## Protocol Section
### Identification Module
**NCT ID:** NCT02081079

**Brief Title:** Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection

**Official Title:** A Phase 2, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection

#### Organization Study ID Info
**ID:** GS-US-337-1119
#### Organization
**Class:** INDUSTRY
**Full Name:** Gilead Sciences
#### Secondary ID Infos
**ID:** 2013-003978-27
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2015-02

**Type:** ACTUAL

#### Disp First Post Date
**Date:** 2015-10-27

**Type:** ESTIMATED

**Disp First Submit Date:** 2015-10-21
**Disp First Submit QC Date:** 2015-10-21

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-11-19

**Type:** ACTUAL

**Last Update Submit Date:** 2018-10-19

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-11

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2016-01-14

**Type:** ESTIMATED

**Results First Submit Date:** 2015-12-10

**Results First Submit QC Date:** 2015-12-10

#### Start Date
**Date:** 2014-03

**Status Verified Date:** 2016-04

#### Study First Post Date
**Date:** 2014-03-07
**Type:** ESTIMATED
**Study First Submit Date:** 2014-03-05
**Study First Submit QC Date:** 2014-03-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Gilead Sciences

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained virologic response (SVR12), defined as HCV RNA \< lower limit of quantification (LLOQ) 12 weeks after discontinuation of therapy.

### Conditions Module

**Conditions:**

- Chronic Genotype 4 HCV

- Chronic Genotype 5 HCV

**Keywords:**

- HCV GT 4

- HCV GT 5

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 85

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** LDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 4 hepatitis C virus (HCV) infection

**Intervention Names:**

- Drug: LDV/SOF

**Label:** Genotype 4

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** LDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 5 hepatitis C virus (HCV) infection

**Intervention Names:**

- Drug: LDV/SOF

**Label:** Genotype 5

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Genotype 4

- Genotype 5

**Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily

**Name:** LDV/SOF

**Other Names:**

- Harvoni®

- GS-5885/GS-7977

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

**Measure:** Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

**Time Frame:** Posttreatment Week 12

**Measure:** Percentage of Participants Who Permanently Discontinued LDV/SOF Due to an Adverse Event

**Time Frame:** Up to 12 weeks

#### Secondary Outcomes

**Description:** SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

**Measure:** Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

**Time Frame:** Posttreatment Weeks 4 and 24

**Description:** Virologic failure was defined as either:

* On-treatment virologic failure:

  * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or
  * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
  * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment); or
* Relapse:

  * HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while receiving treatment

**Measure:** Percentage of Patients With Virologic Failure

**Time Frame:** Up to posttreatment Week 24

**Measure:** Change From Baseline in HCV RNA at Weeks 2, 4, 8, and 12

**Time Frame:** Baseline; Weeks 2, 4, 8, and 12

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* HCV RNA ≥ 10\^4 IU/mL at screening
* Chronic genotype 4 or 5 HCV Infection
* Individuals may be treatment naive or treatment experienced
* Presence or absence of cirrhosis, a liver biopsy may be required
* Healthy according to medical history and physical examination with the exception of HCV diagnosis
* Agree to use two forms of highly effective contraception for the duration of the study

Exclusion Criteria:

* History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the individual's participation for the full duration of the study or not be in the best interest of the individual in the opinion of the investigator
* Prior exposure to approved or experimental HCV specific direct acting antiviral(s) (DAA) other than NS3/4A protease inhibitors
* History of any other clinically significant chronic liver disease
* Evidence of or history of decompensated liver disease
* HIV or chronic hepatitis B (HBV) infection
* Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
* Chronic use of immunosuppressive agents or immunomodulatory agents

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Clermont Ferrand

**Country:** France

**Zip:** 63003

**Location 2:**

**City:** Clichy

**Country:** France

**Zip:** 92110

**Location 3:**

**City:** Limoges

**Country:** France

**Zip:** 87042

**Location 4:**

**City:** Toulouse

**Country:** France

**Zip:** 31059

**Location 5:**

**City:** Villejuif

**Country:** France

**Zip:** 94800

#### Overall Officials

**Official 1:**

**Affiliation:** Gilead Sciences

**Name:** Kathryn Kersey, MSc

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Access Criteria:** A secured external environment with username, password, and RSA code.

**Description:** Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

**Info Types:**

- STUDY_PROTOCOL

- SAP

**IPD Sharing:** YES

**Time Frame:** 18 months after study completion

**URL:** http://www.gilead.com/research/disclosure-and-transparency

### References Module

#### References

**Citation:** Abergel A, Metivier S, Samuel D, Jiang D, Kersey K, Pang PS, Svarovskaia E, Knox SJ, Loustaud-Ratti V, Asselah T. Ledipasvir plus sofosbuvir for 12 weeks in patients with hepatitis C genotype 4 infection. Hepatology. 2016 Oct;64(4):1049-56. doi: 10.1002/hep.28706. Epub 2016 Jul 29.

**PMID:** 27351341

**Citation:** Abergel A, Asselah T, Metivier S, Kersey K, Jiang D, Mo H, Pang PS, Samuel D, Loustaud-Ratti V. Ledipasvir-sofosbuvir in patients with hepatitis C virus genotype 5 infection: an open-label, multicentre, single-arm, phase 2 study. Lancet Infect Dis. 2016 Apr;16(4):459-64. doi: 10.1016/S1473-3099(15)00529-0. Epub 2016 Jan 21.

**PMID:** 26803446

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9611

- Name: Hepatitis C

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: HIGH

- As Found: Chronic

### Intervention Browse Module - Ancestors

- ID: D000000998

- Term: Antiviral Agents

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M443

- Name: Sofosbuvir

- Relevance: HIGH

- As Found: Pertuzumab

- ID: M349895

- Name: Ledipasvir

- Relevance: HIGH

- As Found: Lung Transplantation

- ID: M184719

- Name: Ledipasvir, sofosbuvir drug combination

- Relevance: HIGH

- As Found: Polycystic Ovary Syndrome

- ID: M4314

- Name: Antiviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069474

- Term: Sofosbuvir

- ID: C000595958

- Term: Ledipasvir, sofosbuvir drug combination

- ID: C000586541

- Term: Ledipasvir

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Safety Analysis Set: participants were randomized and received at least 1 dose of study drug

#### Event Groups

**Group ID:** EG000

**Title:** Genotype 4

**Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 4 HCV infection

**ID:** EG000

**Other Num Affected:** 31

**Other Num at Risk:** 44

**Serious Number At Risk:** 44

**Title:** Genotype 4

**Group ID:** EG001

**Title:** Genotype 5

**Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 5 HCV infection

**ID:** EG001

**Other Num Affected:** 31

**Other Num at Risk:** 41

**Serious Number Affected:** 1

**Serious Number At Risk:** 41

**Title:** Genotype 5

**Frequency Threshold:** 5

#### Other Events

**Term:** Vertigo

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Abdominal pain upper

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Asthenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.1)

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.1)

**Term:** Wound

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (17.1)

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Musculoskeletal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Myalgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (17.1)

#### Serious Events

**Term:** Depression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 44

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 41

**Time Frame:** Up to 12 weeks plus 30 days

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 22

**Group ID:** BG001

**Value:** 22

**Group ID:** BG002

**Value:** 21

**Group ID:** BG003

**Value:** 20

**Group ID:** BG004

**Value:** 85

**Units:** Participants

### Group

**ID:** BG000

**Title:** Genotype 4: Treatment-naive

**Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection

### Group

**ID:** BG001

**Title:** Genotype 4: Treatment-experienced

**Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection

### Group

**ID:** BG002

**Title:** Genotype 5: Treatment-naive

**Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection

### Group

**ID:** BG003

**Title:** Genotype 5: Treatment-experienced

**Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection

### Group

**ID:** BG004

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.2

**Value:** 52

#### Measurement

**Group ID:** BG001

**Spread:** 8.8

**Value:** 50

#### Measurement

**Group ID:** BG002

**Spread:** 10.4

**Value:** 61

#### Measurement

**Group ID:** BG003

**Spread:** 8.6

**Value:** 64

#### Measurement

**Group ID:** BG004

**Spread:** 10.8

**Value:** 57

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 11

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 10

#### Measurement

**Group ID:** BG003

**Value:** 10

#### Measurement

**Group ID:** BG004

**Value:** 36

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 11

#### Measurement

**Group ID:** BG001

**Value:** 17

#### Measurement

**Group ID:** BG002

**Value:** 11

#### Measurement

**Group ID:** BG003

**Value:** 10

#### Measurement

**Group ID:** BG004

**Value:** 49

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 8

**Class Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 19

#### Measurement

**Group ID:** BG001

**Value:** 17

#### Measurement

**Group ID:** BG002

**Value:** 21

#### Measurement

**Group ID:** BG003

**Value:** 20

#### Measurement

**Group ID:** BG004

**Value:** 77

**Class Title:** White

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 22

#### Measurement

**Group ID:** BG001

**Value:** 22

#### Measurement

**Group ID:** BG002

**Value:** 21

#### Measurement

**Group ID:** BG003

**Value:** 20

#### Measurement

**Group ID:** BG004

**Value:** 85

**Class Title:** France

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 0.40

**Value:** 6.0

#### Measurement

**Group ID:** BG001

**Spread:** 0.48

**Value:** 6.3

#### Measurement

**Group ID:** BG002

**Spread:** 0.48

**Value:** 6.2

#### Measurement

**Group ID:** BG003

**Spread:** 0.39

**Value:** 6.6

#### Measurement

**Group ID:** BG004

**Spread:** 0.48

**Value:** 6.3

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 22

#### Measurement

**Group ID:** BG001

**Value:** 22

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 44

**Class Title:** Genotype 4

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 21

#### Measurement

**Group ID:** BG003

**Value:** 20

#### Measurement

**Group ID:** BG004

**Value:** 41

**Class Title:** Genotype 5

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 21

#### Measurement

**Group ID:** BG001

**Value:** 13

#### Measurement

**Group ID:** BG002

**Value:** 18

#### Measurement

**Group ID:** BG003

**Value:** 14

#### Measurement

**Group ID:** BG004

**Value:** 66

**Class Title:** Absence

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 9

#### Measurement

**Group ID:** BG002

**Value:** 3

#### Measurement

**Group ID:** BG003

**Value:** 6

#### Measurement

**Group ID:** BG004

**Value:** 19

**Class Title:** Presence

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 13

#### Measurement

**Group ID:** BG003

**Value:** 6

#### Measurement

**Group ID:** BG004

**Value:** 27

**Class Title:** CC

#### Measurement

**Group ID:** BG000

**Value:** 11

#### Measurement

**Group ID:** BG001

**Value:** 16

#### Measurement

**Group ID:** BG002

**Value:** 7

#### Measurement

**Group ID:** BG003

**Value:** 11

#### Measurement

**Group ID:** BG004

**Value:** 45

**Class Title:** CT

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 3

#### Measurement

**Group ID:** BG004

**Value:** 13

**Class Title:** TT

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 5
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** HCV RNA
**Unit of Measure:** log10 copies/mL
### Measure 6
**Parameter Type:** NUMBER
**Title:** HCV Genotype
**Unit of Measure:** participants
### Measure 7
**Parameter Type:** NUMBER
**Title:** Cirrhosis Status
**Unit of Measure:** participants
### Measure 8
**Description:** The CC, CT, and TT alleles are different forms of the IL28b gene.
**Parameter Type:** NUMBER
**Title:** IL28b Status
**Unit of Measure:** participants
**Population Description:** Safety Analysis Set: participants were enrolled and received at least 1 dose of study drug
## Results Section - More Information Module
### Certain Agreement
**Other Details:** After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
* The study has been completed at all study sites for at least 2 years
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Limitations and Caveats
**Description:** There were no limitations affecting the analysis or results.
### Point of Contact
**Email:** ClinicalTrialDisclosures@gilead.com
**Organization:** Gilead Sciences
**Title:** Clinical Trial Disclosures
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 95.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 90.9
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 95.2
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 95.0
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 95.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 90.9
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 95.2
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 95.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 95.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 90.9
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 95.2
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 95.0
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9.1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4.8
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5.0
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.397
- **Upper Limit:** 
- **Value:** -4.65
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.495
- **Upper Limit:** 
- **Value:** -4.77
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.479
- **Upper Limit:** 
- **Value:** -4.97
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.477
- **Upper Limit:** 
- **Value:** -4.94
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.396
- **Upper Limit:** 
- **Value:** -4.86
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.490
- **Upper Limit:** 
- **Value:** -5.17
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.474
- **Upper Limit:** 
- **Value:** -5.07
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.381
- **Upper Limit:** 
- **Value:** -5.39
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.401
- **Upper Limit:** 
- **Value:** -4.88
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.484
- **Upper Limit:** 
- **Value:** -5.18
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.474
- **Upper Limit:** 
- **Value:** -5.07
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.387
- **Upper Limit:** 
- **Value:** -5.45
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.401
- **Upper Limit:** 
- **Value:** -4.88
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.484
- **Upper Limit:** 
- **Value:** -5.18
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.474
- **Upper Limit:** 
- **Value:** -5.07
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.387
- **Upper Limit:** 
- **Value:** -5.45
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
**Parameter Type:** NUMBER
**Population Description:** Full Analysis Set: participants with genotype 4 or 5 HCV infection who were enrolled and received at least on dose of study drug.
**Reporting Status:** POSTED
**Time Frame:** Posttreatment Week 12
**Title:** Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection
**ID:** OG000
**Title:** Genotype 4: Treatment-naive
##### Group
**Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection
**ID:** OG001
**Title:** Genotype 4: Treatment-experienced
##### Group
**Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection
**ID:** OG002
**Title:** Genotype 5: Treatment-naive
##### Group
**Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection
**ID:** OG003
**Title:** Genotype 5: Treatment-experienced
#### Outcome Measure 2
**Parameter Type:** NUMBER
**Population Description:** Safety Analysis Set: participants were enrolled and received at least 1 dose of study drug
**Reporting Status:** POSTED
**Time Frame:** Up to 12 weeks
**Title:** Percentage of Participants Who Permanently Discontinued LDV/SOF Due to an Adverse Event
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 4 HCV infection
**ID:** OG000
**Title:** Genotype 4
##### Group
**Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 5 HCV infection
**ID:** OG001
**Title:** Genotype 5
#### Outcome Measure 3
**Description:** SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
**Parameter Type:** NUMBER
**Population Description:** Full Analysis Set
**Reporting Status:** POSTED
**Time Frame:** Posttreatment Weeks 4 and 24
**Title:** Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection
**ID:** OG000
**Title:** Genotype 4: Treatment-naive
##### Group
**Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection
**ID:** OG001
**Title:** Genotype 4: Treatment-experienced
##### Group
**Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection
**ID:** OG002
**Title:** Genotype 5: Treatment-naive
##### Group
**Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection
**ID:** OG003
**Title:** Genotype 5: Treatment-experienced
#### Outcome Measure 4
**Description:** Virologic failure was defined as either:

* On-treatment virologic failure:

  * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or
  * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
  * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment); or
* Relapse:

  * HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while receiving treatment
**Parameter Type:** NUMBER
**Population Description:** Full Analysis Set
**Reporting Status:** POSTED
**Time Frame:** Up to posttreatment Week 24
**Title:** Percentage of Patients With Virologic Failure
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection
**ID:** OG000
**Title:** Genotype 4: Treatment-naive
##### Group
**Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection
**ID:** OG001
**Title:** Genotype 4: Treatment-experienced
##### Group
**Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection
**ID:** OG002
**Title:** Genotype 5: Treatment-naive
##### Group
**Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection
**ID:** OG003
**Title:** Genotype 5: Treatment-experienced
#### Outcome Measure 5
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Full Analysis Set
**Reporting Status:** POSTED
**Time Frame:** Baseline; Weeks 2, 4, 8, and 12
**Title:** Change From Baseline in HCV RNA at Weeks 2, 4, 8, and 12
**Type:** SECONDARY
**Unit of Measure:** log10 IU/mL
##### Group
**Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection
**ID:** OG000
**Title:** Genotype 4: Treatment-naive
##### Group
**Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection
**ID:** OG001
**Title:** Genotype 4: Treatment-experienced
##### Group
**Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection
**ID:** OG002
**Title:** Genotype 5: Treatment-naive
##### Group
**Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection
**ID:** OG003
**Title:** Genotype 5: Treatment-experienced
### Participant Flow Module
#### Group
**Description:** Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally once daily for up to 12 weeks in participants with genotype 4 hepatitis C virus (HCV) infection
**ID:** FG000
**Title:** Genotype 4
#### Group
**Description:** LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 5 HCV infection
**ID:** FG001
**Title:** Genotype 5
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Lack of Efficacy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 44
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 41
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 40
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 39
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 4
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 2
**Pre-Assignment Details:** 91 participants were screened.
**Recruitment Details:** Participants were enrolled at study sites in France. The first participant was screened on 07 March 2014. The last study visit occurred on 17 February 2015.
**Has Results:** True