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First Demonstration Project of Long-Acting Injectable Antiretroviral Therapy for Persons With and Without Detectable HIV Viremia in an Urban HIV Clinic
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Clinical Infectious Diseases 01 August 2022
Katerina A. Christopoulos1, Janet Grochowski1, Francis Mayorga-Munoz1, Matthew D. Hickey1,
Elizabeth Imbert1, John D. Szumowski1, Samantha Dilworth2, Jon Oskarsson1, Mary Shiels1, Diane Havlir1, Monica Gandhi1
This study describes the first demonstration project to our knowledge to use CBV/RPV-LA in patients with challenges adhering to oral ART. Our data demonstrate preliminary short-term effectiveness of using every 4-week CAB/RPV-LA in patients with and without viral suppression in a diverse urban clinic serving publicly insured patients with high levels of marginal housing and stimulant use. Consistent with clinical trial populations, those who initiated injections with viral suppression maintained suppression. A more striking finding is that those who began injections with detectable viremia successfully achieved viral suppression or had a two-log decline in viral load within a month of their first injection. Two of these patients, who had been living with HIV for over ten years, had never previously been virally suppressed, including the patient with the baseline N155H mutation, who has now demonstrated >8 months of viral suppression. The program allowed this patient to enroll because clinical trial participants on every 4-week dosing who developed CVF failed with rilpivirine in addition to INST mutations, rather than a single INSTI mutation alone. Achieving viral suppression in those who have never been suppressed spotlights the key role LA-ART can play in benefitting those with challenges adhering to oral ART.
Nearly all injections were "on-time," and no patient had viral rebound after a late injection. In-person outreach was deployed twice for patients with unplanned missed injections. The case of the patient who went to his home country emphasizes the importance of a supply of oral ART in the event of an unplanned missed injection. No patients discontinued injections due to injection site reactions. While patients were willing to regularly attend injection appointments, some had difficulty with the recommended lab monitoring schedule. Small incentives, e.g. $10 grocery store vouchers, are one strategy to encourage blood draws that our program has utilized with success.
Abstract
Background
Long-acting injectable antiretroviral therapy (LAI-ART) is approved for treatment-naïve or experienced people living with HIV (PLWH) based on trials that only included participants with viral suppression. We performed the first LAI-ART demonstration project to include PLWH unable to achieve or maintain viral suppression due to challenges adhering to oral ART.
Methods
Ward 86 is a large HIV clinic in San Francisco that serves publicly insured or underinsured patients. We started patients on LAI-ART via a structured process of provider referral, multidisciplinary review (MD, RN, pharmacist), and monitoring for on-time injections. Inclusion criteria were willingness to receive monthly injections and a reliable contact method. Descriptive statistics evaluated program outcomes.
Results
Between June 2021-April 2022, 51 patients initiated LAI-ART, with 39 receiving at least two follow-up injections by database closure (median age 46; 90% cisgender men, 61% non-White, 41% marginally housed, 54% currently using stimulants).
Of 24 patients initiating injections with viral suppression (median CD4 706), 100% (95% CI 86-100%) maintained viral suppression.
Of 15 patients initiating injections with detectable viremia (median CD4 99, mean log10 viral load 4.67 SD 1.16), 12 (80%; 95% CI 55-93%) achieved viral suppression and the other 3 had a 2-log viral load decline by a median of 22 days.
Conclusions
This small demonstration project of LAI-ART in a diverse group of patients with high levels of substance use and marginal housing demonstrated promising early treatment outcomes, including in those with detectable viremia due to adherence challenges. More data on LAI-ART in hard-to-reach populations are needed.
Of 15 patients starting with detectable viremia, (median CD4 cell count 99 cells/mm3, mean log10 viral load 4.67 SD 1.16), all direct-to-inject, with median 6 injections (range 3-11 injections), 12 (80%; 95% CI 55- 93%) have achieved and maintained viral suppression, including the patient with the baseline N155H24 mutation.
For the 3 patients who have not yet achieved viral suppression, all had a 2-log decline by a median of 22 days (Figure 1). No patient decided to discontinue CAB/RPV-LA due to side effects.
In general, injection site reactions were mild to moderate; one patient developed cellulitis at the injection site and received oral antibiotics. No cases of hepatitis B viremia were observed with discontinuation of tenofovir/emtricitabine containing regimens, although we did not systematically measure hepatitis B DNA levels in our cohort.
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