed.

Most of the research on long-acting ART has focused on cabotegravir-rilpivirine (Cabenuva), the first therapy of this kind approved by the FDA. Initially, it was approved as a monthly injection for patients who had achieved virological suppression. However, a label change now allows for every 2-month dosing with a higher dose of the product as well. Recent studies have demonstrated that higher-dose cabotegravir-rilpivirine injections every 2 months are non-inferior to a daily oral regimen for maintaining viral suppression.

Guidelines on HIV.gov currently recommend long-acting injectable ART only for people living with HIV who are virally suppressed. However, some experts argue that its use should be expanded to include disenfranchised populations facing multiple barriers to treatment adherence. These barriers include housing and food insecurity, competing subsistence needs, lack of transportation, and mental health concerns. Considering the challenges faced by these populations, long-acting ART may offer a viable treatment option.

Patients with HIV generally seem open to the idea of long-acting therapy. A French study conducted in 2018 found that 74% of the surveyed patients were interested in an every-other-month regimen. However, some expressed concerns about potential side effects and the perceived constraint of an injectable therapy. It is crucial to address these concerns and ensure proper education and counseling to alleviate any fears or misconceptions surrounding long-acting injectable ART.

Recently, a study conducted by Dr. Monica Gandhi and her colleagues explored the use of long-acting ART in a safety-net population in San Francisco. The study involved 133 people living with HIV, including a significant number who were homeless, actively using drugs, and facing mental health issues. Despite these challenges, the researchers projected that 97.5% of the participants would be virologically suppressed at a median of 33 weeks. This study highlights the potential effectiveness of long-acting therapy in vulnerable populations.

While injectable therapy is currently the only long-acting form available, researchers are already exploring other drug delivery mechanisms and treatment intervals. Current oral long-acting therapies in development are not designed to be taken every few months like injectables. Instead, they are designed for once per week or at most once per month. The recent FDA approval of long-acting lenacapavir, given orally at first and then subcutaneously every 6 months, presents another option for heavily treatment-experienced patients with multidrug resistance.

Research conducted by Dr. Samir Gupta and his colleagues has analyzed the potential of lenacapavir in treatment-naive patients as well. Lenacapavir, a capsid inhibitor, is being investigated as part of a once-weekly combination with investigational islatravir. Although safety concerns temporarily paused research on this regimen in 2021, drug developers have relaunched a phase III program using a lower dose of islatravir. Further studies are needed to determine the optimal combination and dosing to ensure long-lasting efficacy without the development of virologic resistance.

The introduction of long-acting injectable ART offers a promising alternative for people living with HIV. It provides convenience and addresses some of the challenges associated with daily oral pills. However, it is crucial to consider the specific needs and concerns of individual patients. By expanding the use of long-acting therapy, addressing barriers, and exploring different drug delivery mechanisms, we can improve treatment outcomes and continue to advance HIV care. Long-acting therapy is a valuable addition to the arsenal of treatment options, but there is still work to be done to ensure its accessibility and efficacy for all patients.

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