Viral infections:

Indications for DELSTRIGO:

As a complete regimen for the treatment of HIV-1 infection in antiretroviral treatment-naïve patients, or to replace the current antiretroviral regimen in virologically suppressed (HIV-1 RNA <50copies/mL) patients on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Delstrigo.

Adult Dosage:

Test for HBV infection prior to initiation. ≥18yrs: 1 tab once daily. Concomitant rifabutin: give additional doravirine 100mg approx. 12hrs after Delstrigo dose.

Children Dosage:

<18yrs: not established.

DELSTRIGO Contraindications:

Concomitant strong CYP3A inducers (eg, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, enzalutamide, rifampin, rifapentine, mitotane, St. John's wort): discontinue for ≥4wks prior to starting Delstrigo.

Boxed Warning:

Post-treatment acute exacerbation of hepatitis B.

DELSTRIGO Warnings/Precautions:

Test for HBV before starting antiretroviral therapy. Discontinuation of lamivudine and/or tenofovir disoproxil may be associated with severe acute exacerbations of hepatitis B. Closely monitor patients co-infected with HBV and HIV for several months after stopping treatment; if appropriate, anti-HBV therapy may be warranted (esp. in those with advanced liver disease or cirrhosis). New onset or worsening renal impairment. Assess SCr, estimated CrCl, urine glucose, urine protein in all patients, and serum phosphorus (in chronic kidney disease) before initiating and during therapy; discontinue if significant renal dysfunction or Fanconi syndrome develops. History of pathologic fracture or risk factors for osteoporosis or bone loss: consider monitoring bone mineral density (BMD); calcium/vitamin D supplement may be beneficial. Renal impairment (CrCl<50mL/min): not recommended. Severe hepatic impairment (Child-Pugh C): not studied. Elderly. Pregnancy. Nursing mothers: not recommended.

DELSTRIGO Classification:

Non-nucleoside reverse transcriptase inhibitor + reverse transcriptase inhibitors (nucleoside + nucleotide analogue).

DELSTRIGO Interactions:

May be antagonized by CYP3A inducers (see Contraindications). May be potentiated by CYP3A inhibitors. Avoid concomitant or recent use of nephrotoxic agents. Tenofovir levels increased by ledipasvir/sofosbuvir, sofosbuvir/velpatasvir; monitor. Lamivudine levels decreased by sorbitol; avoid if possible. Concomitant drugs that reduce renal function or compete for active tubular secretion may potentiate lamivudine, tenofovir, (eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, high-dose or multiple NSAIDs).

Adverse Reactions:

Dizziness, nausea, abnormal dreams, insomnia, diarrhea, somnolence, rash; decreased BMD, immune reconstitution syndrome.

Note:

To register pregnant patients to the Antiretroviral Pregnancy Registry, call (800) 258–4263.

Generic Drug Availability:

NO

How Supplied:

Tabs—30

Pricing for DELSTRIGO

100mg/300mg/300mg tablet (Qty: 30)
Appx. price $2259
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