Abstract

Abstract Background Little is known about the risk of SARS-CoV-2 Omicron infection in people with HIV (PWH) with vaccine-induced or hybrid immunity. We assessed the incidence of Omicron infection in 209 AGEhIV COVID-19 substudy participants with well-controlled HIV on ART and 280 comparable controls, who had received at least the primary vaccination series. Methods From September 2020 onward, participants were assessed every six months for SARS-CoV-2 infection incidence, as per SARS-CoV-2 nucleocapsid (N)-antibody assay or self-reported positive antigen- or PCR-test. Between January 1, 2022 and October 31, 2022, the cumulative incidence of Omicron infection and associated risk factors were estimated using a conditional risk-set Cox proportional hazards model. Results The cumulative incidence of a first Omicron infection was 58.3% by October 31, 2022, not significantly different between both groups. HIV-status was not independently associated with acquiring Omicron infection. Former and current smoking, as well as an increased predicted anti-S IgG titer were significantly associated with a lower risk of Omicron infection. The majority of infections were symptomatic, but none required hospitalization. Conclusions People with well-controlled HIV and controls in our cohort experienced a similarly high proportion of Omicron infections. A greater number of booster vaccinations significantly reduced the risk of infection. Clinical Trial Registration NCT01466582

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