Sovaldi-based Regimens in Patients in Mexico With Chronic Hepatitis C Virus Infection in Clinical Practice

NCT02783976 | Completed FDA Drug

• 1 other identifier: GS-US-334-1685
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

HCV Infection

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

  Up to Posttreatment Week 24

Study Arms (1)

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.

Drug: Sovaldi

Interventions

Sovaldi DRUG

Sovaldi 400 mg tablets administered orally once daily

Also known as: Sofosbuvir, GS-7977

Sovaldi-based regimens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with chronic HCV infection living in Mexico who take SOF as part of routine clinical care at a participating clinical site.

You may qualify if:

• HCV-infected patients living in Mexico
• Treatment with a Sovaldi-based regimen, per the approved prescribing information, as determined by the patient's treating physician

You may not qualify if:

• Concurrent participation in an HCV clinical trial (except trials not testing investigational medicinal products)
• Patients presenting a risk of not being able to be followed (eg, patients planning to move or leave the country prior to their SVR12 visit)

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (6)

Unknown Facility

Cuernavaca, Mexico

Location

Unknown Facility

Durango, Mexico

Location

Unknown Facility

Guadalajara, 44680, Mexico

Location

Unknown Facility

Guadalajara, Mexico

Location

Unknown Facility

Mexico City, Mexico

Location

Unknown Facility

Monterrey, 64460, Mexico

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Sofosbuvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: May 26, 2016
• Study Start: October 28, 2016
• Primary Completion: June 20, 2018
• Study Completion: June 20, 2018
• Last Updated: October 2, 2018

Record last verified: 2018-09

Locations

ME (6)