Generic Name (Abbreviation) Trade Name | Usual Dosea | Dosing in Adults With Renal Insufficiency | Dosing in Adults With Hepatic Impairment | |||
---|---|---|---|---|---|---|
Recommendations for FDCs based on CrCl level are outlined in the table below. | ||||||
NRTIs | ||||||
Abacavir (ABC) | 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 | |||
Abacavir/Lamivudine (ABC/3TC) | One tablet PO once daily | Not FDA recommended if CrCl <30 mL/min due to the 3TC component. Note: There is insufficient evidence to recommend for or against the use of full-dose 3TC in people with CrCl <30 mL/min. Some Panel members use full-dose 3TC to allow people to remain on the FDC product. See the 3TC entry for more information. | 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 | |||
Emtricitabine (FTC) Emtriva | FTC 200-mg oral capsule once daily or FTC 240-mg (24-mL) oral solution once daily Note: There is insufficient evidence to recommend for or against the use of full-dose, daily FTC in people with CrCl <30 mL/min who are not on HD. To allow people to remain on certain TAF-containing FDC products, some Panel members use full-dose, daily FTC in people with CrCl 15–29 mL/min who are not on HD. | Dose by Formulation | No dose recommendation. | |||
CrCl (mL/min) | Capsule | Solution | ||||
30–49b | No dose adjustment necessary. | |||||
15–29 (see Note) | 200 mg every 72 hours | 80 mg every 24 hours | ||||
<15 (not on HD) (see Note) | 200 mg every 96 hours | 60 mg every 24 hours | ||||
On HDb | No dose adjustment necessary. On HD days, administer after dialysis. | |||||
Lamivudinec (3TC) Epivir | 3TC 300 mg PO once daily or 3TC 150 mg PO twice daily Note: PK and safety data are limited on the use of 3TC doses higher than those recommended by the FDA in people with CrCl <30 mL/min. Clinicians may consider using the nearest available tablet strength (100 mg or 150 mg), as outlined in the “Alternative Dose” column (BIII) (see rationaled). There is insufficient evidence to recommend for or against the use of full-dose 3TC in people with CrCl <30 mL/min. Some Panel members use full-dose 3TC to allow people to remain on certain ABC and/or DTG-containing FDC products. | CrCl (mL/min) | Epivir Label Dose | Alternative Dosed | No dose adjustment necessary | |
15–29 (see Note) | 1 × 150 mg, then 100 mg every 24 hours | 100–150 mg every 24 hours | ||||
5–14 (see Note) | 1 × 150 mg, then 50 mg every 24 hours | 100–150 mg every 24 hours | ||||
<5 or on HD (see Note) | 1 × 50 mg, then 25 mg every 24 hours | 100–150 mg every 24 hours | ||||
Tenofovir Alafenamide (TAF) Vemlidy | Vemlidy is available as a 25-mg tablet for the treatment of HBV. | CrCl (mL/min) | Dose | Child-Pugh Class A: No dose adjustment Child-Pugh Class B or C: Not recommended | ||
<15 and not on HD | Not recommended | |||||
On HD | No dose adjustment necessary. On HD days, administer after dialysis. | |||||
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).
| CrCl (mL/min) | Dose | Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No dose recommendation | ||
15-29 | Not recommended Note: There is insufficient evidence to recommend for or against the use of full-dose, daily FTC in people with CrCl <30 mL/min. To allow people to remain on the FDC product, some Panel members use full-dose FTC in people with CrCl 15–29 mL/min. | |||||
<15 (not on HD) | Not recommended | |||||
On HD | No dose adjustment necessary. On HD days, administer after dialysis. | |||||
Tenofovir Disoproxil Fumarate (TDF) Viread | TDF 300 mg PO once daily | CrCl (mL/min) | Dose | No dose adjustment necessary. | ||
30–49 | 300 mg every 48 hours | |||||
10–29 | 300 mg twice weekly (every 72–96 hours) | |||||
<10 and not on HD | No recommendation | |||||
On HD | 300 mg every 7 days (administer after completion of HD) | |||||
Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC) Truvada | One tablet PO once daily | CrCl (mL/min) | Dose | No dose recommendation. | ||
30–49 | One tablet every 48 hours | |||||
<30 or on HD | FDC of TDF/FTC not recommended | |||||
Tenofovir Disoproxil Fumarate/Lamivudine (TDF/3TC) Cimduo | One tablet PO once daily | CrCl (mL/min) | Dose | No dose recommendation. | ||
<50 or on HD | FDC of TDF/FTC not recommended | |||||
NNRTIs | ||||||
Doravirine (DOR) Pifeltro | DOR 100 mg 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 | FDC of DOR/TDF/3TC not recommended if CrCl <50 mL/min or on HD | Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: Not studied | |||
Efavirenz (EFV) | 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) | One tablet PO once daily on an empty stomach, preferably at bedtime | FDC of DOR/TDF/3TC not recommended if CrCl <50 mL/min or on HD | No dose recommendation; use with caution in patients with hepatic impairment. | |||
Efavirenz 600 mg/Tenofovir Disoproxil Fumarate/Lamivudine (EFV/TDF/3TC) Symfi | One tablet PO once daily on an empty stomach, preferably at bedtime | FDC of DOR/TDF/3TC not recommended if CrCl <50 mL/min or on HD | 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 PO once daily on an empty stomach, preferably at bedtime | FDC of DOR/TDF/3TC not recommended if CrCl <50 mL/min or on HD | 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 | |||
Rilpivirine (RPV PO) Edurant | RPV 25 mg PO once daily with food | No dose adjustment necessary. | Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No dose recommendation | |||
Rilpivirine IM plus Cabotegravir IM (RPV IM and CAB IM) Cabenuva | Monthly Dosing
Every 2-month Dosing
| No dose adjustment necessary for mild or moderate renal impairment. For patients with severe renal impairment or on HD, increase monitoring for adverse events. | Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No recommendation | |||
Rilpivirine/Tenofovir Alafenamide/Emtricitabine (RPV/TAF/FTC) Odefsey | One tablet PO once daily with food | In People With CrCl 15–29 mL/min
In People With CrCl <15 mL/min (not on HD)
In People on 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 with food | FDC of RPV/TDF/FTC not recommended if CrCl <50 mL/min or on HD | 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 with food or (ATV 300 mg plus RTV 100 mg) PO once daily with food | In People Without Prior ARV Treatment on HD
In ARV-Experienced People 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 with food | If Used with TDF
| Not recommended in patients with hepatic impairment. | |||
Darunavir (DRV) Prezista | In People Without Prior ARV Treatment or ARV- Experienced Treatment With No DRV Mutations
In ARV-Experienced Patients with at Least One DRV Resistance Mutation
| No dose adjustment necessary. | In People with Mild-to-Moderate Hepatic Impairment: No dose adjustment In People with Severe Hepatic Impairment: Not recommended | |||
Darunavir/Cobicistat (DRV/c) Prezcobix | One tablet PO once daily with food | 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 with food | In People With CrCl 15–29 mL/min
In People With CrCl <15 mL/min (not on HD)
In People on Chronic HD
| Not recommended for patients with severe 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 PO once daily | In People With CrCl 15–29 mL/min
In People With CrCl <15 mL/min (not on HD)
In People on Chronic HD
| Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: Not recommended | |||
Cabotegravir (CAB PO) Vocabria | Treatment (As Optional Oral Lead-In or As Oral Bridging)
Pre-exposure Prophylaxis (Optional Oral Lead-In)
| No dose adjustment necessary. | Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No recommendation | |||
Cabotegravir (CAB IM) Apretude | Pre-exposure Prophylaxis
| No dose adjustment necessary. | Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No recommendation | |||
Cabotegravir IM plus Rilpivirine IM (CAB IM plus RPV IM) Cabenuva | Monthly Dosing
Every 2-month Dosing
| No dose adjustment necessary for mild or moderate renal impairment. For patients with severe renal impairment or on HD, increase monitoring for adverse events. | Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No recommendation | |||
Dolutegravir (DTG) Tivicay | DTG 50 mg PO once daily or DTG 50 mg PO 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 PO once daily | Not FDA recommended if CrCl <30 mL/min due to the 3TC component Note: There is insufficient evidence to recommend for or against the use of full-dose 3TC in people with CrCl <30 mL/min. Some Panel members use full-dose 3TC to allow people to remain on the FDC product.d | 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/Lamivudine (DTG/3TC) Dovato | One tablet PO once daily | Not FDA recommended if CrCl <30 mL/min due to the 3TC component Note: There is insufficient evidence to recommend for or against the use of full-dose 3TC in people with CrCl <30 mL/min. Some Panel members use full-dose 3TC to allow people to remain on the FDC product.d | Child-Pugh Class C: Not recommended | |||
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 PO once daily with food | In People With CrCl 15–29 mL/min
In People With CrCl <15 mL/min (not on HD)
In People on Chronic HD
| In People With Mild-to-Moderate Hepatic Insufficiency: No dose adjustment necessary In People With Severe Hepatic Insufficiency: Not recommended | |||
Elvitegravir/Cobicistat/Tenofovir Disoproxil Fumarate/Emtricitabine (EVG/c/TDF/FTC) Stribild | One tablet PO once daily with food | EVG/c/TDF/FTC should not be initiated in people with CrCl <70 mL/min. Discontinue EVG/c/TDF/FTC if CrCl declines to <50 mL/min while patient is on therapy. | In People with Mild-to-Moderate Hepatic Insufficiency: No dose adjustment necessary In People with Severe Hepatic Insufficiency: Not recommended | |||
Raltegravir (RAL) Isentress Isentress HD | RAL 400 mg PO twice daily (using Isentress formulation) or RAL 1,200 mg PO once daily (using Isentress HD formulation only) | No dose adjustment necessary. | In People with Mild-to-Moderate Hepatic Insufficiency: No dose adjustment necessary In People 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 People with CrCl <30 mL/min or People Who Are on HD Without Potent CYP3A Inhibitors or Inducers
With Potent CYP3A Inducers or Inhibitors
| No dose recommendations. MVC concentrations will likely be increased in people 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. | |||
gp-120 Attachment Inhibitor | ||||||
Fostemsavir (FTR) Rukobia | FTR 600 mg PO twice daily | No dose adjustment recommended. | No dose adjustment recommended. | |||
Capsid Inhibitor | ||||||
Lenacapavir (LEN) Sunlenca | Initiation Option 1
Initiation Option 2
Maintenance Dosing
| No dose adjustment recommended. | Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No recommendation | |||
a Refer to Appendix B, Tables 1–10 for additional dosing information. b The prescribing information for FTC (Emtriva) recommends adjusted doses for people with CrCl 30–49 mL/min and people on hemodialysis. However, the prescribing information for several FDC products that contain emtricitabine (including Descovy, Biktarvy, Genvoya, and Odefsey) recommends that the standard dose (emtricitabine 200 mg) can be given once daily in these patients (i.e., on the days of hemodialysis, administer standard dose after completion of dialysis). The recommendation in this table incorporates the dosing guidance from the FDC products. c The prescribing information for 3TC recommends dosage adjustment from 300 mg once daily to 150 mg once daily for people with CrCl 30–49 mL/min. However, the prescribing information for several FDC products that contain 3TC (including ABC plus 3TC, Dovato, and Triumeq) recommends no dose adjustment for CrCl 30–49 mL/min. The recommendation in this table incorporates the dosing guidance from the FDC products. d Use of 3TC doses higher than those recommended by the FDA for people with CrCl <30 mL/min has been reported in clinical practice 1-4 and endorsed in the Guidelines for Chronic Kidney Disease in People With HIV for many years 5; limited published literature has supported the safety of this practice 2,3. 3TC has a wide therapeutic index with no established correlation between elevated concentrations and AEs. Serious AEs, such as lactic acidosis and severe hematologic toxicities, have been reported in rare cases; however, these effects typically occurred in the setting of combination use with older NRTIs (such as didanosine, stavudine, zidovudine). Clinicians may consider using the nearest available tablet strength (100 mg or 150 mg) to avoid the need for 3TC oral solution, thereby simplifying ARV regimens and facilitating adherence (BIII). See the Alternative Dose column in 3TC table entry. There is insufficient evidence to recommend for or against the use of full-dose 3TC in people with CrCl <30 mL/min. Some Panel members use full-dose 3TC to allow people to remain on certain FDC products. Key: 3TC = lamivudine; ABC = abacavir; ATV = atazanavir; ATV/c = atazanavir/cobicistat; ATV/r = atazanavir/ritonavir; BIC = bictegravir; CAB = cabotegravir; COBI = cobicistat; CrCl = creatinine clearance; CYP = cytochrome P; DOR = doravirine; DRV = darunavir; DRV/c = darunavir/cobicistat; DTG = dolutegravir; EFV = efavirenz; ESRD = end stage renal disease; ETR = etravirine; EVG = elvitegravir; EVG/c = elvitegravir/cobicistat; FDC = fixed-dose combination; FTC = emtricitabine; FTR = Fostemsavir; HBV = hepatitis B virus; HD = hemodialysis; IBA = ibalizumab; IM = intramuscular; INSTI = integrase strand transfer inhibitor; IV = intravenous; LEN = lenacapavir; LPV = lopinavir; LPV/r = lopinavir/ritonavir; MVC = maraviroc; 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; T 20 = enfuvirtide; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate; XR = extended release |
Male: | Female: |
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 |
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. |
References
- Bohjanen P, Johnson M, Szczech L, et al. Steady-state pharmacokinetics of lamivudine in human immunodeficiency virus-infected patients with end-stage renal disease receiving chronic dialysis. Antimicrob Agents Chemother. 2002;46(8):2387-2392. Available at: https://pubmed.ncbi.nlm.nih.gov/12121909.
- Fischetti B, Shah K, Taft D, Berkowitz L, Bakshi A, Cha A. Real-world experience with higher-than-recommended doses of lamivudine in patients with varying degrees of renal impairment. Open Forum Infect Di 2018;5(10):ofy225. Available at: https://pubmed.ncbi.nlm.nih.gov/30302352.
- Michienzi S, Schriever C, Badowski M. Abacavir/lamivudine/dolutegravir single tablet regimen in patients with human immunodeficiency virus and end-stage renal disease on hemodialysis. Int J STD AIDS. 2019;30(2):181-187. Available at: https://pubmed.ncbi.nlm.nih.gov/30381029.
- Wood B, Pozniak A. Dosing lamivudine or emtricitabine in renal impairment: new data confirm it's time for updated guidance! AID 2021;35(8):1305-1307. Available at: https://pubmed.ncbi.nlm.nih.gov/34076616.
- Lucas G, Ross M, Stock P, et al. Clinical practice guideline for the management of chronic kidney disease in patients infected with HIV: 2014 update by the HIV Medicine Association of the Infectious Diseases Society of America. Clin Infect Dis. 2014;59(9):e96-e138. Available at: https://academic.oup.com/cid/article/59/9/e96/422813.