Injection site reaction experience in clinical studies of people using lenacapavir for HIV treatment

Title

Injection site reaction experience in clinical studies of people using lenacapavir for HIV treatment

Presenter

Princy Kumar

Authors

P. Kumar * (1), S. Gupta (2), S. Segal-Maurer (3), O. Ogbuagu (4), C. McDonald (5), C. Brinson (6), A. Chester (7), H. Wang (7), H. Dvory-Sobol (7), M. Rhee (7), J. Baeten (7), J.-M. Molina (8)

Institutions

(1) Georgetown University Medical Center, Washington, United States, (2) Indiana University, Indianapolis, United States, (3) New York Presbyterian Queens, Flushing, United States, (4) Yale University School of Medicine, New Haven, United States, (5) Texas Centers for Infectious Disease Associates, Fort Worth, United States, (6) Central Texas Clinical Research, Austin, United States, (7) Gilead Sciences, Foster City, United States, (8) Hopital Saint Louis, Paris, France

BACKGROUND: Lenacapavir (LEN), a potent first-in-class capsid inhibitor, is in development as a 6-monthly subcutaneous (SC) injection for treatment and prevention of HIV-1 infection. In animals, SC injection led to reversible chronic granulomatous inflammation at the injection site as a foreign body response to LEN drug depot.
METHODS: We characterized the injection site reactions (ISRs) in participants who received at least one dose of subcutaneous (SC) LEN 927 mg (2 x 1.5 mL) in clinical studies in heavily treatment experienced (CAPELLA) and in treatment naïve (CALIBRATE) people with HIV (PWH).
RESULTS: In CAPELLA, 72 participants received at least one and 70 two doses of SC LEN. In CALIBRATE, 103 received at least one and 95 two doses. The median duration of follow up was 376and 449 days, respectively. Most ISRs (97%, 99/102 participants) were Grade 1 or 2, rarely leading to discontinuation (4 participants: 1 [nodule], 2 [induration] 1 [erythema/swelling]). Common ISRs (any ISR '¥10% in both studies) were swelling, erythema, pain, nodule and induration, which generally occurred less frequently with subsequent injection (Table). Swelling, erythema and pain generally resolved within days; nodule and induration resolved over months. Investigators reported nodules and induration as generally palpable, not visible, non-erythematous, nonpainful.
CONCLUSIONS: Among PWH using SC LEN, ISRs were generally mild to moderate, rarely leading to discontinuation, and decreased in frequency with subsequent injection. Most ISRs resolved within days, while induration and nodules gradually improved over months but were generally not visible or painful. The pattern and nature of ISRs is consistent with preclinical experience.

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