NCT02487030 is a Phase 3 clinical trial of LDV/SOF in Hepatitis C Virus Infection, sponsored by Gilead Sciences.

Who is sponsoring NCT02487030?

NCT02487030 is sponsored by Gilead Sciences.

What drugs are being tested in NCT02487030?

Interventions in NCT02487030: LDV/SOF, RBV.

What condition does NCT02487030 study?

NCT02487030 studies Hepatitis C Virus Infection.

Is NCT02487030 still recruiting?

NCT02487030 is currently completed. Last updated 16 November 2018.

Are results published for NCT02487030?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-11-16 · How we verify

NCT02487030

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection

Completed Phase 3 Results posted Last updated 16 November 2018

What this trial tests

Phase 3 trial testing LDV/SOF in Hepatitis C Virus Infection in 255 participants. Completed in 4 February 2017.

Timeline

7 September 2015

Primary endpoint
11 November 2016

4 February 2017

Quick facts

Lead sponsor	Gilead Sciences
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	255
Start date	7 September 2015
Primary completion	11 November 2016
Estimated completion	4 February 2017
Sites	4 locations across Egypt

Drugs / interventions tested

LDV/SOF — full drug profile →
RBV — full drug profile →

Conditions studied

Hepatitis C Virus Infection — all drugs for Hepatitis C Virus Infection →

Sponsor

Gilead Sciences — full company profile →

Who can join

18 and older, any sex, with Hepatitis C Virus Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) Primary · Posttreatment Week 12

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.

Group	Value	95% CI
LDV/SOF 8 wk TN (Cohort 1, Group 1)	95.3	84.2 – 99.4
LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2)	90.5	77.4 – 97.3
LDV/SOF 12 wk TN (Cohort 1, Group 3)	97.7	87.7 – 99.9
LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4)	97.6	87.4 – 99.9
LDV/SOF 12 wk TE (Cohort 3, Group 1)	94.4	81.3 – 99.3
LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2)	100.0	90.7 – 100.0
LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2)	100.0	71.5 – 100.0

Percentage of Participants Who Discontinued LDV/SOF Drug Due to an Adverse Event (AE) Primary · 12 weeks

Group	Value	95% CI
LDV/SOF 8 Weeks	0
LDV/SOF + RBV 8 Weeks	0
LDV/SOF 12 Weeks	0
LDV/SOF + RBV 12 Weeks	1.1

Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) Secondary · Posttreatment Weeks 4 and 24

SVR4 and SVR24 were defined as HCV RNA \< LLOQ 4 and 24 weeks after the last dose of study drug, respectively.

SVR4

Group	Value	95% CI
LDV/SOF 8 wk TN (Cohort 1, Group 1)	95.3	84.2 – 99.4
LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2)	95.2	83.8 – 99.4
LDV/SOF 12 wk TN (Cohort 1, Group 3)	97.7	87.7 – 99.9
LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4)	97.6	87.4 – 99.9
LDV/SOF 12 wk TE (Cohort 3, Group 1)	100.0	90.3 – 100.0
LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2)	100.0	90.7 – 100.0
LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2)	100.0	71.5 – 100.0

SVR24

Group	Value	95% CI
LDV/SOF 8 wk TN (Cohort 1, Group 1)	95.3	84.2 – 99.4
LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2)	90.5	77.4 – 97.3
LDV/SOF 12 wk TN (Cohort 1, Group 3)	97.7	87.7 – 99.9
LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4)	97.6	87.4 – 99.9
LDV/SOF 12 wk TE (Cohort 3, Group 1)	94.4	81.3 – 99.3
LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2)	100.0	90.7 – 100.0
LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2)	100.0	71.5 – 100.0

Percentage of Participants With Overall Virologic Failure Secondary · Up to Posttreatment Week 24

Virologic failure was defined as * On-treatment virologic failure * confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ, while on treatment (ie, breakthrough), * confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound), * HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie, nonresponse) * Relapse * HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement

Group	Value	95% CI
LDV/SOF 8 wk TN (Cohort 1, Group 1)	4.7
LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2)	9.5
LDV/SOF 12 wk TN (Cohort 1, Group 3)	2.3
LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4)	0.0
LDV/SOF 12 wk TE (Cohort 3, Group 1)	2.8
LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2)	0.0
LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2)	0.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 12 weeks + 30 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

LDV/SOF 8 Weeks

Serious: 0/43 (0%)

Deaths: —

LDV/SOF + RBV 8 Weeks

Serious: 0/42 (0%)

Deaths: —

LDV/SOF 12 Weeks

Serious: 0/79 (0%)

Deaths: —

LDV/SOF + RBV 12 Weeks

Serious: 3/91 (3%)

Deaths: —

Serious adverse events (3 terms)

Reaction	System	LDV/SOF 8 Weeks	LDV/SOF + RBV 8 Weeks	LDV/SOF 12 Weeks	LDV/SOF + RBV 12 Weeks
Road traffic accident	Injury, poisoning and procedural complications	—	—	—	—
Chest Pain	General disorders	—	—	—	—
Peripheral vascular disorder	Vascular disorders	—	—	—	—

Other adverse events (8 terms — click to expand)

Reaction	System	LDV/SOF 8 Weeks	LDV/SOF + RBV 8 Weeks	LDV/SOF 12 Weeks	LDV/SOF + RBV 12 Weeks
Headache	Nervous system disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—

Most-reported serious reactions: Road traffic accident, Chest Pain, Peripheral vascular disorder.

Data from ClinicalTrials.gov NCT02487030 adverse events section.

Sponsor's own description

The primary objective of this study was to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Ledipasvir/sofosbuvir with or without ribavirin for 8 or 12 weeks for the treatment of HCV genotype 4 infection: results from a randomised phase III study in Egypt.
Shiha G, Esmat G, Hassany M, Soliman R, et al · · 2019 · cited 28× · PMID 29666174 · DOI 10.1136/gutjnl-2017-315906

Verify or expand the search:

Other trials of LDV/SOF

Trials testing the same drug.

NCT03036839 — Ledipasvir/Sofosbuvir in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Are on Dialysis for End Stage Renal D · Phase 2 · completed
NCT02951364 — Harvoni in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea · completed
NCT02868242 — Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infectio · Phase 2 · completed
NCT02738333 — Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection · Phase 3 · completed
NCT02707601 — Efficacy, Safety, and Tolerability of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Participants Who · Phase 3 · completed

Other recruiting trials for Hepatitis C Virus Infection

Currently open trials in the same condition.

NCT06870019 — Hepatitis C Tracker Study · NA · recruiting
NCT06463912 — Screening for Hepatitis c in People Who Inject Drugs in Armenia-Colombia · recruiting
NCT06718530 — Characterization of Immune Genotypes and Antibody Profiles to Foster the discoVERY of diagnosticbioMARKERS of Liver Canc · recruiting
NCT06155006 — Adult Screening for Hepatitis c and Linkage to Treatment in Hospitals in Colombia · recruiting
NCT06431945 — Early Detection of HCV in Injection Drug Users · recruiting

Other Gilead Sciences trials

Trials by the same sponsor.

NCT07115368 — Study of GS-1219 in Participants With HIV-1 · Phase 1 · terminated
NCT06784973 — Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection · Phase 2 · terminated
NCT06683482 — A Qualitative Study on Advanced Breast Cancer Patients and Their Caregivers in Spain · completed
NCT06613685 — Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated · Phase 2, PHASE3 · terminated
NCT06585150 — Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection · Phase 2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02487030 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gilead Sciences
Last refreshed: 16 November 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02487030.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02487030

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (3 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of LDV/SOF

Other recruiting trials for Hepatitis C Virus Infection

Other Gilead Sciences trials

Verify against primary sources