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Updated Adult and Adolescent ARV Guidelines
On Wednesday, July 10, 2019 the HHS Panel on Antiretroviral Guidelines for Adults and Adolescents released an updated version of the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV.
Feedback on the revised guidelines is welcome. Please email your comments with the subject line “Comments on the Adult and Adolescent ARV Guidelines” to ContactUs@aidsinfo.nih.gov by July 24, 2019.Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV
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- 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
- What to Start
- What Not to Use
- Management of the Treatment-Experienced Patient
- 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 (354 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: July 10, 2019; Last Reviewed: July 10, 2019
Appendix B, Table 10. Antiretroviral Dosing Recommendations in Patients 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 (Abbreviation) Trade Name |
Usual Daily Dosea |
Dosing in Patients with Renal Insufficiencyb | Dosing in Patients with Hepatic Impairment | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NRTIs Stribild should not be initiated in patients with CrCl <70 mL/min. The following FDC tablets are not recommended in patients with CrCl <50 mL/min: Atripla, Combivir, Complera, Delstrigo, Dovato, Epzicom, Triumeq, or Trizivir. Biktarvy, Descovy, Odefsey, Symtuza, and Truvada are not recommended in patients with CrCl <30 mL/min. |
|||||||||||||||
| 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 |
||||||||||||
| Didanosine EC (ddI) Videx EC |
Body Weight ≥60 kg:
|
|
No dose adjustment necessary. | ||||||||||||
| Didanosine Oral Solution
(ddI) Videx |
Body Weight ≥60 kg:
|
|
No dose adjustment necessary. | ||||||||||||
| 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. | ||||||||||||
| Stavudine (d4T) Zerit |
Body Weight ≥60 kg:
|
|
No dose recommendation. | ||||||||||||
| Tenofovir Alafenamide/ Emtricitabine (TAF/FTC) Descovy |
TAF for HIV treatment is only available as a component of FDC tablets (i.e., 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 ESRD or 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 once daily on an empty stomach, preferably at bedtime | Not recommended if CrCl <50 mL/min. Instead, use the individual drugs 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 drugs and adjust TDF and 3TC doses according to CrCl level. | Not recommended for patients with moderate or severe hepatic impairment. Use 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 drugs and adjust TDF and 3TC doses according to CrCl level. | Not recommended for patients with moderate or severe hepatic impairment. Use 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 | Not recommended if CrCl <30 mL/min. | 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 drugs 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 | Not recommended if CrCl <30 mL/min. | Not recommended for patients with severe hepatic impairment. | ||||||||||||
| Fosamprenavir
(FPV) Lexiva |
1,400 mg PO twice daily
or (FPV 1,400 mg plus RTV 100–200 mg) PO once daily or (FPV 700 mg plus RTV 100 mg) PO twice daily |
No dose adjustment necessary. | In PI-Naive Patients Only (without RTV)
Child-Pugh Score 5–9:
Child-Pugh Score 5–6:
|
||||||||||||
| Indinavir
(IDV) Crixivan |
IDV 800 mg PO q8h | No dose adjustment necessary. | In Patients with Mild-to-Moderate Hepatic Insufficiency Due to Cirrhosis: IDV 600 mg q8h | ||||||||||||
| 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. | ||||||||||||
| Nelfinavir
(NFV) Viracept |
NFV 1,250 mg PO twice daily | No dose adjustment necessary. | In Patients with Mild Hepatic Impairment: No dose adjustment
In Patients with Moderate-to-Severe Hepatic Impairment: Not recommended |
||||||||||||
| Ritonavir
(RTV) Norvir |
As a PI-Boosting Agent:
|
No dose adjustment necessary. | Refer to recommendations for the primary PI. | ||||||||||||
| Saquinavir
(SQV) Invirase |
(SQV 1,000 mg plus RTV 100 mg) PO twice daily | No dose adjustment necessary. | In Patients with Mild-to-Moderate Hepatic Impairment: Use with caution
In Patients with Severe Hepatic Impairment: Contraindicated |
||||||||||||
| Tipranavir
(TPV) Aptivus |
(TPV 500 mg plus RTV 200 mg) PO twice daily | No dose adjustment necessary. | Child-Pugh Class A:
Use with caution
Child-Pugh Class B or C: Contraindicated |
||||||||||||
| 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 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 of IBA 2,000 mg IV, followed by a maintenance dose of 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 Including patients who are on CAPD and HD. c 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; DLV = delavirdine; 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; FDC = fixed-dose combination; FPV = fosamprenavir; FTC = emtricitabine; 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; q(n)d = every (n) days; q(n)h = every (n) hours; 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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| 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 | 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 | 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 (354 KB)
- Full Guideline PDF (4.7 MB)
- Recommendations Only PDF (88.9 KB)
- Tables Only PDF (563 KB)
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