Generic Name (Abbreviation) Trade Name | Usual Dosea | Dosing in Adults with Renal Insufficiency | Dosing in Adults 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.
The component drugs in some of the FDC products listed above may be prescribed as individual formulations with dose adjustment based on CrCl level as indicated below in this table. | ||||||
NRTIs | ||||||
Abacavir (ABC) Ziagen | ABC 300 mg PO twice daily oder 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) Epzicom | One tablet PO once daily | Not recommended if CrCl <30 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 | |||
Emtricitabine (FTC) Emtriva | FTC 200-mg oral capsule once daily oder FTC 240-mg (24-mL) oral solution once daily | Dose by Formulation | No dose recommendation. | |||
CrCl (mL/min) | Capsule | Solution | ||||
30–49 | 200 mg every 48 hours | 120 mg every 24 hours | ||||
15–29 | 200 mg every 72 hours | 80 mg every 24 hours | ||||
<15 | 200 mg every 96 hours | 60 mg every 24 hours | ||||
On HDb | 200 mg every 24 hours | 240 mg every 24 hours | ||||
Lamivudinec (3TC) Epivir | 3TC 300 mg PO once daily oder 3TC 150 mg PO twice daily | CrCl (mL/min) | Dose | No dose adjustment necessary. | ||
15–29 | 1 × 150 mg, then 100 mg every 24 hours | |||||
5–14 | 1 × 150 mg, then 50 mg every 24 hours | |||||
<5 or on HD | 1 × 50 mg, then 25 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 B or C: Not recommended | ||
<15 and not on HD | Not recommended | |||||
On HD | One tablet PO once daily | |||||
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 | CrCl (mL/min) | Dose | Child-Pugh Class A or B: No dose adjustment Child-Pugh Class C: No dose recommendation | ||
<30 and not on HD | Not recommended | |||||
<30 and on HD | One tablet once daily | |||||
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 | |||||
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 | 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 | 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 | 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 PO 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 PO 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 oder 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 PO) 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 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 | 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 oder (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
In ARV-Experienced 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
In ARV-Experienced Patients with at Least One DRV Resistance Mutation
| 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 oder (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 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: 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 oder 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 recommended if CrCl <30 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/Lamivudine (DTG/3TC) Dovato | One tablet PO once daily | Not recommended if CrCl <30 mL/min. Instead, use the individual component drugs and adjust 3TC dose according to CrCl. | 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 | In Patients on Chronic HD
Not recommended in patients with CrCl <30 mL/min who are not receiving 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 PO 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 PO twice daily (using Isentress formulation) oder RAL 1,200 mg PO 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
With Potent CYP3A Inducers or Inhibitors
| 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. | |||
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 emtricitabine (Emtriva) recommends a dose of 200 mg every 96 hours for patients with CrCl <15 mL/min or 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 lamivudine (Epivir) recommends dosage adjustment from 300 mg once daily to 150 mg once daily for patients with CrCl 30–49 mL/min. However, the prescribing information for several FDC products that contain lamivudine (including Epzicom, 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. 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. |