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

Appendix B: Drug Characteristics Tables

Table 7

(Last updated:3/27/2012; last reviewed:3/27/2012)

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Appendix B, Table 7. Antiretroviral Dosing Recommendations in Patients with Renal or Hepatic Insufficiency
See reference section following tables for creatinine clearance (CrCl) calculation formulas and criteria for Child-Pugh classification.

 Antiretrovirals
Generic Name (abbreviation)/Trade Name

Usual Daily Dose
(Refer to Appendix B Tables 1–6 for additional dosing information.)

 Dosing in Renal Insufficiency
(Including with chronic ambulatory peritoneal dialysis and hemodialysis)

Dosing in Hepatic Impairment 
Nucleoside Reverse Transcriptase Inhibitors
Use of fixed-dose combination NRTI (+/- NNRTI) of Atripla, Combivir, Complera, Trizivir, or Epzicom is not recommended in patients with CrCl <50 mL/min. 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 Dose
 5-6 200 mg BID (use oral solution)
>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 125mg
 10-29 125 mg 125 mg
 <10, HD, CAPD 125 mg use 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 150mg
 10-29 150 mg 100 mg
 <10, HD, 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 HD 200 mg q96h 60 mg q24h
On dialysis days, take dose after HD session.		  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 HD  1 x 50 mg, then 25 mg q24h
On dialysis days, take dose after HD session. 		 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 HD 20 mg q24h 15 mg q24h
On dialysis days, take dose after HD session.		 No dosage recommendation
Tenofovir
(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 hr)
 <10 not on HD  no recommendation
 HD 300 mg q7d
On dialysis days, take dose after HD session.		  No dosage adjustment necessary
Emtricitabine (FTC) + Tenofovir (TDF)/
Truvada
  1 tablet PO once daily  
CrCl (mL/min)  Dose
 30-49  1 tablet q48h
 <30 or HD not recommended
 No dosage recommendation
Zidovudine
(AZT, ZDV)/
Retrovir
  300 mg PO BID  
CrCL (mL/min)  Dose
 <15 or HD 100 mg TID or 300 mg once daily
On dialysis days, take dose after HD session.		  No dosage recommendation
 Non-Nucleoside Reverse Transcriptase Inhibitors
 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) + Tenofovir (TDF) + Emtricitabine (FTC)
Atripla
  1 tablet PO once daily Not recommended for use in patients with CrCl <50 mL/min. Instead use individual drug components 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) + Tenofovir (TDF) + Emtricitabine (FTC)/
Complera
  1 tablet PO once daily  Not recommended for use in patients with CrCl <50 mL/min. Instead use individual drug components 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
 Protease Inhibitors
Atazanavir
(ATV)/
Reyataz
  400 mg PO once daily or
(ATV 300 mg + RTV 100 mg) PO once daily
 

No dosage adjustment for patients with renal dysfunction not requiring HD

ARV-naive patients on HD:
(ATV 300 mg + RTV 100 mg) once daily

ARV-experienced patients on HD: ATV or RTV-boosted ATV not recommended

  

 Child-Pugh Class

Dose

 B

 300 mg once daily

 C

not recommended

RTV boosting is not recommended in patients with hepatic impairment (Child-Pugh Class B or C).
Darunavir
(DRV)/
Prezista
  (DRV 800 mg + RTV 100 mg) PO once daily (ARV-naive patients only) or
(DRV 600 mg + RTV 100 mg) PO BID
  No dosage adjustment necessary Mild-to-moderate hepatic impairment: no dosage adjustment

Severe hepatic impairment: not recommended
Fosamprenavir
(FPV)/
Lexiva
 1400 mg PO BID or
(FPV 1400 mg +
RTV 100–200 mg) PO once daily or
(FPV 700 mg + RTV 100 mg) PO BID
  No dosage adjustment necessary

 Child-Pugh Score

Dose
PI-naive patients only:
 5-9  700 mg BID
 10-15  350 mg BID
PI-naive or PI-experienced patients:
 5-6 700 mg BID + RTV 100 mg once daily
 7-9 450 mg BID + RTV 100 mg once daily
 10-15 300 mg BID + 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
 400/100 mg PO BID or
800/200 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 + 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 + RTV 200 mg) PO BID No dosage adjustment necessary Child-Pugh Class A: use with caution

Child-Pugh Class B or C: contraindicated
 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 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.
Integrase Inhibitor
Raltegravir
(RAL)/
Isentress
 400 mg BID No dosage adjustment necessary Mild-to-moderate hepatic insufficiency: no dosage adjustment necessary

Severe hepatic insufficiency: no recommendation

Key to Abbreviations: 3TC = lamivudine, ABC = abacavir, ARV = antiretroviral, ATV = atazanavir, AZT = zidovudine, BID = twice daily, CAPD = chronic ambulatory peritoneal dialysis, CrCl = creatinine clearance, CYP = cytochrome P, d4T = stavudine, ddI = didanosine, DLV = delavirdine, DRV = darunavir, EC = enteric coated, EFV = efavirenz, ETR = etravirine, FPV = fosamprenavir, FTC = emtricitabine, hr = hour, 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, RAL = raltegravir, RPV = rilpivirine, RTV = ritonavir, SQV = saquinavir, T20 = enfuvirtide, TDF = tenofovir, TID = three times daily, TPV = tipranavir, XR = extended release, ZVD = zidovudine

 Creatinine Clearance Calculation

 Male:    (140 − age in years) x weight (kg)
72 x Serum Creatinine

Female:     (140 - age in years) x weight (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 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

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