dm+d

Unassigned

New Medicines

HIV infection

Information

New molecular entity
Gilead Sciences
Gilead Sciences

Development and Regulatory status

None
Pre-registration (Filed)
Pre-registration (Filed)
Aug 21Filed in EU for treatment of HIV-1 infection, in combination with other antiretroviral(s), in adults with multidrug resistant HIV-1 infection who are currently on a failing antiretroviral treatment regimen due to resistance, intolerance or safety considerations [12].
Jun 21Gilead have completed submission of an NDA to the U.S. FDA for lenacapavir, for the treatment of HIV-1 infection in heavily treatment-experienced people with multi-drug resistant (MDR) HIV-1 infection [9].
Jun 21Gilead announce plans to submit for filing to EMA and other global regulatory authorities in the coming months. [10]
Nov 20Gilead announce intention to submit regulatory applications (likely 2021) for HIV infections following positive outcomes from the PII/III CAPELLA study. [6-8]
May 19US FDA grants breakthrough therapy designation to lenacapavir for the treatment of HIV-1 infection in heavily treatment experienced patients with multi-drug resistance [3].

Category

A long-acting HIV capsid inhibitor
A long-acting HIV capsid inhibitor Epidemiology: In 2017, ~ 84,725 people in England were living with HIV and 78,000 were aware of their infection. Of these, 90% are treated and 3% fail to achieve viral suppression following treatment which indicates multi-drug resistance. [5]
HIV infection
Pts are stabilised on oral tablets and then continuation is with s.c. injection
Subcutaneous injection

Trial or other data

Nov 20PII/III CAPELLA trial found that 88% of participants receiving lenacapavir (n=21/24) experienced at least a 0.5 log10 reduction in HIV-1 viral load by the end of 14 days of functional monotherapy as compared with 17% of those receiving placebo (n=2/12) [4].
Sep 20PII/III CAPELLA trial is recruiting [2].
Nov 19PII CALIBRATE trial to evaluate the efficacy of lenacapavir containing regimens in people living with HIV (PLWH) starts (NCT04143594; GS-US200-4334). 175 patients will be recruited in the US, Dominican Republic and Puerto Rico. Collection of primary outcome data due to complete Oct 21 [2].
Nov 19PII/III CAPELLA trial to evaluate the antiviral activity of lenacapavir (formerly GS-6207) administered as an add-on to a failing regimen (functional monotherapy) in people living with HIV (PLWH) with multi-drug resistance (MDR) starts (NCT04150068). 100 patients aged 12 years and older will be recruited in countries including the US and EU (not UK). Collection of primary outcome data due to complete Oct 20 [2].