Indications for DESCOVY:
Treatment of 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 children ≥25–<35kg. Pre-exposure prophylaxis (PrEP) to reduce the risk of sexually-acquired HIV-1, excluding from receptive vaginal sex, in at-risk patients ≥35kg.
Adults and Children:
Test for HBV infection prior to initiation. HIV treatment: <25kg or (concomitant PI plus ritonavir or cobicistat in pediatric patients <35kg or adults with CrCl <15mL/min ± hemodialysis): not established. ≥25kg (and CrCl ≥30mL/min) or adults (with CrCl <15mL/min) receiving chronic hemodialysis (on hemodialysis days, give dose after session): 1 tab once daily. PrEP: <35kg: not established. Confirm negative HIV-1 prior to initiation. ≥35kg (and CrCl ≥30mL/min) or adults (with CrCl <15mL/min) receiving chronic hemodialysis (on hemodialysis days, give dose after session): 1 tab once daily. Both: severe renal impairment (CrCl 15-<30mL/min) or ESRD (CrCl <15mL/min) not receiving chronic hemodialysis: not recommended.
PrEP: unknown or positive HIV-1 status.
Post-treatment acute exacerbation of Hepatitis B. Risk of drug resistance with Descovy use for HIV-1 PrEP in undiagnosed early HIV-1 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, anti-hepatitis B therapy may be warranted (esp. in those with advanced liver disease or cirrhosis). Risk of drug resistance with use for PrEP in undiagnosed HIV-1 infection. Do not initiate for PrEP if signs/symptoms of acute HIV infection present; use approved test and confirm negative status prior to initiation, at least every 3 months during therapy, and upon diagnosis of any other STIs. Suspend therapy if lactic acidosis or pronounced hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Assess SCr, estimated CrCl, urine glucose, urine protein in all patients, and serum phosphorus (in chronic kidney disease) prior to or when initiating, and during therapy. Discontinue if significant renal dysfunction or Fanconi syndrome occurs. Severe hepatic impairment: not studied. Pregnancy. Nursing mothers: not recommended.
Nucleoside analogues (reverse transcriptase inhibitors).
Concomitant drugs that strongly affect P-gp and BCRP 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, diarrhea; new onset or worsening renal impairment, immune reconstitution syndrome.
Register pregnant patients in the Antiretroviral Pregnancy Registry (APR) by calling (800) 258-4263.