Appendix B: Drug Characteristics Tables

Antiretroviral Dosing Recommendations in Patients with Renal or Hepatic Insufficiency

Appendix B, Table 10. Antiretroviral Dosing Recommendations in Patients with Renal or Hepatic Insufficiency

The older ARV drugs ddI, d4T, FPV, IDV, NFV, SQV, and TPV are no longer commonly used in clinical practice and have been removed from this table. Please refer to the July 10, 2019, guidelines in the Guidelines Archive section of ClinicalInfo or to the FDA product labels for these drugs for recommendations on dosing in persons with renal or hepatic insufficiency.

See the reference section at the end of this table for CrCl calculation formulas and criteria for Child-Pugh classification.

Appendix B, Table 10. Antiretroviral Dosing Recommendations in Patients with Renal or Hepatic Insufficiency
Generic Name
(Abbreviations)
Trade Name		 Usual Daily Dosea Dosing in Persons 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, Combivir, Complera, Delstrigo, Dovato, Epzicom, Triumeq, or Trizivir.
  • CrCl <30 mL/min: FDCs not recommended: Biktarvy and Truvada.
  • CrCl <30 mL/min and not on HD: FDCs not recommended: Descovy, Genvoya, Odefsey, 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
Emtricitabine
(FTC)
Emtriva		 FTC 200 mg oral capsule once daily
or
FTC 240 mg (24 mL) oral solution once daily
 
Dose by Formulation
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
No dose recommendation.
Lamivudine
(3TC)
Epivir		 3TC 300 mg PO once daily
or
3TC 150 mg PO twice daily
CrCl (mL/min) Dose
30–49 150 mg every 24 hours
15–29 1 x 150 mg, then 100 mg every 24 hours
5–14 1 x 150 mg, then 50 mg every 24 hours
<5 or on HDb 1 x 50 mg, then 25 mg every 24 hours
No dose adjustment necessary.
Tenofovir Alafenamide
(TAF)
Vemlidy		 Vemlidy is available as a 25-mg tablet for the treatment of HBV.
CrCl (mL/min) Dose
<15 and not on HD Not recommended
On HDb One tablet once daily.
Child-Pugh Class B or C: Not recommended
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
<30 and not on HD Not recommended
<30 and on HDb One tablet once daily.
Child-Pugh Class A or B: No dose adjustment

Child-Pugh Class C: No dose recommendation
Tenofovir Disoproxil Fumarate
(TDF)
Viread		 TDF 300 mg PO once daily
CrCl (mL/min) Dose
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 HDb 300 mg every 7 days
No dose adjustment necessary.
Tenofovir Disoproxil Fumarate/ Emtricitabine
(TDF/FTC)
Truvada		 One tablet PO once daily
CrCl (mL/min) Dose
30–49 One tablet every 48 hours
<30 or on HD Not recommended
No dose recommendation.
Tenofovir Disoproxil Fumarate/ Lamivudine
(TDF/3TC)
Cimduo		 One tablet PO once daily
CrCl (mL/min) Dose
<50 or on HD Not recommended
No dose recommendation.
Zidovudine
(ZDV)
Retrovir		 ZDV 300 mg PO twice daily
CrCl (mL/min) Dose
<15 or on HDb 100 mg three times a day or 300 mg once daily
No dose recommendation.
NNRTIs
Doravirine
(DOR)
Pifeltro		 One tablet 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 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 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)
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/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 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 once daily Not recommended for use in patients with CrCl <30 mL/min. Child-Pugh Class A or B: No dose adjustment

Child-Pugh Class C: Not recommended
Dolutegravir
(DTG)
Tivicay		 DTG 50 mg once daily
or
DTG 50 mg 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 once daily Not recommended if CrCl <50 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/ 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 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 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 twice daily (using Isentress formulation)
or
RAL 1,200 mg 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.
a Refer to Appendix B, Tables 1–9 for additional dosing information.             

b On dialysis days, the patient should take the dose after the HD session.

Key: 3TC = lamivudine; ABC = abacavir; ARV = antiretroviral; ATV = atazanavir; ATV/c = atazanavir/cobicistat; ATV/r = atazanavir/ritonavir; BIC = bictegravir; CAPD = chronic ambulatory peritoneal dialysis; COBI = cobicistat; CrCl = creatinine clearance; CYP = cytochrome P; d4T = stavudine; ddI = didanosine; DOR = doravirine; DRV = darunavir; DRV/c = darunavir/cobicistat; DTG = dolutegravir; EC = enteric coated; EFV = efavirenz; ESRD = end stage renal disease; ETR = etravirine; EVG = elvitegravir; EVG/c = elvitegravir/cobicistat; FDA = Food and Drug Administration; FDC = fixed-dose combination; FPV = fosamprenavir; FTC = emtricitabine; HBV = hepatitis B virus; HD = hemodialysis; IBA = ibalizumab; IDV = indinavir; INSTI = integrase strand transfer inhibitor; IV = intravenous; LPV = lopinavir; LPV/r = lopinavir/ritonavir; MVC = maraviroc; NFV = nelfinavir; 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; SQV = saquinavir; T-20 = enfuvirtide; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate; TPV = tipranavir; XR = extended release; ZDV = zidovudine
Creatine Clearance
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 indinavir or atazanavir.

Child-Pugh Classification Scores
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

Appendix B: Drug Characteristics Tables

Antiretroviral Dosing Recommendations in Patients with Renal or Hepatic Insufficiency

Appendix B, Table 10. Antiretroviral Dosing Recommendations in Patients with Renal or Hepatic Insufficiency

The older ARV drugs ddI, d4T, FPV, IDV, NFV, SQV, and TPV are no longer commonly used in clinical practice and have been removed from this table. Please refer to the July 10, 2019, guidelines in the Guidelines Archive section of ClinicalInfo or to the FDA product labels for these drugs for recommendations on dosing in persons with renal or hepatic insufficiency.

See the reference section at the end of this table for CrCl calculation formulas and criteria for Child-Pugh classification.

Appendix B, Table 10. Antiretroviral Dosing Recommendations in Patients with Renal or Hepatic Insufficiency
Generic Name
(Abbreviations)
Trade Name		 Usual Daily Dosea Dosing in Persons 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, Combivir, Complera, Delstrigo, Dovato, Epzicom, Triumeq, or Trizivir.
  • CrCl <30 mL/min: FDCs not recommended: Biktarvy and Truvada.
  • CrCl <30 mL/min and not on HD: FDCs not recommended: Descovy, Genvoya, Odefsey, 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
Emtricitabine
(FTC)
Emtriva		 FTC 200 mg oral capsule once daily
or
FTC 240 mg (24 mL) oral solution once daily
 
Dose by Formulation
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
No dose recommendation.
Lamivudine
(3TC)
Epivir		 3TC 300 mg PO once daily
or
3TC 150 mg PO twice daily
CrCl (mL/min) Dose
30–49 150 mg every 24 hours
15–29 1 x 150 mg, then 100 mg every 24 hours
5–14 1 x 150 mg, then 50 mg every 24 hours
<5 or on HDb 1 x 50 mg, then 25 mg every 24 hours
No dose adjustment necessary.
Tenofovir Alafenamide
(TAF)
Vemlidy		 Vemlidy is available as a 25-mg tablet for the treatment of HBV.
CrCl (mL/min) Dose
<15 and not on HD Not recommended
On HDb One tablet once daily.
Child-Pugh Class B or C: Not recommended
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
<30 and not on HD Not recommended
<30 and on HDb One tablet once daily.
Child-Pugh Class A or B: No dose adjustment

Child-Pugh Class C: No dose recommendation
Tenofovir Disoproxil Fumarate
(TDF)
Viread		 TDF 300 mg PO once daily
CrCl (mL/min) Dose
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 HDb 300 mg every 7 days
No dose adjustment necessary.
Tenofovir Disoproxil Fumarate/ Emtricitabine
(TDF/FTC)
Truvada		 One tablet PO once daily
CrCl (mL/min) Dose
30–49 One tablet every 48 hours
<30 or on HD Not recommended
No dose recommendation.
Tenofovir Disoproxil Fumarate/ Lamivudine
(TDF/3TC)
Cimduo		 One tablet PO once daily
CrCl (mL/min) Dose
<50 or on HD Not recommended
No dose recommendation.
Zidovudine
(ZDV)
Retrovir		 ZDV 300 mg PO twice daily
CrCl (mL/min) Dose
<15 or on HDb 100 mg three times a day or 300 mg once daily
No dose recommendation.
NNRTIs
Doravirine
(DOR)
Pifeltro		 One tablet 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 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 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)
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/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 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 once daily Not recommended for use in patients with CrCl <30 mL/min. Child-Pugh Class A or B: No dose adjustment

Child-Pugh Class C: Not recommended
Dolutegravir
(DTG)
Tivicay		 DTG 50 mg once daily
or
DTG 50 mg 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 once daily Not recommended if CrCl <50 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/ 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 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 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 twice daily (using Isentress formulation)
or
RAL 1,200 mg 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.
a Refer to Appendix B, Tables 1–9 for additional dosing information.             

b On dialysis days, the patient should take the dose after the HD session.

Key: 3TC = lamivudine; ABC = abacavir; ARV = antiretroviral; ATV = atazanavir; ATV/c = atazanavir/cobicistat; ATV/r = atazanavir/ritonavir; BIC = bictegravir; CAPD = chronic ambulatory peritoneal dialysis; COBI = cobicistat; CrCl = creatinine clearance; CYP = cytochrome P; d4T = stavudine; ddI = didanosine; DOR = doravirine; DRV = darunavir; DRV/c = darunavir/cobicistat; DTG = dolutegravir; EC = enteric coated; EFV = efavirenz; ESRD = end stage renal disease; ETR = etravirine; EVG = elvitegravir; EVG/c = elvitegravir/cobicistat; FDA = Food and Drug Administration; FDC = fixed-dose combination; FPV = fosamprenavir; FTC = emtricitabine; HBV = hepatitis B virus; HD = hemodialysis; IBA = ibalizumab; IDV = indinavir; INSTI = integrase strand transfer inhibitor; IV = intravenous; LPV = lopinavir; LPV/r = lopinavir/ritonavir; MVC = maraviroc; NFV = nelfinavir; 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; SQV = saquinavir; T-20 = enfuvirtide; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate; TPV = tipranavir; XR = extended release; ZDV = zidovudine
Creatine Clearance
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 indinavir or atazanavir.

Child-Pugh Classification Scores
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
Updated
Reviewed
Dec. 18, 2019

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