June 7, 2023
By Lauren Richey, MD, MPH, FIDSA
Long-acting injectable antiretroviral therapy (ART) has the potential to reach patients with barriers to daily pill adherence and the inability to achieve viral suppression. However, the current FDA approval for co-formulated cabotegravir/rilpivirine is for patients who have viral suppression. This study in Clinical Infectious Diseases describes the real-world rollout of a long-acting injectable ART program in an urban safety net clinic with patients with high psychosocial and economic vulnerability.
The program allowed patients both with and without viral suppression to enroll. Patients had to be willing to receive injections, attend visits, and provide a reliable form of contact as well as a back-up contact. Patients with resistance to rilpivirine and more than one integrase mutation or significant drug-drug interactions with cabotegravir/rilpivirine were excluded from enrolling. The program favored a direct-to-inject approach without an oral lead-in. Patients without viral suppression had individualized plans, which included identifying community-based supports as well as small financial incentives for visits and blood draws. Patients received follow-up calls, appointment reminders, and follow-up for missed visits. Patients without viral suppression had their viral loads measured every 4 weeks until undetectable.
Fifty-one patients were started on the long-acting ART, and 39 had at least two follow-up injections. The average age was 46, 61% were non-White race, 41% were unstably housed or homeless, and 54% had current stimulant use. Twenty-four patients started injections with viral suppression, and all maintained that suppression. Of the 15 without viral suppression, 12 (80%) achieved and maintained viral suppression. In-person outreach, drop-in clinics, and in-the-field injections were additional pieces of the program.
While highly intensive, this program demonstrates it is possible to achieve viral suppression in the most hard to reach patients without viral suppression with long-acting injectable ART. This remaining group of unsuppressed patients are vulnerable, with substantial treatment challenges, and it is unlikely they will achieve viral suppression without innovation and an intensive intervention.