Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02071082
First received: February 21, 2014
Last updated: March 7, 2016
Last verified: March 2016
Results First Received: January 21, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV
HBV
Intervention: Drug: E/C/F/TAF

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at study sites in the North America and Japan. The first participant was screened on 25 February 2014. The last Week 48 study visit occurred on 26 June 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
113 participants were screened.

Reporting Groups
  Description
HIV/HBV Treatment-Naive 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-Suppressed 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.

Participant Flow:   Overall Study
    HIV/HBV Treatment-Naive     HIV-Suppressed  
STARTED     4     75  
COMPLETED     0     0  
NOT COMPLETED     4     75  
Enrolled and Never Treated                 1                 1  
Adverse Event                 0                 1  
Non-Compliance with Study Drug                 0                 1  
Withdrew Consent                 0                 3  
Lost to Follow-up                 0                 1  
Participants Still on Study                 3                 68  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.

Reporting Groups
  Description
HIV/HBV Treatment-Naive 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-Suppressed 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 Total of all reporting groups

Baseline Measures
    HIV/HBV Treatment-Naive     HIV-Suppressed     Total  
Number of Participants  
[units: participants]
  3     74     77  
Age  
[units: years]
Mean (Standard Deviation)
  27  (4.0)     49  (7.8)     49  (8.9)  
Gender  
[units: participants]
     
Female     0     6     6  
Male     3     68     71  
Race/Ethnicity, Customized  
[units: 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  
[units: participants]
     
Hispanic or Latino     0     12     12  
Not Hispanic or Latino     3     62     65  
Region of Enrollment  
[units: participants]
     
Canada     0     10     10  
United States     1     62     63  
Japan     2     2     4  
HIV-1 RNA  
[units: log10 copies/mL]
Mean (Standard Deviation)
  4.20  (1.242)     1.29  (0.068)     1.41  (0.606)  
HIV-1 RNA Category  
[units: participants]
     
< 50 copies/mL     0     73     73  
≥ 50 copies/mL     3     1     4  
HBV DNA  
[units: log10 IU/mL]
Mean (Standard Deviation)
  8.31  (0.416)     1.49  (0.883)     1.75  (1.588)  
HBV DNA Category  
[units: participants]
     
< 29 IU/mL     0     64     64  
≥ 29 IU/mL     3     10     13  
Alanine Aminotransferase (ALT)  
[units: U/L]
Mean (Standard Deviation)
  84  (38.9)     31  (21.1)     33  (23.9)  
Hepatitis B Surface Antigen Status  
[units: participants]
     
Positive     3     71     74  
Negative     0     3     3  
Hepatitis B e-Antibody Status  
[units: participants]
     
Positive     0     26     26  
Negative     3     43     46  
Borderline     0     5     5  
Fibrotest® Score [1]
[units: units on a scale]
Median (Inter-Quartile Range)
  0.27  
  (0.16 to 0.28)  
  0.35  
  (0.21 to 0.54)  
  0.34  
  (0.21 to 0.53)  
[1] 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.



  Outcome Measures
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1.  Primary:   Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL   [ Time Frame: Week 24 ]

2.  Primary:   Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL   [ Time Frame: Week 24 ]

3.  Secondary:   Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL   [ Time Frame: Week 48 ]

4.  Secondary:   Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL   [ Time Frame: Week 48 ]

5.  Secondary:   Percentage of Participants With Normalized Alanine Aminotransferase (ALT) at Week 24   [ Time Frame: Baseline; Week 24 ]

6.  Secondary:   Percentage of Participants With Normalized ALT at Week 48   [ Time Frame: Baseline; Week 48 ]

7.  Secondary:   Percentage of Participants With Seroconversion to Hepatitis B Surface Antibody (Anti-HBs) at Week 24   [ Time Frame: Baseline; Week 24 ]

8.  Secondary:   Percentage of Participants With Seroconversion to Anti-HBs at Week 48   [ Time Frame: Baseline; Week 48 ]

9.  Secondary:   Percentage of Participants With Seroconversion to Hepatitis B e Antibody (Anti-HBe) at Week 24   [ Time Frame: Baseline; Week 24 ]

10.  Secondary:   Percentage of Participants With Seroconversion to Anti-HBe at Week 48   [ Time Frame: Baseline; Week 48 ]

11.  Secondary:   Change From Baseline in FibroTest® Score at Week 24   [ Time Frame: Baseline; Week 24 ]

12.  Secondary:   Change From Baseline in FibroTest® Score at Week 48   [ Time Frame: Baseline; Week 48 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There were no limitations affecting the analysis or results.


  More Information
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Certain Agreements:  
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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences
e-mail: ClinicalTrialDisclosures@gilead.com



Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02071082     History of Changes
Other Study ID Numbers: GS-US-292-1249
Study First Received: February 21, 2014
Results First Received: January 21, 2016
Last Updated: March 7, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Japan: Pharmaceuticals and Medical Devices Agency