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Clinical Studies Overview

PREZCOBIX® Safety Study 1301

  • An open-label, single-arm, 48-week, Phase 3 clinical trial evaluating the safety and efficacy of Once-Daily DRV 800 mg (2 x 400 mg) + COBI 150 mg in HIV-1–infected treatment-naïve adults (n=295) and treatment-experienced adults (n=18) with HIV-1 RNA ≥1000 copies/mL and no darunavir resistance-associated mutations (DRV RAMs). All patients received an investigator-selected optimized background regimen (OBR) consisting of 2 NRTIs chosen based upon resistance testing (if M184V/I mutation present, may add 3TC or FTC)

Primary objective

  • Safety and tolerability of Once-Daily DRV/COBI + 2 NRTIs through 24 weeks of treatment

Secondary objectives

  • Safety and tolerability of the regimen through 48 weeks of treatment
  • Virologic response (HIV-1 RNA <50 copies/mL) at Weeks 24 and 48 of treatment
  • Change from baseline in CD4+ cell counts at Weeks 24 and 48
  • Pharmacokinetics/pharmacodynamics

130 baseline demographics

3TC=lamivudine; COBI=cobicistat; DRV=darunavir; FTC=emtricitabine; NRTI=nucleoside reverse transcriptase inhibitor; OBR=optimized background regimen.

Reference: 1. Data on file. Janssen Therapeutics, Division of Janssen Products, LP.

ARTEMIS1

  • A randomized, controlled, open-label, 192-week, Phase 3, noninferiority clinical trial comparing darunavir 800 mg (two 400-mg tablets) coadministered with ritonavir 100 mg once daily (n=343) vs LPV/r 800/200 mg/day (n=346) in treatment-naïve adult patients with HIV-1 RNA ≥5000 copies/mL
  • All patients also received a fixed-dose combination of tenofovir disoproxil fumarate (TDF) 300 mg + emtricitabine (FTC) 200 mg once daily
  • Randomization was stratified by screening plasma viral load (<100,000 copies/mL or ≥100,000 copies/mL) and screening CD4+ cell count (<200 cells/mm3 or ≥200 cells/mm3)

Primary objective

  • Demonstrate noninferiority in virologic response (<50 copies/mL, ITT-TLOVR) of DRV/r 800/100 mg + TDF/FTC vs LPV/r 400/100 mg twice daily or 800/200 mg/day + TDF/FTC over 48 weeks
    • Noninferiority was determined using a 12% margin (delta): The lower limit of the 95% confidence interval of the difference in virologic response between the treatment groups could not cross -12%

Secondary objectives

  • Durability of virologic response over 192 weeks
  • Superiority in virologic response in the event of noninferiority being confirmed

ARTEMIS baseline demographics

DRV/r=darunavir coadministered with ritonavir; ITT-TLOVR=intent-to-treat, time-to-loss of virologic response; LPV/r=lopinavir/ritonavir; TDF/FTC= tenofovir disoproxil fumarate/emtricitabine.

Reference: 1. Data on file. Janssen Therapeutics, Division of Janssen Products, LP.

ODIN1

  • A randomized, open-label, 48-week, Phase 3, noninferiority clinical trial comparing darunavir 800 mg coadministered with ritonavir 100 mg once daily vs darunavir 600 mg coadministered with 100 mg ritonavir twice daily in treatment-experienced adult patients with viral load >1000 copies/mL and no darunavir resistance-associated mutations, or DRV RAMs (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, and L89V)
  • Patients were stratified by screening HIV-1 RNA (≤50,000 or >50,000 copies/mL) and then randomized (1:1) to receive Once-Daily DRV/r 800/100 mg (n=294) or twice-daily DRV/r 600/100 mg (n=296) plus an investigator-selected optimized background regimen (OBR) consisting of ≥2 NRTIs based on ARV history and resistance testing

Primary objective

  • Demonstrate noninferiority of Once-Daily DRV/r 800/100 mg vs twice-daily DRV/r 600/100 mg in confirmed virologic response (HIV-1 RNA <50 copies/mL [ITT-TLOVR]) at Week 48 with a noninferiority margin (delta) of 12%

ODIN baseline demographics

ODIN baseline ARV

*40% of subjects used boosted PIs and 14% of subjects used unboosted PIs. The most common previously used PIs were LPV/r (26%) and indinavir (21%).1

ARV=antiretroviral; DRV/r=darunavir coadministered with ritonavir; ITT-TLOVR=intent-to-treat, time-to-loss of virologic response; LPV/r=lopinavir/ritonavir; NNRTI=non-nucleoside reverse transcriptase inhibitor; NRTI=nucleoside reverse transcriptase inhibitor; OBR=optimized background regimen; PI=protease inhibitor; RAMs=resistance-associated mutations.

References: 1. Data on file. Janssen Therapeutics, Division of Janssen Products, LP. 2. Cahn P, Fourie J, Grinsztejn B, et al. Week 48 analysis of once-daily vs. twice-daily darunavir/ritonavir in treatment-experienced HIV-1-infected patients. AIDS. 2011;25:929-939.