Study to Evaluate Effect of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination on the Pharmacokinetics of a Representative Hormonal Contraceptive Medication, Norgestimate/Ethinyl Estradiol

Gilead Sciences

Status and phase: Completed; Phase 1

Conditions: HCV Infection

Treatments: Drug: VOX; Drug: Norgestimate/ethinyl estradiol; Drug: SOF/VEL/VOX

Study type: Interventional

Funder types: Industry

Identifiers

NCT02533427

GS-US-367-1909

Details and patient eligibility

About

This study will evaluate the effect of sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) fixed-dose combination (FDC) + voxilaprevir on the pharmacokinetics (PK) of a representative hormonal contraceptive medication, norgestimate/ethinyl estradiol (Ortho Tri-Cyclen® Lo (OC)) and will assess the effect of norgestimate/ethinyl estradiol on the PK of SOF/VEL/VOX+VOX.

Enrollment: 15 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Premenopausal female
• Must have a calculated body mass index (BMI) ≥ 19.0 and ≤ 30.0 kg/m^2 at screening
• Must have a negative serum pregnancy test at screening and urine pregnancy test at Day -1
• Be willing and able to comply with all study requirements.

Exclusion criteria

• Lactating female

• Have a history of any of the following:

  • Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity)
  • Known hypersensitivity to the study drugs, the metabolites or formulation excipients

• Believed, by the study investigator, to be inappropriate for study participation for any reason

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

SOF/VEL/VOX + VOX

Experimental group

Description:

Part A: Participants without a documented history of taking norgestimate/ethinyl estradiol for at least one menstrual cycle will receive norgestimate/ethinyl estradiol. Participants with a documented history of taking norgestimate/ethinyl estradiol may enroll directly into Part B of the study. Part B: Participants will continue taking norgestimate/ethinyl estradiol for the remainder of the study and will receive SOF/VEL/VOX FDC plus VOX.

Treatment:

Drug: Norgestimate/ethinyl estradiol

Drug: SOF/VEL/VOX

Drug: VOX