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Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection

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: NCT02073656
Recruitment Status : Completed
First Posted : February 27, 2014
Results First Posted : October 21, 2016
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hepatitis C Virus
HIV
Interventions Drug: LDV/SOF
Drug: RBV
Enrollment 335
Recruitment Details Participants were enrolled at study sites in the United States (including Puerto Rico), Canada, and New Zealand. The first participant was screened on 24 February 2014. The last study visit occurred on 01 December 2015.
Pre-assignment Details 429 participants were screened.
Arm/Group Title LDV/SOF 12 Weeks
Hide Arm/Group Description

Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for up to 12 weeks.

Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 24 weeks.
Period Title: Primary Study
Started 335
Completed 327
Not Completed 8
Reason Not Completed
Lost to Follow-up             6
Death             1
Withdrew Consent             1
Period Title: Retreatment Substudy
Started 9 [1]
Completed 9
Not Completed 0
[1]
Only participants experiencing virologic relapse in the Primary Study were eligible for retreatment.
Arm/Group Title LDV/SOF 12 Weeks
Hide Arm/Group Description Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for up to 12 weeks.
Overall Number of Baseline Participants 335
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who enrolled and received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 335 participants
52  (8.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 335 participants
Female
59
  17.6%
Male
276
  82.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 335 participants
Hispanic or Latino
56
  16.7%
Not Hispanic or Latino
276
  82.4%
Unknown or Not Reported
3
   0.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 335 participants
Black or African American 115
White 203
Asian 6
American Indian/ Alaska Native 2
Other 6
Not Disclosed 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 335 participants
New Zealand 9
Canada 26
United States 290
Puerto Rico 10
HCV Genotype  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 335 participants
Genotype 1a 250
Genotype 1b 77
Genotype 4 8
Cirrhosis Status  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 335 participants
No 268
Yes 67
IL28b Status   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 335 participants
CC 81
CT 185
TT 69
[1]
Measure Description: The CC, CT, and TT alleles are different forms of the IL28b gene.
Baseline HCV RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 335 participants
6.7  (0.64)
Baseline HCV RNA Category  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 335 participants
< 800,000 IU/mL 36
≥ 800,000 IU/mL 299
Baseline Serum Creatinine  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 335 participants
1.00  (0.210)
Estimated Glomerular Filtration Rate Using the Cockcroft-Gault Equation  
Mean (Standard Deviation)
Unit of measure:  mL/min
Number Analyzed 335 participants
101.6  (30.78)
Baseline CD4 Count  
Mean (Standard Deviation)
Unit of measure:  cells/uL
Number Analyzed 335 participants
662  (293.8)
Prior HCV Treatment   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 335 participants
Treatment-Naive 150
Treatment-Experienced with DAA+Peg-IFN+RBV 53
Treatment-Experienced with Peg-IFN+RBV 113
Treatment-Experienced with DAA+RBV 14
Treatment-Experienced with Other 5
[1]
Measure Description:

Acronyms for prior treatment:

DAA = direct-acting antiviral; Peg-IFN = pegylated interferon; RBV = ribavirin
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Hide Description SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Time Frame Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: participants who enrolled and received at least 1 dose of study drug.
Arm/Group Title LDV/SOF 12 Weeks
Hide Arm/Group Description:
Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
Overall Number of Participants Analyzed 335
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
96.1
(93.5 to 97.9)
2.Primary Outcome
Title Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Hide Description [Not Specified]
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: participants who enrolled and received at least 1 dose of study drug.
Arm/Group Title LDV/SOF 12 Weeks
Hide Arm/Group Description:
Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
Overall Number of Participants Analyzed 335
Measure Type: Number
Unit of Measure: percentage of participants
0
3.Secondary Outcome
Title Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Hide Description SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Time Frame Posttreatment Weeks 4 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF 12 Weeks
Hide Arm/Group Description:
Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
Overall Number of Participants Analyzed 335
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
SVR4
96.7
(94.2 to 98.3)
SVR24
96.1
(93.5 to 97.9)
4.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Hide Description [Not Specified]
Time Frame Weeks 1, 2, 4, 6, 8, 10, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF 12 Weeks
Hide Arm/Group Description:
Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
Overall Number of Participants Analyzed 335
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 1 (N = 335)
29.3
(24.4 to 34.4)
Week 2 (N = 335)
81.2
(76.6 to 85.2)
Week 4 (N = 335)
98.8
(97.0 to 99.7)
Week 6 (N = 335)
99.1
(97.4 to 99.8)
Week 8 (N = 334)
99.4
(97.9 to 99.9)
Week 10 (N = 332)
100.0
(98.9 to 100.0)
Week 12 (N = 332)
100.0
(98.9 to 100.0)
5.Secondary Outcome
Title Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, and 8
Hide Description [Not Specified]
Time Frame Baseline; Weeks 1, 2, 4, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF 12 Weeks
Hide Arm/Group Description:
Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
Overall Number of Participants Analyzed 335
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Change at Week 1 (N = 331) -4.68  (0.674)
Change at Week 2 (N = 334) -5.21  (0.654)
Change at Week 4 (N = 335) -5.30  (0.743)
Change at Week 6 (N = 334) -5.30  (0.772)
Change at Week 8 (N = 333) -5.33  (0.645)
6.Secondary Outcome
Title Percentage of Participants With Virologic Failure
Hide Description

Virologic failure was defined as:

  • On-treatment virologic failure:

    • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
    • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
    • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)

  • Virologic relapse:

    • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Time Frame Up to Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF 12 Weeks
Hide Arm/Group Description:
Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
Overall Number of Participants Analyzed 335
Measure Type: Number
Unit of Measure: percentage of participants
On-Treatment Virologic Failure (N = 335) 0.6
Virologic Relapse (N = 333) 3.0
7.Secondary Outcome
Title Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment
Hide Description [Not Specified]
Time Frame Weeks 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF 12 Weeks
Hide Arm/Group Description:
Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
Overall Number of Participants Analyzed 335
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 (N = 335) 98.5
Week 8 (N = 334) 98.2
Week 12 (N = 334) 97.9
8.Secondary Outcome
Title Change From Baseline in Serum Creatinine at the End of Treatment (Week 12) and at Posttreatment Weeks 12 and 24
Hide Description [Not Specified]
Time Frame Baseline; Week 12, Posttreatment Weeks 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF 12 Weeks
Hide Arm/Group Description:
Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
Overall Number of Participants Analyzed 335
Mean (Standard Deviation)
Unit of Measure: mg/dL
Change at Week 12 (N = 320) 0.05  (0.111)
Change at Posttreatment Week 12 (N = 325) 0.03  (0.143)
Change at Posttreatment Week 24 (N = 313) -0.02  (0.134)
9.Secondary Outcome
Title For Participants in the Retreatment Substudy, Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24)
Hide Description SVR4, SVR12, and SVR 24 were defined as HCV RNA < LLOQ at 4, 12, and 24 weeks after stopping study treatment, respectively.
Time Frame Posttreatment Weeks 4, 12, and 24 of Retreatment Substudy
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed.
Arm/Group Title LDV/SOF+RBV 24 Weeks (Retreatment Substudy)
Hide Arm/Group Description:
Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
Overall Number of Participants Analyzed 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
SVR4
88.9
(51.8 to 99.7)
SVR12
88.9
(51.8 to 99.7)
SVR24
88.9
(51.8 to 99.7)
10.Secondary Outcome
Title For Participants in the Retreatment Substudy, Percentage of Participants With HCV RNA < LLOQ at Retreatment Weeks 2, 4, 8, 12, 16, 20, and 24
Hide Description [Not Specified]
Time Frame Weeks 2, 4, 8, 12, 16, 20, and 24 of the Retreatment Substudy
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed.
Arm/Group Title LDV/SOF+RBV 24 Weeks (Retreatment Substudy)
Hide Arm/Group Description:
Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
Overall Number of Participants Analyzed 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2 Retreatment
88.9
(51.8 to 99.7)
Week 4 Retreatment
100.0
(66.4 to 100.0)
Week 8 Retreatment
100.0
(66.4 to 100.0)
Week 12 Retreatment
100.0
(66.4 to 100.0)
Week 16 Retreatment
100.0
(66.4 to 100.0)
Week 20 Retreatment
100.0
(66.4 to 100.0)
Week 24 Retreatment
100.0
(66.4 to 100.0)
11.Secondary Outcome
Title For Participants in the Retreatment Substudy, Change From Baseline in HCV RNA at Retreatment Weeks 2, 4, and 8
Hide Description [Not Specified]
Time Frame Baseline; Weeks 2, 4, and 8 of Retreatment Substudy
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed.
Arm/Group Title LDV/SOF+RBV 24 Weeks (Retreatment Substudy)
Hide Arm/Group Description:
Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Change at Week 2 Retreatment -5.01  (0.775)
Change at Week 4 Retreatment -5.04  (0.802)
Change at Week 8 Retreatment -5.04  (0.802)
12.Secondary Outcome
Title For Participants in the Retreatment Substudy, Percentage of Participants With Virologic Failure
Hide Description

Virologic failure was defined as:

  • On-treatment virologic failure:

    • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
    • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
    • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)

  • Virologic relapse:

    • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Time Frame Up to Posttreatment Week 24 of Retreatment Substudy
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed.
Arm/Group Title LDV/SOF+RBV 24 Weeks (Retreatment Substudy)
Hide Arm/Group Description:
Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: percentage of participants
On-Treatment Virologic Failure 0
Virologic Relapse 11.1
Time Frame LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set
 
Arm/Group Title LDV/SOF 12 Weeks (Primary Study) LDV/SOF+RBV 24 Weeks (Retreatment)
Hide Arm/Group Description LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks. Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
All-Cause Mortality
LDV/SOF 12 Weeks (Primary Study) LDV/SOF+RBV 24 Weeks (Retreatment)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
LDV/SOF 12 Weeks (Primary Study) LDV/SOF+RBV 24 Weeks (Retreatment)
Affected / at Risk (%) Affected / at Risk (%)
Total   8/335 (2.39%)   0/9 (0.00%) 
Gastrointestinal disorders     
Diarrhoea † 1  1/335 (0.30%)  0/9 (0.00%) 
Ileus † 1  1/335 (0.30%)  0/9 (0.00%) 
Hepatobiliary disorders     
Portal vein thrombosis † 1  2/335 (0.60%)  0/9 (0.00%) 
Infections and infestations     
Clostridium difficile colitis † 1  1/335 (0.30%)  0/9 (0.00%) 
Peritonitis bacterial † 1  1/335 (0.30%)  0/9 (0.00%) 
Respiratory tract infection † 1  1/335 (0.30%)  0/9 (0.00%) 
Sepsis † 1  1/335 (0.30%)  0/9 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  1/335 (0.30%)  0/9 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Hepatocellular carcinoma † 1  2/335 (0.60%)  0/9 (0.00%) 
Psychiatric disorders     
Substance abuse † 1  1/335 (0.30%)  0/9 (0.00%) 
Renal and urinary disorders     
Azotaemia † 1  1/335 (0.30%)  0/9 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  1/335 (0.30%)  0/9 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LDV/SOF 12 Weeks (Primary Study) LDV/SOF+RBV 24 Weeks (Retreatment)
Affected / at Risk (%) Affected / at Risk (%)
Total   179/335 (53.43%)   9/9 (100.00%) 
Blood and lymphatic system disorders     
Anaemia † 1  2/335 (0.60%)  3/9 (33.33%) 
Haemolytic anaemia † 1  0/335 (0.00%)  1/9 (11.11%) 
Eye disorders     
Vision blurred † 1  2/335 (0.60%)  1/9 (11.11%) 
Gastrointestinal disorders     
Diarrhoea † 1  35/335 (10.45%)  1/9 (11.11%) 
Nausea † 1  33/335 (9.85%)  1/9 (11.11%) 
Vomiting † 1  14/335 (4.18%)  1/9 (11.11%) 
General disorders     
Fatigue † 1  71/335 (21.19%)  6/9 (66.67%) 
Chest discomfort † 1  0/335 (0.00%)  1/9 (11.11%) 
Cyst † 1  0/335 (0.00%)  1/9 (11.11%) 
Infections and infestations     
Upper respiratory tract infection † 1  18/335 (5.37%)  1/9 (11.11%) 
Acute sinusitis † 1  0/335 (0.00%)  1/9 (11.11%) 
Investigations     
Blood uric acid increased † 1  0/335 (0.00%)  1/9 (11.11%) 
Metabolism and nutrition disorders     
Decreased appetite † 1  8/335 (2.39%)  1/9 (11.11%) 
Increased appetite † 1  1/335 (0.30%)  1/9 (11.11%) 
Abnormal loss of weight † 1  0/335 (0.00%)  1/9 (11.11%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  23/335 (6.87%)  2/9 (22.22%) 
Back pain † 1  7/335 (2.09%)  1/9 (11.11%) 
Musculoskeletal pain † 1  3/335 (0.90%)  1/9 (11.11%) 
Foot deformity † 1  0/335 (0.00%)  1/9 (11.11%) 
Nervous system disorders     
Headache † 1  82/335 (24.48%)  1/9 (11.11%) 
Dizziness † 1  11/335 (3.28%)  1/9 (11.11%) 
Psychiatric disorders     
Irritability † 1  10/335 (2.99%)  1/9 (11.11%) 
Emotional disorder † 1  0/335 (0.00%)  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  8/335 (2.39%)  4/9 (44.44%) 
Upper-airway cough syndrome † 1  1/335 (0.30%)  1/9 (11.11%) 
Dysphonia † 1  0/335 (0.00%)  1/9 (11.11%) 
Nasal dryness † 1  0/335 (0.00%)  1/9 (11.11%) 
Skin and subcutaneous tissue disorders     
Rash † 1  4/335 (1.19%)  1/9 (11.11%) 
Dry skin † 1  2/335 (0.60%)  1/9 (11.11%) 
Ingrowing nail † 1  1/335 (0.30%)  1/9 (11.11%) 
Rash generalised † 1  0/335 (0.00%)  1/9 (11.11%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
[Not Specified]
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: Clinical Trial Disclosures
Organization: Gilead Sciences
EMail: ClinicalTrialDisclosures@gilead.com
Publications of Results:
Cooper C, Naggie S, Saag M, Yang JC, Stamm LM, Dvory-Sobol H, et al. Retreatment of Patients Who Failed 12 Weeks of Ledipasvir/Sofosbuvir-Based Regimens with Ledipasvir/Sofosbuvir with Ribavirin for 24 Weeks [Poster Presentation]. 23nd Conference on Retroviruses and Opportunistic Infections (CROI); 2016 February 22-25; Boston, MA.
Naggie S, Cooper C, Saag M, Workowski K, Ruane P, Towner WJ, Marks K, Luetkemeyer A, Baden RP, Sax PE, Gane E, Santana-Bagur J, Stamm LM, Yang JC, German P, Dvory-Sobol H, Ni L, Pang PS, McHutchison JG, Stedman CA, Morales-Ramirez JO, Brau N, Jayaweera D, Colson AE, Tebas P, Wong DK, Dieterich D, Sulkowski M; ION-4 Investigators. Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1. N Engl J Med. 2015 Aug 20;373(8):705-13. doi: 10.1056/NEJMoa1501315. Epub 2015 Jul 21.
Naggie S, Cooper C, Saag M, Stamm LM, Yang JC, Pang PS, et al. Ledipasvir/Sofosbuvir for 12 Weeks in Patients Coinfected With HCV and HIV-1 [Oral Presentation]. 22nd Conference on Retroviruses and Opportunistic Infections (CROI); 2015 February 23-26; Seattle, WA.
Cooper C, Naggie S, Saag M, Yang JC, Stamm LM, Dvory-Sobol H, Han L, Pang PS, McHutchison JG, Dieterich D, Sulkowski M. Successful Re-treatment of Hepatitis C Virus in Patients Coinfected With HIV Who Relapsed After 12 Weeks of Ledipasvir/Sofosbuvir. Clin Infect Dis. 2016 Aug 15;63(4):528-31. doi: 10.1093/cid/ciw349. Epub 2016 May 25.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02073656    
Other Study ID Numbers: GS-US-337-0115
First Submitted: February 25, 2014
First Posted: February 27, 2014
Results First Submitted: August 30, 2016
Results First Posted: October 21, 2016
Last Update Posted: November 16, 2018