From the Guidelines
For patients with a creatinine clearance (CrCl) of 28 mL/min, alternative antiretroviral regimens to Biktarvy should be considered due to the potential risk of renal toxicity associated with tenofovir alafenamide in severe renal impairment.
Alternatives to Biktarvy
- Dovato (dolutegravir 50 mg/lamivudine 300 mg once daily) can be used without dose adjustment in patients with CrCl as low as 15 mL/min, as no dose adjustments are needed for dolutegravir in patients with CKD 1.
- Juluca (dolutegravir 50 mg/rilpivirine 25 mg once daily) is another option that doesn't require dose adjustment for mild to moderate renal impairment, and since rilpivirine is primarily metabolized by the liver, its use in severe renal impairment is less concerning compared to renally cleared drugs 1.
- For patients requiring a protease inhibitor-based regimen, Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) can be considered, as tenofovir alafenamide has less renal toxicity than tenofovir disoproxil fumarate, although careful monitoring of renal function is still necessary 1.
Key Considerations
- The choice of antiretroviral regimen in patients with severe renal impairment should prioritize components that are either not renally cleared or have a lower risk of renal toxicity.
- Regular monitoring of renal function is essential with any antiretroviral therapy, especially in patients with pre-existing renal impairment.
- Dose adjustments may be necessary for certain antiretroviral drugs based on the patient's CrCl, and clinicians should consult the most recent guidelines and drug labels for specific recommendations, such as those provided for lamivudine, emtricitabine, and tenofovir disoproxil fumarate in the context of CKD 1.
From the Research
Alternatives to Biktarvy in Patients with Impaired Renal Function
In patients with severe renal impairment, such as a creatinine clearance rate (CrCl) of 28, alternative antiretroviral regimens to Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) should be considered due to the potential nephrotoxic effects of tenofovir alafenamide 2.
Recommended Alternatives
- Dual-therapy regimens containing lamivudine and darunavir/ritonavir or atazanavir/ritonavir may be effective alternatives, as they have been shown to be well-tolerated and effective in maintaining virological suppression in patients with HIV 3.
- Other antiretroviral regimens that do not contain tenofovir or other nephrotoxic agents may also be considered, such as those containing non-nucleoside reverse transcriptase inhibitors or protease inhibitors 4, 5.
Considerations for Patients with Severe Renal Impairment
- Patients with severe renal impairment require careful monitoring of their renal function and antiretroviral regimen, as they may be at increased risk of nephrotoxicity and other adverse effects 6, 2.
- The choice of antiretroviral regimen should be individualized based on the patient's specific needs and medical history, taking into account factors such as the severity of renal impairment, the presence of other comorbidities, and the potential for drug interactions 4, 5.
Key Points to Consider
- The use of tenofovir alafenamide in patients with severe renal impairment should be avoided due to the potential for high tenofovir exposures and nephrotoxicity 2.
- Alternative antiretroviral regimens should be chosen based on their efficacy, safety, and tolerability in patients with renal impairment, as well as their potential for drug interactions and other adverse effects 4, 5, 3.