Last Updated: May 22, 2018; Last Reviewed: May 22, 2018
Cobicistat (COBI, Tybost)
|Cobicistat (COBI, Tybost)
For additional information see Drugs@FDA: https://www.accessdata.fda.gov/scripts/cder/daf/
|Tablets: 150 mg
Fixed-Dose Combination Tablets:
- [Stribild] Elvitegravir 150 mg plus cobicistat 150 mg plus emtricitabine 200 mg plus tenofovir disoproxil fumarate (TDF) 300 mg
- [Genvoya] Elvitegravir 150 mg plus cobicistat 150 mg plus emtricitabine 200 mg plus tenofovir alafenamide (TAF) 10 mg
- [Evotaz] Atazanavir 300 mg plus cobicistat 150 mg
- [Prezcobix] Darunavir 800 mg plus cobicistat 150 mg
||Selected Adverse Events
|Cobicistat is a Pharmacokinetic (PK) Enhancer:
- The only use of cobicistat is as a PK enhancer (boosting agent) of selected protease inhibitors (PIs) and selected integrase inhibitors. Cobicistat is not interchangeable with ritonavir. See dosing information for elvitegravir and specific PIs that require cobicistat for boosting.
Not Food and Drug Administration (FDA)-Approved for Use in Children Aged <18 Years:
Not FDA-Approved for Use in Children Aged <6 Years or Weighing <25 kg:
Not FDA-Approved for Use in Children Aged <12 years Weighing <35 kg:
Child and Adolescent (Weighing ≥25 kg) Dose:
- Cobicistat alone (as Tybost)
- Some members of the Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV regard the above agents as potentially appropriate for use in select children aged <18 years and weighing ≥35 kg. An expert in pediatric HIV infection should be consulted.
Adolescent (Weighing ≥35 kg and SMR 4 or 5) Dose:
- Cobicistat 150 mg orally once daily as a component of Genvoya
Adult (Aged ≥18 Years) Dose:
- Cobicistat 150 mg orally once daily as a component of Stribild
- Cobicistat must be administered as:
- The combination tablets Stribild or Genvoya, in which case it would not be dosed with any other antiretroviral (ARV) drugs; or
- The tablet Tybost co-administered with atazanavir or darunavir at the doses listed in the table below and at the same time, in combination with other ARV drugs; or
- Combination tablets with atazanavir (Evotaz) or darunavir (Prezcobix), with food, and in combination with other ARV drugs.
- When co-administered with TDF, cobicistat may be associated with higher risk of renal tubular adverse events than ritonavir.
- Cobicistat is not interchangeable with ritonavir.
- Do not administer cobicistat with ritonavir or with drugs containing cobicistat.
- Not recommended for use with more than one ARV drug that requires PK enhancement (e.g., elvitegravir in combination with a PI) because no data are available.
- Use with PIs other than atazanavir 300 mg or darunavir 800 mg administered once daily is not recommended because no data are available on other combinations or doses.
- Patients with a confirmed increase in serum creatinine >0.4 mg/dL from baseline should be closely monitored for renal safety.
- When used in combination with TDF, monitor serum creatinine, urine protein, and urine glucose at baseline and every 3 to 6 months while on therapy (see Table 15i). In patients at risk of renal impairment, also monitor serum phosphate.
- When used in combination with other ARV drugs, see those specific sections of the appendix (atazanavir, darunavir, elvitegravir, TDF, TAF).
Cobicistat Dosing in Patients with Renal Impairment:
- Cytochrome P (CYP) 3A4 and CYP2D6 inhibitor
- P-glycoprotein and breast cancer resistance protein inhibitor
- Cobicistat inhibits renal tubular secretion of creatinine, increasing the serum creatinine concentration (and decreasing estimated glomerular filtration rate) without decreasing actual glomerular function.
- Stribild should not be initiated in patients with estimated creatinine clearance (CrCl) <70 mL/min and should be discontinued in patients with estimated CrCl <50 mL/min because dose adjustments required for emtricitabine and TDF cannot be achieved with a fixed-dose combination tablet.
- Genvoya should not be initiated in patients with estimated CrCl <30 mL/min.
- Neither Stribild nor Genvoya should be used in patients with severe hepatic impairment.