{"id":54873,"date":"2026-10-30T00:17:32","date_gmt":"2026-10-30T00:17:32","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=54873"},"modified":"2026-10-30T00:20:59","modified_gmt":"2026-10-30T00:20:59","slug":"off-label-use-of-injectable-lenacapavir-plus-cab-la","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/54873","title":{"rendered":"Injectable lenacapavir plus CAB-LA: high viral efficacy but ViiV and Gilead block further research"},"content":{"rendered":"

Simon Collins, HIV i-Base<\/strong><\/p>\n

Almost as soon as long-acting injectable HIV drugs were approved, independent researchers wanted to look at their use in several off-label indications where they had the potential to help people who had particular difficulties with oral ART.<\/strong><\/p>\n

This included:<\/p>\n

    \n
  1. Use of CAB-LA\/RPV-LA as switch option in people who struggled to become undetectable on oral ART, especially those with adherence difficulties.<\/li>\n
  2. Use as initial ART rather than only as a switch option.<\/li>\n
  3. Using the combination of 2-monthly CAB-LA with 6-monthly lenacapavir as a new injectable combination, in setting or populations who were unable to use RPV-LA.<\/li>\n<\/ol>\n

    As data becomes available from small studies however, all three options appear both safe and effective in all three examples, often resulting in sustained viral suppression in complex cases for the first time.<\/p>\n

    Researchers from the Ward 86 HIV clinic in San Francisco previously reported on successfully using CAB-LA\/RPV-LA in people with detectable viral load. [1, 2]<\/div>\n

    The same team now report encouraging results from the third example \u2013 combining CAB-LA with lenacapavir \u2013 published as an open access research letter in JAMA Network Open. [3]<\/p>\n

    The new study is a retrospective case review of 46 participants (43 cisgender men, 11 cisgender women, 3 gender diverse and 1 transgender women) using CAB-LA + LEN, of whom 22 were already virally suppressed and 24 had detectable viral load although further details for levels of detectable viral load were found some reason not included. However, half of those with detectable viral load also had a CD4 count <200 cells\/mm3.<\/p>\n

    Roughly 40% of the cohort were in unstable housing and one-third were using crystal meth.<\/p>\n

    Baseline NNRTI resistance was present in 33\/46 and 17\/46 still included RPV-LA in the combination.<\/p>\n

    The impressive results included all participants either rapidly achieving \u00a0viral suppression (within 13 weeks) or maintaining undetectable viral load. The median follow up from baseline was 100 weeks (IQR: 63 to 131), with no consecutive viral load rebound >200 copies\/mL.<\/p>\n

    comment<\/h3>\n

    These tentative data warrant further research, especially given the the limited options for people unable to use RPV-LA.<\/strong><\/p>\n

    However, this strategy appears to be actively blocked by both ViiV and Gilead (the manufacturer\u2019s of CAB-LA and LEN, respectively) perhaps to try to protect in-house pipeline combinations. These pipeline combinations however will take many years to develop, and this will not help people who depend on injectable ART now, especially in low-income countries where both drugs are already available as PrEP.<\/strong><\/p>\n

    A WHO workshop on treatment optimisation just before the IAS 2026 conference reported that at least six independent research studies (listed below) that are already funded have not been allowed to purchase these drugs. [4]<\/strong><\/p>\n

    \n