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DRV/r+TAF/FTC

Overview

TAF/FTC+DRV/r* is a regimen containing two NRTIs, and a boosted PI, and is dosed as two pills taken once a day. It is considered a recommended regimen by the DHHS and a recommended regimen for patients who cannot take an INSTI by the IAS.

*There is evidence from bioequivalence or relative bioavailability studies that TAF can be substituted for TDF without loss of efficacy and with an improved side effect profile, particularly less impact on kidney function and on bone loss[1]. As such, TAF, an oral prodrug of TDF, is now included (since 2016) as a component of several recommended regimens and first line therapy in both DHHS and IAS guidance. TAF is FDA approved for use in patients with estimated CrCl as low as 30mL/min.

Recommendations for Treatment-Naïve Patients

DHHS: TAF/FTC+DRV/r is a recommended initial regimen in certain clinical situations. Situations include when ART is to be started before resistance results are available, such as in acute HIV or other circumstances when rapid ART initiaion is needed. Regarding PI selection, in general boosted DRV is preferred over boosted ATV. Regarding tenofovir selection, TAF has fewer bone and renal toxicities than TDF, while TDF is associated with lower lipid levels than TAF.

 

IAS: TAF/FTC+DRV/r is a recommended initial regimen for individuals in whom an INSTI is not an option. 

Recommendations for Treatment-Experienced Patients

DHHS: In cases of virologic failure, this regimen is recommended for patients who fail an NNRTI-based regimen (with 2 NRTIs) due to the failure often being a result of NNRTI resistance, rather than NRTI resistance. Additionally, in patients who fail firstline therapy with an INSTI-based regimen, a regimen of a boosted PI with NRTIs may also be considered as an option. In virally suppressed patients, switching to this type of regimen (2 NRTIs + 1 boosted PI) is only recommended for consideration as a within-class regimen to reduce pill burden, improve the safety profile of the drugs or reduce the dosing frequency; for example, switching from a ritonavir-boosted PI to a cobicistat-boosted PI. The DHHS does not recommend a between-class switch to a boosted PI if the drugs in their current regimen are fully active.

IAS: There is no explicit recommendation to switch to this regimen in the IAS guidelines. The guidelines recommend considering switching patients on older regimens to regimens with lower pill burden. Other situations in which patients should be recommended a switch include use of old NRTIs as they have long-term toxic effects, or older PIs that have higher pill burdens and are more metabolically toxic than DRV or ATV.

Other Considerations

TAF

  • Equivalent efficacy to TDF, with improved side effect profile and less impact on kidney function and on bone loss [1]
  • Not recommended for patients with CrCl<30

DRV/r

  • Must be taken with food
  • Low risk of virologic failure, even with intermittent use
  • PI booster (ritonavir) interacts with many other drugs 
  • Possible side effects include rash, severe rash with fever, and elevated transaminases

 

Efficacy in Clinical Trials

Trial Name

Drugs Compared

Participants

Study Results

N/A

ABC/3TC+DRV/r (single arm)

67, 48% tx-naive

At 48 weeks, 79% achieved viral suppression [2].

ARTEMIS

TDF/FTC plus DRV/r or LPV/r 

689 tx-naive

At 92 weeks, DRV/r was superior to LPV/r with respect to virological response. Among participants with baseline HIV RNA levels >100,000 copies/mL, virologic response rates were lower in the LPV/r arm than in the DRV/r arm [3].

FLAMINGO

2 NRTIs plus DRV/r or DTG

488 tx-naive

At week 96, virologic suppression was significantly greater among those who received DTG. The excess failure observed in the DRV/r group was related to a higher rate of virologic failure among those with a viral load >100,000 copies/mL and more drug discontinuations in the DRV/r group [4].

ACTG A5257

TDF/FTC plus DRV/r, ATV/r, or RAL

1809 tx-naive

Similar virologic efficacy in all three arms, but more participants in the ATV/r group discontinued randomized treatment because of adverse events [5].

 

 

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