Indications for DESCOVY:
HIV-1 infection: in combination with other antiretroviral agents in patients ≥35kg; or in combination with other antiretroviral agents other than protease inhibitors (PI) that require a CYP3A inhibitor in pediatric patients ≥25kg-<35kg.
Limitations of Use:
Not for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in high-risk adults.
Adults and Children:
Test for HBV infection prior to initiation. <25kg or <35kg with concomitant PI plus ritonavir or cobicistat: not established. ≥25kg (and CrCl ≥30mL/min): 1 tab once daily. Severe renal impairment (CrCl <30mL/min): not recommended.
Post-treatment acute exacerbation of Hepatitis B.
Not for treating chronic HBV infection; test for HBV before starting therapy and closely monitor patients co-infected with HBV and HIV for several months after stopping treatment (discontinuing therapy may exacerbate HBV infection); if appropriate, initiate anti-hepatitis B therapy may be warranted (esp. in those with advanced liver disease or cirrhosis). Suspend therapy if lactic acidosis or hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Monitor CrCl, urine glucose, urine protein, serum phosphorus (in patients at risk for chronic renal disease); discontinue if significant renal dysfunction or Fanconi syndrome occurs). Severe hepatic impairment. Pregnancy. Nursing mothers: not recommended.
Nucleoside analogues (reverse transcriptase inhibitors).
Concomitant drugs that strongly affect P-gp activity may lead to changes in TAF absorption. Avoid with concurrent or recent use of nephrotoxic agents. Concomitant tipranavir/ritonavir, antimycobacterials (eg, rifabutin, rifampin, rifapentine), St. John's wort: not recommended. May be antagonized by anticonvulsants (eg, carbamazepine, oxcarbazepine, phenobarbital, phenytoin; consider alternatives. May be potentiated by drugs that decrease renal function or compete for active tubular secretion (eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, NSAIDs).
Nausea; new onset or worsening renal impairment, immune reconstitution syndrome.
Register pregnant patients in the Antiretroviral Pregnancy Registry (APR) by calling (800) 258-4263.