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

A Prospective, Non-Interventional Cohort Study of Approved Sofosbuvir-based Regimens in Patients in Mexico With Chronic Hepatitis C Virus Infection in Clinical Practice

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02783976

Enrollment

Registered

2016-05-26

Start date

2016-10-28

Completion date

2018-06-20

Last updated

2018-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCV Infection

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.

Interventions

DRUGSovaldi

Sovaldi 400 mg tablets administered orally once daily

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * 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 Key

Exclusion criteria

* 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) Note: Other protocol defined Inclusion/

Design outcomes

Primary

Measure	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

Secondary

Measure	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	Up to Posttreatment Week 24

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026