Analysis of pooled data from proof-of-concept trials shows bnAb VRC01 does reduce incidence of infection with VRC01-sensitive isolates<\/p>\n<\/h3>\n
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THURSDAY, March 18, 2021 (HealthDay News) — Infusion of a broadly neutralizing antibody (bnAb) does not prevent overall HIV-1 acquisition more effectively than placebo, according to a study of two trials published in the March 18 issue of the New England Journal of Medicine<\/em>.<\/p>\n Lawrence Corey, M.D., from the Fred Hutchinson Cancer Research Center in Seattle, and colleagues randomly assigned 2,699 at-risk cisgender men and transgender persons in the Americas and Europe in the HVTN 704\/HPTN 085 trial and 1,924 at-risk women in sub-Saharan Africa in the HVTN 703\/HPTN 081 trial to receive either infusions of a bnAb (VRC01; low dose [10 mg\/kg] or high dose [30 mg\/kg]) or placebo for 10 infusions.<\/p>\n The researchers found that within each trial, adverse events were similar in number and severity among the treatment groups. In the HVTN 704\/HPTN 085 trial, the incidence of HIV-1 infection was 2.35 and 2.98 per 100 person-years in the pooled VRC01 groups and the placebo group, respectively (estimated prevention efficacy, 26.6 percent; 95 percent confidence interval, \u00e2\u0088\u009211.7 to 51.8; P = 0.15); in the HVTN 703\/HPTN 081 group, the corresponding incidences were 2.49 and 3.10 (estimated prevention efficacy, 8.8 percent; 95 percent confidence interval, \u00e2\u0088\u009245.1 to 42.6; P = 0.70). In prespecified analyses pooling data across trials, the incidence of infection with VRC01-sensitive isolates was 0.20 and 0.86 per 100 person-years among VRC01 and placebo recipients, respectively (estimated prevention efficacy, 75.4 percent; 95 percent confidence interval, 45.5 to 88.9).<\/p>\n “Passive immunization with VRC01 indeed protected against acquisition of HIV-1, but only against viruses that were highly sensitive to the antibody. And even for these sensitive viruses, the protection was not absolute,” write the authors of an accompanying editorial.<\/p>\n Abstract\/Full Text (subscription or payment may be required)<\/a><\/p>\n Editorial (subscription or payment may be required)<\/a><\/p>\n <\/i><\/p>\n