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This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in hepatitis C virus (HCV) treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic genotype 1 or 4 HCV infection who are co-infected with HIV-1.
Participants who experience confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 may be eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF plus ribavirin (RBV) for 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDV/SOF 12 Weeks | Experimental | LDV/SOF for 12 weeks |
|
| Retreatment Substudy | Experimental | LDV/SOF plus RBV for 24 weeks |
|
| 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 (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. | Posttreatment Week 12 |
| Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. | Posttreatment Weeks 4 and 24 |
| Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jenny Yang, PharmD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294-2170 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| 26196665 | Result | 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. | |
| Result | 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. |
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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.
429 participants were screened.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | LDV/SOF 12 Weeks | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Primary Study |
|
Not provided
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| RBV | Drug | Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) |
|
| Weeks 1, 2, 4, 6, 8, 10, and 12 |
| Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, and 8 | Baseline; Weeks 1, 2, 4, 6, and 8 |
| Percentage of Participants With Virologic Failure | Virologic failure was defined as:
| Up to Posttreatment Week 24 |
| Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment | Weeks 4, 8, and 12 |
| Change From Baseline in Serum Creatinine at the End of Treatment (Week 12) and at Posttreatment Weeks 12 and 24 | Baseline; Week 12, Posttreatment Weeks 12 and 24 |
| 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) | SVR4, SVR12, and SVR 24 were defined as HCV RNA < LLOQ at 4, 12, and 24 weeks after stopping study treatment, respectively. | Posttreatment Weeks 4, 12, and 24 of Retreatment Substudy |
| For Participants in the Retreatment Substudy, Percentage of Participants With HCV RNA < LLOQ at Retreatment Weeks 2, 4, 8, 12, 16, 20, and 24 | Weeks 2, 4, 8, 12, 16, 20, and 24 of the Retreatment Substudy |
| For Participants in the Retreatment Substudy, Change From Baseline in HCV RNA at Retreatment Weeks 2, 4, and 8 | Baseline; Weeks 2, 4, and 8 of Retreatment Substudy |
| For Participants in the Retreatment Substudy, Percentage of Participants With Virologic Failure | Virologic failure was defined as:
| Up to Posttreatment Week 24 of Retreatment Substudy |
| Los Angeles |
| California |
| 90027 |
| United States |
| Newport Beach | California | 92663 | United States |
| Palo Alto | California | 94304-5350 | United States |
| Sacramento | California | 95817 | United States |
| San Diego | California | 92103 | United States |
| San Francisco | California | 94110 | United States |
| Torrance | California | 90502 | United States |
| Denver | Colorado | 80209 | United States |
| Washington D.C. | District of Columbia | 20815 | United States |
| Bradenton | Florida | 34209 | United States |
| Miami | Florida | 33136 | United States |
| Orlando | Florida | 32803 | United States |
| Tampa | Florida | 33614 | United States |
| Atlanta | Georgia | 30312 | United States |
| Decatur | Georgia | 30033 | United States |
| Chicago | Illinois | 60612 | United States |
| Lutherville | Maryland | 21093 | United States |
| Boston | Massachusetts | 02115 | United States |
| Kansas City | Missouri | 64111 | United States |
| Santa Fe | New Mexico | 87505 | United States |
| New York | New York | 10065 | United States |
| The Bronx | New York | 10468 | United States |
| Chapel Hill | North Carolina | 27599 | United States |
| Durham | North Carolina | 27710 | United States |
| Cincinnati | Ohio | 45267-0595 | United States |
| Allentown | Pennsylvania | 18102 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Providence | Rhode Island | 02906 | United States |
| Dallas | Texas | 75235 | United States |
| Houston | Texas | 77004 | United States |
| Annandale | Virginia | 22003 | United States |
| Richmond | Virginia | 23298-0341 | United States |
| Seattle | Washington | 98104 | United States |
| Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto | Ontario | M5G 2N2 | Canada |
| Montreal | Quebec | H2L 5B1 | Canada |
| Auckland | 1142 | New Zealand |
| Christchurch | 8011 | New Zealand |
| San Juan | 00936-5607 | Puerto Rico |
| 27225242 | Result | 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. |
| 26743093 | Derived | Saeed S, Strumpf EC, Walmsley SL, Rollet-Kurhajec K, Pick N, Martel-Laferriere V, Hull M, Gill MJ, Cox J, Cooper C, Klein MB; Canadian Co-Infection Cohort Study; Cohen J, Conway B, Cooper C, Cote P, Cox J, Gill J, Haider S, Harris M, Haase D, Hull M, Montaner J, Moodie E, Pick N, Rachlis A, Rouleau D, Sandre R, Tyndall JM, Vachon ML, Walmsley S, Wong D. How Generalizable Are the Results From Trials of Direct Antiviral Agents to People Coinfected With HIV/HCV in the Real World? Clin Infect Dis. 2016 Apr 1;62(7):919-926. doi: 10.1093/cid/civ1222. Epub 2016 Jan 6. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Retreatment Substudy |
|
Safety Analysis Set: participants who enrolled and received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LDV/SOF 12 Weeks | Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for up to 12 weeks. |
| 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 |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| HCV Genotype | Number | participants |
| |||||||||||||||||||||||
| Cirrhosis Status | Number | participants |
| |||||||||||||||||||||||
| IL28b Status | The CC, CT, and TT alleles are different forms of the IL28b gene. | Number | participants |
| ||||||||||||||||||||||
| Baseline HCV RNA | Mean | Standard Deviation | log10 IU/mL |
| ||||||||||||||||||||||
| Baseline HCV RNA Category | Number | participants |
| |||||||||||||||||||||||
| Baseline Serum Creatinine | Mean | Standard Deviation | mg/dL |
| ||||||||||||||||||||||
| Estimated Glomerular Filtration Rate Using the Cockcroft-Gault Equation | Mean | Standard Deviation | mL/min |
| ||||||||||||||||||||||
| Baseline CD4 Count | Mean | Standard Deviation | cells/uL |
| ||||||||||||||||||||||
| Prior HCV Treatment | Acronyms for prior treatment: DAA = direct-acting antiviral; Peg-IFN = pegylated interferon; RBV = ribavirin | Number | 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 (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. | Full Analysis Set: participants who enrolled and received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Week 12 |
|
|
| |||||||||||||||||||||||||
| Primary | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | Safety Analysis Set: participants who enrolled and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Up to 12 weeks |
|
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. | Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Weeks 4 and 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 1, 2, 4, 6, 8, 10, and 12 |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, and 8 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; Weeks 1, 2, 4, 6, and 8 |
|
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virologic Failure | Virologic failure was defined as:
| Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | percentage of participants | Up to Posttreatment Week 24 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment | Participants in the Safety Analysis Set with available data were analyzed. | Posted | Number | percentage of participants | Weeks 4, 8, and 12 |
|
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum Creatinine at the End of Treatment (Week 12) and at Posttreatment Weeks 12 and 24 | Participants in the Safety Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | mg/dL | Baseline; Week 12, Posttreatment Weeks 12 and 24 |
|
| |||||||||||||||||||||||||||
| Secondary | 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) | SVR4, SVR12, and SVR 24 were defined as HCV RNA < LLOQ at 4, 12, and 24 weeks after stopping study treatment, respectively. | Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Weeks 4, 12, and 24 of Retreatment Substudy |
|
| ||||||||||||||||||||||||||
| Secondary | For Participants in the Retreatment Substudy, Percentage of Participants With HCV RNA < LLOQ at Retreatment Weeks 2, 4, 8, 12, 16, 20, and 24 | Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 2, 4, 8, 12, 16, 20, and 24 of the Retreatment Substudy |
|
| |||||||||||||||||||||||||||
| Secondary | For Participants in the Retreatment Substudy, Change From Baseline in HCV RNA at Retreatment Weeks 2, 4, and 8 | Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; Weeks 2, 4, and 8 of Retreatment Substudy |
|
| |||||||||||||||||||||||||||
| Secondary | For Participants in the Retreatment Substudy, Percentage of Participants With Virologic Failure | Virologic failure was defined as:
| Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed. | Posted | Number | percentage of participants | Up to Posttreatment Week 24 of Retreatment Substudy |
|
|
LDV/SOF 12 Weeks: Up to 12 weeks plus 30 days; LDV/SOF+RBV 24 Weeks: Up to 24 weeks plus 30 days
Safety Analysis Set
Not provided
| 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 12 Weeks (Primary Study) | LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks. | 8 | 335 | 179 | 335 | ||
| EG001 | LDV/SOF+RBV 24 Weeks (Retreatment) | 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. | 0 | 9 | 9 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Substance abuse | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cyst | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abnormal loss of weight | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Emotional disorder | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
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 |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000595958 | ledipasvir, sofosbuvir drug combination |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Asian |
|
| American Indian/ Alaska Native |
|
| Other |
|
| Not Disclosed |
|
| United States |
|
| Puerto Rico |
|
| Genotype 4 |
|
| TT |
|
| Treatment-Experienced with Peg-IFN+RBV |
|
| Treatment-Experienced with DAA+RBV |
|
| Treatment-Experienced with Other |
|
| Denominators |
|---|
| Categories |
|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| SVR4 |
| |||||
| SVR24 |
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Week 1 (N = 335) |
| |||||
| Week 2 (N = 335) |
| |||||
| Week 4 (N = 335) |
| |||||
| Week 6 (N = 335) |
| |||||
| Week 8 (N = 334) |
| |||||
| Week 10 (N = 332) |
| |||||
| Week 12 (N = 332) |
|
| Categories |
|---|
| Change at Week 1 (N = 331) |
| |||||
| Change at Week 2 (N = 334) |
| |||||
| Change at Week 4 (N = 335) |
| |||||
| Change at Week 6 (N = 334) |
| |||||
| Change at Week 8 (N = 333) |
|
|
| Denominators |
|---|
| Categories |
|---|
| Week 4 (N = 335) |
| |||||
| Week 8 (N = 334) |
| |||||
| Week 12 (N = 334) |
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Change at Week 12 (N = 320) |
| |||||
| Change at Posttreatment Week 12 (N = 325) |
| |||||
| Change at Posttreatment Week 24 (N = 313) |
|
|
|
|
|