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Scientific/Clinical Member and Community Representative Nominations Are Being Accepted
The Department of Health and Human Services (HHS) Panel on Antiretroviral Guidelines for Adults and Adolescents is accepting nominations for new scientific/clinical members with expertise in HIV medicine, as well as nominations for a community representative. Nominations should be submitted to Alice Pau, Pharm.D., electronically (apau@niaid.nih.gov) by no later than January 10, 2020.
For more information on the scientific/clinical member nomination requirements, please read this news announcement.
For more information on the community representative nomination requirements, please read this news announcement.
Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV
- Home
- Guidelines
- Adult and Adolescent ARV
- Antiretroviral Dosing Recommendations in Patients with Renal or Hepatic Insufficiency
The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.
- Table of Contents
- What's New in the Guidelines?
- Panel Roster
- Financial Disclosure
- Introduction
- Baseline Evaluation
- Laboratory Testing
- Treatment Goals
- Initiation of Antiretroviral Therapy
- Antiretroviral Therapy to Prevent Sexual Transmission of HIV (Treatment as Prevention)
- What to Start
- What Not to Use
- Management of the Treatment-Experienced Patient
- Poor CD4 Recovery
- Special Patient Populations
- Considerations for Antiretroviral Use in Patients with Coinfections
- Limitations to Treatment Safety and Efficacy
- Drug-Drug Interactions
- Conclusion
- Appendix A: Key to Acronyms
- Appendix B: Drug Characteristics Tables
Download Guidelines
- Section Only PDF (286 KB)
- Full Guideline PDF (4.7 MB)
- Recommendations Only PDF (88.9 KB)
- Tables Only PDF (563 KB)
Appendix B: Drug Characteristics Tables
Antiretroviral Dosing Recommendations in Patients with Renal or Hepatic Insufficiency
Last Updated: December 18, 2019; Last Reviewed: December 18, 2019
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 AIDSinfo 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.
| 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.
|
|||||||||||||||||||||
| 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 |
|
No dose recommendation. | ||||||||||||||||||
| Lamivudine (3TC) Epivir |
3TC 300 mg PO once daily or 3TC 150 mg PO twice daily |
|
No dose adjustment necessary. | ||||||||||||||||||
| Tenofovir Alafenamide (TAF) Vemlidy |
Vemlidy is available as a 25-mg tablet for the treatment of HBV. |
|
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 |
|
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 |
|
No dose adjustment necessary. | ||||||||||||||||||
| Tenofovir Disoproxil Fumarate/ Emtricitabine (TDF/FTC) Truvada |
One tablet PO once daily |
|
No dose recommendation. | ||||||||||||||||||
| Tenofovir Disoproxil Fumarate/ Lamivudine (TDF/3TC) Cimduo |
One tablet PO once daily |
|
No dose recommendation. | ||||||||||||||||||
| Zidovudine (ZDV) Retrovir |
ZDV 300 mg PO twice 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:
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:
|
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 in patients with hepatic impairment. | ||||||||||||||||||
| Darunavir
(DRV) Prezista |
In ARV-Naive Patients and ARV-Experienced Patients with No DRV Resistance Mutations:
|
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:
|
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:
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:
|
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:
|
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:
|
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 |
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| 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. |
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| 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 | |
Download Guidelines
- Section Only PDF (286 KB)
- Full Guideline PDF (4.7 MB)
- Recommendations Only PDF (88.9 KB)
- Tables Only PDF (563 KB)
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