| Primary | Percentage of Participants With Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/mL at Week 54 as Determined by the United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 54 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 54 window was between Day 323 and 413 (inclusive). Percentages were rounded off. | Full Analysis Set included all randomized participants who were randomized and received at least 1 dose of study drug. | Posted | | Number | | percentage of participants | | Week 54 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: SC LEN+(F/TAF→ TAF) | Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. | | OG001 | Group 2: SC LEN + (F/TAF → BIC) | Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus bictegravir (BIC) 75 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards. | | OG002 | Group 3: Oral LEN + F/TAF | Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and continued up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards. | | OG003 | Group 4: B/F/TAF | Participants received bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study up to Week 80. |
| | Units | Counts |
|---|
| Participants | - OG00052
- OG00153
- OG00252
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00090.4
- OG00184.9
- OG00284.6
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Cochran-Mantel-Haenszel | | 0.7178 | P-value was from the Cochran-Mantel-Haenszel (CMH) tests stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs > 100,000 copies/mL). | Difference in percentage | -2.6 | | | 2-Sided | 95 | -18.4 | 13.2 | | | The difference in percentage of participants between LEN-containing and the B/F/TAF groups, and its 95% confidence interval (CI) were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs > 100,000 copies/mL). | | Superiority | | |
|
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 28 as Determined by the US FDA-defined Snapshot Algorithm | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 28 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 28 window was between Days 176 and 231 (inclusive). Percentages were rounded off. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | Week 28 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: SC LEN+(F/TAF→ TAF) | Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. | | OG001 | Group 2: SC LEN + (F/TAF → BIC) | |
|
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 38 as Determined by the US FDA-defined Snapshot Algorithm | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 38 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 38 window was between Days 232 and 322 (inclusive). Percentages were rounded off. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | Week 38 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: SC LEN+(F/TAF→ TAF) | Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. | | OG001 | Group 2: SC LEN + (F/TAF → BIC) | |
|
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 80 as Determined by the US FDA-defined Snapshot Algorithm | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 80 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. The Week 80 window was between Days 505 and 595 (inclusive). Percentages were rounded off. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | Week 80 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: SC LEN+(F/TAF→ TAF) | Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards | | OG001 | Group 2: SC LEN + (F/TAF → BIC) |
|
| Secondary | Change From Baseline in Log10 HIV-1 RNA at Week 28 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | log10 copies/mL | | Baseline, Week 28 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: SC LEN+(F/TAF→ TAF) | Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. | | OG001 | Group 2: SC LEN + (F/TAF → BIC) | Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus bictegravir (BIC) 75 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards. |
|
| Secondary | Change From Baseline in Log10 HIV-1 RNA at Week 38 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | log10 copies/mL | | Baseline, Week 38 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: SC LEN+(F/TAF→ TAF) | Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. | | OG001 | Group 2: SC LEN + (F/TAF → BIC) | Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus bictegravir (BIC) 75 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards. |
|
| Secondary | Change From Baseline in Log10 HIV-1 RNA at Week 54 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | log10 copies/mL | | Baseline, Week 54 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: SC LEN+(F/TAF→ TAF) | Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. | | OG001 | Group 2: SC LEN + (F/TAF → BIC) | Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus bictegravir (BIC) 75 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards. |
|
| Secondary | Change From Baseline in Log10 HIV-1 RNA at Week 80 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | log10 Copies/mL | | Baseline, Week 80 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: SC LEN+(F/TAF→ TAF) | Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. | | OG001 | Group 2: SC LEN + (F/TAF → BIC) | Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus bictegravir (BIC) 75 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards. |
|
| Secondary | Change From Baseline in Clusters of Differentiation 4+ (CD4+) Cell Count at Week 28 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | cells/µL | | Baseline, Week 28 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: SC LEN+(F/TAF→ TAF) | Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. | | OG001 | Group 2: SC LEN + (F/TAF → BIC) | Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus bictegravir (BIC) 75 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards. |
|
| Secondary | Change From Baseline in CD4+ Cell Count at Week 38 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | cells/µL | | Baseline, Week 38 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: SC LEN+(F/TAF→ TAF) | Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. | | OG001 | Group 2: SC LEN + (F/TAF → BIC) | Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. |
|
| Secondary | Change From Baseline in CD4+ Cell Count at Week 54 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | cells/µL | | Baseline, Week 54 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: SC LEN+(F/TAF→ TAF) | Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. | | OG001 | Group 2: SC LEN + (F/TAF → BIC) | Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus bictegravir (BIC) 75 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards. |
|
| Secondary | Change From Baseline in CD4+ Cell Count at Week 80 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | cells/μL | | Baseline, Week 80 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: SC LEN+(F/TAF→ TAF) | Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. | | OG001 | Group 2: SC LEN + (F/TAF → BIC) | Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus bictegravir (BIC) 75 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards. |
|
| Secondary | Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs were defined as 1 or both of any AEs leading to premature discontinuation of study drug, or any AEs with an onset date on or after the study drug start date and no later than the last exposure date after permanent discontinuation of the study drug. Percentages were rounded off. | Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug. | Posted | | Number | | percentage of participants | | Up to 174.9 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group 1: SC LEN+(F/TAF→ TAF) | Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. |
|
| Secondary | Percentage of Participants Who Experienced Maximum Postbaseline Laboratory Abnormalities | Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline visit, up to last exposure date for participants who permanently discontinued study drug. Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening. Percentages were rounded off. | Participants in the Safety Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | Up to 174.9 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group 1: SC LEN+(F/TAF→ TAF) | Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. | | OG001 | Group 2: SC LEN + (F/TAF → BIC) | Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus bictegravir (BIC) 75 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards. |
|
| Secondary | Pharmacokinetics (PK) of LEN: Plasma LEN Pre-dose Concentrations for SC LEN | | Participants in the PK Substudy Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Day 2, 8, Day 1 SC (Day 15), Week 28 and Week 54 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: SC LEN+(F/TAF→ TAF) | Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. | | OG001 | Group 2: SC LEN + (F/TAF → BIC) | Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus bictegravir (BIC) 75 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards. |
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| Secondary | PK of LEN : Plasma LEN Single Anytime Concentrations for the Oral LEN + DVY | | Participants in the PK Substudy Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Day 2, 8, 15 , Week 28 and Week 54 | | | | ID | Title | Description |
|---|
| OG000 | Group 3: Oral LEN + F/TAF | Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and continued up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards. |
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| Secondary | PK of TAF (Tenofovir Alafenamide) and TFV (Tenofovir): Area Under the Concentration Versus Time Curve (AUClast) on Day 1 | AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2) and at least 15 participants in the treatment group receiving oral LEN (Treatment Group 3). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 and 2 on Day 1. | PK Substudy Analysis Set included participants who were randomized into the study, were enrolled into the PK Substudy, had received at least 1 dose of active study drug, and had at least 1 nonmissing intensive PK substudy concentration value for any analyte of interest reported by the PK lab. | Posted | | Mean | Standard Deviation | hours*nanogram/mL (h*ng/mL) | | 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: SC LEN+(F/TAF→ TAF) | Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. |
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| Secondary | PK of TAF and TFV (Tenofovir): Maximum Observed Concentration of Drug (Cmax) on Day 1 | Cmax is defined as the maximum observed concentration of drug. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 and 2 on Day 1. | Participants in the PK Substudy Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: SC LEN+(F/TAF→ TAF) | Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. | | OG001 | Group 2: SC LEN + (F/TAF → BIC) |
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| Secondary | PK of TAF and TFV: Time (Observed Time Point) of Cmax (Tmax) on Day 1 | Tmax is defined as the time (observed time point) of Cmax. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 and 2 on Day 1. | Participants in the PK Substudy Analysis Set with available data were analyzed. | Posted | | Median | Inter-Quartile Range | hours | | 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: SC LEN+(F/TAF→ TAF) | Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. | | OG001 | Group 2: SC LEN + (F/TAF → BIC) |
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| Secondary | PK of TFV: Last Observed Quantifiable Concentration of the Drug (Clast) on Day 1 | Clast is defined as the last observable concentration of drug. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK sub study analysis was conducted for Group 1 and 2 on Day 1. | Participants in the PK Substudy Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: SC LEN+(F/TAF→ TAF) | Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. | | OG001 | Group 2: SC LEN + (F/TAF → BIC) |
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| Secondary | PK of TAF and TFV: AUClast at Weeks 16, 22, or 28 | AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. A PK substudy was conducted in at least 15 participants in the treatment group receiving oral LEN (Treatment Group 3). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. For each participant, PK samples were taken at only one of the three possible visits: Weeks 16, 22, or 28. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits. | Participants in the PK Substudy Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | h*ng/mL | | 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Group 3: Oral LEN + F/TAF | Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and continued up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards. |
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| Secondary | PK of TAF and TFV: Cmax at Weeks 16, 22, or 28 | Cmax is defined as the maximum observed concentration of drug. A PK substudy was conducted in at least 15 participants in the treatment group receiving oral LEN (Treatment Group 3). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. For each participant, PK samples were taken at only one of the three possible visits: Weeks 16, 22, or 28. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits. | Participants in the PK Substudy Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Group 3: Oral LEN + F/TAF | Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and continued up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards. |
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| Secondary | PK of TAF and TFV: Tmax at Weeks 16, 22, or 28 | Tmax is defined as the time (observed time point) of Cmax. A PK substudy was conducted in at least 15 participants in the treatment group receiving oral LEN (Treatment Group 3). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. For each participant, PK samples were taken at only one of the three possible visits: Weeks 16, 22, or 28. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits. | Participants in the PK Substudy Analysis Set with available data were analyzed. | Posted | | Median | Inter-Quartile Range | hours | | 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Group 3: Oral LEN + F/TAF | Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and continued up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards. |
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| Secondary | PK of TFV: Clast at Weeks 16, 22, or 28 | Clast is defined as the last observable concentration of drug. A PK substudy was conducted in at least 15 participants in the treatment group receiving oral LEN (Treatment Group 3). Key PK parameters of TFV was summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. For each participant, PK samples were taken at only one of the three possible visits: Weeks 16, 22, or 28. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits. | Participants in the PK Substudy Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Group 3: Oral LEN + F/TAF | Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and continued up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards. |
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| Secondary | PK of TAF: AUClast at Week 38 | AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TAF was summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 at Week 38. | Participants in the PK Substudy Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | h*ng/mL | | 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Group 1: SC LEN+(F/TAF→ TAF) | Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. |
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| Secondary | PK of TAF: Cmax at Week 38 | Cmax is defined as the maximum observed concentration of drug. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TAF was summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 at Week 38. | Participants in the PK Substudy Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Group 1: SC LEN+(F/TAF→ TAF) | Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. |
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| Secondary | PK of TAF: Tmax at Week 38 | Tmax is defined as the time (observed time point) of Cmax. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TAF was summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 at Week 38. | Participants in the PK Substudy Analysis Set with available data were analyzed. | Posted | | Median | Inter-Quartile Range | hours | | 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Group 1: SC LEN+(F/TAF→ TAF) | Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. |
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| Secondary | PK of Tenofovir Diphosphate (TFV-DP): AUClast at Weeks 4, 10, 16, or 22 | AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. A peripheral blood mononuclear cell (PBMC) substudy was conducted in a total of approximately 15 participants in Treatment Groups 1 and 2. For each participant, PK samples were taken at only one of the four possible visits: Weeks 4, 10, 16, or 22. A 12-hour postdose sample was collected, if possible. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits. | The PBMC PK Substudy Analysis Set included all randomized participants who took at least 1 dose of study drug, participated in the PBMC substudy, and have at least 1 nonmissing postdose concentration value for tenofovir diphosphate (TFV-DP). The PBMC PK Substudy Analysis Set was used for PK analyses of TFV-DP. | Posted | | Mean | Standard Deviation | h*μM | | 0 hours (Predose) and at 1, 2, and 6 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Group 1: SC LEN+(F/TAF→ TAF) | Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. |
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| Secondary | PK of TFV-DP: Cmax at Weeks 4, 10, 16, or 22 | Cmax is defined as the maximum observed concentration of drug. A PBMC substudy was conducted in a total of approximately 15 participants in Treatment Groups 1 and 2. For each participant, PK samples were taken at only one of the four possible visits: Weeks 4, 10, 16, or 22. A 12-hour postdose sample was collected, if possible. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits. | Participants in the PBMC PK Substudy Analysis Set with the available data were analyzed. | Posted | | Mean | Standard Deviation | micrometer (μM) | | 0 hours (Predose) and at 1, 2, and 6 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Group 1: SC LEN+(F/TAF→ TAF) | Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. | | OG001 | Group 2: SC LEN + (F/TAF → BIC) |
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| Secondary | PK of TFV-DP: Tmax at Weeks 4, 10, 16, or 22 | Tmax is defined as the time (observed time point) of Cmax. A PBMC substudy was conducted in a total of approximately 15 participants in Treatment Groups 1 and 2. For each participant, PK samples were taken at only one of the four possible visits: Weeks 4, 10, 16, or 22. A 12-hour postdose sample was collected, if possible. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits. | Participants in the PBMC PK Substudy Analysis Set with the available data were analyzed. | Posted | | Median | Inter-Quartile Range | hours | | 0 hours (Predose) and at 1, 2, and 6 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Group 1: SC LEN+(F/TAF→ TAF) | Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards. | | OG001 | Group 2: SC LEN + (F/TAF → BIC) |
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| Secondary | PK of Bictegravir (BIC): AUClast at Week 38 | AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). At Week 38, samples were analyzed for BIC only in Treatment Group 2. | Participants in the PK Substudy Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | h*ng/mL | | 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Group 2: SC LEN + (F/TAF → BIC) | Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus bictegravir (BIC) 75 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards. |
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| Secondary | PK of BIC: Cmax at Week 38 | Cmax is defined as the maximum observed concentration of drug. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). At Week 38, samples were analyzed for BIC only in Treatment Group 2. | Participants in the PK Substudy Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Group 2: SC LEN + (F/TAF → BIC) | Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus bictegravir (BIC) 75 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards. |
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| Secondary | PK of BIC: Tmax at Week 38 | Tmax is defined as the time (observed time point) of Cmax. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). At Week 38, samples were analyzed for BIC only in Treatment Group 2. | Participants in the PK Substudy Analysis Set with available data were analyzed. | Posted | | Median | Inter-Quartile Range | hours | | 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Group 2: SC LEN + (F/TAF → BIC) | Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus bictegravir (BIC) 75 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards. |
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| Secondary | PK of BIC: Clast at Week 38 | Clast is defined as the last observable concentration of drug. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). At Week 38, samples were analyzed for BIC only in Treatment Group 2. | Participants in the PK Substudy Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | 0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Group 2: SC LEN + (F/TAF → BIC) | Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus bictegravir (BIC) 75 mg tablets once daily orally at Week 28 and continued up to Week 80. Participants willing to continue the study beyond Week 80 continued to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards. |
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