Regimen for patients with HIV-1 infection.
Black Box Warning: Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued emtricitabine or tenofovir disoproxil fumarate. Hepatic function should be monitored closely, with both clinical and laboratory follow-up for at least several months. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
Monitor viral load prior to initiation or modification of treatment.
Monitor CD4 cell counts prior to initiation or with modification of ARV treatment and every 3-6 months; thereafter during at least the first 2 years of treatment.
Monitor hepatitis B screening.
Perform hepatitis C antibody testing prior to initiation or modification of ARV treatment.
Monitor ALT,AST, and total bilirubin.
Monitor estimated creatinine clearance, serum creatinine, urine glucose, and urine protein prior to initiation and throughout treatment.
Common
Serious
Multiple drug-drug interactions
Contraindications:
Antimicrobial class: Antiviral agent, Integrase inhibitor, Nucleoside reverse transcriptase inhibitor
Pregnancy category: Not recommended in pregnancy
Average serum half life: Cobicistat: 3.5 hours Elvitegravir: 12.9 hours Emtricitabine: 10 hours Tenofovir disoproxil fumarate: 17 hours
Precautions:
Screening and monitoring required in patients with renal impairment. Additional monitoring in patients with increase in serum creatinine >0.4 mg/dL from baseline or those with chronic kidney disease; discontinuation may be necessary.
Consider proximal renal tubulopathy in patients presenting with persistent or worsening bone or muscle symptoms.
Interrupt use if lactic acidosis or severe hepatomegaly with steatosis are suspected.