Product labeling

Drug Interactions

• Human immunodeficiency virus (HIV) and the lentivirus used to make CARVYKTI have limited, short spans of identical genetic material (ribonucleic acid [RNA]). Therefore, some commercial HIV nucleic acid tests (NATs) may yield false-positive results in patients who have received CARVYKTI.¹

Case report

A published case report provided details of a 66-year-old female patient with relapsed and refractory multiple myeloma who developed a false-positive HIV nucleic acid amplification tests (NAAT) result 41 days after receiving CARVYKTI.²

• The patient was diagnosed with immunoglobulin G lambda multiple myeloma in 2016. After 4 cycles of lenalidomide, bortezomib, and dexamethasone followed by an autologous stem cell transplantation, her disease relapsed and became refractory to subsequent multiple lines of chemotherapy. The patient underwent a second autologous stem cell transplant in January 2022 and later received CARVYKTI following lymphodepleting chemotherapy in December 2022.
• An HIV NAAT was inadvertently performed 41 days after receiving CARVYKTI and yielded a positive result below the assay’s limit of detection (<20 copies/mL), while a fourth-generation HIV antigen/antibody test was negative. Infectious disease consultation revealed no symptoms or risk factors for HIV infection, and the pre-CAR T-cell screening for HIV and NAAT had been negative.
• Given that CARVYKTI utilizes a lentiviral vector, a false positive HIV result was suspected. The initial HIV NAAT (Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test v2.0) amplifies the 5′ long terminal repeat (LTR) and gag genes, which are shared with the lentiviral vector used in CAR T-cell manufacturing.
• Repeat testing with the Abbott Alinity m HIV-1 Viral Load assay, which targets the pol gene region not shared by the lentivirus, showed no detectable HIV RNA, confirming a false-positive result.

Literature search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 15 October 2025.