The Impact of COVID-19 on the HIV Cascade of Care in Botswana - An Interrupted Time Series.

Globally, Botswana has one of the highest burdens of HIV. This study estimated the impact of the COVID-19 pandemic on the HIV cascade of care in Sub-Saharan Africa. We conducted an interrupted time series analysis on national-level data to estimate the effect of COVID-19 on the numbers of HIV tests, positive HIV tests and ART initiations from April 2019 until March 2021. In multivariable Poisson interrupted time series regression, the COVID-19 lockdown was associated with a 27% decrease in the monthly numbers of HIV tests (IRR 0.73, 95%CI 0.72-0.73), a 25% decrease in HIV positive tests (IRR 0.75, 95%CI 0.71-0.79), and a 43% reduction in ART initiations (IRR 0.57, 95%CI 0.55-0.60). The impact of the pandemic on all three outcomes was worse in males and those aged ≥ 50 years. In conclusion, COVID-19 had a strong negative impact on HIV screening, diagnosis and ART initiation in Botswana.

Infusion Reactions After Receiving the Broadly Neutralizing Antibody VRC01 or Placebo to Reduce HIV-1 Acquisition: Results From the Phase 2b Antibody-Mediated Prevention Randomized Trials.

BACKGROUND: The antibody-mediated prevention (AMP) studies (HVTN 703/HPTN 081 and HVTN 704/HPTN 085) are harmonized phase 2b trials to assess HIV prevention efficacy and safety of intravenous infusion of anti-gp120 broadly neutralizing antibody VRC01. Antibodies for other indications can elicit infusion-related reactions (IRRs), often requiring premedication and limiting their application. We report on AMP study IRRs. METHODS: From 2016 to 2018, 2699 HIV-uninfected, at-risk men and transgender adults in the Americas and Switzerland (704/085) and 1924 at-risk heterosexual women in sub-Saharan Africa (703/081) were randomized 1:1:1 to VRC01 10 mg/kg, 30 mg/kg, or placebo. Participants received infusions every 8 weeks (n = 10/participant) over 72 weeks, with 104 weeks of follow-up. Safety assessments were conducted before and after infusion and at noninfusion visits. A total of 40,674 infusions were administered. RESULTS: Forty-seven participants (1.7%) experienced 49 IRRs in 704/085; 93 (4.8%) experienced 111 IRRs in 703/081 (P < 0.001). IRRs occurred more frequently in VRC01 than placebo recipients in 703/081 (P < 0.001). IRRs were associated with atopic history (P = 0.046) and with younger age (P = 0.023) in 703/081. Four clinical phenotypes of IRRs were observed: urticaria, dyspnea, dyspnea with rash, and "other." Urticaria was most prevalent, occurring in 25 (0.9%) participants in 704/085 and 41 (2.1%) participants in 703/081. Most IRRs occurred with the initial infusion and incidence diminished through the last infusion. All reactions were managed successfully without sequelae. CONCLUSIONS: IRRs in the AMP studies were uncommon, typically mild or moderate, successfully managed at the research clinic, and resolved without sequelae. Analysis is ongoing to explore potential IRR mechanisms.