Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With Other Antiretroviral Agents in People Living With HIV

Summary

The primary objective of this study is to evaluate the efficacy of lenacapavir (formerly GS-6207) containing regimens in people living with human immunodeficiency virus (HIV) (PLWH).

Timeline

Start

2019-11-22

Primary completion

2021-10-05

Completion

2023-09-19

Outcome

Missed primary endpoint

registry analysis (superiority test); Group 1: SC LEN+(F/TAF→ TAF) vs Group 4: B/F/TAF; p = 0.7178; Difference in percentage -2.6 (95% CI -18.4 to 13.2) NCT04143594 ↗

registry analysis (superiority test); Group 2: SC LEN + (F/TAF → BIC) vs Group 4: B/F/TAF; p = 0.3900; Difference in percentage -7.1 (95% CI -23.4 to 9.3) NCT04143594 ↗

registry analysis (superiority test); Group 3: Oral LEN + F/TAF vs Group 4: B/F/TAF; p = 0.3797; Difference in percentage -7.2 (95% CI -23.5 to 9.1) NCT04143594 ↗

Publications

• Background Gupta SK, Berhe M, Crofoot G, Benson P, Ramgopal M, Sims J, McDonald C, Ruane P, Sanchez WE, Scribner A, Liu SY, VanderVeen LA, Dvory-Sobol H, Rhee MS, Baeten JM, Koenig E. Lenacapavir administered every 26 weeks or daily in combination with oral daily antiretroviral therapy for initial treatment of HIV: a randomised, open-label, active-controlled, phase 2 trial. Lancet HIV. 2023 Jan;10(1):e15-e23. doi: 10.1016/S2352-3018(22)00291-0.
• Background VanderVeen, L. A., et al. Resistance Analysis of Long-Acting Lenacapavir in People With HIV Who are Treatment-Naïve After 80 Weeks of Treatment [Poster14]. European Meeting on HIV & Hepatitis 2023, Rome, Italy.
• Background Jogiraju V, Shelton M, Dheri P, Ling J, Wang H, Dvory-Sobol H, et al. Pharmacokinetics of Lenacapavir Alone and When Coadministered With Other Antiretrovirals in People With HIV [Poster PII-056]. American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting; 2023 22-24 March; Atlanta, GA.
• Background Hagins D, Koenig E, Safran R, Santiago L, Wohlfeiler M, Hsiao C, et al. Long-Acting Lenacapavir in a Combination Regimen for Treatment Naïve PWH: Week 80 [Poster 522]. Conference on Retroviruses and Opportunistic Infections (CROI); 2023 19-22 February; Seattle, WA.
• Background VanderVeen LA, Margot N, Naik V, Dvory-Sobol H, Rhee MS, Callebaut C. Resistance Analysis of Long-Acting Lenacapavir in Treatment-Naïve People With HIV at 54 Weeks [Poster EPB239]. AIDS 2022; 2022 29 July-2 August; Montreal, Quebec, Canada.
• Background Gupta SK, Sims J, Brinson C, Cruickshank FA, Oguchi G, Morales J, et al. Lenacapavir as part of a Combination Regimen in Treatment-Naïve People with HIV: Week 54 Results [Presentation]. Virtual Conference on Retroviruses and Opportunistic Infections (CROI) 2022; 2022 12-16 February.
• Background VanderVeen, L, Margot N, Naik V, et al. Interim Resistance Analysis of Long-Acting Lenacapavir in Treatment-Naïve People with HIV at 28 Weeks (CALIBRATE) [Abstract Oral 73]. Presented at: ID Week; 2021 September 29 - October 03.
• Background Gupta SK, Berhe M, Crofoot G, et al. Long-Acting Subcutaneous Lenacapavir Dosed Every 6 Months as part of a Combination Regimen in Treatment-Naïve People with HIV: Interim 16-week Results of a Randomized, Open-label, Phase 2 Induction-Maintenance Study (CALIBRATE) [Abstract OALB0302]. Presented at: International AIDS Society (IAS) Conference; 2021 July 18-21.
• Hagins D, Berhe M, Crofoot GE, Ramgopal MN, Sims J, McDonald C, Ruane PJ, Sanchez WE, Scribner A, Benson P, Liu SY, Vanderveen LA, Dvory-Sobol H, Rhee MS, Gupta SK. Final efficacy and safety of twice-yearly subcutaneous lenacapavir in treatment-naive people with HIV. AIDS. 2026 Mar 1;40(3):302-311. doi: 10.1097/QAD.0000000000004372. Epub 2025 Oct 6.
• Harris P, Henderson R, Hayward P. Highlights from the 11th IAS Conference on Science. Lancet HIV. 2021 Aug;8(8):e459. doi: 10.1016/S2352-3018(21)00161-2. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	B/F/TAF	Unknown	—	Oral
Subject	BIC	Unknown	75 mg	Oral
Subject	F/TAF	Unknown	—	Oral
Subject	Lenacapavir	Small molecule	927 mg	Oral
Subject	TAF	Unknown	25 mg	Oral

Indications