Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) plus ribavirin (RBV) in adults with chronic genotypes 1, 2, and 3 HCV infection who are coinfected with HIV-1.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF+RBV 12 Weeks (GT 2/3, TN) | Experimental | Treatment-naive (TN) participants coinfected with HIV-1 and genotype (GT) 2 or genotype 3 HCV infection will receive SOF+RBV for 12 weeks. |
|
| SOF+RBV 24 Weeks (GT 2/3, TE) | Experimental | Treatment-experienced (TE) participants coinfected with HIV-1 and genotype 2 or genotype 3 HCV infection will receive SOF+RBV for 24 weeks. |
|
| SOF+RBV 24 Weeks (GT 1, TN) | Experimental | Treatment-naive (TN) participants coinfected with HIV-1 and genotype 1 HCV infection will receive SOF+RBV for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF | Drug | Sofosbuvir (SOF) 400 mg tablet administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response (SVR) at 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 |
| Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) | The percentage of participants discontinuing any study drug due to an adverse event was summarized. | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. | Posttreatment Weeks 4 and 24 |
| Change From Baseline in HCV RNA at Week 1 |
Not provided
Inclusion Criteria:
Willing and able to provide written informed consent
Male or female, age ≥ 18 years with chronic HCV and HIV-1 infection
HCV RNA > 1 x 10^4 IU/mL at screening
Infection with HCV genotype 1, 2 or 3 as determined at screening
HIV-1 infection confirmed with positive ELISA or Western blot at screening
Medical records must be sufficient to be categorized on interferon (IFN) eligibility or prior treatment history with PEG/RBV.
Confirmation of chronic HCV infection
Ability to determine presence/absence of cirrhosis.
HIV antiretroviral therapy (ARV) criteria of one of the following:
Approved HIV antiretroviral medications based on drug interaction studies
Not been treated with any investigational drug or device within 30 days of the screening visit
Females if confirmed that she is not pregnant or nursing of non-childbearing potential or of childbearing potential but has a negative serum pregnancy test at screening and agrees to use protocol approved method of birth control from screening through 6 months after the last dose of RBV
Males who agree to consistently and correctly use a condom while their female partner agrees to use protocol approved method of birth control from screening through 7 months after the last dose of RBV
Must be of generally good health as determined by the investigator.
Liver imaging within 6 months of baseline/Day 1 is required in cirrhotic patients only, to exclude hepatocellular carcinoma (HCC)
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anuj Gaggar, MD, PhD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 25583164 |
Not provided
Not provided
330 participants were screened.
Participants were enrolled at a total of 34 study sites in the United States. The first participant was screened on 20 July 2012. The last participant observation occurred on 10 February 2014.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SOF+RBV 12 Wk GT 2 TN | Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive (TN), genotype (GT) 2) |
| FG001 | SOF+RBV 12 Wk GT 3 TN |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| RBV | Drug | Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg) |
|
| Baseline; Week 1 |
| Change From Baseline in HCV RNA at Week 2 | Baseline; Week 2 |
| Change From Baseline in HCV RNA at Week 4 | Baseline; Week 4 |
| Change From Baseline in HCV RNA at Week 6 | Baseline; Week 6 |
| Change From Baseline in HCV RNA at Week 8 | Baseline; Week 8 |
| Percentage of Participants Experiencing On-treatment Virologic Failure | On-treatment virologic failure was defined as:
| Up to 24 weeks |
| Percentage of Participants Experiencing Viral Relapse | Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR. | Up to Posttreatment Week 24 |
| Coronado |
| California |
| United States |
| Los Angeles | California | United States |
| Lutherville | California | United States |
| Oakland | California | United States |
| Sacramento | California | United States |
| San Francisco | California | United States |
| Torrance | California | United States |
| Washington D.C. | District of Columbia | United States |
| Miami | Florida | United States |
| Orlando | Florida | United States |
| Tampa | Florida | United States |
| Chicago | Illinois | United States |
| Springfield | Massachusetts | United States |
| Kansas City | Missouri | United States |
| Hillsborough | New Jersey | United States |
| Santa Fe | New Mexico | United States |
| New York | New York | United States |
| Chapel Hill | North Carolina | United States |
| Durham | North Carolina | United States |
| Allentown | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Providence | Rhode Island | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| Seattle | Washington | United States |
| San Juan | Puerto Rico |
| Derived |
| Younossi ZM, Stepanova M, Sulkowski M, Naggie S, Puoti M, Orkin C, Hunt SL. Sofosbuvir and Ribavirin for Treatment of Chronic Hepatitis C in Patients Coinfected With Hepatitis C Virus and HIV: The Impact on Patient-Reported Outcomes. J Infect Dis. 2015 Aug 1;212(3):367-77. doi: 10.1093/infdis/jiv005. Epub 2015 Jan 12. |
| 25038354 | Derived | Sulkowski MS, Naggie S, Lalezari J, Fessel WJ, Mounzer K, Shuhart M, Luetkemeyer AF, Asmuth D, Gaggar A, Ni L, Svarovskaia E, Brainard DM, Symonds WT, Subramanian GM, McHutchison JG, Rodriguez-Torres M, Dieterich D; PHOTON-1 Investigators. Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection. JAMA. 2014 Jul 23-30;312(4):353-61. doi: 10.1001/jama.2014.7734. |
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
| FG002 | SOF+RBV 24 Wk GT 2 TE | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced (TE), genotype 2) |
| FG003 | SOF+RBV 24 Wk GT 3 TE | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3) |
| FG004 | SOF+RBV 24 Wk GT 1 TN | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SOF+RBV 12 Wk GT 2 TN | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2) |
| BG001 | SOF+RBV 12 Wk GT 3 TN | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3) |
| BG002 | SOF+RBV 24 Wk GT 2 TE | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2) |
| BG003 | SOF+RBV 24 Wk GT 3 TE | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3) |
| BG004 | SOF+RBV 24 Wk GT 1 TN | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1) |
| BG005 | 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| HCV Genotype | Number | participants |
| ||||||||||||||||
| Liver Cirrhosis | Number | participants |
| ||||||||||||||||
| IL28b Status | CC, CT, and TT alleles are different forms of the IL28b gene. | Number | participants |
| |||||||||||||||
| HCV RNA (log10 IU/mL) | Mean | Standard Deviation | log10 IU/mL |
| |||||||||||||||
| HCV RNA Category | 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) at 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 were enrolled and received at least 1 dose of study drug | Posted | Number | percentage of participants | Posttreatment Week 12 |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) | The percentage of participants discontinuing any study drug due to an adverse event was summarized. | Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug | Posted | Number | percentage of participants | Up to 24 weeks |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. | Full Analysis Set | Posted | Number | percentage of participants | Posttreatment Weeks 4 and 24 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HCV RNA at Week 1 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; Week 1 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HCV RNA at Week 2 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; Week 2 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HCV RNA at Week 4 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; Week 4 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HCV RNA at Week 6 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; Week 6 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HCV RNA at Week 8 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; Week 8 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing On-treatment Virologic Failure | On-treatment virologic failure was defined as:
| Full Analysis Set | Posted | Number | percentage of participants | Up to 24 weeks |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing Viral Relapse | Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | percentage of participants | Up to Posttreatment Week 24 |
|
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 | SOF+RBV 12 Wk GT 2/3 TN | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotypes 2 and 3) | 5 | 68 | 57 | 68 | ||
| EG001 | SOF+RBV 24 Wk GT 2/3 TE | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotypes 2 and 3) | 1 | 41 | 37 | 41 | ||
| EG002 | SOF+RBV 24 Wk GT 1 TN | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1) | 8 | 114 | 106 | 114 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 16.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 16.1 | Systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA Version 16.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA Version 16.1 | Systematic Assessment |
| |
| Incision site infection | Infections and infestations | MedDRA Version 16.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA Version 16.1 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA Version 16.1 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA Version 16.1 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA Version 16.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Drug abuse | Psychiatric disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Leukocytoclastic vasculitis | Skin and subcutaneous tissue disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 16.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 16.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 16.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA Version 16.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA Version 16.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 16.1 | 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, Inc. | ClinicalTrialDisclosures@gilead.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000163 | Acquired Immunodeficiency Syndrome |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| 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 |
| D015658 | HIV Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| White |
|
| Asian |
|
| American Indian/Alaska Native/First Nations |
|
| Hawaiian or Other Pacific Islander |
|
| Other |
|
| Genotype 2 |
|
| Genotype 3 |
|
| Yes |
|
| CT |
|
| TT |
|
| Missing |
|
| ≥ 6 log10 IU/mL |
|
|
|
| OG004 | SOF+RBV 24 Wk GT 1 TN | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1) |
|
|
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1) |
|
|
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1) |
|
|
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1) |
|
|
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1) |
|
|
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1) |
|
|
| OG003 | SOF+RBV 24 Wk GT 3 TE | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3) |
| OG004 | SOF+RBV 24 Wk GT 1 TN | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1) |
|
|
| OG004 | SOF+RBV 24 Wk GT 1 TN | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1) |
|
|