“Is this something to worry about?” Yes and

“Is this something to worry about?”

Yes and no.

No. The HIV Combo BLA is for, “treatment-experienced HIV-infected patients with CCR5-tropic virus who demonstrates evidence of HIV-1 replication despite ongoing antiretroviral therapy with documented genotypic or phenotypic resistance to ART drugs within three drug classes (or within two or more drug classes with limited treatment options). The combo BLA is for treatment experienced patients who’ve failed treatments (<5% of HIV patients), which will not be impacted by this drug UNLESS it results in less drug resistance (that would reduce the number of treatment experienced patients).

Yes. The mono indication is for, “shifting clinically stable patients receiving suppressive combination antiretroviral therapy to PRO 140 monotherapy and maintaining viral suppression for 48 weeks following study entry.” So, leronlimab mono is for clinically stable patients to a once weekly dose of leronlimab. Canenuva’s indication is below, which is nearly the same: transitioning virally suppressed patients with no history of treatment failure. I’m unsure if the leronlimab mono is for patients with or without treatment failure, but cabenuva is a direct competitor, especially because it’s once a month. The injection is IM vs sub-q for leronlimab.

“Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure.”

NP has mentioned in the past that they believe leronlimab can be a once a month treatment. Given Cabenuva’s approval, I imagine the leronlimab monotherapy trial will be a once a month regime once the protocol is rewritten and submitted. Below is the side effect profile for Cabenuva. Slightly more side effects than leronlimab, including a few severe that let you drug discontinuation.

“In both studies (1,100 patients), the most common adverse reactions (Grades 1 to 4) observed in ≥ 2% of clinical trial participants receiving Cabenuva were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness and rash. Serious adverse events occurred in 4% (24/591) of patients taking Cabenuva, and 3% (17/591) of adverse events led to withdrawal.”