PPC: For monoclonal antibodies (mAbs) for HIV prophylaxis

Preferred/Optimal/Ideal: Prevention of HIV-1 infection in confirmed HIV-negative individuals. Prevention of HIV-1 infection in neonates and infants with HIV exposure.

Preferred/Optimal/Ideal: People at substantial risk of HIV infection and their sexual partners, including MSM, male and female sex workers, PWID, transgender people, and people in prisons and closed settings ; Adolescents and cisgender men and women in high-prevalence settings; Pregnant and breastfeeding women in settings with high HIV prevalence; Neonates and infants with HIV exposure ; Serodiscordant couples; Other target populations at high risk may be considered based on local epidemiology. 

Formulation/presentation: Preferred/Optimal/Ideal: WHO-defined recommendations on presentation, packaging, storage volume and disposal should be met, where applicable to mAbs. A single vial product is preferred. For infants, 0.5 ml per dose is preferred. For children aged 5 years or younger, 1 ml per dose or less is preferred. Dose regimen:: Preferred/Optimal/Ideal: Administration every 3 months; longer may be preferable depending on the population and product characteristics. Fixed, non-weight-based dosing is preferred, with age-appropriate fixed dosing presentations for adolescents/adults, infants, neonates. Coformulation of mAb combination products is preferred. Single site, single injection is preferred but not required. Route of administration:: Preferred/Optimal/Ideal: Subcutaneous or intramuscular injection is highly preferred for use in LMICs. Stability and storage:: Preferred/Optimal/Ideal: It is preferred that mAbs should be stable at refrigerated condition (2–8°C) preferably for 2–3 years; a CTC product is preferred. Storage footprint should be minimized.

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