Trial Outcomes & Findings for Short Duration Therapy of Acute Hepatitis C Genotypes 1 or 4 (NCT NCT02886624)

NCT ID: NCT02886624

Last Updated: 2020-01-29

Results Overview

Undetectable plasma HCV RNA (\<12 IU/mL) 12 weeks post-treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2020-01-29

Participant Flow

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.

Participant milestones

Measure	Grazoprevir/Elbasvir 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
8-week Treatment STARTED	30
8-week Treatment COMPLETED	30
8-week Treatment NOT COMPLETED	0
12-week Post Treatment Follow-up STARTED	30
12-week Post Treatment Follow-up COMPLETED	29
12-week Post Treatment Follow-up NOT COMPLETED	1
48-week Post Treatment Follow-up STARTED	29
48-week Post Treatment Follow-up COMPLETED	28
48-week Post Treatment Follow-up NOT COMPLETED	1

Reasons for withdrawal

Measure	Grazoprevir/Elbasvir 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
12-week Post Treatment Follow-up Death	1
48-week Post Treatment Follow-up Lost to Follow-up	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Grazoprevir/Elbasvir n=30 Participants 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
Age, Continuous	44 years n=30 Participants
Sex: Female, Male Female	0 Participants n=30 Participants
Sex: Female, Male Male	30 Participants n=30 Participants
Region of Enrollment France	30 participants n=30 Participants
Co-infection with HIV	28 Participants n=30 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Intent-to-treat analysis

Undetectable plasma HCV RNA (<12 IU/mL) 12 weeks post-treatment.

Outcome measures

Measure	Grazoprevir/Elbasvir n=30 Participants 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
Sustained Virological Response 12 Weeks Post-treatment (SVR12)	28 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Intent-to-treat analysis

Number of patients harboring HCV (NS5A and NS3/4) resistance mutations 12 weeks post treatment

Outcome measures

Measure	Grazoprevir/Elbasvir n=30 Participants 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
Virological Failure	1 Participants

SECONDARY outcome

Timeframe: 8 weeks

Number of patients missing study drug within the last four days during treatment

Outcome measures

Measure	Grazoprevir/Elbasvir n=30 Participants 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
Treatment Adherence	2 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Out of 28 HIV-positive individuals, 27 had available data. All 27 participants analyzed had undetectable HIV RNA.

Number of participants with undetectable HIV RNA at 12 weeks post treatment (in HIV-positive co-infected patients)

Outcome measures

Measure	Grazoprevir/Elbasvir n=27 Participants 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
Number of Participants With Undetectable HIV RNA	27 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Out of 28 HIV-positive individuals, 27 had available data.

CD4+ T cell count at 12 weeks post treatment (in HIV-positive co-infected patients)

Outcome measures

Measure	Grazoprevir/Elbasvir n=27 Participants 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
CD4 Cell Count	655 cells/mm^3 Interval 488.0 to 829.0

SECONDARY outcome

Timeframe: 48 weeks

Number of patients with positive HCV RNA 48-weeks post treatment.

Outcome measures

Measure	Grazoprevir/Elbasvir n=28 Participants 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
Incidence of HCV Re-infection With phylogentically different strain	2 Participants
Incidence of HCV Re-infection With phylogentically similar strain	1 Participants

Adverse Events

Grazoprevir/Elbasvir

Serious events: 2 serious events

Other events: 23 other events

Deaths: 1 deaths

Serious adverse events

Measure	Grazoprevir/Elbasvir n=30 participants at risk 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
Psychiatric disorders Suicide	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Psychiatric disorders Panic attack	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Psychiatric disorders Suicidal ideation	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.

Other adverse events

Measure	Grazoprevir/Elbasvir n=30 participants at risk 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
Infections and infestations Syphilis	10.0% 3/30 • Number of events 3 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Infections and infestations Primary HIV infection	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Psychiatric disorders Depressive disorder	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
General disorders Insomnia	6.7% 2/30 • Number of events 2 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Cardiac disorders Secondary tremor from pulmonary heart disease	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Vascular disorders Superficial thrombophlebitis	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Respiratory, thoracic and mediastinal disorders Acute nasopharyngitis	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Respiratory, thoracic and mediastinal disorders Other disorders of the nasal cavity	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Respiratory, thoracic and mediastinal disorders Bronchitis	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Skin and subcutaneous tissue disorders Xerostomia	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Musculoskeletal and connective tissue disorders Dental caries	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Musculoskeletal and connective tissue disorders Tooth ache	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Skin and subcutaneous tissue disorders Vesicular dermatitis of hands and feet	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Skin and subcutaneous tissue disorders Eczematous dermatosis	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Skin and subcutaneous tissue disorders Hyperhidrosis	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Skin and subcutaneous tissue disorders Chronic paronychia	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Musculoskeletal and connective tissue disorders Myalgia	6.7% 2/30 • Number of events 2 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Reproductive system and breast disorders Male erectile dysfunction	10.0% 3/30 • Number of events 3 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Psychiatric disorders Anxiety	10.0% 3/30 • Number of events 3 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Metabolism and nutrition disorders Binge eating	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Metabolism and nutrition disorders Dysgeusia	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Musculoskeletal and connective tissue disorders Cramp or spasm	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Nervous system disorders Vertigo	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Respiratory, thoracic and mediastinal disorders Cough	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Musculoskeletal and connective tissue disorders Pain localised to abdomen	6.7% 2/30 • Number of events 2 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Gastrointestinal disorders Abdominal distension	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Gastrointestinal disorders Diarrhea	20.0% 6/30 • Number of events 7 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Musculoskeletal and connective tissue disorders Pain in knee joint	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Renal and urinary disorders Pollakiuria	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
General disorders Fatigue	16.7% 5/30 • Number of events 6 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Injury, poisoning and procedural complications Insect bite	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Injury, poisoning and procedural complications Voluntary drug intoxication	3.3% 1/30 • Number of events 1 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.
Infections and infestations Mycoplasma genitalium	6.7% 2/30 • Number of events 2 • Through evaluation of the primary endpoint (i.e. sustained virological response 12 weeks post treatment), an average of 20 weeks 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.

Additional Information

Prof. Karine Lacombe

Hôpital Saint Antoine

Phone: +33 1 49 28 24 38

Email: karine.lacombe2@aphp.fr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place