Intervention: Ledipasvir and sofosbuvir
Trial phase: Phase 2
ATC code: J05AP51
SMILES: CC(C)OC(=O)C(C)NP(=O)(OCC1OC(n2ccc(=O)[nH]c2=O)C(C)(F)C1O)Oc1ccccc1.COC(=O)NC(C(=O)N1CC2(CC2)CC1c1ncc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5nc(C6C7CCC(C7)N6C(=O)C(NC(=O)OC)C(C)C)[nH]c5c4)ccc2-3)[nH]1)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Ledipasvir/sofosbuvir for 24 weeks, followed by 24 weeks of post-treatment follow-up.
Eligibility criteria:
Inclusion Criteria:

Willing and able to provide written informed consent
Documentation of non-cirrhotic or cirrhotic status
HIV-1 infection
HIV antiretroviral treatment status (ART), CD4+ T-cell (CD4) count and HIV-1 RNA as follows: (1) not on ART with CD4 count >500 cells/mm^3 within 42 days of study entry, (2) elite controller not on ART with CD4 >200 cells/mm^3 within 42 days of study entry and HIV-1 RNA <500 copies/mL on all measurements within 48 weeks prior to study entry, (3) on a stable protocol-approved ART with CD4 count >200 cells/mm^3 and HIV-1 RNA <50 copies/mL within 42 days of study entry
HCV GT-1 within 12 months prior to study entry
Prior virologic treatment failure with SOF-containing regimen (SOF/RBV, SOF/PEG/RBV, and SOF/SIM)
Body mass index (BMI) ≥18 kg/m^2 within 42 days prior to study entry
Certain laboratory values obtained within 42 days prior to study entry
Hemoglobin ≥12.0 g/dL for male, ≥11.0 g/dL for female participants
Aspartate aminotransferase (AST) (SGOT) and Alanine aminotransferase (ALT) (SGOT) <10 x ULN
For female participants of reproductive potential, a negative serum pregnancy test with a sensitivity of at least 25 mIU/mL performed at screening and within 48 hours prior to study entry
Agreement to use at least two reliable forms of contraceptive simultaneously while receiving study treatment and for 6 months afterward
Intention to comply with the dosing instructions and study schedule of assessments

Exclusion Criteria:

Receipt of any investigational drug or device within 60 days prior to study entry
Prior exposure to a DAA other than SOF and SIM
Chronic liver disease of a non-HCV etiology
Presence of active or acute AIDS-defining opportunistic infections within 42 days prior to study entry
Active, serious infection (other than HIV-1 or HCV) requiring parenteral antibiotics, antivirals, or antifungals within 42 days prior to study entry
Hepatitis B virus (HBV) infection (defined as HBsAg positive) within 42 days prior to study entry
History of clinically significant hemoglobinopathy
Chronic current use of systemically administered immunosuppressive agents
History of solid organ transplantation
Current or prior history of clinical hepatic decompensation
History of a gastrointestinal disorder (or postoperative condition) that could interfere with the absorption of the study drug
History of significant or symptomatic pulmonary disease, cardiac disease, or porphyria that in the opinion of the investigator would interfere with the study
History of difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
Active drug or alcohol use or dependence
Use of any prohibited concomitant medications per the LDV/SOF product labeling, within 42 days prior to study entry
Known hypersensitivity to RBV, SOF, LDV, their metabolites, or formulation excipients or any other contraindication to the use of RBV, SOF or LDV
Currently receiving zidovudine (ZDV), didanosine (ddI), stavudine (d4T) or tipranavir
Acute HIV infection defined as the phase immediately following infection during which anti-HIV antibodies are undetectable
Known hepatocellular carcinoma
Breastfeeding or pregnancy
A male participant with a pregnant female partner
Receipt of colony stimulating agents, including but not limited to erythropoietin, within 42 days prior to study entry