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DRV/c+DTG/ABC/3TC

Overview

ABC/3TC/DTG+DRV/c+ is a regimen containing two NRTIs, an INSTI, and a boosted PI. There is currently no evidence in the literature supporting ABC/3TC/DTG+DRV/c as an effective antiretroviral therapy, but ABC/3TC/DTG is recommended by both the DHHS and the IAS for treatment-naive patients. Furthermore, some experts believe that it is possible that this regimen may have treatment potential given promising results can be extrapolated from a clinical trial of a similar regimen (which also consists of 1 boosted PI, 1 INSTI, and 2 NRTIs), DRV+EVG/c/TAF/FTC[1]. This regimen also has potential to be a good alternative for patients who are HLA-B*5701 negative. This regimen consists of two pills taken once daily.

+DRV/c was found to be bioequivalent to DRV/r in healthy volunteers[2]. Based on the results of the study, efficacy of DRV/c has been extrapolated from DRV/r data. Therefore, many experts may consider use of DRV/c despite the limited supporting data from clinical trials due to the reduced pill burden. Use of DRV/c is discussed in both the DHHS and IAS guidelines for use in treatment-naïve and treatment-experienced patients. Cobicistat inhibits active tubular secretion of creatinine, which can increase serum creatinine without an effect on renal glomerular function.

Recommendations for treatment-naïve patients

DHHS: ABC/3TC/DTC+DRV/c does not appear in the DHHS guidelines, however, ABC/3TC/DTG is a recommended initial regimen for most patients with HIV who are treatment-naive and patients who are HLA-B*5701 negative. 

IAS: ABC/3TC/DTC+DRV/c does not appear in the IAS guidelines, but ABC/3TC/DTG is one of the INSTI-based regimens that are "optimal for initial therapy".

Recommendations for treatment-experienced patients

DHHS: This regimen is not discussed in the DHHS guidelines for treatment-experienced patients who are experiencing either viral suppression or virologic failure. However, a similar regimen, DRV+EVG/c/TAF/FTC, is discussed for treatment of virally suppressed patients who have resistance to at least 2 ARV drug classes without INSTI resistance, given promising results[1]. The DHHS states that the aforementioned regimen has potential to be a good option for simplification of patients who have complicated rescue regimens, but that there is not enough evidence to support the regimen beyond special circumstances without an additional clinical trial. This regimen is not discussed in regards to cases of virologic failure, but patients are recommended to start a regimen with at least 2 to 3 active agents. In cases where there is resistance to RAL or EVG/c, a regimen containing DTG with a boosted PI can be considered. Furthermore, the DHHS recommends considering a component of this regimen, 1 boosted PI and 1 INSTI, both for patients who are virologically suppressed and who have experienced virologic failure.

IAS: This regimen is not discussed in the IAS guidelines for treatment-experienced patients. However, the IAS recommends using a boosted PI in secondline regimens because of the high barrier to resistance.

Other Considerations

DTG

  • Lowest risk of resistance with virological failure among INSTIs
  • Relatively few drug interactions
  • Can be taken with or without food (but not with polyvalent ions, which may be found in antacids, laxatives, and mineral supplements)
  • May raise serum creatinine 
  • Largest tablet among co-formulated single-pill regimens 
  • Possible side effects include insomnia, headache, and (rarely) hypersensitivity reaction

DRV/c

  • Must be taken with food
  • Low risk of virologic failure, even with intermittent use
  • PI booster (cobicistat) interacts with many other drugs 
  • Possible side effects include diarrhea, nausea, and headache

ABC

  • Possibility of hypersensitivity reaction in patients who are not HLA-B*5701 negative
  • Dosing does not need to be adjusted for patients with renal insufficiency

 

Efficacy in Clinical Trials 

DTG

Trial Name

Drugs Compared

Participants

Results

SINGLE

ABC/3TC/DTG vs. FTC/TDF/EFV

833 tx-naive

At 48 weeks, the treatment discontinuation rate was higher in the EFV arm. At week 144, DTG plus ABC/3TC remained superior. [3] [4] [5]

ARIA

ABC/3TC/DTG vs. FTC/TDF/ATVr

495 tx-naïve women

At 48 weeks, ABC/3TC/DTG was superior. There were fewer virological nonresponses and fewer discontinuations due to adverse events in the 3TC/ABC/DTG arm [6].

FLAMINGO

2 NRTIs plus DTG or DRV/r

484 tx-naive

At 48 weeks, DTG outperformed DRV/r [7].

SPRING-2

2 NRTIs plus DTG or RAL

822 tx-naive

At 48 and 96 weeks, DTG was non-inferior to RAL, with a similar safety profile [8] [9].

​DRV/c <![endif]-->

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 [10].

Study 115

DRV/c vs.DRV/r

62 tx-naive

DRV/c is bioequivalent to DRV/r in healthy volunteers [2].

 

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References

  1. Citekey 219 not found
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  7. Citekey 120 not found
  8. Citekey 121 not found
  9. Citekey 122 not found
  10. Citekey 148 not found