Triple Combination DAAs for Treating HCV GT1b Subjects

Humanity and Health Research Centre

Status and phase: Withdrawn; Phase 2

Conditions: Chronic Hepatitis C Infection

Treatments: Drug: SOF+DCV+SMV

Study type: Interventional

Funder types: Other

Identifiers

NCT02932293

H&H_SODAPI II

Details and patient eligibility

About

There is only one kind of treatment (simeprevir 150 mg + sofosbuvir 400 mg+daclatasvir 60 mg) in this study but the treatment duration may be different depending on patients' response to the antiviral therapy and whether patients have liver cirrhosis. If patients have no cirrhosis and the HCV viral load on day 2 is <500 IU/ml, patients will receive sofosbuvir, daclatasvir and simeprevir for 3 weeks, otherwise the treatment duration is 4 weeks. If patients have cirrhosis and the HCV viral load on day 2 is <500 IU/ml, patients will receive sofosbuvir, daclatasvir and simeprevir for 6 weeks, otherwise the treatment duration will be 8 weeks.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. HCV RNA positive >2000 IU/ml or NAT POC positive
2. Genotype 1b
3. CP score ≤6

Exclusion criteria

1. Pregnant or nursing female or male with pregnant female partner
2. Hematologic or biochemical parameters at Screening outside the protocol- specified requirements
3. Active or recent history (≤ 1 year) of drug or alcohol abuse
4. Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers)
5. 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 subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

SOF+DCV+SMV 3-4 wks

Experimental group

Description:

Patients without cirrhosis will receive sofosbuvir, daclatasvir and simeprevir for (a) 3 weeks if HCV viral load on day 2 is \<500 IU/ml or (b) 4 weeks if HCV viral load on day 2 is \>500 IU/ml.

Treatment:

Drug: SOF+DCV+SMV

SOF+DCV+SMV 6-8 wks

Experimental group

Description:

Patients with cirrhosis and CP-A will receive sofosbuvir, daclatasvir and simeprevir (a) 6 weeks if HCV VL on day 2 is \<500 IU/ml or (b) 8 weeks if HCV VL on day 2 is \>500 IU/ml.

Treatment:

Drug: SOF+DCV+SMV