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Dosing of Antiretroviral Drugs in Adults with Chronic Kidney Disease and Hemodialysis
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Introduction
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Tables
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transparent imageNucleoside/Nucleotide Analogues
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transparent imageNRTI Fixed-Dose Combination Tablets
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transparent imageIntegrase Inhibitors
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transparent imageNonnucleoside Reverse-Transcriptase Inhibitors
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transparent imageProtease Inhibitors
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transparent imagePharmacokinetic Booster Drugs
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transparent imageFusion Inhibitors
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transparent imageChemokine Coreceptor Antagonists
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transparent imageSingle-Tablet Regimens
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References
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Related Resources
transparent imageRenal Manifestations of HIV
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Introduction
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Several nucleoside/nucleotide analogue reverse transcriptase inhibitors are excreted primarily through the kidney and must be dose-adjusted for patients with chronic kidney disease, and for those who are on hemodialysis. Although there are few data on the pharmacokinetic properties of the integrase inhibitors, nonnucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors, fusion inhibitors, or chemokine coreceptor antagonists in patients with chronic kidney disease, the pharmacokinetic profiles of these drugs suggest that renal function has minimal effect on drug elimination. Despite this, protease inhibitors and the NNRTI nevirapine may require modified dosing strategies in patients on hemodialysis, and the chemokine coreceptor antagonist maraviroc should not be used in certain patients with chronic kidney disease (see below). In the case of fixed-dose combination tablets (eg, Descovy, Epzicom, Truvada) and single-tablet regimens (eg, Atripla, Genvoya, Odefsey, Triumeq), the combination tablets often will need to be replaced with the individual components in patients with renal dysfunction so that each medication is dosed appropriately.

These tables summarize antiretroviral drug dosing recommendations for patients with impaired renal function.

The following abbreviations are used throughout these tables:
BID = twice daily
CrCl = creatinine clearance
HD = hemodialysis
PO = orally, by mouth
Q2H, Q4H, etc = every 2 hours, every 4 hours, etc

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Tables
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Nucleoside/Nucleotide Analogues
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Drug Standard Dosage Dosing in Chronic Kidney Disease and Hemodialysis References
Note: Tenofovir alafenamide tablets (Vemlidy®) are FDA approved only for treatment of hepatitis B.(18)
Abacavir (tablets) 300 mg PO BID Dosage adjustment does not appear necessary (1,2)
Didanosine (enteric-coated capsules) 250 mg to 400 mg PO daily, depending on body weightCrCl (mL/min) Wt ≥60 kgWt <60 kg (3,4,5)
≥60 400 mg daily 250 mg daily
30-59 200 mg daily 125 mg daily
10-29 125 mg daily 125 mg daily
<10 125 mg daily Capsules not recommended, use 75 mg oral solution once daily
HD 125 mg daily Capsules not recommended, use 75 mg oral solution once daily
Emtricitabine (capsule) 200 mg PO daily CrCl (mL/min) (6)
≥50 200 mg daily
30-49 200 mg Q48H
15-29 200 mg Q72H
<15 200 mg Q96H
HD 200 mg Q96H, give dose after dialysis
Lamivudine (tablets) 150 mg PO BID or 300 mg PO daily CrCl (mL/min) (7,8,9,10)
≥50 150 mg BID or 300 mg daily
30-49 150 mg daily
15-29 150 mg first dose, then 100 mg daily
5-14 150 mg first dose, then 50 mg daily
<5 50 mg first dose, then 25 mg daily
Stavudine (capsules) 20 mg PO BID to 40 mg PO BID, depending on weight CrCl (mL/min) Wt ≥60 kgWt <60 kg (11,12)
>50 40 mg BID 30 mg BID
26-50 20 mg BID 15 mg BID
10-25 20 mg daily 15 mg daily
HD 20 mg daily 15 mg daily
Tenofovir disoproxil (tablets) 300 mg PO daily CrCl (mL/min) (13)
≥50 300 mg daily
30-49 300 mg Q48H
10-29 300 mg twice weekly (ie, Q 3-4 days)
HD 300 mg once weekly
Zidovudine (tablets, capsules) 300 mg PO BID CrCl (mL/min) (14,15,16,17)
<15 100 mg Q6-8H
HD 100 mg Q6-8H
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NRTI Fixed-Dose Combination Tablets
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Drug Standard Dosage Dosing in Chronic Kidney Disease and Hemodialysis References
Combivir (zidovudine/lamivudine) 1 tablet PO BID CrCl ≥50 mL/min: No dosage adjustment
CrCl <50 mL/min: Do not use fixed-dose combination tablet; adjust dosage based on individual components
(19)
Descovy (emtricitabine/tenofovir alafenamide) 1 tablet PO daily CrCl ≥30 mL/min: No dosage adjustment
CrCl <30 mL/min: Do not use fixed-dose combination tablet; adjust dosage based on individual components
(20)
Epzicom (abacavir/lamivudine) 1 tablet PO daily CrCl ≥50 mL/min: No dosage adjustment
CrCl <50 mL/min: Do not use fixed-dose combination tablet; adjust dosage based on individual components
(21)
Trizivir (zidovudine/lamivudine/abacavir) 1 tablet PO BID CrCl ≥50 mL/min: No dosage adjustment
CrCl <50 mL/min: Do not use fixed-dose combination tablet; adjust dosage based on individual components
(22)
Truvada (emtricitabine/tenofovir disoproxil) 1 tablet PO daily HIV treatment:
CrCl ≥50 mL/min: No dosage adjustment
CrCl 30-49 mL/min: 1 tablet PO Q48H
CrCl <30 mL/min or HD: Do not use fixed-dose combination tablet; adjust dosage based on individual components

PrEP:
CrCl: ≥60 mL/min: No dosage adjustment
CrCl <60 mL/min: Do not use fixed-dose combination tablet; no available data on use of dosage-adjusted individual components

(23)
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Integrase Inhibitors
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Drug(s)Dosing in Chronic Kidney Disease and HemodialysisReferences
ElvitegravirDosage adjustment for chronic kidney disease does not appear necessary (24)
Raltegravir (tablets) Dosage adjustment for chronic kidney disease does not appear necessary (25)
Dolutegravir (tablets) No dosage adjustment is necessary for INSTI-naive patients with mild, moderate, or severe renal impairment; caution should be used in INSTI-experienced patients with severe renal impairment (26)
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Nonnucleoside Reverse-Transcriptase Inhibitors
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Drug(s)Dosing in Chronic Kidney Disease and HemodialysisReferences
Delavirdine (tablets) No data on patients with renal impairment (27)
Efavirenz (capsules and tablets) No data on patients with renal impairment, but less than 1% of efavirenz is excreted unchanged in urine; therefore, dosage adjustment does not appear necessary (28)
Nevirapine (tablets and oral suspension)
  • CrCl >20 mL/min: No dosage adjustment necessary

  • CrCl <20 mL/min: No data

For patients on HD: An additional 200 mg dose of nevirapine following each dialysis treatment is recommended

(29)
Rilpivirine (tablets) Dosage adjustment not necessary in mild-moderate renal impairment; use with caution in severe renal impairment (30)
Etravirine (tablets) No dosage adjustment necessary for patients with renal impairment or patients on HD (31)
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Protease Inhibitors
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Drug(s)ManagementReferences
Amprenavir, atazanavir, darunavir, fosamprenavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir, tipranavir
  • For patients with chronic kidney disease (not on HD): Dosage adjustment does not appear necessary

  • For patients on HD: HD is not expected to change serum levels of drugs that are hepatically cleared (eg, protease inhibitors); however, some pharmacokinetic studies suggest that levels of atazanavir, lopinavir, and ritonavir are reduced significantly in patients on HD; the mechanism of this is not clear; pharmacokinetic evaluations of other protease inhibitors in HD have not been conducted; further studies are needed to describe protease inhibitor levels in patients on HD and to define dosing recommendations

Atazanavir (capsules) Treatment naive: No dosage adjustment necessary in renal dysfunction

Treatment experienced: Not recommended in patients receiving HD

(32)
Lopinavir/ritonavir (caspules and oral solution) Lopinavir and ritonavir also are not cleared by HD, but a recent study found that levels of both agents were lower than those of historical controls (Cmin was 44% lower)

For patients receiving HD, once-daily dosing should not be used (consider twice-daily dosing; dosage adjustments have not been studied)

(33)
Other PIsWhile changes in serum levels are not expected, the pharmacokinetics of other protease inhibitors in the setting of HD have not been studied, and it is not known whether the finding of lower-than-expected drug levels in HD patients is a drug-class effect
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Pharmacokinetic Booster Drugs
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Drug(s)Dosing in Chronic Kidney Disease and HemodialysisReferences
Cobicistat (tablets) No dosage adjustment necessary (34)
Ritonavir (capsules) No dosage adjustment necessary (35)
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Fusion Inhibitors
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Drug(s)Dosing in Chronic Kidney Disease and HemodialysisReferences
Enfuvirtide (solution for subcutaneous injection) CrCl >35 mL/min: No dosage adjustment necessary

CrCl <35 mL/min: No data

(36)
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Chemokine Coreceptor Antagonists
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Drug(s)Dosing in Chronic Kidney Disease and HemodialysisReferences
Maraviroc (tablets) Dosage adjustment for patients with mild or moderate chronic kidney disease does not appear necessary

CrCl <30 mL/min: Do not use in patients with severe renal impairment or end-stage renal disease who are taking a potent CYP3A inhibitor or inducer

(37)
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Single-Tablet Regimens
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Drug Standard Dosage Dosing in Chronic Kidney Disease and Hemodialysis References
Atripla (efavirenz/emtricitabine/tenofovir disoproxil) 1 tablet PO nightly at bedtime CrCl ≥50 mL/min: No dosage adjustment
CrCl <50 mL/min: Not recommended
(38)
Complera or Eviplera (rilpivirine/emtricitabine/tenofovir disoproxil) 1 tablet PO daily CrCl ≥50 mL/min: No dosage adjustment
CrCl <50 mL/min: Not recommended
(39)
Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) 1 tablet PO daily CrCl ≥30 mL/min: No dosage adjustment
CrCl <30 mL/min: Not recommended
(40)
Odefsey (rilpivirine/tenofovir alafenamide/emtricitabine) 1 tablet PO BID CrCl ≥30 mL/min: No dosage adjustment
CrCl <30 mL/min: Not recommended
(41)
Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil) 1 tablet PO daily Do not initiate in patients with CrCl <70 mL/min; discontinue in patients whose CrCl falls to <50 mL/min (42)
Triumeq (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) 1 tablet PO daily CrCl ≥50 mL/min: No dosage adjustment
CrCl <50 mL/min: Not recommended
(43)
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References

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1.   Izzedine H, Launay-Vacher V, Aymard G, et al. Pharmacokinetics of abacavir in HIV-1-infected patients with impaired renal function. Nephron 2001; 89:62-7.
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2.  Ziagen [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2008.
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3.   Singlas E, Taburet AM, Borsa Lebas F, et al. Didanosine pharmacokinetics in patients with normal and impaired renal function: influence of hemodialysis. Antimicrob Agents Chemother 1992; 36:1519-24.
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4.   Knupp CA, Hak LJ, Coakley DF, et al. Disposition of didanosine in HIV-seropositive patients with normal renal function or chronic renal failure: influence of hemodialysis and continuous ambulatory peritoneal dialysis. Clin Pharmacol Ther 1996; 60:535-42.
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5.  Videx EC [package insert]. Princeton, NJ: Bristol-Myers Squibb; 2015.
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6.  Emtriva [package insert]. Foster City, CA: Gilead Sciences; 2017.
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7.   Bohjanen PR, Johnson MD, Szczech LA, et al. Steady-state pharmacokinetics of lamivudine in human immunodeficiency virus-infected patients with end-stage renal disease receiving chronic dialysis. Antimicrob Agents Chemother 2002; 46:2387-92.
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8.   Izzedine H, Launay-Vacher V, Deray G. Dosage of lamivudine in a haemodialysis patient. Nephron 2000; 86:553.
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9.   Johnson MA, Verpooten GA, Daniel MJ, et al. Single dose pharmacokinetics of lamivudine in subjects with impaired renal function and the effect of haemodialysis. Br J Clin Pharmacol 1998; 46:21-7.
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12.   Grasela DM, Stoltz RR, Barry M, et al. Pharmacokinetics of single-dose oral stavudine in subjects with renal impairment and in subjects requiring hemodialysis. Antimicrob Agents Chemother 2000; 44:2149-53.
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13.  Viread [package insert]. Foster City, CA: Gilead Sciences; 2017.
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14.  14. Retrovir [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2008.
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15.   Kimmel PL, Lew SQ, Umana WO, et al. Pharmacokinetics of zidovudine in HIV-infected patients with end-stage renal disease. Blood Purif 1995; 13:340-6.
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16.   Pachon J, Cisneros JM, Castillo JR, et al. Pharmacokinetics of zidovudine in end-stage renal disease: influence of haemodialysis. Aids 1992; 6:827-30.
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17.   Tartaglione TA, Holeman E, Opheim K, Smith T, Collier AC. Zidovudine disposition during hemodialysis in a patient with acquired immunodeficiency syndrome. J Acquir Immune Defic Syndr 1990; 3:32-4.
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18.  Vemlidy [package insert]. Foster City, CA: Gilead Sciences; 2017.
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19.  Combivir [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2015.
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20.  Descovy [package insert]. Foster City, CA: Gilead Sciences; 2017.
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21.  Epzicom [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2009.
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22.  Trizivir [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2015.
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23.  Truvada [package insert]. Foster City, CA: Gilead Sciences; 2017.
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24.  Vitekta [package insert]. Foster City, CA: Gilead Sciences; 2014.
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25.  Isentress [package insert]. Whitehouse Station, NJ: Merck & Co; 2012.
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27.  Rescriptor [package insert]. Research Triangle Park, NC: ViiV Healthcare; 2012.
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33.   Gupta SK, Rosenkranz SL, Cramer YS, et al. The pharmacokinetics and pharmacogenomics of efavirenz and lopinavir/ritonavir in HIV-infected persons requiring hemodialysis. AIDS. 2008 Oct 1;22(15):1919-27.
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34.  Tybost [package insert]. Foster City, CA: Gilead Sciences; 2017.
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35.  Norvir [package insert]. North Chicago, IL: Abbott Laboratories; 2012.
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36.  Fuzeon [package insert]. Nutley, NJ: Roche Laboratories; 2006.
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37.  Selzentry [package insert]. New York, NY: Pfizer; 2007.
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38.  Atripla [package insert]. Foster City, CA: Gilead Sciences; 2017.
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39.  Complera [package insert]. Foster City, CA: Gilead Sciences; 2017.
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40.  Genvoya [package insert]. Foster City, CA: Gilead Sciences; 2017.
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41.  Odefsey [package insert]. Foster City, CA: Gilead Sciences; 2017.
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42.  Stribild [package insert]. Foster City, CA: Gilead Sciences; 2017.
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43.  Triumeq [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2014.
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