Game-changing HIV research offers hope for people with HIV and to end AIDS
Shobha Shukla - CNS
Contd from previous issue
Lenacapavir, a first-in-class capsid inhibitor, shows multi-stage activity in early and late lifecycle of the virus. It can be given orally or subcutaneously. Its pharmacokinetics supports six-monthly dosing.
Phase-3 studies for six-monthly injectable Lenacapavir (in combination with an optimized background regimen) are ongoing: CAPELLA study is for highly treatment-experienced people with multi-drug resistance, and CALIBRATE study is for those on first-line treatment. So far this drug has been found to be non-inferior at 26 weeks in both studies.
Two phase-3 studies- PURPOSE-1 (in high risk adolescent girls and young women) and PURPOSE-2 (in high risk cisgender men, transgender women, transgender men and gender non-binary people who have sex with men) - are examining six-monthly injectable Lenacapavir for PrEP.
However, currently all Lenacapavir studies (for treatment as well as PrEP) have been put on a partial hold by the US Food and Drug Administration (FDA) due to concerns about compatibility of borosilicate vials with the drug solution. (To be contd)