| Primary | Percentage of Participants With Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/mL at Week 12 as Defined by Pure Virologic Response (PVR) | The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 12 was summarized. PVR was the percentage of participants who did not have a confirmed virologic rebound. Virologic rebound was defined as 2 consecutive HIV-1 RNA values ≥ 50 copies/mL or the last available HIV-1 RNA value ≥ 50 copies/mL during the study followed by premature discontinuation from the study. | The Full Analysis Set included all the randomized participants who received at least one dose of study drug and excluded participants with any major protocol violations. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG001 | Part 2: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG002 | Total E/C/F/TAF | Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000100.0(90.3 to 100.0)
- OG001100.0(86.8 to 100.0)
- OG002100.0(94.2 to 100.0)
|
|
| |
| Secondary | Percentage of Participants With Emergence of New Mutations in HIV-1 Reverse Transcriptase and Integrase | Development of new resistance mutations was assessed in participants who developed virologic failure, defined as 2 consecutive HIV-1 RNA result ≥ 50 copies/mL at any point in the study or with HIV-1 RNA ≥ 50 copies/mL at last visit. | Participants in the Full Analysis Set were included in the analysis. | Posted | | Number | | percentage of participants | | Day 1 up to 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Part 1: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG001 | Part 2: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG002 | Total E/C/F/TAF | Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. |
|
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using PVR | The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 24 was summarized. PVR was the percentage of participants who did not have a confirmed virologic rebound. Virologic rebound was defined as 2 consecutive HIV-1 RNA values ≥ 50 copies/mL or the last available HIV-1 RNA value ≥ 50 copies/mL during the study followed by premature discontinuation from the study. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG001 | Part 2: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG002 | Total E/C/F/TAF |
|
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using PVR | The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 48 was summarized. PVR was the percentage of participants who did not have a confirmed virologic rebound. Virologic rebound was defined as 2 consecutive HIV-1 RNA values ≥ 50 copies/mL or the last available HIV-1 RNA value ≥ 50 copies/mL during the study followed by premature discontinuation from the study. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG001 | Part 2: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG002 | Total E/C/F/TAF |
|
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the FDA Snapshot Analysis | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 12 was also 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 12 window was between Day 71 and 98 (inclusive). | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG001 | Part 2: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG002 | Total E/C/F/TAF |
|
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the FDA Snapshot Analysis | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was also 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 24 window was between Day 141 and 210 (inclusive). | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG001 | Part 2: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG002 | Total E/C/F/TAF |
|
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA Snapshot Analysis | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was also 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 12 window was between Day 295 and 378 (inclusive). | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG001 | Part 2: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG002 | Total E/C/F/TAF |
|
| Secondary | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 12 Using the FDA Snapshot Analysis | The percentage of participants with HIV-1 RNA < 20 copies/mL at Week 12 was also 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 12 window was between Day 71 and 98 (inclusive). | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG001 | Part 2: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG002 | Total E/C/F/TAF |
|
| Secondary | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 24 Using the FDA Snapshot Analysis | The percentage of participants with HIV-1 RNA < 20 copies/mL at Week 24 was also 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 24 window was between Day 141 and 210 (inclusive). | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG001 | Part 2: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG002 | Total E/C/F/TAF |
|
| Secondary | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 Using the FDA Snapshot Analysis | The percentage of participants with HIV-1 RNA < 20 copies/mL at Week 48 was also 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 12 window was between Day 295 and 378 (inclusive). | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG001 | Part 2: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG002 | Total E/C/F/TAF |
|
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the Missing = Failure (M = F) Approach | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 12 was analyzed using the M = F approach. In this approach, all missing data was treated as HIV-1 RNA ≥ 50 copies/mL. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG001 | Part 2: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG002 | Total E/C/F/TAF | Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. |
|
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the M = F Approach | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the M = F approach. In this approach, all missing data was treated as HIV-1 RNA ≥ 50 copies/mL. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG001 | Part 2: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG002 | Total E/C/F/TAF | Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. |
|
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = F Approach | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the M = F approach. In this approach, all missing data was treated as HIV-1 RNA ≥ 50 copies/mL. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG001 | Part 2: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG002 | Total E/C/F/TAF | Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. |
|
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the Missing = Excluded (M = E) Approach | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 12 was also analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions. | 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 | Part 1: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG001 | Part 2: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG002 | Total E/C/F/TAF | Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. |
|
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the M = E Approach | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was also analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions. | 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 | Part 1: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG001 | Part 2: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG002 | Total E/C/F/TAF | Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. |
|
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = E Approach | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was also analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG001 | Part 2: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG002 | Total E/C/F/TAF | Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. |
|
| Secondary | Change From Baseline in Cluster Determinant 4+ (CD4+) Cell Count at Week 12 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | cells/µL | | Baseline (Day 1); Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG001 | Part 2: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG002 | Total E/C/F/TAF | Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. |
| |
| Secondary | Change From Baseline in CD4+ Cell Count at Week 24 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | cells/µL | | Baseline (Day 1); Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG001 | Part 2: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG002 | Total E/C/F/TAF | Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. |
| |
| Secondary | Change From Baseline in CD4+ Cell Count at Week 48 | | Participants in the Full Analysis Set were analyzed. | Posted | | Mean | Standard Deviation | cells/µL | | Baseline (Day 1); Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG001 | Part 2: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG002 | Total E/C/F/TAF | Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. |
| |
| Secondary | Change From Baseline in CD4 Percentage (%) at Week 12 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | percentage of CD4 cells | | Baseline (Day 1); Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG001 | Part 2: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG002 | Total E/C/F/TAF | Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. |
| |
| Secondary | Change From Baseline in CD4 % at Week 24 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | percentage of CD4 cells | | Baseline (Day 1); Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG001 | Part 2: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG002 | Total E/C/F/TAF | Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. |
| |
| Secondary | Change From Baseline in CD4 % at Week 48 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | percentage of CD4 cells | | Baseline (Day 1); Week 48 | | | | ID | Title | Description |
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| OG000 | Part 1: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG001 | Part 2: E/C/F/TAF | Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. | | OG002 | Total E/C/F/TAF | Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. |
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