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
Not provided
Not provided
This study will collect and evaluate information on the safety and efficacy of Sovaldi-based regimens in routine clinical practice in Mexico. The primary objective of this study is to assess the rates of serious adverse events/reactions (SAEs/SADRs) and adverse events/reactions (AEs/ADRs) in adult participants with chronic hepatitis C virus (HCV) infection treated with Sovaldi in routine clinical practice.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sovaldi-based regimens | Adult patients with chronic HCV infection living in Mexico who take Sovaldi as part of routine clinical care at a participating clinical site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sovaldi | Drug | Sovaldi 400 mg tablets administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants experiencing adverse drug reactions (ADRs), serious adverse events (SAEs), and adverse events (AEs) during the treatment period and posttreatment follow-up period | Up to Posttreatment Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of concurrent use of Sovaldi with amiodarone and another direct acting antiviral (DAA) or with potent intestinal P-gp inducers in routine clinical practice | Up to 24 weeks | |
| Proportion of patients with sustained virologic response (SVR) at 12 weeks post treatment (SVR12), defined as HCV RNA < lower limit of quantification between 10 and 24 weeks post-treatment |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Adult patients with chronic HCV infection living in Mexico who take SOF as part of routine clinical care at a participating clinical site.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cuernavaca | Mexico | |||||
Not provided
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to Posttreatment Week 24 |
| Durango |
| Mexico |
| Guadalajara | 44680 | Mexico |
| Guadalajara | Mexico |
| Mexico City | Mexico |
| Monterrey | 64460 | Mexico |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |