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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:2/12/2013; last reviewed:2/12/2013)

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See the reference section following Table 7 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
 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

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, Stribild, Trizivir, or Epzicom. 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 PO 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 125 mg
 10-29 125 mg 125 mg
 <10, HD, CAPD 125 mg use ddI 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 on 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 hours)
<10 and not on HD Not recommended
On 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 on 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 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) + Tenofovir (TDF) + 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
 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 700 mg BID + RTV 100 mg once daily
PI-naive patients only:
Child-Pugh Score Dose
 5-9  700 mg BID
 10-15  350 mg BID
PI-naive or PI-experienced patients:
Child-Pugh Score  Dose
 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
Integrase Inhibitors
Raltegravir
(RAL)/
Isentress
400 mg BID No dosage adjustment necessary Mild-to-moderate hepatic insufficiency: No dosage adjustment necessary

Severe hepatic insufficiency: No recommendation
Elvitegravir (EVG)/
Cobicistat (COBI)/
Tenofovir (TDF)/
Emtricitabine (FTC)/
Stribild (only available as a co-formulated product)
1 tablet once daily EVG/COBI/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
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.
Key to Abbreviations: 3TC = lamivudine, ABC = abacavir, ARV = antiretroviral, ATV = atazanavir, AZT = zidovudine, BID = twice daily, CAPD = chronic ambulatory peritoneal dialysis, COBI = cobicistat, CrCl = creatinine clearance, CYP = cytochrome P, d4T = stavudine, ddI = didanosine, DLV = delavirdine, DRV = darunavir, EC = enteric coated, 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, 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 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

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