Percentage of Participants With Sustained Virologic Response (SVR) at 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 at 4 and 24 weeks following the last dose of study drug, respectively.
Percentage of Participants With Virologic FailureSecondary· 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
Percentage of HIV/HCV- Coinfected Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4Secondary· Up to Posttreatment Week 4
Week 4
Group
Value
95% CI
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)
100.0
Week 8
Group
Value
95% CI
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)
100.0
Posttreatment Week 4
Group
Value
95% CI
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)
97.2
For HIV/HCV- Coinfected Participants, Change From Baseline in CD4 T-cell Count at the End of Treatment and Posttreatment Week 4Secondary· Up to Posttreatment Week 4
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected, ARV Experienced)
172
± 114.1
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 12 weeks plus 30 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in adults with chronic hepatitis C virus (HCV) infection.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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.
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· NA
· recruiting
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· recruiting
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NCT06155006 — Adult Screening for Hepatitis c and Linkage to Treatment in Hospitals in Colombia
· recruiting
NCT06431945 — Early Detection of HCV in Injection Drug Users
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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
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/NCT02472886.