Background
Lenacapavir (LEN) is a first-in-class capsid inhibitor indicated for the treatment of HIV-1 in heavily treatment-experienced (HTE) adults in combination with other antiretrovirals (ARVs) and for HIV-1 prevention. We describe real-world effectiveness of LEN across 18 months (M) in a US-based cohort and optimized background regimen (OBR) patterns pre- and post-LEN.
Methods
We retrospectively examined participant characteristics, LEN uptake since US authorization, HIV-1 viral suppression, and OBR patterns among HTE people with HIV-1 (PWH) prescribed LEN using administrative data from HealthVerity Marketplace (N=593,872 PWH enrolled at any point between 1 Jan 2023 – 30 June 2025). Inclusion criteria were age ≥18 years, pharmacy claim of ≥1 LEN injection, and ≥1 HIV-RNA test during 12M pre-index and 1M post-index. Descriptive statistics were used to summarize demographics, clinical characteristics, viral suppression (missing=excluded analysis), OBRs, LEN adherence and discontinuation.
Results
Of 81 PWH who received ≥1 LEN injection, 94% started LEN subcutaneous injection with oral loading on Days 1 and 2. Median (interquartile range [IQR]) age was 52 years (37–59), 40% were female, 43% were non-Hispanic, 27% were Black, and 48% had Medicaid. Median (IQR) CD4 count (n=13) was 260 cells/mm3 (43–298). Median (IQR) Charlson Comorbidity Index score and the number of co-medication classes were 4 (3–9) and 10 (6–16), respectively. At LEN initiation, 48% and 36% had HIV-1 RNA <200 and <50 copies/mL, respectively. Overall, 87% and 82% of participants had HIV-1 RNA <200 copies/mL and 67% and 71% had <50 copies/mL during the 12M (n=46) to 18M (n=28) follow-up (FU) period (Figure 1). Median FU was 480 (286–628) days. In the 2M windows before and after first LEN injection, a median (IQR) of 2 (1–3) core ARVs were prescribed. Excluding LEN, 33% maintained the OBR regimen prior to LEN switch. Before and after LEN initiation, the most common ARV class was integrase strand transfer inhibitors (70%). Median (IQR) adherence to LEN was 87% (46, 100). LEN was discontinued by 14% (11/80) after their first injection; discontinuation could not be confirmed for one participant.
Conclusions
These results demonstrate that long-term LEN effectiveness was maintained over an 18M FU period in a PWH population with a high level of comorbidity and polypharmacy.
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