Practical considerations relevant to treatment with the gene therapy beremagene geperpavec-svdt for dystrophic epidermolysis bullosa

Figures & data

Table 1. Summary of the key considerations for each step of B-VEC application.

Steps to B-VEC application	Considerations for HCPs
1. Decide which wounds to treat	Prioritize wounds that most impact daily life, regardless of size. Set reasonable expectations about time to closure. In infants, consider prioritizing the diaper area and areas with congenital absence of skin (Bart syndrome) to prevent long-term wounding and scarring. Consider prioritizing hands/feet to reduce risk of deformity.
2. Cleanse the skin	Gentle cleansers or saline-based solutions can be used prior to application. If additives like bleach or acetic acid are used, rinse thoroughly before applying B-VEC to ensure efficacy. Bandages can be removed before or during a bath/shower. Ointments (e.g., petroleum jelly) can loosen bandages for easier removal. Pat gently to clean and dry skin without shearing the tissue.
3. Examine wounds for infection or SCC	Infection can present as increased redness, local pain, odor, and exudate. SCC can present as a nonhealing or rapidly growing wound, a deep ulcer with a raised edge, an area of hyperkeratosis (especially with surrounding raised skin), or a wound with altered sensation (e.g., tingling, increased pain).
4. Position the patient comfortably	Forced air (such as air conditioning, heat, ceiling fans) may need to be turned off. Use a pillow to pad bony prominences. Place a nonabsorbent dressing below the wound to capture B-VEC droplets that migrate from the wound area.
5. Drain blisters	Drain blisters with a sterile needle, scalpel, or clean sharp scissors, using gauze to absorb drainage. Use care when emptying blisters to avoid blister expansion. Leave the blister roof intact to protect the wound area.
6. Apply B-VEC to wounds	B-VEC syringes can be left at room temperature for 3–5 min before application if the temperature is uncomfortable; longer periods are not recommended. Avoid contact of skin with syringe tip itself. Place B-VEC droplets in a 1 cm-by-1cm grid, evenly spaced apart. Start at the top of the wound and work downward. Apply B-VEC into the blister opening at an approximate number of drops to the size of the wound beneath.
7. Cover with a hydrophobic layer	Suggested first-layers are soft-plastic or silicone (Glad^® or Saran^TM Wrap, Mepitel^®, silicone scar sheets), etc. Should be trimmed to fit the shape of the wound (unless patient prefers otherwise). Cover each wound with a hydrophobic layer before moving to the next wound. Should stay in place for ∼24 h after administration (but can vary based on patient preference). Ensure the layer is flat so bunching does not occur and irritate the surrounding skin.
8. Apply standard dressings	Standard dressing material to absorb drainage and pad/protect the body should be larger than the hydrophobic layer. Ensure dressings are not heavy enough to cause overheating. Netting or Tubifast^® are options to hold top dressings in place, but should not contact skin. Continue to cover wounds with non-adherent dressings and ointment until fully healed. If scabbing occurs, apply moisturizer after bathing to allow scabs to soften and detach.
9. Continue application weekly	Wounds should be treated until they are completely closed. Continue weekly administration even when wounds begin to heal. Prioritize wounds that re-open. Allowing a reprieve in treatment or moving to new wound areas while prior-treated wounds have not completely closed is acceptable, but weekly application until closure is recommended.