| Primary | Percentage of Participants Experiencing Treatment Emergent Grade 3 or 4 Drug-related Adverse Events Through Week 12 (Co-Primary Endpoint) | Treatment emergent adverse events (TEAEs) were defined as any AE that began on or after the date of first dose of study drug up to the date of last dose of study drug plus 30 days or any AE leading to study drug discontinuation. The severity of AEs were be graded using the Division of AIDS (DAIDS) Toxicity Grading Scale. The DAIDS grading table provide an adverse events (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines:
- Grade 1 indicates a mild event
- Grade 2 indicates a moderate event
- Grade 3 indicates a severe event
- Grade 4 indicates a potentially life-threatening event
- Grade 5 indicates death
| Participants in the Safety Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | B/F/TAF | Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks. |
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| Primary | Percentage of Participants Experiencing Treatment-emergent Grade 3 or 4 Laboratory Abnormalities Through Week 12 (Co-Primary Endpoint) | Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any time after baseline up to and including the date of last dose of study drug plus 30 days. The DAIDS Toxicity Grading Scale, Version 2.1 was used to assign toxicity grades (0 to 4) to laboratory results for analysis. Grade 0 included all values that did not meet the criteria for an abnormality of at least Grade 1. Grade 1 mild, Grade 2 moderate, Grade 3 severe, and Grade 4 potentially life-threatening. | Participants in the Safety Analysis Set with at least 1 postbaseline value for the test under evaluation, were analyzed. | Posted | | Number | | percentage of participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | B/F/TAF | Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks. |
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| Secondary | Plasma Concentrations of Cabotegravir (CAB), and Rilpivirine (RPV) at Day 1 (Predose) | | CAB Pharmacokinetics (PK) Analysis Set and RPV PK Analysis Set included all enrolled participants who received at least 1 dose of study drug and CAB and RPV prior to joining the study, and had at least 1 nonmissing CAB and RPV concentration values reported by the PK laboratory tests. Participants in the CAB PK and RPV PK Analysis Sets with available data (samples collected as per the protocol) were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Day 1 (Predose) | | | | ID | Title | Description |
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| OG000 | B/F/TAF | Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks. |
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| Secondary | Plasma Concentration of Bictegravir (BIC), CAB, and RPV at Week 4 | | BIC PK Analysis Set included all enrolled participants who received at least 1 dose of study drug and CAB and RPV prior to joining the study, and had at least 1 nonmissing BIC concentration value reported by the PK laboratory test. Participants in the BIC PK, CAB PK and RPV PK Analysis Sets with available data (samples collected as per the protocol) were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Week 4 (at trough and 2 hours postdose) | | | | ID | Title | Description |
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| OG000 | B/F/TAF | Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks. |
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| Secondary | Plasma Concentration of BIC, CAB, and RPV at Week 12 | | Participants in the BIC PK, CAB PK and RPV PK Analysis Sets with available data (samples collected as per the protocol) were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Week 12 (at trough and 2 hours postdose) | | | | ID | Title | Description |
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| OG000 | B/F/TAF | Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks. |
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| Secondary | Plasma Concentration of BIC, CAB, and RPV at Week 24 | | Participants in the BIC PK, CAB PK and RPV PK Analysis Sets with available data (samples collected as per the protocol) were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Week 24 (at trough and 2 hours postdose) | | | | ID | Title | Description |
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| OG000 | B/F/TAF | Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks. |
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| Secondary | Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 12 as Determined by Missing = Excluded Approach | This outcome measure analyzed using the Missing = Excluded (M = E) method. In this approach, all missing data were excluded in the analysis. | The Full Analysis Set included all enrolled participants who received at least 1 dose of the study drug (B/F/TAF). Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | B/F/TAF | Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks. |
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| Secondary | Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by Missing = Excluded Approach | This outcome measure analyzed using the Missing = Excluded (M = E) method. In this approach, all missing data were excluded in the analysis. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 24 | | | | ID | Title | Description |
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| OG000 | B/F/TAF | Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks. |
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| Secondary | Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 12 as Determined by Discontinuation = Failure Approach | This outcome measure was analyzed using the Discontinuation = Failure (D = F) method. In this approach, all discontinuation were treated as HIV-1 RNA >= 50 copies/mL (failure) in the analysis. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | B/F/TAF | Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks. |
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| Secondary | Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by Discontinuation = Failure Approach | This outcome measure was analyzed using the Discontinuation = Failure (D = F) method. In this approach, all discontinuation were treated as HIV-1 RNA >= 50 copies/mL (failure) in the analysis. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | B/F/TAF | Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks. |
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| Secondary | Percentage of Participants With Discontinuation of B/F/TAF by Week 12 | | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to 12 Weeks | | | | ID | Title | Description |
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| OG000 | B/F/TAF | Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks. |
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| Secondary | Percentage of Participants With Discontinuation of B/F/TAF by Week 24 | | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to 24 Weeks | | | | ID | Title | Description |
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| OG000 | B/F/TAF | Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks. |
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| Secondary | Percentage of Participants Experiencing Treatment-emergent Grade 3 or 4 Laboratory Abnormalities Through Week 24 | Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any time after baseline up to and including the date of last dose of study drug plus 30 days. The DAIDS Toxicity Grading Scale, Version 2.1 was used to assign toxicity grades (0 to 4) to laboratory results for analysis. Grade 0 included all values that did not meet the criteria for an abnormality of at least Grade 1. Grade 1 mild, Grade 2 moderate, Grade 3 severe, and Grade 4 potentially life-threatening. | Participants in the Safety Analysis Set with at least 1 postbaseline value for the test under evaluation value were analyzed. | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | B/F/TAF | Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks. |
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| Secondary | HIV Treatment Satisfaction (HIVTSQc) Score at Week 4 | The HIVTSQc was a 1-12 items questionnaire. Each item was scored -3 to 3. The total score ranged from -33 to +33, based on 11 items. Higher the score, greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 represented no change. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | score on scale | | Week 4 | | | | ID | Title | Description |
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| OG000 | B/F/TAF | Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks. |
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