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The primary objective of this study was to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDV/SOF 8 wk TN (Cohort 1, Group 1) | Experimental | LDV/SOF for 8 weeks (treatment-naive (TN)) |
|
| LDV/SOF+RBV 8 wk TN (Cohort 1, Group 2) | Experimental | LDV/SOF+RBV for 8 weeks (treatment-naive) |
|
| LDV/SOF 12 wk TN (Cohort 1, Group 3) | Experimental | LDV/SOF for 12 weeks (treatment-naive) |
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| LDV/SOF+RBV 12 wk TN (Cohort 1, Group 4) | Experimental | LDV/SOF+RBV for 12 weeks (treatment-naive) |
|
| LDV/SOF+RBV 12 wk TE (Cohort 2) | Experimental | Treatment-experienced (TE) participants who completed treatment in Gilead sponsored study GS-US-334-0138 or in Cohort 1 of this study and did not achieve SVR12 will receive LDV/SOF+RBV for 12 weeks. |
|
| LDV/SOF 12 wk TE (Cohort 3, Group 1) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDV/SOF | Drug | 90/400 mg FDC tablet administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. | Posttreatment Week 12 |
| Percentage of Participants Who Discontinued LDV/SOF Drug Due to an Adverse Event (AE) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR24 were defined as HCV RNA < LLOQ 4 and 24 weeks after the last dose of study drug, respectively. | Posttreatment Weeks 4 and 24 |
| Percentage of Participants With Overall Virologic Failure |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al Mansurah | Egypt | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Shiha G, Waked I, Soliman R, Abdelrazek W, Hassany M, Fouad R, et al. Ledipasvir/sofosbuvir for 8 or 12 weeks with or without ribavirin in HCV genotype 4 patients in Egypt. [Abstract OP158]. Asian Pacific Association for the Study of the Liver (APASL); 2017 15-19 February; Shanghai, China | ||
| 29666174 | Derived | Shiha G, Esmat G, Hassany M, Soliman R, Elbasiony M, Fouad R, Elsharkawy A, Hammad R, Abdel-Razek W, Zakareya T, Kersey K, Massetto B, Osinusi A, Lu S, Brainard DM, McHutchison JG, Waked I, Doss W. Ledipasvir/sofosbuvir with or without ribavirin for 8 or 12 weeks for the treatment of HCV genotype 4 infection: results from a randomised phase III study in Egypt. Gut. 2019 Apr;68(4):721-728. doi: 10.1136/gutjnl-2017-315906. Epub 2018 Apr 17. |
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Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
18 months after study completion
A secured external environment with username, password, and RSA code.
289 participants were screened.
Participants were enrolled in 4 sites in Egypt. The first participant was screened on 07 September 2015 and the last study visit was on 04 February 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | LDV/SOF 8 wk TN (Cohort 1, Group 1) | Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed dose combination (FDC) tablet administered orally once daily for 8 weeks (wk) in treatment-naive (TN) participants |
| FG001 | LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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LDV/SOF for 12 weeks (treatment-experienced) |
|
| LDV/SOF+RBV 12 wk TE (Cohort 3, Group 2) | Experimental | LDV/SOF+RBV for 12 weeks (treatment-experienced) |
|
|
| RBV | Drug | Tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) |
|
Virologic failure was defined as
|
| Up to Posttreatment Week 24 |
| Cairo |
| 11559 |
| Egypt |
| Cairo | 11796 | Egypt |
| Shibīn al Kawm | Egypt |
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + Ribavirin (RBV) tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks in TN participants |
| FG002 | LDV/SOF 12 wk TN (Cohort 1, Group 3) | LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks in TN participants |
| FG003 | LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4) | LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TN participants |
| FG004 | LDV/SOF 12 wk TE (Cohort 3, Group 1) | LDV/SOF (90/400 mg) FDC tablet administered orally once daily in treatment-experienced (TE) participants |
| FG005 | LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2) | LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TE participants |
| FG006 | LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in SOF or LDV/SOF experienced participants. Participants who completed treatment in Study GS-US-334-0138 with SOF+RBV for 12 or 24 weeks or those who participated in Cohort 1 of this study with LDV/SOF ± RBV for 8 weeks and did not achieve SVR12 were in enrolled into Cohort 2. |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set: participants who were randomized or enrolled and received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | LDV/SOF 8 wk TN (Cohort 1, Group 1) | LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 8 weeks in TN participants |
| BG001 | LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2) | LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks in TN participants |
| BG002 | LDV/SOF 12 wk TN (Cohort 1, Group 3) | LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks in TN participants |
| BG003 | LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4) | LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TN participants |
| BG004 | LDV/SOF 12 wk TE (Cohort 3, Group 1) | LDV/SOF (90/400 mg) FDC tablet administered orally once daily in TE participants |
| BG005 | LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2) | LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TE participants |
| BG006 | LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in SOF or LDV/SOF experienced participants. Participants who completed treatment in Study GS-US-334-0138 with SOF+RBV for 12 or 24 weeks or those who participated in Cohort 1 of this study with LDV/SOF ± RBV for 8 weeks and did not achieve SVR12 were enrolled into Cohort 2. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| IL28b Status | The CC, CT, and TT alleles are different forms of the IL28b gene. | Count of Participants | Participants |
| |||||||||||||||
| HCV RNA | Mean | Standard Deviation | log10 IU/mL) |
| |||||||||||||||
| HCV RNA Category | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. | Full Analysis Set: all randomized or enrolled participants who had genotype 4 HCV infection and who took at least 1 dose of study drug. | Posted | Number | 99% Confidence Interval | percentage of participants | Posttreatment Week 12 |
|
|
| |||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Discontinued LDV/SOF Drug Due to an Adverse Event (AE) | Safety analysis Set | Posted | Number | percentage of participants | 12 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR24 were defined as HCV RNA < LLOQ 4 and 24 weeks after the last dose of study drug, respectively. | Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Weeks 4 and 24 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Overall Virologic Failure | Virologic failure was defined as
| Full Analysis Set | Posted | Number | percentage of participants | Up to Posttreatment Week 24 |
|
Up to 12 weeks + 30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LDV/SOF 8 Weeks | LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 8 weeks | 0 | 43 | 11 | 43 | ||
| EG001 | LDV/SOF + RBV 8 Weeks | LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks | 0 | 42 | 15 | 42 | ||
| EG002 | LDV/SOF 12 Weeks | LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks | 0 | 79 | 23 | 79 | ||
| EG003 | LDV/SOF + RBV 12 Weeks | LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks | 3 | 91 | 41 | 91 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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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:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Gilead Sciences | ClinicalTrialDisclosures@gilead.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019698 | Hepatitis C, Chronic |
| D008107 | Liver Diseases |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D004066 | Digestive System Diseases |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000595958 | ledipasvir, sofosbuvir drug combination |
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| Male |
|
| CT |
|
| TT |
|
| ≥ 800,000 IU/mL |
|
| Units | Counts |
|---|
| Participants |
|
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LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TN participants
| OG004 | LDV/SOF 12 wk TE (Cohort 3, Group 1) | LDV/SOF (90/400 mg) FDC tablet administered orally once daily in TE participants |
| OG005 | LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2) | LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TE participants |
| OG006 | LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in SOF or LDV/SOF experienced participants. Participants who completed treatment in Study GS-US-334-0138 with SOF+RBV for 12 or 24 weeks or those who participated in Cohort 1 of this study with LDV/SOF ± RBV for 8 weeks and did not achieve SVR12 were enrolled into Cohort 2. |
|
|
| OG003 | LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4) | LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TN participants |
| OG004 | LDV/SOF 12 wk TE (Cohort 3, Group 1) | LDV/SOF (90/400 mg) FDC tablet administered orally once daily in TE participants |
| OG005 | LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2) | LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TE participants |
| OG006 | LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in SOF or LDV/SOF experienced participants. Participants who completed treatment in Study GS-US-334-0138 with SOF+RBV for 12 or 24 weeks or those who participated in Cohort 1 of this study with LDV/SOF ± RBV for 8 weeks and did not achieve SVR12 were enrolled into Cohort 2. |
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