Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults
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ClinicalTrials.gov Identifier: NCT02071082 |
Recruitment Status :
Completed
First Posted : February 25, 2014
Results First Posted : April 4, 2016
Last Update Posted : November 16, 2018
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Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
HIV HBV |
Intervention |
Drug: E/C/F/TAF |
Enrollment | 79 |
Participant Flow
Recruitment Details | Participants were enrolled at study sites in North America and Japan. The first participant was screened on 25 February 2014. The last study visit occurred on 26 October 2016. |
Pre-assignment Details | 113 participants were screened. |
Arm/Group Title | HIV/HBV Treatment-Naive (Cohort 1) | HIV-Suppressed (Cohort 2) |
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HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 48 weeks. | HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks. |
Period Title: Overall Study | ||
Started | 4 | 75 |
Completed | 2 | 68 |
Not Completed | 2 | 7 |
Reason Not Completed | ||
Enrolled and Never Treated | 1 | 1 |
Adverse Event | 0 | 1 |
Withdrew Consent | 0 | 4 |
Lost to Follow-up | 1 | 1 |
Baseline Characteristics
Arm/Group Title | HIV/HBV Treatment-Naive | HIV-Suppressed | Total | |
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HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks. | HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks. | Total of all reporting groups | |
Overall Number of Baseline Participants | 3 | 74 | 77 | |
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Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 3 participants | 74 participants | 77 participants | |
27 (4.0) | 49 (7.8) | 49 (8.9) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 3 participants | 74 participants | 77 participants | |
Female |
0 0.0%
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6 8.1%
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6 7.8%
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Male |
3 100.0%
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68 91.9%
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71 92.2%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 3 participants | 74 participants | 77 participants |
American Indian or Alaska Native | 0 | 1 | 1 | |
Asian | 2 | 7 | 9 | |
Black | 0 | 14 | 14 | |
White | 1 | 50 | 51 | |
Other | 0 | 2 | 2 | |
Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 3 participants | 74 participants | 77 participants |
Hispanic or Latino | 0 | 12 | 12 | |
Not Hispanic or Latino | 3 | 62 | 65 | |
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 3 participants | 74 participants | 77 participants |
Canada | 0 | 10 | 10 | |
United States | 1 | 62 | 63 | |
Japan | 2 | 2 | 4 | |
HIV-1 RNA
Mean (Standard Deviation) Unit of measure: Log10 copies/mL |
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Number Analyzed | 3 participants | 74 participants | 77 participants | |
4.20 (1.242) | 1.29 (0.068) | 1.41 (0.606) | ||
HIV-1 RNA Category
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 3 participants | 74 participants | 77 participants |
< 50 copies/mL | 0 | 73 | 73 | |
≥ 50 copies/mL | 3 | 1 | 4 | |
HBV DNA
Mean (Standard Deviation) Unit of measure: Log10 IU/mL |
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Number Analyzed | 3 participants | 74 participants | 77 participants | |
8.31 (0.416) | 1.49 (0.883) | 1.75 (1.588) | ||
HBV DNA Category
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 3 participants | 74 participants | 77 participants |
< 29 IU/mL | 0 | 64 | 64 | |
≥ 29 IU/mL | 3 | 10 | 13 | |
Alanine Aminotransferase (ALT)
Mean (Standard Deviation) Unit of measure: U/L |
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Number Analyzed | 3 participants | 74 participants | 77 participants | |
84 (38.9) | 31 (21.1) | 33 (23.9) | ||
Hepatitis B Surface Antigen Status
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 3 participants | 74 participants | 77 participants |
Positive | 3 | 71 | 74 | |
Negative | 0 | 3 | 3 | |
Hepatitis B e-Antibody Status
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 3 participants | 74 participants | 77 participants |
Positive | 0 | 26 | 26 | |
Negative | 3 | 43 | 46 | |
Borderline | 0 | 5 | 5 | |
Fibrotest® Score
[1] Median (Inter-Quartile Range) Unit of measure: Units on a scale |
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Number Analyzed | 3 participants | 74 participants | 77 participants | |
0.27
(0.16 to 0.28)
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0.35
(0.21 to 0.54)
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0.34
(0.21 to 0.53)
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[1]
Measure Description: The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
- The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
- The study has been completed at all study sites for at least 2 years
Results Point of Contact
Name/Title: | Clinical Trial Disclosures |
Organization: | Gilead Sciences |
EMail: | ClinicalTrialDisclosures@gilead.com |
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT02071082 |
Other Study ID Numbers: |
GS-US-292-1249 |
First Submitted: | February 21, 2014 |
First Posted: | February 25, 2014 |
Results First Submitted: | January 21, 2016 |
Results First Posted: | April 4, 2016 |
Last Update Posted: | November 16, 2018 |