---
title: Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection
nct_id: NCT01713283
overall_status: COMPLETED
phase: PHASE2
sponsor: Gilead Sciences
study_type: INTERVENTIONAL
primary_condition: Hepatitis C Virus
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01713283.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01713283"
ct_last_update_post_date: 2014-11-25
last_seen_at: "2026-05-12T06:20:12.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection

**Official Title:** A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 HCV Infection

**NCT ID:** [NCT01713283](https://clinicaltrials.gov/study/NCT01713283)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** Gilead Sciences
- **Conditions:** Hepatitis C Virus
- **Start Date:** 2012-10
- **Completion Date:** 2014-02
- **CT.gov Last Update:** 2014-11-25

## Brief Summary

This study is to evaluate the safety, tolerability, and antiviral activity of sofosbuvir (SOF) with ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* First generation Egyptian; must have been born in Egypt and can trace both maternal and paternal Egyptian ancestry
* Treatment-experienced or treatment-naive
* Chronic genotype 4 HCV infection
* Not co-infected with HIV
* Screening laboratory values within defined thresholds
* Use of highly effective contraception methods
* Must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments

Exclusion Criteria:

* History of any other clinically significant chronic liver disease
* Pregnant or nursing female or male with pregnant female partner
* History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol
* Excessive alcohol ingestion or significant drug abuse
```

## Arms

- **SOF+RBV 12 Weeks** (EXPERIMENTAL) — Treatment-naive and treatment-experienced participants will receive SOF+RBV for 12 weeks.
- **SOF+RBV 24 Weeks** (EXPERIMENTAL) — Treatment-naive and treatment-experienced participants will receive SOF+RBV for 24 weeks.

## Interventions

- **SOF** (DRUG) — Sofosbuvir (SOF) 400 mg tablet administered orally once daily
- **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)

## Primary Outcomes

- **Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)** _(time frame: Posttreatment Week 12)_ — SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
- **Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)** _(time frame: Up to 24 weeks)_ — The percentage of participants discontinuing any study drug due to an adverse event was summarized.

## Secondary Outcomes

- **Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)** _(time frame: Posttreatment Weeks 4 and 24)_
- **Percentage of Participants Experiencing On-treatment Virologic Failure** _(time frame: Up to 24 weeks)_
- **Percentage of Participants Experiencing Viral Relapse** _(time frame: Up to Posttreatment Week 24)_

## Locations (1)

- Los Angeles, California, United States

## Recent Field Changes (last 30 days)

- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.|los angeles|california|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01713283.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01713283*  
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