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Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents

Appendix B: Drug Characteristics Tables

Antiretroviral Dosing Recommendations in Patients with Renal or Hepatic Insufficiency

(Last updated: May 1, 2014; last reviewed: April 8, 2015)

Appendix B, Table 7. Antiretroviral Dosing Recommendations in Patients with Renal or Hepatic Insufficiency

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

Appendix B, Table 7. Antiretroviral Dosing Recommendations in Patients with Renal or Hepatic Insufficiency
ARVs
Generic Name (Abbreviation)/
Trade Name
Usual Daily Dosea 
 Dosing in Renal Insufficiencyb
Dosing in Hepatic Impairment 
NRTIs
Stribild should not be initiated in patients with CrCl <70 mL/min. Use of the following fixed-dose combinations is not recommended in patients with CrCl <50 mL/min: Atripla, Combivir, Complera, Epzicom, Stribild, Triumeq, or Trizivir. Use of Truvada is not recommended in patients with CrCl <30 mL/min. 
Abacavir
(ABC)
Ziagen
300 mg PO BID No dosage adjustment necessary. Child-Pugh Score 5–6
  • 200 mg PO BID (use oral solution)
Child-Pugh Score >6
  • Contraindicated
Didanosine EC
(ddI)
Videx EC
Body Weight ≥60 kg:
  • 400 mg PO once daily
Body Weight <60 kg:
  • 250 mg PO once daily
Dose (Once Daily)
CrCl
(mL/min)
≥60 kg <60 kg
 30-59 200 mg 125 mg
 10-29 125 mg 125 mg
 <10, HDc, CAPD 125 mg 75 mg oral solution
 
 
 
 
 
 
  
No dosage adjustment necessary.
Didanosine Oral Solution
(ddI)
Videx
Body Weight ≥60 kg
  • 200 mg PO BID, or
  • 400 mg PO once daily
Body Weight <60 kg
  • 250 mg PO once daily, or
  • 125 mg PO BID
 
Dose (Once Daily)
CrCl
(mL/min)
≥60 kg <60 kg
30-59 200 mg 150 mg
10-29 150 mg 100 mg
<10, HDc, CAPD 100 mg 75 mg

No dosage adjustment necessary
Emtricitabine
(FTC)
Emtriva
200 mg oral capsule once daily
or
240 mg (24 mL) oral solution once daily
 Dose
CrCL
(mL/min)
Capsule Solution
 30-49 200 mg q48h 120 mg q24h
 15-29 200 mg q72h 80 mg q24h
 <15 or HDc 200 mg q96h 60 mg q24h

No dosage recommendation.
Lamivudine
(3TC)
Epivir
300 mg PO once daily
or
150 mg PO BID
CrCl (mL/min) Dose
 30-49  150 mg q24h
 15-29  1 x 150 mg, then 100 mg q24h
 5-14  1 x 150 mg, then 50 mg q24h
 <5 or HDc  1 x 50 mg, then 25 mg q24h

No dosage adjustment necessary.
Stavudine
(d4T)
Zerit
Body Weight ≥60 kg:
  • 40 mg PO BID
Body Weight <60 kg:
  • 30 mg PO BID
Dose
CrCl (mL/min)  ≥60 kg <60 kg
 26-50  20 mg q12h 15 mg q12h
 10-25 or on HDc 20 mg q24h 15 mg q24h

No dosage recommendation.
Tenofovir Disoproxil Fumarate 
(TDF)
Viread

300 mg PO once daily
CrCl (mL/min) Dose
30-49 300 mg q48h
10-29 300 mg twice weekly (every 72-96 hours)
<10 and not on HD No recommendation
On HDc 300 mg q7d

No dosage adjustment necessary.
Emtricitabine
(FTC)
plus
Tenofovir Disoproxil Fumarate
(TDF)
Truvada
1 tablet PO once daily
CrCl (mL/min)  Dose
30-49 1 tablet q48h
<30 or on HD Not recommended
No dosage recommendation.
Zidovudine
(AZT, ZDV)
Retrovir
 300 mg PO BID
CrCL (mL/min)  Dose
 <15 or HDc 100 mg TID or 300 mg once daily

No dosage recommendation.
NNRTIs
Delavirdine
(DLV)
Rescriptor
400 mg PO TID No dosage adjustment necessary. No dosage recommendation; use with caution in patients with hepatic impairment.
Efavirenz
(EFV)
Sustiva
600 mg PO once daily, at or before bedtime No dosage adjustment necessary No dosage recommendation; use with caution in patients with hepatic impairment.
Efavirenz (EFV)
plus
Tenofovir Disoproxil Fumarate 
(TDF)
plus
Emtricitabine (FTC)
Atripla
1 tablet PO once daily Not recommended for use in patients with CrCl <50 mL/min. Instead use the individual drugs of the fixed-dose combination and adjust TDF and FTC doses according to CrCl level.
Etravirine
(ETR)
Intelence
200 mg PO BID   No dosage adjustment necessary. Child-Pugh Class A or B:
  • No dosage adjustment
Child-Pugh Class C:
  • No dosage recommendation
Nevirapine
(NVP)
Viramune or Viramune XR
200 mg PO BID
or
400 mg PO once daily (using Viramune XR formulation)
Patients on HD
  • Limited data; no dosage recommendation.
Child-Pugh Class A:
  • No dosage adjustment
Child-Pugh Class B or C:
  • Contraindicated
Rilpivirine
(RPV)
Edurant
 
25 mg PO once daily No dosage adjustment necessary. Child-Pugh Class A or B:
No dosage adjustment

Child-Pugh Class C:

No dosage recommendation
Rilpivirine (RPV) 
plus 
Tenofovir Disoproxil Fumarate (TDF) 
plus 
Emtricitabine (FTC)
Complera
1 tablet PO once daily Not recommended for use in patients with CrCl <50 mL/min. Instead use the individual drugs of the fixed-dose combination and adjust TDF and FTC doses levels according to CrCl level. Child-Pugh Class A or B:
  • No dosage adjustment
Child-Pugh Class C:
  • No dosage recommendation
 PIs
Atazanavir
(ATV)
Reyataz
400 mg PO once daily
or
(ATV 300 mg plus RTV 100 mg) PO once daily
No dosage adjustment for patients with renal dysfunction who do not require HD.

ARV-Naive Natients on HD
:
  • (ATV 300 mg plus RTV 100 mg) once daily
ARV-Experienced Patients on HD:
  • ATV or ATV/r not recommended
Child-Pugh Class B:
  • 300 mg once daily
Child-Pugh Class C
  • Not recommended
RTV boosting is not recommended in patients with hepatic impairment (Child-Pugh Class B or C).
Atazanavir
(ATV)
plus
Cobicistat
(COBI)
Evotaz
1 tablet PO once daily If Used with TDF:
  • Not recommended for use in patients with CrCl <70 mL/min.
If Not Used with TDF:
  • No dosage adjustment for patients with renal dysfunction who do not require HD.
No dosage recommendation; not recommended in patients with hepatic impairment.
Darunavir
(DRV)
Prezista
ARV-Naive Patients and ARV-Experienced Patients with No DRV Resistance Mutations:
  • (DRV 800 mg plus RTV 100 mg) PO once daily 
ARV-Experienced Patients with at Least One DRV Resistance Mutation:
  • (DRV 600 mg plus RTV 100 mg) PO BID
 No dosage adjustment necessary. Mild-to-Moderate Hepatic Impairment:
  • No dosage adjustment
Severe Hepatic Impairment:
  • Not recommended
Darunavir
(DRV)
plus
Cobicistat
(COBI)
Prezcobix
1 tablet PO once daily (only recommended for patients without DRV-associated resistance mutations) If Used with TDF:
  • Not recommended for use in patients with CrCl <70 mL/min.
If Not Used with TDF:
  • No dosage adjustment necessary.
Child-Pugh Class A or B:
  • No dosage adjustment
Child-Pugh Class C
  • Not recommended
Fosamprenavir
(FPV)
Lexiva
1400 mg PO BID 
or 
(FPV 1400 mg plus RTV 100–200 mg) PO once daily 
or
(FPV 700 mg plus RTV 100 mg) PO BID
 
 No dosage adjustment necessary. PI-Naive Patients Only:
Child-Pugh Score 5–9:
  • 700 mg BID
Child-Pugh Score 10–15:
  • 350 mg BID
PI-Naive or PI-Experienced Patients:
Child-Pugh Score 5–6
  • (700 mg BID plus RTV 100 mg) once daily
Child-Pugh Score 7–9
  • (450 mg BID plus RTV 100 mg) once daily
Child-Pugh Score 10–15
  • (300 mg BID plus RTV 100 mg) once daily
Indinavir
(IDV)
Crixivan

800 mg PO q8h No dosage adjustment necessary. Mild-to-Moderate Hepatic Insufficiency Because of Cirrhosis
  • 600 mg q8h
Lopinavir/ritonavir
(LPV/r)
Kaletra
(LPV 400 mg plus RTV 100 mg) PO BID 
or 
(LPV 800 mg plus RTV 200 mg) PO once daily 
Avoid once-daily dosing in patients on HD. No dosage recommendation; use with caution in patients with hepatic impairment.
Nelfinavir
(NFV)
Viracept
1250 mg PO BID No dosage adjustment necessary. Mild Hepatic Impairment:
  • No dosage adjustment
Moderate-to-Severe Hepatic Impairment:
  • Do not use
Ritonavir
(RTV)
Norvir
As a PI-Boosting Agent:
  • 100–400 mg per day
No dosage adjustment necessary. Refer to recommendations for the primary PI.
Saquinavir
(SQV)
Invirase
(SQV 1000 mg plus RTV 100 mg) PO BID
No dosage adjustment necessary. Mild-to-Moderate Hepatic Impairment:
  • Use with caution
Severe Hepatic Impairment
  • Contraindicated
Tipranavir
(TPV)
Aptivus
(TPV 500 mg plus RTV 200 mg) PO BID
No dosage adjustment necessary. Child-Pugh Class A:
  • Use with caution
Child-Pugh Class B or C:
  • Contraindicated
INSTIs
Dolutegravir 
(DTG)
Tivicay
50 mg once daily 
or
50 mg BID
No dosage adjustment necessary.
Child-Pugh Class A or B:
  • No dosage adjustment
Child-Pugh Class C:
  • Not recommended
Elvitegravir
(EVG)
Vitekta
85 mg or 150 mga once daily No dosage adjustment necessary.
Child-Pugh Class A or B:
  • No dosage adjustment
Child-Pugh Class C:
  • Not recommended
Elvitegravir (EVG) 
plus
Cobicistat (COBI) 
plus
Tenofovir Disoproxil Fumarate (TDF) 
plus
Emtricitabine (FTC)
Stribild 
1 tablet once daily
EVG/c/TDF/FTC should not be initiated in patients with CrCl <70 mL/min. 

Discontinue EVG/cobi/TDF/FTC if CrCl declines to <50 mL/min while patient is on therapy.
Mild-to-Moderate Hepatic Insufficiency:
  • No dosage adjustment necessary
Severe Hepatic Insufficiency:
  • Not recommended
Raltegravir
(RAL)
Isentress
400 mg BID No dosage adjustment necessary. Mild-to-Moderate Hepatic Insufficiency:
  • No dosage adjustment necessary
Severe Hepatic Insufficiency:
  • No recommendation
Fusion Inhibitor
Enfuvirtide
(T20)
Fuzeon
90 mg subcutaneous BID No dosage adjustment necessary. No dosage 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 6 for detailed dosing information. CrCl <30 mL/min or on HD
Without Potent CYP3A Inhibitors or Inducers:
  • 300 mg BID; reduce to 150 mg BID if postural hypotension occurs
With Potent CYP3A Inducers or Inhibitors:
  • Not recommended
No dosage recommendations. Concentrations will likely be increased in patients with hepatic impairment.
a Refer to Appendix B, Tables 1–6 for additional dosing information
b Including with chronic ambulatory peritoneal dialysis and hemodialysis
c On dialysis days, take dose after HD session


Key to Abbreviations: 3TC = lamivudine; ABC = abacavir; ARV = antiretroviral; ATV = atazanavir; AZT = zidovudine; BID = twice daily; CAPD = chronic ambulatory peritoneal dialysis; COBI, c = cobicistat; CrCl = creatinine clearance; CYP = cytochrome P; d4T = stavudine; ddI = didanosine; DLV = delavirdine; DRV = darunavir; EC = enteric coated; DTG = dolutegravir; EFV = efavirenz; ETR = etravirine; EVG= elvitegravir; FPV = fosamprenavir; FTC = emtricitabine; HD = hemodialysis; IDV = indinavir; 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; q(n)d = every (n) days; q(n)h = every (n) hours; RAL = raltegravir; RPV = rilpivirine; RTV = ritonavir; SQV = saquinavir; T20 = enfuvirtide; TDF = tenofovir disoproxil fumarate; TID = three times daily; TPV = tipranavir; XR = extended release; ZVD = zidovudine

Creatinine Clearance Calculation

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

Child-Pugh Score

 Component

Points Scored

 1

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 µmol/L to 50 µmol/L)

 >3mg/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 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 Scorec

 Class A

 5-6 points

 Class B

 7-9 points

 Class C

>9 points

c Sum of points for each component

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