Appendix B, Table 11. Antiretroviral Dosing Recommendations in Persons with Renal or Hepatic Insufficiency

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Appendix B, Table 11. Antiretroviral Dosing Recommendations in Persons with Renal or Hepatic Insufficiency
Generic Name
(Abbreviation)
Trade Name
Usual Dosea Dosing in Adults and Adolescents with Renal Insufficiency Dosing in Persons 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 HDb

200 mg every 24 hours

240 mg every 24 hours

Lamivudinec
(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.

<50 or on HD

Not recommended

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.

Fostemsavir
(FTR)
Rukobia

FTR 600 mg PO twice daily

No dose adjustment recommended.

No dose adjustment recommended.

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; EV = 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; 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: [(140 - age in years) x (weight in kg)] ÷ 72 x (serum creatinine)

Female: [(140 - age in years) x (weight in kg) x (0.85)] ÷ 72 x (serum creatinine)

 

Child-Pugh Score
Component Points Scored
1 2 3
Encephalopathya 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 Bilirubinb <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 Scorea
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