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 (Co-STARs)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02707601

Recruitment Status : Completed

First Posted : March 14, 2016

Results First Posted : October 9, 2018

Last Update Posted : November 14, 2018

Sponsor:

Information provided by (Responsible Party):

Gilead Sciences

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	HIV-1 Infection HCV Infection
Interventions	Drug: E/C/F/TAF Drug: F/R/TAF Drug: LDV/SOF
Enrollment	150

Participant Flow

Recruitment Details	Participants were enrolled at study sites in the United States. The first participant was screened on 01 April 2016. The last study visit occurred on 29 September 2017.
Pre-assignment Details	259 participants were screened.


Arm/Group Title	E/C/F/TAF + LDV/SOF	F/R/TAF + LDV/SOF
Arm/Group Description	Part 1: Participants received elvit...	Part 1: Participants received emtri...
Arm/Group Description	Part 1: Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) 150/150/200/10 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to E/C/F/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study. Part 2: Participants continued receiving E/C/F/TAF 150/150/200/10 mg orally once daily with food until the end of the study and received ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).	Part 1: Participants received emtricitabine/rilpivirine/tenofovir alafenamide (F/R/TAF) 200/25/25 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to F/R/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study. Part 2: Participants continued receiving F/R/TAF 200/25/25 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).
Period Title: Overall Study
Started	76	74
Completed	72	70
Not Completed	4	4
Reason Not Completed
Death	0	1
Lack of Efficacy	0	1
Investigator's Discretion	1	0
Withdrew Consent	0	1
Lost to Follow-up	1	1
Participants Randomized but Not Treated	2	0

Baseline Characteristics

Arm/Group Title		E/C/F/TAF + LDV/SOF	F/R/TAF + LDV/SOF	Total
Arm/Group Description		Part 1: Participants received E/C/F...	Part 1: Participants received F/R/T...	Total of all reporting groups
Arm/Group Description		Part 1: Participants received E/C/F/TAF 150/150/200/10 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to E/C/F/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study. Part 2: Participants continued receiving E/C/F/TAF 150/150/200/10 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).	Part 1: Participants received F/R/TAF 200/25/25 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to F/R/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study. Part 2: Participants continued receiving F/R/TAF 200/25/25 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).	Total of all reporting groups
Overall Number of Baseline Participants		74	74	148
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Safety Analysis Set: 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).
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	74 participants	74 participants	148 participants
		51 (9.5)	52 (9.9)	51 (9.7)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	74 participants	74 participants	148 participants
	Female	16 21.6%	22 29.7%	38 25.7%
	Male	58 78.4%	52 70.3%	110 74.3%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	74 participants	74 participants	148 participants
	Hispanic or Latino	13 17.6%	14 18.9%	27 18.2%
	Not Hispanic or Latino	61 82.4%	59 79.7%	120 81.1%
	Unknown or Not Reported	0 0.0%	1 1.4%	1 0.7%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	74 participants	74 participants	148 participants
	Asian	1 1.4%	0 0.0%	1 0.7%
	Black	30 40.5%	31 41.9%	61 41.2%
	White	41 55.4%	37 50.0%	78 52.7%
	Native Hawaiian or Pacific Islander	0 0.0%	2 2.7%	2 1.4%
	Other	2 2.7%	3 4.1%	5 3.4%
	American Indian or Alaska Native	0 0.0%	1 1.4%	1 0.7%
HCV RNA Category Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	74 participants	74 participants	148 participants
	< 800,000 IU/mL	25 33.8%	14 18.9%	39 26.4%
	≥ 800,000 IU/mL	49 66.2%	60 81.1%	109 73.6%
HIV-1 RNA Category Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	74 participants	74 participants	148 participants
	< 50 copies/mL	73 98.6%	74 100.0%	147 99.3%
	≥ 50 copies/mL	1 1.4%	0 0.0%	1 0.7%
HCV RNA Mean (Standard Deviation) Unit of measure: Log10 IU/mL
	Number Analyzed	74 participants	74 participants	148 participants
		6.0 (1.07)	6.3 (0.74)	6.2 (0.92)

Outcome Measures

1.Primary Outcome


Title	Percentage of Participants With HCV RNA < LLOQ at 12 Weeks After Discontinuation of LDV/SOF Treatment (SVR12)
Description	Sustained Virologic Response (SVR12) was defined as HCV RNA < the l...
Description	Sustained Virologic Response (SVR12) was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping LDV/SOF treatment.
Time Frame	HCV Posttreatment Week 12

Outcome Measure Data

Analysis Population Description

HCV Full Analysis Set: participants who were randomized into the study and received at least 1 dose of HCV study drug, LDV/SOF.


Arm/Group Title	E/C/F/TAF + LDV/SOF	F/R/TAF + LDV/SOF
Arm/Group Description:	Part 1: Participants received E/C/F...	Part 1: Participants received F/R/T...
Arm/Group Description:	Part 1: Participants received E/C/F/TAF 150/150/200/10 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to E/C/F/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study. Part 2: Participants continued receiving E/C/F/TAF 150/150/200/10 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).	Part 1: Participants received F/R/TAF 200/25/25 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to F/R/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study. Part 2: Participants continued receiving F/R/TAF 200/25/25 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).
Overall Number of Participants Analyzed	72	72
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	98.6 (92.5 to 100.0)	95.8 (88.3 to 99.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	E/C/F/TAF + LDV/SOF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.002
	Comments	The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.
	Method	Binomial test
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	F/R/TAF + LDV/SOF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.042
	Comments	The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.
	Method	Binomial test
	Comments	[Not Specified]

2.Secondary Outcome


Title	Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of LDV/SOF Treatment (SVR4)
Description	SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping LDV/SO...
Description	SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping LDV/SOF treatment.
Time Frame	HCV Posttreatment Week 4

Outcome Measure Data

Analysis Population Description

HCV Full Analysis Set


Arm/Group Title	E/C/F/TAF + LDV/SOF	F/R/TAF + LDV/SOF
Arm/Group Description:	Part 1: Participants received E/C/F...	Part 1: Participants received F/R/T...
Arm/Group Description:	Part 1: Participants received E/C/F/TAF 150/150/200/10 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to E/C/F/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study. Part 2: Participants continued receiving E/C/F/TAF 150/150/200/10 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).	Part 1: Participants received F/R/TAF 200/25/25 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to F/R/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study. Part 2: Participants continued receiving F/R/TAF 200/25/25 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).
Overall Number of Participants Analyzed	72	72
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	98.6 (92.5 to 100.0)	98.6 (92.5 to 100.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	E/C/F/TAF + LDV/SOF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.002
	Comments	The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.
	Method	Binomial test
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	F/R/TAF + LDV/SOF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.002
	Comments	The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.
	Method	Binomial test
	Comments	[Not Specified]

3.Secondary Outcome


Title	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
Description	The percentage of participants with HIV-1 RNA ≥ 50 copies/mL 24 ...
Description	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.
Time Frame	24 weeks after start of HIV treatment

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title	E/C/F/TAF + LDV/SOF	F/R/TAF + LDV/SOF
Arm/Group Description:	Part 1: Participants received E/C/F...	Part 1: Participants received F/R/T...
Arm/Group Description:	Part 1: Participants received E/C/F/TAF 150/150/200/10 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to E/C/F/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study. Part 2: Participants continued receiving E/C/F/TAF 150/150/200/10 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).	Part 1: Participants received F/R/TAF 200/25/25 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to F/R/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study. Part 2: Participants continued receiving F/R/TAF 200/25/25 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).
Overall Number of Participants Analyzed	74	74
Measure Type: Number Unit of Measure: percentage of participants
	1.4	1.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	E/C/F/TAF + LDV/SOF, F/R/TAF + LDV/SOF
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	1.00
	Comments	[Not Specified]
	Method	Fisher exact test
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Difference in Percentages
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95% -6.1 to 6.1
	Estimation Comments	The differences in percentages of participants between treatment groups and their 95% confidence intervals (CIs) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.

4.Secondary Outcome


Title	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
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Up to 32 weeks plus 30 days

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title	E/C/F/TAF + LDV/SOF (Co-administration: Week 8 to Week 20)	F/R/TAF + LDV/SOF (Co-administration: Week 8 to Week 20)	E/C/F/TAF + LDV/SOF (Whole Study: Day 1 to Post-HCV Week 12)	F/R/TAF + LDV/SOF (Whole Study: Day 1 to Post-HCV to Week 12)
Arm/Group Description:	In Part 2 of the study, participant...	In Part 2 of the study, participant...	Part 1: Participants received E/C/F...	Part 1: Participants received F/R/T...
Arm/Group Description:	In Part 2 of the study, participants from part 1 continued receiving E/C/F/TAF 150/150/200/10 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).	In Part 2 of the study, participants from part 1 continued receiving (F/R/TAF) 200/25/25 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).	Part 1: Participants received E/C/F/TAF 150/150/200/10 mg tablet orally once daily with food for 8 weeks. Part 2: Participants continued receiving E/C/F/TAF 150/150/200/10 mg tablet orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).	Part 1: Participants received F/R/TAF 200/25/25 mg tablet orally once daily with food for 8 weeks. Part 2: Participants continued receiving (F/R/TAF) 200/25/25 mg tablet orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).
Overall Number of Participants Analyzed	72	72	74	74
Measure Type: Number Unit of Measure: percentage of participants
	62.5	69.4	83.8	79.7

Adverse Events

Time Frame	Up to 32 weeks plus 30 days
Adverse Event Reporting Description	Safety Analysis Set: 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).

Arm/Group Title	E/C/F/TAF + LDV/SOF	F/R/TAF + LDV/SOF
Arm/Group Description	Part 1: Participants received E/C/F...	Part 1: Participants received F/R/T...
Arm/Group Description	Part 1: Participants received E/C/F/TAF 150/150/200/10 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to E/C/F/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study. Part 2: Participants continued receiving E/C/F/TAF 150/150/200/10 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).	Part 1: Participants received F/R/TAF 200/25/25 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to F/R/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study. Part 2: Participants continued receiving F/R/TAF 200/25/25 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).
All-Cause Mortality
	E/C/F/TAF + LDV/SOF	F/R/TAF + LDV/SOF
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/74 (0.00%)	1/74 (1.35%)
Serious Adverse Events Serious Adverse Events
	E/C/F/TAF + LDV/SOF	F/R/TAF + LDV/SOF
	Affected / at Risk (%)	Affected / at Risk (%)
Total	7/74 (9.46%)	12/74 (16.22%)
Blood and lymphatic system disorders
Iron deficiency anaemia ^† 1	1/74 (1.35%)	0/74 (0.00%)
Gastrointestinal disorders
Abdominal pain ^† 1	0/74 (0.00%)	1/74 (1.35%)
General disorders
Asthenia ^† 1	0/74 (0.00%)	1/74 (1.35%)
Chest pain ^† 1	0/74 (0.00%)	1/74 (1.35%)
Infections and infestations
Gastroenteritis ^† 1	1/74 (1.35%)	0/74 (0.00%)
Influenza ^† 1	0/74 (0.00%)	1/74 (1.35%)
Pneumonia ^† 1	0/74 (0.00%)	2/74 (2.70%)
Testicular abscess ^† 1	0/74 (0.00%)	1/74 (1.35%)
Tooth infection ^† 1	1/74 (1.35%)	0/74 (0.00%)
Injury, poisoning and procedural complications
Ankle fracture ^† 1	0/74 (0.00%)	1/74 (1.35%)
Investigations
Blood pressure orthostatic abnormal ^† 1	0/74 (0.00%)	1/74 (1.35%)
Metabolism and nutrition disorders
Dehydration ^† 1	0/74 (0.00%)	1/74 (1.35%)
Musculoskeletal and connective tissue disorders
Flank pain ^† 1	0/74 (0.00%)	1/74 (1.35%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site ^† 1	0/74 (0.00%)	1/74 (1.35%)
Nervous system disorders
Headache ^† 1	1/74 (1.35%)	0/74 (0.00%)
Syncope ^† 1	0/74 (0.00%)	1/74 (1.35%)
Psychiatric disorders
Confusional state ^† 1	0/74 (0.00%)	1/74 (1.35%)
Depression ^† 1	1/74 (1.35%)	0/74 (0.00%)
Suicidal ideation ^† 1	0/74 (0.00%)	1/74 (1.35%)
Suicide attempt ^† 1	1/74 (1.35%)	1/74 (1.35%)
Renal and urinary disorders
Acute kidney injury ^† 1	0/74 (0.00%)	1/74 (1.35%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease ^† 1	1/74 (1.35%)	0/74 (0.00%)
Skin and subcutaneous tissue disorders
Angioedema ^† 1	1/74 (1.35%)	0/74 (0.00%)
1 Term from vocabulary, MedDRA Version 20.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	E/C/F/TAF + LDV/SOF	F/R/TAF + LDV/SOF
	Affected / at Risk (%)	Affected / at Risk (%)
Total	46/74 (62.16%)	36/74 (48.65%)
Gastrointestinal disorders
Abdominal pain ^† 1	4/74 (5.41%)	3/74 (4.05%)
Diarrhoea ^† 1	6/74 (8.11%)	3/74 (4.05%)
Nausea ^† 1	4/74 (5.41%)	6/74 (8.11%)
General disorders
Fatigue ^† 1	4/74 (5.41%)	5/74 (6.76%)
Influenza like illness ^† 1	4/74 (5.41%)	0/74 (0.00%)
Infections and infestations
Bronchitis ^† 1	1/74 (1.35%)	4/74 (5.41%)
Upper respiratory tract infection ^† 1	9/74 (12.16%)	5/74 (6.76%)
Urinary tract infection ^† 1	10/74 (13.51%)	2/74 (2.70%)
Metabolism and nutrition disorders
Vitamin D deficiency ^† 1	5/74 (6.76%)	2/74 (2.70%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	7/74 (9.46%)	5/74 (6.76%)
Back pain ^† 1	4/74 (5.41%)	2/74 (2.70%)
Musculoskeletal pain ^† 1	4/74 (5.41%)	1/74 (1.35%)
Pain in extremity ^† 1	6/74 (8.11%)	1/74 (1.35%)
Nervous system disorders
Headache ^† 1	3/74 (4.05%)	8/74 (10.81%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	6/74 (8.11%)	10/74 (13.51%)
Vascular disorders
Hypertension ^† 1	0/74 (0.00%)	5/74 (6.76%)
1 Term from vocabulary, MedDRA Version 20.0 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

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.

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

Layout table for Results Point of Contact information

Name/Title:	Gilead Clinical Study Information Center
Organization:	Gilead Sciences
Phone:	1-833-445-3230 (GILEAD-0)
EMail:	GileadClinicalTrials@gilead.com

Publications of Results:

Ramgopal M, Jain M, Hinestrosa F, Asmuth D, Huhn G, Slim J, et al. HIV-1/HCV Coinfection Treatment with Single-Tablet Antiviral Regimens (CoSTARs): 12 Weeks of Ledipasvir/Sofosbuvir (LDV/SOF) after Randomized Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Rilpivirine/F/TAF (R/F/TAF) [Poster LB-12]. AASLD: The Liver Meeting 2017 20-24 October; Washington DC.

Huhn G, Jain M, Hinestrosa F, Asmuth D, Huhn G, Slim J, et al. HIV-1/HCV Coinfection Treatment with Single-Tablet Antiviral Regimens (CoSTARs): 12 Weeks of Ledipasvir/Sofosbuvir (LDV/SOF) after Randomized Switch to Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Rilpivirine/F/TAF (R/F/TAF) [Poster PE16/52]. European AIDS Conference 2017 25-27 October; Milan Italy.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Huhn GD, Ramgopal M, Jain MK, Hinestrosa F, Asmuth DM, Slim J, Goldstein D, Applin S, Ryu JH, Jiang S, Cox S, Das M, Nguyen-Cleary T, Piontkowsky D, Guyer B, Rossaro L, Haubrich RH. HIV/HCV therapy with ledipasvir/sofosbuvir after randomized switch to emtricitabine-tenofovir alafenamide-based single-tablet regimens. PLoS One. 2020 Jan 29;15(1):e0224875. doi: 10.1371/journal.pone.0224875. eCollection 2020.

Layout table for additonal information

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT02707601
Other Study ID Numbers:	GS-US-366-1992 2014-004545-27 ( EudraCT Number )
First Submitted:	March 9, 2016
First Posted:	March 14, 2016
Results First Submitted:	September 12, 2018
Results First Posted:	October 9, 2018
Last Update Posted:	November 14, 2018

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