Appendix B: Antiretroviral Dosing in Adults with Renal or Hepatic Insufficiency

Generic Name (Abbreviation) Trade Name	Usual Dose^a	Dosing in Adults with Renal Insufficiency				Dosing in Adults with Hepatic Impairment
Some FDC products are not recommended in persons with different degrees of renal insufficiency. The recommendations for individual FDCs based on CrCl level are outlined below. CrCl <70 mL/min: Initiation of Stribild is not recommended. CrCl <50 mL/min: FDCs not recommended: Atripla, Cimduo, Complera, Delstrigo, Truvada, Symfi, Symfi-Lo CrCl <30 mL/min: FDCs not recommended: Dovato, Epzicom, Triumeq CrCl <30 mL/min and* not on HD:* FDCs not recommended: Biktarvy, Descovy, Genvoya, Odefsey, and Symtuza. The component drugs in some of the FDC products listed above may be prescribed as individual formulations with dose adjustment based on CrCl level as indicated below in this table.
NRTIs
Abacavir (ABC) Ziagen	ABC 300 mg PO twice daily or ABC 600 mg PO once daily	No dose adjustment necessary.				Child-Pugh Class A: ABC 200 mg PO twice daily (use oral solution) Child-Pugh Class B or C: Contraindicated
Abacavir/Lamivudine (ABC/3TC) Epzicom	One tablet PO once daily	Not recommended if CrCl <30 mL/min. Instead, use the individual component drugs and adjust 3TC dose according to CrCl.				Child-Pugh Class A: Patients with mild hepatic impairment require a dose reduction of ABC. Use the individual drugs instead of the FDC tablet in these patients. 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	Dose by Formulation				No dose recommendation.
		CrCl (mL/min)	Capsule		Solution
		30–49	200 mg every 48 hours		120 mg every 24 hours
		15–29	200 mg every 72 hours		80 mg every 24 hours
		<15	200 mg every 96 hours		60 mg every 24 hours
		On HD^b	200 mg every 24 hours		240 mg every 24 hours
Lamivudine^c (3TC) Epivir	3TC 300 mg PO once daily or 3TC 150 mg PO twice daily	CrCl (mL/min)		Dose		No dose adjustment necessary.
		15–29		1 × 150 mg, then 100 mg every 24 hours
		5–14		1 × 150 mg, then 50 mg every 24 hours
		<5 or on HD		1 × 50 mg, then 25 mg every 24 hours
Tenofovir Alafenamide (TAF) Vemlidy	Vemlidy is available as a 25-mg tablet for the treatment of HBV.	CrCl (mL/min)		Dose		Child-Pugh Class B or C: Not recommended
		<15 and not on HD		Not recommended
		On HD		One tablet PO once daily
Tenofovir Alafenamide/Emtricitabine (TAF/FTC) Descovy	TAF for HIV treatment is only available as a component of FDC tablets (i.e., in Descovy, Genvoya, Odefsey, Biktarvy, and Symtuza). TAF 10 mg PO daily with EVG/c (Genvoya) or DRV/c (Symtuza) TAF 25 mg PO 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
		<30 and not on HD		Not recommended
		<30 and on HD		One tablet once daily
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 and not on HD		No recommendation
		On HD		300 mg every 7 days
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		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		Not recommended		No dose recommendation.
NNRTIs
Doravirine (DOR) Pifeltro	DOR 100 mg PO once daily	No dose adjustment required in mild, moderate, or severe renal impairment. Has not been studied in individuals with ESRD or on HD.				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: Not studied
Doravirine/Tenofovir Disoproxil Fumarate/Lamivudine (DOR/TDF/3TC) Delstrigo	One tablet PO once daily	Not recommended if CrCl <50 mL/min.				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: Not studied
Efavirenz (EFV) Sustiva	EFV 600 mg PO once daily on an empty stomach, preferably at bedtime	No dose adjustment necessary.				No dose recommendation; use with caution in patients with hepatic impairment.
Efavirenz/Tenofovir Disoproxil Fumarate/Emtricitabine (EFV/TDF/FTC) Atripla	One tablet PO once daily on an empty stomach, preferably at bedtime	Not recommended if CrCl <50 mL/min. Instead, use the individual component ARVs and adjust TDF and FTC doses according to CrCl level.				No dose recommendation; use with caution in patients with hepatic impairment.
Efavirenz 600 mg/Tenofovir Disoproxil Fumarate/Lamivudine (EFV/TDF/3TC) Symfi	One tablet PO once daily on an empty stomach, preferably at bedtime	Not recommended if CrCl <50 mL/min or if patient is on HD. Instead, use the individual component ARVs and adjust TDF and 3TC doses according to CrCl level.				Not recommended for patients with moderate or severe hepatic impairment. Use with caution in patients with mild hepatic impairment.
Efavirenz 400 mg/Tenofovir Disoproxil Fumarate/Lamivudine (EFV/TDF/3TC) Symfi Lo	One tablet PO once daily on an empty stomach, preferably at bedtime	Not recommended if CrCl <50 mL/min or if patient is on HD. Instead, use the individual component ARVs and adjust TDF and 3TC doses according to CrCl level.				Not recommended for patients with moderate or severe hepatic impairment. Use with caution in patients with mild hepatic impairment.
Etravirine (ETR) Intelence	ETR 200 mg PO twice daily	No dose adjustment necessary.				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No dose recommendation
Nevirapine (NVP) Viramune or Viramune XR	NVP 200 mg PO twice daily or NVP 400 mg PO once daily (using Viramune XR formulation)	No dose adjustment for patients with renal impairment. Patients on HD should receive an additional dose of NVP 200 mg following each dialysis treatment.				Child-Pugh Class A: No dose adjustment Child-Pugh Class B or C: Contraindicated
Rilpivirine (RPV PO) Edurant	RPV 25 mg PO once daily	No dose adjustment necessary.				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-month 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 necessary for mild or moderate renal impairment. For patients with severe renal impairment or on HD, increase monitoring for adverse events.				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No recommendation
Rilpivirine/Tenofovir Alafenamide/Emtricitabine (RPV/TAF/FTC) Odefsey	One tablet PO once daily	In Patients on Chronic HD One tablet once daily. On HD days, administer after dialysis. Not recommended in patients with CrCl <30 mL/min who are not receiving chronic HD.				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	Not recommended if CrCl <50 mL/min. Instead, use the individual component ARVs and adjust TDF and FTC doses according to CrCl level.				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
PIs
Atazanavir (ATV) Reyataz	ATV 400 mg PO once daily or (ATV 300 mg plus RTV 100 mg) PO once daily	No dose adjustment for patients with renal dysfunction who do not require HD. In ARV-Naive Patients on HD (ATV 300 mg plus RTV 100 mg) once daily In ARV-Experienced Patients on HD ATV and ATV/r are not recommended				Child-Pugh Class A: No dose adjustment Child-Pugh Class B: ATV 300 mg once daily (unboosted) for ARV-naive patients only Child-Pugh Class C: Not recommended RTV boosting is not recommended in patients with hepatic impairment.
Atazanavir/Cobicistat (ATV/c) Evotaz	One tablet PO once daily	If Used with TDF Not recommended if CrCl <70 mL/min				Not recommended in patients with hepatic impairment.
Darunavir (DRV) Prezista	In ARV-Naive Patients and ARV-Experienced Patients with No DRV Resistance Mutations (DRV 800 mg plus RTV 100 mg) PO once daily with food In ARV-Experienced Patients with at Least One DRV Resistance Mutation (DRV 600 mg plus RTV 100 mg) PO twice daily	No dose adjustment necessary.				In Patients with Mild-to-Moderate Hepatic Impairment: No dose adjustment In Patients with Severe Hepatic Impairment: Not recommended
Darunavir/Cobicistat (DRV/c) Prezcobix	One tablet PO once daily	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	In Patients on Chronic HD One tablet once daily. On HD days, administer after dialysis. Not recommended in patients with CrCl <30 mL/min who are not receiving chronic HD.				Not recommended for patients with severe hepatic impairment.
Lopinavir/Ritonavir (LPV/r) Kaletra	(LPV/r 400 mg/100 mg) PO twice daily or (LPV/r 800 mg/200 mg) PO once daily	Avoid once-daily dosing in patients on HD.				No dose recommendation; use with caution in patients with hepatic impairment.
Ritonavir (RTV) Norvir	As a PI-Boosting Agent RTV 100–400 mg PO per day	No dose adjustment necessary.				Refer to recommendations for the primary (i.e., boosted) PI.
INSTIs
Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/TAF/FTC) Biktarvy	One tablet PO once daily	In Patients on Chronic HD One tablet once daily. On HD days, administer after dialysis. Patients receiving chronic HD should be virologically suppressed before Biktarvy is initiated. Not recommended in patients with CrCl <30 mL/min who are not receiving chronic HD.				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 Pre-exposure Prophylaxis (Optional Oral Lead-In) CAB 30 mg PO once daily before switching to CAB IM	No dose adjustment necessary.				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No recommendation
Cabotegravir (CAB IM) Apretude	Pre-exposure Prophylaxis Loading dose: CAB 600 mg/3 mL IM monthly for 2 doses Continuation phase: CAB 600 mg/3 mL IM every 2 months	No dose adjustment necessary.				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-month 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 necessary for mild or moderate renal impairment. For patients with severe renal impairment or on HD, increase monitoring for adverse events.				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No recommendation
Dolutegravir (DTG) Tivicay	DTG 50 mg PO once daily or DTG 50 mg PO twice daily	No dose adjustment necessary.				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 recommended if CrCl <30 mL/min. Instead, use the individual component drugs and adjust 3TC dose according to CrCl.				Child-Pugh Class A: Patients with mild hepatic impairment require a dose reduction of ABC. Use the individual drugs instead of the FDC tablet in these patients. Child-Pugh Class B or C: Contraindicated due to the ABC component
Dolutegravir/Lamivudine (DTG/3TC) Dovato	One tablet PO once daily	Not recommended if CrCl <30 mL/min. Instead, use the individual component drugs and adjust 3TC dose according to CrCl.				Child-Pugh Class C: Not recommended
Dolutegravir/Rilpivirine (DTG/RPV) 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
Elvitegravir/Cobicistat/Tenofovir Alafenamide/Emtricitabine (EVG/c/TAF/FTC) Genvoya	One tablet PO once daily	In Patients on Chronic HD One tablet once daily. On HD days, administer after dialysis. Not recommended in patients with CrCl <30 mL/min who are not receiving chronic HD.				In Patients with Mild-to-Moderate Hepatic Insufficiency: No dose adjustment necessary In Patients with Severe Hepatic Insufficiency: Not recommended
Elvitegravir/Cobicistat/Tenofovir Disoproxil Fumarate/Emtricitabine (EVG/c/TDF/FTC) Stribild	One tablet PO once daily	EVG/c/TDF/FTC should not be initiated in patients with CrCl <70 mL/min. Discontinue EVG/c/TDF/FTC if CrCl declines to <50 mL/min while patient is on therapy.				In Patients with Mild-to-Moderate Hepatic Insufficiency: No dose adjustment necessary In Patients with Severe Hepatic Insufficiency: 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 necessary.				In Patients with Mild-to-Moderate Hepatic Insufficiency: No dose adjustment necessary In Patients with Severe Hepatic Insufficiency: No recommendation
Fusion Inhibitor
Enfuvirtide (T-20) Fuzeon	T-20 90 mg SQ twice daily	No dose adjustment necessary.				No dose adjustment necessary.
CCR5 Antagonist
Maraviroc (MVC) Selzentry	The recommended dose differs based on concomitant medications and potential for drug-drug interactions. See Appendix B, Table 8 for detailed dosing information.	In Patients with CrCl <30 mL/min or Patients 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 patients 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 recommended.				No recommendation.
gp-120 Attachment Inhibitor
Fostemsavir (FTR) Rukobia	FTR 600 mg PO twice daily	No dose adjustment recommended.				No dose adjustment recommended.
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 recommended.				Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No recommendation
^a Refer to Appendix B, Tables 1–10 for additional dosing information. ^b The prescribing information for emtricitabine (Emtriva) recommends a dose of 200 mg every 96 hours for patients with CrCl <15 mL/min or on hemodialysis. However, the prescribing information for several FDC products that contain emtricitabine (including Descovy, Biktarvy, Genvoya, and Odefsey) recommends that the standard dose (emtricitabine 200 mg) can be given once daily in these patients (i.e., on the days of hemodialysis, administer standard dose after completion of dialysis). The recommendation in this table incorporates the dosing guidance from the FDC products. ^c The prescribing information for lamivudine (Epivir) recommends dosage adjustment from 300 mg once daily to 150 mg once daily for patients with CrCl 30–49 mL/min. However, the prescribing information for several FDC products that contain lamivudine (including Epzicom, 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. Key: 3TC = lamivudine; ABC = abacavir; ATV = atazanavir; ATV/c = atazanavir/cobicistat; ATV/r = atazanavir/ritonavir; BIC = bictegravir; CAB = cabotegravir; COBI = cobicistat; CrCl = creatinine clearance; CYP = cytochrome P; DOR = doravirine; DRV = darunavir; DRV/c = darunavir/cobicistat; DTG = dolutegravir; EFV = efavirenz; ESRD = end stage renal disease; ETR = etravirine; EVG = elvitegravir; EVG/c = elvitegravir/cobicistat; FDC = fixed-dose combination; FTC = emtricitabine; FTR = Fostemsavir; HBV = hepatitis B virus; HD = hemodialysis; IBA = ibalizumab; IM = intramuscular; INSTI = integrase strand transfer inhibitor; IV = intravenous; LEN = lenacapavir; LPV = lopinavir; LPV/r = lopinavir/ritonavir; MVC = maraviroc; NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside reverse transcriptase inhibitor; NVP = nevirapine; PI = protease inhibitor; PO = orally; RAL = raltegravir; RPV = rilpivirine; RTV = ritonavir; SQ = subcutaneous; T 20 = enfuvirtide; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate; XR = extended release

Creatinine Clearance Calculation

Male:

Female:

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	5–6 points
Class B	7–9 points
Class C	>9 points
^a Sum of points for each component of the Child-Pugh Score.

Back to Appendix B

Appendix B, Table 12. Antiretroviral Dosing Recommendations in Adults with Renal or Hepatic Insufficiency