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Short Duration Therapy of Acute Hepatitis C Genotypes 1 or 4 (SAHIV)

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ClinicalTrials.gov Identifier: NCT02886624
Recruitment Status : Completed
First Posted : September 1, 2016
Results First Posted : January 29, 2020
Last Update Posted : January 29, 2020
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Hepatitis C
HIV
Intervention Drug: Grazoprevir/Elbasvir
Enrollment 30
Recruitment Details Recruitment occurred between May 31, 2017 and August 20, 2019. Recruitment took place at 6 university hospitals in France (Paris, Lyon, and Nice). 33 individuals were assessed for eligibility and 3 did not meet inclusion criteria.
Pre-assignment Details  
Arm/Group Title Grazoprevir/Elbasvir
Hide Arm/Group Description

Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks

Grazoprevir/Elbasvir: Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks

Period Title: 8-week Treatment
Started 30
Completed 30
Not Completed 0
Period Title: 12-week Post Treatment Follow-up
Started 30
Completed 29
Not Completed 1
Reason Not Completed
Death             1
Period Title: 48-week Post Treatment Follow-up
Started 29
Completed 28
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Grazoprevir/Elbasvir
Hide Arm/Group Description

Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks

Grazoprevir/Elbasvir: Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks

Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 30 participants
44
(34 to 52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
0
   0.0%
Male
30
 100.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
France Number Analyzed 30 participants
30
Co-infection with HIV  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
28
  93.3%
1.Primary Outcome
Title Sustained Virological Response 12 Weeks Post-treatment (SVR12)
Hide Description Undetectable plasma HCV RNA (<12 IU/mL) 12 weeks post-treatment.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis
Arm/Group Title Grazoprevir/Elbasvir
Hide Arm/Group Description:

Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks

Grazoprevir/Elbasvir: Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks

Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
28
  93.3%
2.Secondary Outcome
Title Virological Failure
Hide Description Number of patients harboring HCV (NS5A and NS3/4) resistance mutations 12 weeks post treatment
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis
Arm/Group Title Grazoprevir/Elbasvir
Hide Arm/Group Description:

Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks

Grazoprevir/Elbasvir: Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks

Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.3%
3.Secondary Outcome
Title Treatment Adherence
Hide Description Number of patients missing study drug within the last four days during treatment
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Grazoprevir/Elbasvir
Hide Arm/Group Description:

Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks

Grazoprevir/Elbasvir: Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks

Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
2
   6.7%
4.Secondary Outcome
Title Number of Participants With Undetectable HIV RNA
Hide Description Number of participants with undetectable HIV RNA at 12 weeks post treatment (in HIV-positive co-infected patients)
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 28 HIV-positive individuals, 27 had available data. All 27 participants analyzed had undetectable HIV RNA.
Arm/Group Title Grazoprevir/Elbasvir
Hide Arm/Group Description:

Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks

Grazoprevir/Elbasvir: Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks

Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
27
 100.0%
5.Secondary Outcome
Title CD4 Cell Count
Hide Description CD4+ T cell count at 12 weeks post treatment (in HIV-positive co-infected patients)
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 28 HIV-positive individuals, 27 had available data.
Arm/Group Title Grazoprevir/Elbasvir
Hide Arm/Group Description:

Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks

Grazoprevir/Elbasvir: Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks

Overall Number of Participants Analyzed 27
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
655
(488 to 829)
6.Secondary Outcome
Title Incidence of HCV Re-infection
Hide Description Number of patients with positive HCV RNA 48-weeks post treatment.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Grazoprevir/Elbasvir
Hide Arm/Group Description:

Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks

Grazoprevir/Elbasvir: Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks

Overall Number of Participants Analyzed 28
Measure Type: Count of Participants
Unit of Measure: Participants
With phylogentically different strain
2
   7.1%
With phylogentically similar strain
1
   3.6%
Time Frame Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks
Adverse Event Reporting Description Patient reported (relayed by the treating physician) and laboratory adverse events (grading based in ANRS definitions) were provided. Deaths due to any cause were also provided.
 
Arm/Group Title Grazoprevir/Elbasvir
Hide Arm/Group Description

Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks

Grazoprevir/Elbasvir: Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks

All-Cause Mortality
Grazoprevir/Elbasvir
Affected / at Risk (%)
Total   1/30 (3.33%)    
Hide Serious Adverse Events
Grazoprevir/Elbasvir
Affected / at Risk (%) # Events
Total   2/30 (6.67%)    
Psychiatric disorders   
Suicide *  1/30 (3.33%)  1
Panic attack *  1/30 (3.33%)  1
Suicidal ideation *  1/30 (3.33%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Grazoprevir/Elbasvir
Affected / at Risk (%) # Events
Total   23/30 (76.67%)    
Cardiac disorders   
Secondary tremor from pulmonary heart disease *  1/30 (3.33%)  1
Gastrointestinal disorders   
Abdominal distension *  1/30 (3.33%)  1
Diarrhea *  6/30 (20.00%)  7
General disorders   
Insomnia *  2/30 (6.67%)  2
Fatigue *  5/30 (16.67%)  6
Infections and infestations   
Syphilis *  3/30 (10.00%)  3
Primary HIV infection *  1/30 (3.33%)  1
Mycoplasma genitalium *  2/30 (6.67%)  2
Injury, poisoning and procedural complications   
Insect bite *  1/30 (3.33%)  1
Voluntary drug intoxication *  1/30 (3.33%)  1
Metabolism and nutrition disorders   
Binge eating *  1/30 (3.33%)  1
Dysgeusia *  1/30 (3.33%)  1
Musculoskeletal and connective tissue disorders   
Dental caries *  1/30 (3.33%)  1
Tooth ache *  1/30 (3.33%)  1
Myalgia *  2/30 (6.67%)  2
Cramp or spasm *  1/30 (3.33%)  1
Pain localised to abdomen *  2/30 (6.67%)  2
Pain in knee joint *  1/30 (3.33%)  1
Nervous system disorders   
Vertigo *  1/30 (3.33%)  1
Psychiatric disorders   
Depressive disorder *  1/30 (3.33%)  1
Anxiety *  3/30 (10.00%)  3
Renal and urinary disorders   
Pollakiuria *  1/30 (3.33%)  1
Reproductive system and breast disorders   
Male erectile dysfunction *  3/30 (10.00%)  3
Respiratory, thoracic and mediastinal disorders   
Acute nasopharyngitis *  1/30 (3.33%)  1
Other disorders of the nasal cavity *  1/30 (3.33%)  1
Bronchitis *  1/30 (3.33%)  1
Cough *  1/30 (3.33%)  1
Skin and subcutaneous tissue disorders   
Xerostomia *  1/30 (3.33%)  1
Vesicular dermatitis of hands and feet *  1/30 (3.33%)  1
Eczematous dermatosis *  1/30 (3.33%)  1
Hyperhidrosis *  1/30 (3.33%)  1
Chronic paronychia *  1/30 (3.33%)  1
Vascular disorders   
Superficial thrombophlebitis *  1/30 (3.33%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof. Karine Lacombe
Organization: Hôpital Saint Antoine
Phone: +33 1 49 28 24 38
EMail: karine.lacombe2@aphp.fr
Publications:
Layout table for additonal information
Responsible Party: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
ClinicalTrials.gov Identifier: NCT02886624    
Other Study ID Numbers: IMEA 50
First Submitted: August 29, 2016
First Posted: September 1, 2016
Results First Submitted: December 6, 2019
Results First Posted: January 29, 2020
Last Update Posted: January 29, 2020