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DRV/c+RPV/TAF/FTC

Overview

TAF/FTC/RPV+DRV/c is a regimen containing two NRTIs, an NNRTI, and a boosted PI, and is dosed as two pills taken once a day. It does not appear in either the DHHS or IAS guidelines. However, TAF/FTC/RPV is considered an alternative regimen by the DHHS and a recommended regimen for patients who cannot take an INSTI by the IAS.

Recommendations

DHHS: TAF/FTC/RPV+DRV/c is not ranked, but TAF/FTC/RPV is recommended as an intial ART regimen in certain clinical situations if HIV RNA < 100,000 copies/mL and CD4 > 200 cells/mm3. This regimen has potential disadvantages, limitations for use, and/or less supporting data from RCT than recommended regimens.

IAS: TAF/FTC/RPV+DRV/c is not ranked, but TAF/FTC/RPV is a "recommended initial regimen for individuals in whom an INSTI is not an option."

Other Considerations

TAF

  • Equivalent efficacy to TDF, with improved side effect profile and less impact on kidney function and on bone loss [1]
  • Should not be used in patients with CrCl<30

RPV

  • Approved for use in patients with pre-treatment viral loads <100,000 copies/mL and CD4 count >200 cells/mm3
  • Must be taken with food
  • Interacts with many other drugs
  • Should not be taken with a PPI
  • Lowest risk of rash among NNRTI-based therapies, and low risk of metabolic adverse effects
  • Possible side effects include depressive disorders and suicidality

DRV/c

  • Must be taken with food
  • Low risk of virologic failure, even with intermittent use
  • Interacts with many other drugs 
  • Possible side effects include diarrhea, nausea, and headache

Efficacy in Clinical Trials

RPV

Trial Name Drugs Compared Participants Study Results
STaR FTC/TDF/RPV vs. FTC/TDF/EFV 786 tx-naive At 96 weeks, RPV was non-inferior to EFV overall, superior in patients with pre-ART viral loads ≤100,000 copies/mL, and noninferior in those with pre-ART viral loads >100,000 copies/mL. In patients with pre-ART viral loads >500,000 copies/mL, virologic failure was more common in RPV-treated patients. There were more participants with emergent resistance in the RPV arm [2].

ECHO and THRIVE

2 NRTIs plus RPV or EFV 1368 RPV was noninferior to EFV overall. Among participants with a pre-ART viral load >100,000 copies/mL, more RPV-treated participants experienced virologic failure. In participants with virologic failure, NNRTI and NRTI resistance was more frequently identified in those treated with RPV. Among the RPV-treated participants, the rate of virologic failure was greater in those with pre-treatment CD4 counts <200 cells/mm3 [3].

DRV/c

Trial Name Drugs Compared Participants Study Results
N/A 2 NRTIs + DRV/c (single arm) 313, 95% tx-naive At week 48, 81% achieved viral suppression, while 5% discontinued treatment because of adverse events [4].
Study 115 DRV/c vs.DRV/r 62 DRV/c is bioequivalent to DRV/r in healthy volunteers [5].

 

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