Trial · NCT02707601
Efficacy, Safety, and Tolerability of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Participants Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment
NCT02707601, Phase 3, Completed, Gilead Sciences; results first posted 2018-10-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy, Safety, and Tolerability of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Participants Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment. Trials, record NCT02707601. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02707601
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Efficacy, Safety, and Tolerability of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Participants Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment
- NCT number
- NCT02707601
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 150 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- HIV-1 Infection, HCV Infection
- Interventions
- E/C/F/TAF, F/R/TAF, LDV/SOF
- First posted
- 2016-03-14
- Last updated
- 2018-11-14
- Other registries' IDs
- eudract:2014-004545-27
- Results first posted
- 2018-10-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With HCV RNA < LLOQ at 12 Weeks After Discontinuation of LDV/SOF Treatment (SVR12) | HCV Posttreatment Week 12 | Sustained Virologic Response (SVR12) was defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after stopping LDV/SOF treatment. |
| Secondary | Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of LDV/SOF Treatment (SVR4) | HCV Posttreatment Week 4 | SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping LDV/SOF treatment. |
| Secondary | Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL (Virologic Failure) 24 Weeks After Start of the F/TAF-Based Regimen Using Modified FDA Snapshot Algorithm | 24 weeks after start of HIV treatment | The percentage of participants with HIV-1 RNA ≥ 50 copies/mL 24 weeks after start of the F/TAF-based regimen were 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. |
| Secondary | Percentage of Participants Experiencing Grades 1 Through 4 Adverse Events After Switch to E/C/F/TAF or F/R/TAF Throughout the Study and During Coadministeration With LDV/SOF Treatment | Up to 32 weeks plus 30 days |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With HCV RNA < LLOQ at 12 Weeks After Discontinuation of LDV/SOF Treatment (SVR12) | HCV Posttreatment Week 12 | HCV Full Analysis Set: participants who were randomized into the study and received at least 1 dose of HCV study drug, LDV/SOF. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of LDV/SOF Treatment (SVR4) | HCV Posttreatment Week 4 | HCV Full Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL (Virologic Failure) 24 Weeks After Start of the F/TAF-Based Regimen Using Modified FDA Snapshot Algorithm | 24 weeks after start of HIV treatment | HIV Full Analysis Set: participants who were randomized into the study and received at least 1 dose of HIV study drug, E/C/F/TAF or F/R/TAF. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing Grades 1 Through 4 Adverse Events After Switch to E/C/F/TAF or F/R/TAF Throughout the Study and During Coadministeration With LDV/SOF Treatment | Up to 32 weeks plus 30 days | Safety Analysis Set (Whole Study): participants who were randomized into the study and received at least 1 dose of study drug (E/C/F/TAF, F/R/TAF, or LDV/SOF).~Safety Analysis Set (Part 2): participants who entered Part 2 of the study and received at least one dose of study drug LDV/SOF. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With HCV RNA < LLOQ at 12 Weeks After Discontinuation of LDV/SOF Treatment (SVR12) | E/C/F/TAF + LDV/SOF | 98.6 | 95% Confidence Interval 92.5 to 100.0 | percentage of participants | |
| Percentage of Participants With HCV RNA < LLOQ at 12 Weeks After Discontinuation of LDV/SOF Treatment (SVR12) | F/R/TAF + LDV/SOF | 95.8 | 95% Confidence Interval 88.3 to 99.1 | percentage of participants | |
| Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of LDV/SOF Treatment (SVR4) | E/C/F/TAF + LDV/SOF | 98.6 | 95% Confidence Interval 92.5 to 100.0 | percentage of participants | |
| Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of LDV/SOF Treatment (SVR4) | F/R/TAF + LDV/SOF | 98.6 | 95% Confidence Interval 92.5 to 100.0 | percentage of participants | |
| Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL (Virologic Failure) 24 Weeks After Start of the F/TAF-Based Regimen Using Modified FDA Snapshot Algorithm | E/C/F/TAF + LDV/SOF | 1.4 | percentage of participants | ||
| Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL (Virologic Failure) 24 Weeks After Start of the F/TAF-Based Regimen Using Modified FDA Snapshot Algorithm | F/R/TAF + LDV/SOF | 1.4 | percentage of participants | ||
| Percentage of Participants Experiencing Grades 1 Through 4 Adverse Events After Switch to E/C/F/TAF or F/R/TAF Throughout the Study and During Coadministeration With LDV/SOF Treatment | E/C/F/TAF + LDV/SOF (Co-administration: Week 8 to Week 20) | 62.5 | percentage of participants | ||
| Percentage of Participants Experiencing Grades 1 Through 4 Adverse Events After Switch to E/C/F/TAF or F/R/TAF Throughout the Study and During Coadministeration With LDV/SOF Treatment | F/R/TAF + LDV/SOF (Co-administration: Week 8 to Week 20) | 69.4 | percentage of participants | ||
| Percentage of Participants Experiencing Grades 1 Through 4 Adverse Events After Switch to E/C/F/TAF or F/R/TAF Throughout the Study and During Coadministeration With LDV/SOF Treatment | E/C/F/TAF + LDV/SOF (Whole Study: Day 1 to Post-HCV Week 12) | 83.8 | percentage of participants | ||
| Percentage of Participants Experiencing Grades 1 Through 4 Adverse Events After Switch to E/C/F/TAF or F/R/TAF Throughout the Study and During Coadministeration With LDV/SOF Treatment | F/R/TAF + LDV/SOF (Whole Study: Day 1 to Post-HCV to Week 12) | 79.7 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | E/C/F/TAF + LDV/SOF | 76 | |
| Overall Study | STARTED | F/R/TAF + LDV/SOF | 74 | |
| Overall Study | COMPLETED | E/C/F/TAF + LDV/SOF | 72 | |
| Overall Study | COMPLETED | F/R/TAF + LDV/SOF | 70 | |
| Overall Study | NOT COMPLETED | E/C/F/TAF + LDV/SOF | 4 | |
| Overall Study | NOT COMPLETED | F/R/TAF + LDV/SOF | 4 |
Source ClinicalTrials.gov
Adverse events78
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | E/C/F/TAF + LDV/SOF | 4 | 74 | |
| other | Abdominal pain | Gastrointestinal disorders | F/R/TAF + LDV/SOF | 3 | 74 | |
| other | Diarrhoea | Gastrointestinal disorders | E/C/F/TAF + LDV/SOF | 6 | 74 | |
| other | Diarrhoea | Gastrointestinal disorders | F/R/TAF + LDV/SOF | 3 | 74 | |
| other | Nausea | Gastrointestinal disorders | E/C/F/TAF + LDV/SOF | 4 | 74 | |
| other | Nausea | Gastrointestinal disorders | F/R/TAF + LDV/SOF | 6 | 74 | |
| other | Fatigue | General disorders | E/C/F/TAF + LDV/SOF | 4 | 74 | |
| other | Fatigue | General disorders | F/R/TAF + LDV/SOF | 5 | 74 | |
| other | Influenza like illness | General disorders | E/C/F/TAF + LDV/SOF | 4 | 74 | |
| other | Influenza like illness | General disorders | F/R/TAF + LDV/SOF | 0 | 74 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | E/C/F/TAF + LDV/SOF | 0 | 74 |
| Total, all-cause mortality | F/R/TAF + LDV/SOF | 1 | 74 |
| Total, other adverse events | E/C/F/TAF + LDV/SOF | 46 | 74 |
| Total, other adverse events | F/R/TAF + LDV/SOF | 36 | 74 |
| Total, serious adverse events | E/C/F/TAF + LDV/SOF | 7 | 74 |
| Total, serious adverse events | F/R/TAF + LDV/SOF | 12 | 74 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31995556 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| E/C/F/TAF + LDV/SOF vs F/R/TAF + LDV/SOF: deaths from any cause | Trial comparisons |
| E/C/F/TAF + LDV/SOF vs F/R/TAF + LDV/SOF: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02707601
GET https://conductscience.org/api/trials/v1/NCT02707601/events?page=2