Switching Regimen in Treating Cirrhotic HCV GT1b Subjects (SWITCH-1)

Humanity and Health Research Centre

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C Infection

Treatments: Drug: PR4 + LDV/SOF + SMV 12 wk; Drug: PR4 + LDV/SOF + SMV 8 wk; Drug: PR4 + LDV/SOF + SMV 6 wk; Drug: PR4 + LDV/SOF + ASV 12 wk; Drug: PR4 + LDV/SOF + ASV 4 wk; Drug: PR4 + LDV/SOF + ASV 6 wk; Drug: PR4 + LDV/SOF + SMV 4 wk; Drug: PR4 + LDV/SOF + ASV 8 wk

Study type: Interventional

Funder types: Other

Identifiers

NCT02583685

H&H_SWITCH-1

Details and patient eligibility

About

This is a prospective, randomized study to evaluate the efficacy and safety of switching treatment from Peg-interferon and Ribavirin to direct-acting antiviral agents in Chinese with CHC genotype 1b infection, who are interferon/ribavirin-intolerant.

Enrollment: 138 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals with chronic HCV GT1b infection;
• HCV RNA ≥ 10000 IU/mL at screening;
• Received 4 weeks pegylated interferon plus ribavirin (PR4) therapy and are intolerant to PR4;
• Cirrhosis determination; a liver biopsy may be required;
• Use of highly effective contraception methods if female of childbearing potential or sexually active male;

Exclusion criteria

• Pregnant or nursing female or male with pregnant female partner;
• HIV or HBV co-infection;
• Hematologic or biochemical parameters at Screening outside the protocol- specified requirements;
• Active or recent history (≤ 1 year) of drug or alcohol abuse;
• 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: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 8 patient groups

PR4 + LDV/SOF + ASV 4 wk

Experimental group

Description:

Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA \<25 IU/ml by week 2 will receive LDV/SOF + ASV for 4 weeks.

Treatment:

Drug: PR4 + LDV/SOF + ASV 4 wk

PR4 + LDV/SOF + SMV 4 wk

Experimental group

Description:

Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA \<25 IU/ml by week 2 will receive LDV/SOF + SMV for 4 weeks.

Treatment:

Drug: PR4 + LDV/SOF + SMV 4 wk

PR4 + LDV/SOF + ASV 6 wk

Experimental group

Description:

Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA \<25 IU/ml by week 4 will receive LDV/SOF + ASV for 6 weeks.

Treatment:

Drug: PR4 + LDV/SOF + ASV 6 wk

PR4 + LDV/SOF + SMV 6 wk

Experimental group

Description:

Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA \<25 IU/ml by week 4 will receive LDV/SOF + SMV for 6 weeks.

Treatment:

Drug: PR4 + LDV/SOF + SMV 6 wk

PR4 + LDV/SOF + ASV 8 wk

Experimental group

Description:

Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA \> 2 log drop but ≥25 IU/ml by week 4 will receive LDV/SOF + ASV for 8 weeks.

Treatment:

Drug: PR4 + LDV/SOF + ASV 8 wk

PR4 + LDV/SOF + SMV 8 wk

Experimental group

Description:

Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA \> 2 log drop but ≥25 IU/ml by week 4 will receive LDV/SOF + SMV for 8 weeks.

Treatment:

Drug: PR4 + LDV/SOF + SMV 8 wk

PR4 + LDV/SOF + ASV 12 wk

Experimental group

Description:

Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA \<2 log drop by week 4 will receive LDV/SOF + ASV for 12 weeks.

Treatment:

Drug: PR4 + LDV/SOF + ASV 12 wk

PR4 + LDV/SOF + SMV 12 wk

Experimental group

Description:

Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA \<2 log drop by week 4 will receive LDV/SOF + SMV for 12 weeks.

Treatment:

Drug: PR4 + LDV/SOF + SMV 12 wk