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 (<35kg with concomitant PI plus ritonavir or cobicistat): not established. ≥25kg (and CrCl ≥30mL/min): 1 tab once daily. PrEP: <35kg: not established. Confirm negative HIV-1 prior to initiation. ≥35kg (and CrCl ≥30mL/min): 1 tab once daily. Both: severe renal impairment (CrCl <30mL/min): 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. Monitor SCr, CrCl, urine glucose, urine protein, and serum phosphorus (in CKD patients); 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.