Appendix B. Full Table Antiretroviral Dosing Recommendations in Adults With Renal or Hepatic Insufficiency

These tables include antiretroviral (ARV) products that are not approved by the U.S. Food and Drug Administration (FDA) for use in adolescents with HIV. For information regarding the use of ARV medications in adolescents with HIV, including weight limitations and additional dosage forms, please consult FDA product labeling or Appendix A in the Pediatric Antiretroviral Guidelines.

Renal dosing information for fixed-dose combination products, as well as coformulated and copackaged antiretroviral regimens, is included in the tables below. The older antiretroviral drugs fosamprenavir (FPV), lopinavir/ritonavir (LPV/r), nelfinavir (NFV), nevirapine (NVP), tipranavir (TPV), and zidovudine (ZDV) have been removed from this table. Please refer to the FDA product labels for these drugs for recommendations on dosing in adults and adolescents with renal or hepatic insufficiency.

Please refer to the National Institute of Diabetes and Digestive and Kidney Diseases Determining Drug Dosing in Adults With Chronic Kidney Disease webpage for a discussion on using estimated creatinine clearance (CrCl) versus estimated glomerular filtration rate (eGFR) in determining renal function. eGFR based on the 2021 Chronic Kidney Disease Epidemiology Collaboration (or CKD-EPI) equation can be determined using this eGFR calculator. In FDA prescribing information, renal dosing recommendations for most ARVs are based on CrCl using the Cockroft-Gault formula.

See the section at the end of this table for criteria for Child-Pugh Classifications.

Generic Name (Abbreviation) Trade Name	Usual Dose^a	Dosing in Adults With Renal Insufficiency				Dosing in Adults With Hepatic Impairment
Nucleoside Reverse Transcriptase Inhibitors
Abacavir (ABC) Ziagen	ABC 300 mg PO twice daily or ABC 600 mg PO once daily	No dose adjustment.				Child-Pugh Class A: ABC 200 mg PO twice daily (use oral solution) Child-Pugh Class B or C: Contraindicated
Abacavir/Lamivudine (ABC/3TC)	One tablet PO once daily	Not FDA recommended if CrCl <30 mL/min due to the 3TC component. Note: There is insufficient evidence to recommend for or against the use of full-dose 3TC in people with CrCl <30 mL/min. To allow people to remain on the FDC product, some Panel members use full-dose 3TC. See the 3TC entry for more information.				Child-Pugh Class A: People with mild hepatic impairment require a dose reduction of ABC (as noted above). Use the individual drugs instead of the FDC tablet in these people. Child-Pugh Class B or C: Contraindicated due to the ABC component
Emtricitabine (FTC) Emtriva	FTC 200-mg oral capsule once daily or FTC 240-mg (24-mL) oral solution once daily Note: There is insufficient evidence to recommend for or against the use of full-dose, daily FTC in people with CrCl <30 mL/min who are not on HD. To allow people to remain on certain TAF-containing FDC products, some Panel members use full-dose, daily FTC in people with CrCl 15–‍29 mL/min who are not on HD.	Dose by Formulation				No dose recommendation.
		CrCl (mL/min)	Capsule		Solution
		30–49^b	No dose adjustment necessary.
		15–29 (see Note)	200 mg every 72 hours		80 mg every 24 hours
		<15 (not on HD) (see Note)	200 mg every 96 hours		60 mg every 24 hours
		On HD^b	No dose adjustment necessary. On HD days, administer after dialysis.
Lamivudine (3TC) Epivir	3TC 300 mg PO once daily or 3TC 150 mg PO twice daily Note: PK and safety data are limited on the use of 3TC doses higher than those recommended by the FDA in people with CrCl <30 mL/min. Clinicians may consider using the nearest available tablet strength (100 mg or 150 mg), as outlined in the “Alternative Dose” column (BIII) (see rationale^d). There is insufficient evidence to recommend for or against the use of full-‍dose 3TC in people with CrCl <30 mL/min. To allow people to remain on certain ABC and/or DTG-containing FDC products, some Panel members use full-dose 3TC.	CrCl (mL/min)	Epivir Label Dose		Alternative Dose_^d	No dose adjustment necessary
		30-49^c	No dose adjustment.
		15–29 (see Note)	1 × 150 mg, then 100 mg every 24 hours		100–150 mg every 24 hours
		5–14 (see Note)	1 × 150 mg, then 50 mg every 24 hours		100–150 mg every 24 hours
		<5 or on HD (see Note)	1 × 50 mg, then 25 mg every 24 hours		100–150 mg every 24 hours
Tenofovir Alafenamide (TAF) Vemlidy	Vemlidy is available as a 25-mg tablet given PO once daily for the treatment of HBV.	CrCl (mL/min)		Dose		Child-Pugh Class A: No dose adjustment Child-Pugh Class B or C: Not recommended
		<15 and not on HD		Not recommended
		On HD		No dose adjustment necessary. On HD days, administer after dialysis.
Tenofovir Alafenamide/Emtricitabine (TAF/FTC) Descovy	TAF for HIV treatment is only available as a component of FDC tablets (i.e., in Biktarvy, Descovy, Genvoya, Odefsey, and Symtuza). TAF 10 mg PO once daily with EVG/c (Genvoya) or DRV/c (Symtuza) TAF 25 mg PO once daily in other FDC tablets	CrCl (mL/min)		Dose		Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No dose recommendation
		15-29		Not recommended Note: There is insufficient evidence to recommend for or against the use of full-dose, daily FTC in people with CrCl <30 mL/min. To allow people to remain on the FDC product, some Panel members use full-dose FTC in people with CrCl 15–29 mL/min.
		<15 (not on HD)		Not recommended
		On HD		No dose adjustment necessary. On HD days, administer after dialysis.
Tenofovir Disoproxil Fumarate (TDF) Viread	TDF 300 mg PO once daily	CrCl (mL/min)		Dose		No dose adjustment necessary.
		30–49		300 mg every 48 hours
		10–29		300 mg twice weekly (every 72–96 hours)
		<10 (not on HD)		No recommendation
		On HD		300 mg every 7 days (administer after completion of HD)
Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC) Truvada	One tablet PO once daily	CrCl (mL/min)		Dose		No dose recommendation.
		30–49		One tablet every 48 hours
		<30 or on HD		FDC of TDF/FTC not recommended
Tenofovir Disoproxil Fumarate/Lamivudine (TDF/3TC) Cimduo	One tablet PO once daily	CrCl (mL/min)		Dose		No dose recommendation.
	One tablet PO once daily	<50 or on HD		FDC of TDF/FTC not recommended		No dose recommendation.
Non-Nucleoside Reverse Transcriptase Inhibitors
Doravirine (DOR) Pifeltro	DOR 100 mg PO once daily	No dose adjustment				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No dose recommendation
Doravirine/Tenofovir Disoproxil Fumarate/Lamivudine (DOR/TDF/3TC) Delstrigo	One tablet PO once daily	FDC of DOR/TDF/3TC not recommended if CrCl <50 mL/min or on HD				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No dose recommendation
Efavirenz (EFV)	EFV 600 mg PO once daily on an empty stomach, preferably at bedtime	No dose adjustment necessary.				No dose recommendation; use with caution in people with hepatic impairment.
Efavirenz/Tenofovir Disoproxil Fumarate/Emtricitabine (EFV/TDF/FTC)	One tablet PO once daily on an empty stomach, preferably at bedtime	FDC of EFV/TDF/3TC not recommended if CrCl <50 mL/min or on HD				No dose recommendation; use with caution in people with hepatic impairment.
Efavirenz/Tenofovir Disoproxil Fumarate/Lamivudine (EFV/TDF/3TC) Symfi	One tablet PO once daily on an empty stomach, preferably at bedtime	FDC of EFV/TDF/3TC not recommended if CrCl <50 mL/min or on HD				Child-Pugh Class A: Use with caution Child-Pugh Class B or C: Not recommended
Etravirine (ETR) Intelence	ETR 200 mg PO twice daily	No dose adjustment				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No dose recommendation
Rilpivirine (RPV PO) Edurant	RPV 25 mg PO once daily with food	No dose adjustment				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No dose recommendation
Rilpivirine IM plus Cabotegravir IM (RPV IM and CAB IM) Cabenuva	Monthly Dosing Loading dose: RPV 900 mg/3 mL IM × 1 dose and CAB 600 mg/3 mL IM × 1 dose Continuation phase: RPV 600 mg/2 mL IM every 4 weeks and CAB 400 mg/2 mL IM every 4 weeks Every-2-Months Dosing Loading dose: RPV 900 mg/3 mL IM and CAB 600 mg/3 mL IM monthly for 2 doses Continuation phase: RPV 900 mg/3 mL IM and CAB 600 mg/3 mL IM every 2 months	No dose adjustment CrCl<30 or on HD: No dose adjustment; increase monitoring for adverse events				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No dose recommendation
Rilpivirine/Tenofovir Alafenamide/Emtricitabine (RPV/TAF/FTC) Odefsey	One tablet PO once daily with food	In People With CrCl 15–29 mL/min Not recommended Note: There is insufficient evidence to recommend for or against the use of full-dose, daily FTC in people with CrCl <30 mL/min. To allow people to remain on the FDC product, some Panel members use full-dose, daily FTC in people with CrCl 15–29 mL/min. In People With CrCl <15 mL/min (not on HD) Not recommended In People on Chronic HD No dose adjustment. On HD days, administer after dialysis.				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No dose recommendation
Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine (RPV/TDF/FTC) Complera	One tablet PO once daily with food	FDC of RPV/TDF/FTC not recommended if CrCl <50 mL/min or on HD				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No dose recommendation
Rilpivirine/Dolutegravir (RPV/DTG) Juluca	One tablet PO once daily with food	No dose adjustment necessary. In patients with CrCl <30 mL/min: monitor closely for adverse effects.				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No dose recommendation
Protease Inhibitors
Atazanavir (ATV) Reyataz	ATV 400 mg PO once daily with food or (ATV 300 mg plus RTV 100 mg) PO once daily with food	In People Without Prior ARV Treatment on HD (ATV 300 mg plus RTV 100 mg) once daily with food In ARV-Experienced People on HD ATV and ATV/r are not recommended				For Boosted ATV RTV boosting is not recommended in people with any degree of hepatic impairment. For Unboosted ATV Child-Pugh Class A: No dose adjustment Child-Pugh Class B: ATV 300 mg once daily (unboosted) for people without prior ARV treatment Child-Pugh Class C: Not recommended
Atazanavir/Cobicistat (ATV/c) Evotaz	One tablet PO once daily with food	If Used With TDF Not recommended if CrCl <70 mL/min				Not recommended in people with any degree of hepatic impairment.
Darunavir (DRV) Prezista	In People Without Prior ARV Treatment or ARV- Experienced Treatment With No DRV Mutations (DRV 800 mg plus RTV 100 mg) PO once daily with food. In ARV-Experienced Peopole With at Least One DRV Resistance Mutation (DRV 600 mg plus RTV 100 mg) PO twice daily with food.	No dose adjustment necessary.				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: Not recommended
Darunavir/Cobicistat (DRV/c) Prezcobix	One tablet PO once daily with food	If Used With TDF Not recommended if CrCl <70 mL/min				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: Not recommended
Darunavir/Cobicistat/Tenofovir Alafenamide/Emtricitabine (DRV/c/TAF/FTC) Symtuza	One tablet PO once daily with food	In People With CrCl 15–29 mL/min Not recommended Note: There is insufficient evidence to recommend for or against the use of full-dose, daily FTC in people with CrCl <30 mL/min. To allow people to remain on the FDC product, some Panel members use full-dose, daily FTC in people with CrCl 15–29 mL/min. In People With CrCl <15 mL/min (not on HD) Not recommended In People on Chronic HD No dose adjustment. On HD days, administer after dialysis.				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: Not recommended
Ritonavir (RTV) Norvir	As a PI-Boosting Agent RTV 100–400 mg PO per day with food.	No dose adjustment				Refer to recommendations for the primary (i.e., boosted) PI.
Integrase Strand Transfer Inhibitors
Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/TAF/FTC) Biktarvy	One tablet PO once daily	In People With CrCl 15–29 mL/min Not recommended Note: There is insufficient evidence to recommend for or against the use of full-dose, daily FTC in people with CrCl <30 mL/min. To allow people to remain on the FDC product, some Panel members use full-dose, daily FTC in people with CrCl 15–29 mL/min. In People With CrCl <15 mL/min (not on HD) Not recommended In People on Chronic HD No dose adjustment. On HD days, administer after dialysis				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: Not recommended
Cabotegravir (CAB PO) Vocabria	Treatment (As Optional Oral Lead-In or As Oral Bridging) CAB 30 mg PO once daily, given with RPV 25 mg PO, with food before switching to CAB IM and RPV IM	No dose adjustment				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No recommendation
Cabotegravir IM plus Rilpivirine IM (CAB IM plus RPV IM) Cabenuva	Monthly Dosing Loading dose: CAB 600 mg/3 mL IM × 1 dose and RPV 900 mg/‌3 mL IM × 1 dose Continuation phase: CAB 400 mg/2 mL IM every 4 weeks and RPV 600 mg/2 mL IM every 4 weeks Every 2-Months Dosing Loading dose: CAB 600 mg/3 mL IM and RPV 900 mg/3 mL IM monthly for 2 doses Continuation phase: CAB 600 mg/3 mL IM and RPV 900 mg/3 mL IM every 2 months	No dose adjustment CrCl <30 or on HD: No dose adjustment; increase monitoring for adverse events				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No dose recommendation
Dolutegravir (DTG) Tivicay	DTG 50 mg PO once daily or DTG 50 mg PO twice daily	No dose adjustment				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: Not recommended
Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) Triumeq	One tablet PO once daily	Not FDA recommended if CrCl <30 mL/min due to the 3TC component Note: There is insufficient evidence to recommend for or against the use of full-dose 3TC in people with CrCl <30 mL/min. To allow people to remain on the FDC product, some Panel members use full-dose 3TC.^d				Child-Pugh Class A: People with mild hepatic impairment require a dose reduction of ABC. Use the individual drugs instead of the FDC tablet in these people. Child-Pugh Class B or C: Contraindicated due to the ABC component
Dolutegravir/Lamivudine (DTG/3TC) Dovato	One tablet PO once daily	Not FDA recommended if CrCl <30 mL/min due to the 3TC component Note: There is insufficient evidence to recommend for or against the use of full-dose 3TC in people with CrCl <30 mL/min. To allow people to remain on the FDC product, some Panel members use full-dose 3TC.^d				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: Not recommended
Dolutegravir/Rilpivirine (DTG/RPV) Juluca	One tablet PO once daily with food	No dose adjustment CrCl <30 mL/min or on HD: No dose adjustment; increase monitoring for adverse events.				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No dose recommendation
Elvitegravir/Cobicistat/Tenofovir Alafenamide/Emtricitabine (EVG/c/TAF/FTC) Genvoya	One tablet PO once daily with food	In People With CrCl 15–29 mL/min Not recommended Note: There is insufficient evidence to recommend for or against the use of full-dose, daily FTC in people with CrCl <30 mL/min. To allow people to remain on the FDC product, some Panel members use full-dose, daily FTC in people with CrCl 15–29 mL/min. In People With CrCl <15 mL/min (not on HD) Not recommended In People on Chronic HD No dose adjustment. On HD days, administer after dialysis.				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: Not recommended
Elvitegravir/Cobicistat/Tenofovir Disoproxil Fumarate/Emtricitabine (EVG/c/TDF/FTC) Stribild	One tablet PO once daily with food	EVG/c/TDF/FTC should not be initiated in people with CrCl <70 mL/min. Discontinue EVG/c/TDF/FTC if CrCl declines to <50 mL/min while patient is on therapy.				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: Not recommended
Raltegravir (RAL) Isentress Isentress HD	RAL 400 mg PO twice daily (using Isentress formulation) or RAL 1,200 mg PO once daily (using Isentress HD formulation only)	No dose adjustment				For Isentress Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No dose recommendation For Isentress HD Not recommended for people with hepatic impairment.
CCR5 Antagonist
Maraviroc (MVC) Selzentry	The recommended dose differs based on concomitant medications and potential for drug–drug interactions. See Appendix A, Table 7 for detailed dosing information.	In People With CrCl <30 mL/min or People Who Are on HD Without Potent CYP3A Inhibitors or Inducers MVC 300 mg twice daily; if postural hypotension occurs, reduce to MVC 150 mg twice daily With Potent CYP3A Inducers or Inhibitors Not recommended				No dose recommendations. MVC concentrations will likely be increased in people with hepatic impairment.
CD4 Post-Attachment Inhibitor
Ibalizumab (IBA) Trogarzo	Loading dose: IBA 2,000 mg IV Maintenance dose: IBA 800 mg IV every 2 weeks	No dose adjustment				No dose recommendation.
gp-120 Attachment Inhibitor
Fostemsavir (FTR) Rukobia	FTR 600 mg PO twice daily	No dose adjustment				No dose adjustment
Capsid Inhibitor
Lenacapavir (LEN) Sunlenca	Initiation Option 1 Day 1: 927 mg SQ x 1 dose plus 600 mg PO x 1 dose Day 2: 600 mg PO x 1 dose Initiation Option 2 Day 1: 600 mg PO x 1 dose Day 2: 600 mg PO x 1 dose Day 8: 300 mg PO x 1 dose Day 15: 927 mg SQ x 1 dose Maintenance Dosing 927 mg by SQ injection every 6 months from the date of the last injection (+/-‍2 weeks)	No dose adjustment				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No dose recommendation
^a Refer to Appendix A, Tables 1–10 for additional dosing information. ^b The prescribing information for FTC (Emtriva) recommends adjusted doses for people with CrCl 30–49 mL/min and people on hemodialysis. However, the prescribing information for several FDC products that contain FTC (including Descovy, Biktarvy, Genvoya, and Odefsey) recommends that the standard dose (FTC 200 mg) can be given once daily in these people. The recommendations in this table incorporate the dosing guidance from the FDC products. ^c The prescribing information for 3TC (Epivir) recommends dosage adjustment from 300 mg once daily to 150 mg once daily for people with CrCl 30–49 mL/min. However, the prescribing information for several FDC products that contain 3TC (including ABC plus 3TC, Dovato, and Triumeq) recommends no dose adjustment for CrCl 30–49 mL/min. The recommendation in this table incorporates the dosing guidance from the FDC products. ^d Use of 3TC doses higher than those recommended by the FDA for people with CrCl <30 mL/min has been reported in clinical practice^1-4 and endorsed in the Guidelines for Chronic Kidney Disease in People With HIV for many years⁵; limited published literature has supported the safety of this practice.^2,3 3TC has a wide therapeutic index with no established correlation between elevated concentrations and adverse events. Serious adverse events, such as lactic acidosis and severe hematologic toxicities, have been reported in rare cases; however, these effects typically occurred when 3TC was used in combination with older nucleoside reverse transcriptase inhibitors (such as didanosine, stavudine, zidovudine). Clinicians may consider using the nearest available tablet strength (100 mg or 150 mg) to avoid the need for 3TC oral solution, thereby simplifying ARV regimens and facilitating adherence (BIII). See the Alternative Dose column in 3TC table entry. There is insufficient evidence to recommend for or against the use of full-dose 3TC in people with CrCl <30 mL/min. To allow people to remain on certain FDC products, some Panel members use full-dose 3TC. Key: 3TC = lamivudine; ABC = abacavir; AE = adverse effect; ARV = antiretroviral; ATV = atazanavir; ATV/c = atazanavir/cobicistat; ATV/r = atazanavir/ritonavir; BIC = bictegravir; CAB = cabotegravir; CrCl = creatinine clearance; CYP = cytochrome P450; DOR = doravirine; DRV = darunavir; DRV/c = darunavir/cobicistat; DTG = dolutegravir; EFV = efavirenz; ETR = etravirine; EVG/c = elvitegravir/cobicistat; FDA = U.S. Food and Drug Administration; FDC = fixed-dose combination; FTC = emtricitabine; FTR = fostemsavir; HBV = hepatitis B virus; HD = hemodialysis; IBA = ibalizumab; IM = intramuscular; IV = intravenous; LEN = lenacapavir; MVC = maraviroc; the Panel = Panel on Antiretroviral Guidelines for Adults and Adolescents; PK = pharmacokinetic; PI = protease inhibitor; PO = orally; RAL = raltegravir; RPV = rilpivirine; RTV = ritonavir; SQ = subcutaneous; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate

Child-Pugh Classifications

Child-Pugh Score
Component	Points Scored
Component	1	2	3
Encephalopathy^a	None	Grade 1–2	Grade 3–4
Ascites	None	Mild or controlled by diuretics	Moderate or refractory despite diuretics
Albumin	>3.5 g/dL	2.8–3.5 g/dL	<2.8 g/dL
Total Bilirubin, or	<2 mg/dL (<34 µmol/L)	2–3 mg/dL (34–50 µmol/L)	>3 mg/dL (>50 µmol/L)
Modified Total Bilirubin^b	<4 mg/dL	4–7 mg/dL	>7 mg/dL
Prothrombin Time (Seconds Prolonged), or	<4	4–6	>6
International Normalized Ratio (INR)	<1.7	1.7–2.3	>2.3
^a Encephalopathy Grades Grade 1: Mild confusion, anxiety, restlessness, fine tremor, slowed coordination Grade 2: Drowsiness, disorientation, asterixis Grade 3: Somnolent but rousable, marked confusion, incomprehensible speech, incontinence, hyperventilation Grade 4: Coma, decerebrate posturing, flaccidity ^b Modified total bilirubin is used for patients who have Gilbert’s syndrome or who are taking atazanavir.

Child-Pugh Classification	Total Child-Pugh Score^a
Class A (Mild)	5–6 points
Class B (Moderate)	7–9 points
Class C (Severe)	>9 points
^a Sum of points for each component of the Child-Pugh Score.

Back to Appendix B

Appendix B. Antiretroviral Dosing Recommendations in Adults With Renal or Hepatic Insufficiency

Child-Pugh Classifications