SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection.

Vir Biotechnology

Status and phase: Active, not recruiting; Phase 2

Conditions: Hepatitis D, Chronic

Treatments: Drug: VIR-3434; Drug: NRTI; Drug: VIR-2218

Study type: Interventional

Funder types: Industry

Identifiers

NCT05461170

VIR-CHDV-V201

Details and patient eligibility

About

This is a phase 2 trial in which participants with chronic hepatitis D virus (HDV) infection will receive VIR-2218 and/or VIR-3434 and be assessed for safety, tolerability, and efficacy

Full description

Participants may be enrolled into Cohort 1 (1a and 1b) or Cohort 2 (2a, 2b1 or 2b2, 2c), 3, 4, and 5. All participants still receiving VIR-2218 or VIR-3434 monotherapy at the time of implementation of Protocol Amendment 4 will switch to combination therapy at Week 132 (Cohort 2a, 2b1/2b2) or Week 112 (Cohort 3).

Enrollment: 95 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female ages 18 to < 70 years at screening
• Chronic HDV infection for >/= 6 months
• On NRTI therapy for at least 12 weeks prior to day 1
• ALT>ULN and < 5x ULN
• Non-cirrhotic and CPT-A cirrhotic

Exclusion criteria

• Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation.
• History of significant liver disease from non-HBV or non-HDV etiology
• History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients.
• History of anaphylaxis
• History of immune complex disease
• History of autoimmune disorder
• History or evidence of alcohol or drug abuse
• Prior or concomitant therapy with an immunomodulatory agent, IFN-alpha, cytotoxic or chemotherapeutic agent, or chronic corticosteroids.
• Anti-HBs >10 mIU/mL at screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

95 participants in 9 patient groups, including a placebo group

Cohort 1a (VIR-2218)

Experimental group

Description:

Participants will receive multiple doses of VIR-2218 for up to 96 weeks total.

Treatment:

Drug: VIR-2218

Cohort 1b (VIR-3434)

Experimental group

Description:

Participants will receive multiple doses of VIR-3434 for up to 96 weeks total.

Treatment:

Drug: VIR-3434

Cohort 2a (VIR-2218)

Experimental group

Description:

Participants will receive multiple doses of VIR-2218 for up to 132 weeks, then assign to Cohort 2c.

Treatment:

Drug: VIR-2218

Cohort 2b1 (VIR-3434)

Experimental group

Description:

Participants will receive multiple doses of VIR-3434 for up to 132 weeks, then assign to Cohort 2c.

Treatment:

Drug: VIR-3434

Cohort 2b2 (VIR-3434)

Experimental group

Description:

Participants will receive multiple doses of VIR-3434 for up to 132 weeks, then assign to Cohort 2c.

Treatment:

Drug: VIR-3434

Cohort 2c (VIR-2218 + VIR-3434)

Experimental group

Description:

Participants will receive multiple doses of VIR-2218 + VIR-3434 for up to 192 weeks.

Treatment:

Drug: VIR-2218

Drug: VIR-3434

Cohort 3 (VIR-3434)

Experimental group

Description:

Participants will receive multiple doses of VIR-3434 for up to 112 weeks, then assign to Cohort 2c.

Treatment:

Drug: VIR-3434

Cohort 4 (NRTI)

Placebo Comparator group

Description:

Participants will receive NRTI for 12 weeks, then assign to Cohort 2c or Cohort 3.

Treatment:

Drug: NRTI

Cohort 5 (VIR-2218)

Experimental group

Description:

Participants will receive multiple doses of VIR-2218 for 12 weeks, then assign to Cohort 2c.

Treatment:

Drug: VIR-2218