Pemivibart prevents COVID-19 in people with advanced HIV

Individuals living with advanced HIV infection who received pemivibart demonstrate good tolerability, with no cases of RT-PCR-confirmed symptomatic COVID-19 reported through month 6, as shown by the results of a subgroup analysis of the CANOPY study.

“Pemivibart was well tolerated in the advanced HIV subset,” said lead author Dr Kristin Narayan, Invivyd, Inc, New Haven, Connecticut, US.

CANOPY was a phase III trial that examined the safety, tolerability, pharmacokinetics, and efficacy of pemivibart for pre-exposure prophylaxis of COVID-19 in adults aged ≥18 years.

Narayan and her team assessed cohort A, which enrolled 306 participants with significant immune compromise from September 2023 to November 2023. From this cohort, they identified 27 (8.8 percent, median age 60 years, 4 females) adults with advanced HIV at baseline (CD4 <350 cell/mm³).

Cohort A participants received pemivibart 4,500 mg via intravenous infusion on day 1 and another equivalent dose at month 3 over 30 min.

The primary endpoint was safety assessed via treatment-emergent adverse events (TEAEs), serious AEs (SAEs), and treatment interruption or discontinuation. In the secondary analysis, serum virus neutralizing antibody (sVNA) titers against SARS-CoV-2 variants were evaluated after receiving pemivibart.

Narayan and colleagues also explored the composite incidence of RT-PCR-confirmed symptomatic COVID-19, including related hospitalizations and all-cause mortality, analysing data through month 6.

Safety profile

Among participants with advanced HIV, 26 (96.3 percent) were managed through antiviral or antiretroviral treatment, 85.2 percent received at least one dose of COVID-19 vaccine prior to enrolment. Most of them were seropositive to N (74.1 percent) and S (96.3 percent) antigen, but less than half had measurable sVNA titers against historical/concurrent variants. [CROI 2026, abstract 740]

Eighteen patients (66.7 percent) experienced TEAEs, and seven (25.9 percent) reported SAEs. There was only one (3.7 percent) case of study drug-related treatment interruption and not pemivibart-associated serious TEAEs or discontinuations. Unfortunately, two patients died, but these were not considered drug-related or attributable to COVID-19.

Following pemivibart dosing, calculated sVNA in the advanced HIV subset increased to levels associated with protection against COVID-19 and were comparable to that seen in cohort A overall. At month 6, the composite incidence of RT-PCR-confirmed symptomatic COVID-19 was 11 out of 298 (3.7 percent) in cohort A and null (0.0 percent) in the advanced HIV subset.

“These data support pemivibart as a preventative option against COVID-19 in this high-risk clinical group,” Narayan said.

“People living with HIV remain at increased risk of severe outcomes from COVID-19 due to underlying immunologic vulnerability and comorbidities,” according to Narayan and colleagues. [AIDS 2025;39:2114-2122; HIV Med 2025;26:6-16]

“Pemivibart is a recombinant human monoclonal IgG1λ antibody that targets the SARS-CoV-2 spike protein receptor binding domain, thereby inhibiting virus attachment to host cells,” they added.

Pemivibart was granted emergency use authorization in March 2024 as pre-exposure prophylaxis of COVID-19 in adults and adolescents with moderate-to-severe immune compromise. [N Engl J Med 2024;391:1860-1862; CID 2025;81:439-450]