Pregnant women and nursing mothers are ineligible due to the possible risk of adverse effects in the newborn. Eligible patients of reproductive potential should use adequate contraception if sexually active.
Serious concurrent medical illness which would jeopardize the ability of the subject to receive the therapy as outlined in this protocol with reasonable safety.
Malignancy diagnosed or treated within 5 years (recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to screening); subjects under evaluation for a malignancy are not eligible.
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Use of any prohibited concomitant medications within 30 days of the Baseline/Day 1 visit.
Known hypersensitivity to LDV/SOF

NCT02759861_exc_T3
Condition
Malignancy
NCT02759861_exc_T4
Temporal
within 5 years
NCT02759861_exc_T5
Procedure
treatment
NCT02759861_exc_T6
Qualifier
localized
NCT02759861_exc_T7
Temporal
recent
NCT02759861_exc_T8
Condition
uamous o ll skin cancers
NCT02759861_exc_T9
Condition
non-invasive basal cell skin cancer
NCT02759861_exc_T10
Negation
permitted
NCT02759861_exc_T11
Scope
squamous or non-invasive basal cell skin cancer
NCT02759861_exc_T12
Condition
cervical carcinoma in situ
NCT02759861_exc_T13
Negation
allowed
NCT02759861_exc_T14
Procedure
treated
NCT02759861_exc_T15
Qualifier
appropriately
NCT02759861_exc_T16
Temporal
prior to screening
NCT02759861_exc_T18
Condition
hepatitis B virus (HBV)
NCT02759861_exc_T19
Condition
human immunodeficiency virus (HIV)
NCT02759861_exc_T21
Condition
hypersensitivity
NCT02759861_exc_T22
Drug
LDV
NCT02759861_exc_T23
Drug
SOF
NCT02759861_exc_T24
Scope
LDV/SOF