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This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV infection who are co-infected with HIV-1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genotype 2 treatment-naive | Experimental | Treatment-naive (TN) participants with HIV-1 and genotype 2 HCV coinfection will receive sofosbuvir plus RBV for 12 weeks. |
|
| Genotype 2/3 treatment-experienced | Experimental | Treatment-experienced (TE) participants with HIV-1 and genotype 2 or 3 HCV co-infection will receive sofosbuvir plus RBV for 24 weeks. |
|
| Genotype 1/3/4 treatment-naive | Experimental | Treatment naive (TN) participants with HIV-1 and genotype 1, 3, or 4 HCV co-infection will receive sofosbuvir plus RBV for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofosbuvir | Drug | Sofosbuvir 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) 12 weeks following the last dose of study drug. | Posttreatment Week 12 |
| Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) | The percentage of participants permanently 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 < the lower limit of quantitation (LLOQ) 4 weeks and 24 weeks following the last dose of study drug, respectively. | Posttreatment Weeks 4 and 24 |
Not provided
Inclusion Criteria:
Age ≥ 18 years with HIV-1 and chronic HCV genotype 1, 2, 3, or 4 co-infection
HCV RNA > 10,000 IU/mL at screening
HCV treatment history:
HIV antiretroviral (ARV) criteria:
Presence or absence of cirrhosis; a liver biopsy may be required
Healthy according to medical history and physical examination with the exception of HCV and HIV diagnosis
Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anuj Gaggar, MD, PhD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Darlinghurst | New South Wales | Australia | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25659285 | Derived | Molina JM, Orkin C, Iser DM, Zamora FX, Nelson M, Stephan C, Massetto B, Gaggar A, Ni L, Svarovskaia E, Brainard D, Subramanian GM, McHutchison JG, Puoti M, Rockstroh JK; PHOTON-2 study team. Sofosbuvir plus ribavirin for treatment of hepatitis C virus in patients co-infected with HIV (PHOTON-2): a multicentre, open-label, non-randomised, phase 3 study. Lancet. 2015 Mar 21;385(9973):1098-106. doi: 10.1016/S0140-6736(14)62483-1. Epub 2015 Feb 4. | |
| 25583164 |
Not provided
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346 participants were screened.
Participants were enrolled at a total of 39 study sites in Australia and Europe. The first participant was screened on 18 January 2013. The last study visit occurred on 10 July 2014.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Genotype 2 Treatment-naive | Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection |
| FG001 | Genotype 1 Treatment-naive |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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) |
|
| HCV RNA Change From Baseline at Week 1 |
| Baseline; Week 1 |
| HCV RNA Change From Baseline at Week 2 | Baseline; Week 2 |
| HCV RNA Change From Baseline at Week 4 | Baseline; Week 4 |
| HCV RNA Change From Baseline at Week 6 | Baseline; Week 6 |
| HCV RNA Change From Baseline at Week 8 | Baseline; Week 8 |
| Percentage of Participants Experiencing Virologic Failure | On-treatment virologic failure was defined as either:
Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period, having achieved HCV RNA < LLOQ at last on-treatment visit." | Baseline up to Posttreatment Week 24 |
| Sydney |
| New South Wales |
| Australia |
| Melbourne | Victoria | Australia |
| Parkville | Victoria | Australia |
| Lyon | France |
| Nice | France |
| Paris | France |
| Berlin | Germany |
| Bonn | Germany |
| Düsseldorf | Germany |
| Frankfurt | Germany |
| Hamburg | Germany |
| Würzburg | Germany |
| Bergamo | Italy |
| Milan | Italy |
| Naples | Italy |
| Rome | Italy |
| Torino | Italy |
| Barcelona | Spain |
| Madrid | Spain |
| Seville | Spain |
| Glasgow | United Kingdom |
| London | United Kingdom |
| Sussex | United Kingdom |
| 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. |
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection |
| FG002 | Genotype 2 Treatment-experienced | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection |
| FG003 | Genotype 3 Treatment-naive | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection |
| FG004 | Genotype 3 Treatment-experienced | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection |
| FG005 | Genotype 4 Treatment-naive | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Genotype 2 Treatment-naive | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection |
| BG001 | Genotype 1 Treatment-naive | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection |
| BG002 | Genotype 2 Treatment-experienced | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection |
| BG003 | Genotype 3 Treatment-naive | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection |
| BG004 | Genotype 3 Treatment-experienced | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection |
| BG005 | Genotype 4 Treatment-naive | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection |
| BG006 | 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 | Number | participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Cirrhosis Status | Number | participants |
| ||||||||||||||||
| IL28b Status | CC, CT, and TT alleles are different forms of the IL28b gene. | Number | participants |
| |||||||||||||||
| Hepatitis C Virus (HCV) RNA | 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) 12 weeks following the last dose of study drug. | Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. 1 participant with genotype 1 HCV infection did not have subtype information available. | 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 permanently discontinuing any study drug due to an adverse event was summarized. | Safety Analysis Set: participants who were randomized 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 < the lower limit of quantitation (LLOQ) 4 weeks and 24 weeks following the last dose of study drug, respectively. | Full Analysis Set. 1 participant with genotype 1 HCV infection did not have subtype information available. | Posted | Number | percentage of participants | Posttreatment Weeks 4 and 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | HCV RNA Change From Baseline at Week 1 | Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; Week 1 |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | HCV RNA Change From Baseline at Week 2 | Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; Week 2 |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | HCV RNA Change From Baseline at Week 4 | Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; Week 4 |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | HCV RNA Change From Baseline at Week 6 | Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; Week 6 |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | HCV RNA Change From Baseline at Week 8 | Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing Virologic Failure | On-treatment virologic failure was defined as either:
Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period, having achieved HCV RNA < LLOQ at last on-treatment visit." | Full Analysis Set. 1 participant with genotype 1 HCV infection did not have subtype information available. | Posted | Number | percentage of participants | Baseline up to Posttreatment Week 24 |
|
Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
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 | Genotype 2 Treatment-naive | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection | 0 | 19 | 17 | 19 | ||
| EG001 | Genotype 2/3 Treatment-experienced | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 or 3 HCV coinfection | 5 | 55 | 45 | 55 | ||
| EG002 | Genotype 1/3/4 Treatment-naive | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1, 3, or 4 HCV coinfection | 10 | 200 | 166 | 200 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Drug abuse | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Tongue ulceration | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Urethritis gonococcal | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hyperphagia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Mood swings | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Stress | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Claustrophobia | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hair texture abnormal | Skin and subcutaneous tissue disorders | MedDRA (17.0) | 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, Inc. | ClinicalTrialDisclosures@gilead.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |
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 |
|
| White |
|
| Asian |
|
| American Indian/Alaska Native/First Nations |
|
| Other |
|
| Not Permitted |
|
| Not Hispanic or Latino |
|
| Not Permitted |
|
| Yes |
|
| CT |
|
| TT |
|
| Missing |
|
| ≥ 6 log10 IU/mL |
|
| Units | Counts |
|---|
| Participants |
|
|
| OG003 | Genotype 1b Treatment-naive | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group) |
| OG004 | Genotype 2 Treatment-experienced | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection |
| OG005 | Genotype 3 Treatment-naive | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection |
| OG006 | Genotype 3 Treatment-experienced | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection |
| OG007 | Genotype 4 Treatment-naive | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection |
|
|
| OG004 | Genotype 2 Treatment-experienced | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection |
| OG005 | Genotype 3 Treatment-naive | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection |
| OG006 | Genotype 3 Treatment-experienced | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection |
| OG007 | Genotype 4 Treatment-naive | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection |
|
|
| OG004 | Genotype 2 Treatment-experienced | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection |
| OG005 | Genotype 3 Treatment-naive | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection |
| OG006 | Genotype 3 Treatment-experienced | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection |
| OG007 | Genotype 4 Treatment-naive | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection |
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| OG004 | Genotype 2 Treatment-experienced | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection |
| OG005 | Genotype 3 Treatment-naive | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection |
| OG006 | Genotype 3 Treatment-experienced | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection |
| OG007 | Genotype 4 Treatment-naive | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection |
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| OG004 | Genotype 2 Treatment-experienced | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection |
| OG005 | Genotype 3 Treatment-naive | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection |
| OG006 | Genotype 3 Treatment-experienced | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection |
| OG007 | Genotype 4 Treatment-naive | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection |
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| OG004 | Genotype 2 Treatment-experienced | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection |
| OG005 | Genotype 3 Treatment-naive | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection |
| OG006 | Genotype 3 Treatment-experienced | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection |
| OG007 | Genotype 4 Treatment-naive | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection |
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SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
| OG003 | Genotype 1b Treatment-naive | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group) |
| OG004 | Genotype 2 Treatment-experienced | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection |
| OG005 | Genotype 3 Treatment-naive | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection |
| OG006 | Genotype 3 Treatment-experienced | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection |
| OG007 | Genotype 4 Treatment-naive | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection |
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