Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection (QUANTUM)

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Hepatitis C, Chronic

Treatments: Drug: Sofosbuvir; Drug: RBV; Drug: Placebo to match sofosbuvir; Drug: Placebo to match GS-0938; Drug: GS-0938

Study type: Interventional

Funder types: Industry

Identifiers

NCT01435044

P2938-0721

Details and patient eligibility

About

This study was designed to assess the safety and efficacy of multiple interferon-free treatment regimens of sofosbuvir (Sovaldi™; GS-7977; PSI-7977) and GS-0938 (PSI-352938) alone and in combination, with and without ribavirin (RBV). Each regimen was to be evaluated over 12 and 24 weeks to identify the optimal duration of therapy to maximize the benefit (sustained virologic response [SVR]) versus risk (safety and resistance).

Enrollment: 239 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic HCV-infection
• Naive to all HCV antiviral treatment
• Otherwise healthy patients

Exclusion criteria

• Positive test at Screening for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab
• History of any other clinically significant chronic liver disease
• Medical history which the investigator considers the patient unsuitable for the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

239 participants in 7 patient groups

SOF+RBV 12 Weeks

Experimental group

Description:

Participants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 12 weeks.

Treatment:

Drug: Sofosbuvir

Drug: RBV

SOF+RBV 24 Weeks

Experimental group

Description:

Participants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 24 weeks.

Treatment:

Drug: Sofosbuvir

Drug: RBV

GS-0938 Alone

Experimental group

Description:

Participants were randomized to receive GS-0938 plus placebo to match sofosbuvir for up to 24 weeks.

Treatment:

Drug: GS-0938

Drug: Placebo to match sofosbuvir

GS-0938+SOF

Experimental group

Description:

Participants were randomized to receive GS-0938 plus sofosbuvir for up to 24 weeks.

Treatment:

Drug: GS-0938

Drug: Sofosbuvir

GS-0938+SOF+RBV

Experimental group

Description:

Participants were randomized to receive GS-0938 plus sofosbuvir plus RBV for up to 24 weeks.

Treatment:

Drug: GS-0938

Drug: Sofosbuvir

Drug: RBV

Placebo

Experimental group

Description:

Deferred start group: Participants were randomized to receive placebo to match GS-0938 plus placebo to match sofosbuvir for 24 Weeks.

Treatment:

Drug: Placebo to match sofosbuvir

Drug: Placebo to match GS-0938

Retreatment Group - SOF+RBV 24 Weeks

Experimental group

Description:

After discontinuing a regimen containing GS-0938, participants received sofosbuvir plus RBV for up to 24 weeks.

Treatment:

Drug: Sofosbuvir

Drug: RBV