Efficacy, Safety, and Tolerability of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Participants Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment
Condition: HIV-1 Infection; HCV Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: E/C/F/TAF; F/R/TAF; LDV/SOF
Intervention description: 150/150/200/10 mg fixed dose combination (FDC) tablet administered orally once daily; 200/25/25 mg FDC tablet administered orally once daily; 90/400 mg FDC tablet administered orally once daily
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; HCV; Antiretroviral therapy; HCV direct acting antiviral(s) (DAA)

Summary:

      This study will evaluate efficacy of ledipasvir/sofosbuvir (LDV/SOF) and safety and
      tolerability of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide
      (E/C/F/TAF) or emtricitabine/rilpivirine/tenofovir alafenamide (F/R/TAF) from the current
      antiretroviral (ARV) therapy and in virologically-suppressed, HIV-1/HCV co-infected
      participants.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Chronic genotype (GT) 1, HCV infected, male and non-pregnant/ non-lactating female
             individuals, without cirrhosis, treatment-naive or treatment-experienced with
             interferon (IFN) +/- ribavirin (RBV) +/- HCV protease inhibitor (PI).

          -  Compensated cirrhotic individuals must be HCV treatment-naive.

          -  No prior treatments with NS5A and NS5B or any HCV direct acting antivirals, except
             boceprevir, telaprevir and simeprevir, in combination with IFN and RBV

          -  Currently on an ARV regimen (2 NRTI + a third agent) without change for 6 months prior
             to screening.

          -  Documented plasma HIV-1 RNA levels < 50 copies/mL (or undetectable HIV-1 RNA level
             according to the local assay being used if the limit of detection is ≥ 50 copies/mL)
             for ≥ 6 months preceding the screening visit. After reaching HIV-1 RNA < 50 copies/mL,
             single values ("blips") of HIV-1 RNA ≥ 50 copies/mL followed by resuppression is
             allowed.

          -  For individuals with 3 or more prior ARV regimens, a regimen history should be
             provided for approval by the Sponsor.

               -  Note: Individuals that changed from TDF to TAF less than 6 months ago will be
                  eligible as long as the TDF/ TAF change was the only change to the regimen.

          -  Plasma HIV-1 RNA level < 50 copies/mL at the screening visit

          -  Have no documented resistance to any of the HIV study agents at time in the past,
             including but not limited to the reverse transcriptase resistance mutations K65R,
             K70E, K101E/P, E138A/G/K/R/Q, V179L, Y181C/I/V, M184V/I, Y188L, H221Y, F227C, M230I/L,
             the combination of K103N+L100I, or 3 or more thymidine analog associated mutations
             (TAMs) that include M41L or L210W (TAMs are M41L, D67N, K70R, L210W, T215Y/F,
             K219Q/E/N/R). If a historical genotype prior to first ARV is not available or
             individual had 3 or more prior ARV regimens, individual will have proviral genotype
             analysis for archived resistance prior to Day 1.

          -  No history of HIV virologic failure

          -  No evidence of Hepatitis B infection

          -  Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min as estimated by
             Cockcroft-Gault formula

        Note: Other protocol defined Inclusion/ Exclusion criteria may apply.