Trioday

Efavirenz 600 mg, lamivudine 300 mg, tenofovir disoproxil fumarate 300 mg

Alone or in combination w/ other antiretroviral agents for HIV-1 infection in adults & adolescents >16 yr (at least 40 kg).

Adult & adolescent >16 yr (at least 40 kg) 1 tab daily.

Should be taken on an empty stomach.

Hypersensitivity (eg, SJS, erythema multiforme, or toxic skin eruptions). Coadministration w/ elbasvir & grazoprevir.

Severe acute exacerbations of hepatitis B in patients who are co-infected w/ HBV & HIV-1 & after discontinuation of lamivudine & tenofovir. May warrant resumption of anti-hepatitis therapy especially in patients w/ advanced liver disease or cirrhosis since posttreatment exacerbation of hepatitis may lead to hepatic decompensation & liver failure. May develop an inflammatory response to indolent or residual opportunistic infections (eg, Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia, or TB) during initial phase of treatment. Autoimmune disorders (eg, Graves' disease, polymyositis, & Guillain-Barré syndrome). Suspend treatment if the patient develops lactic acidosis or pronounced hepatotoxicity including hepatomegaly & steatosis, even in the absence of marked transaminase elevations. HIV-1 Ab testing should be done to all HBV-infected patients before initiating therapy. HIV-1 patients should tested for the presence of chronic hepatitis B before initiating treatment. Stop treatment immediately if signs, symptoms, or lab abnormalities suggestive of pancreatitis occurs. Avoid concurrent or recent use of a nephrotoxic agent (eg, high-dose or multiple NSAIDs). Assess bone mineral density in adult & ped patients w/ history of pathologic bone fracture or other risk factors for osteoporosis or bone lose. Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral/facial wasting, breast enlargement, & cushingoid appearance. Perform cholesterol & triglyceride testing before & at periodic intervals during therapy. Do not give in patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Females of reproductive potential should undergo pregnancy testing before initiation of treatment. Females of reproductive potential should use effective contraception during treatment & for 12 wk after discontinuing; always use combination of barrier method w/ other methods of contraception. Avoid use during pregnancy. Lactation. Efavirenz: QTc prolongation. Psychiatric symptoms. Discontinue if patient develops severe rash associated w/ blistering, desquamation, mucosal involvement, or fever; in patients w/ persistent elevations of serum transaminases >5x ULN or is accompanied by signs or symptoms of hepatitis or hepatic decompensation. Hepatitis including fulminant hepatitis progressing to liver failure requiring transplantation or resulting in death. History of seizures. Increased conc of total cholesterol & triglycerides. Periodic monitoring of plasma levels w/ concomitant use of anticonvulsant medications (eg, phenytoin or phenobarb). Concomitant use w/ drugs metabolized by CYP3A or CYP2B6; drug w/ known risk of Torsade de Pointes; alcohol or psychoactive drugs. Avoid potentially hazardous tasks eg, driving or operating machinery if patient experiences CNS symptoms eg, dizziness, impaired conc, &/or drowsiness. Not recommended for patients w/ moderate or severe hepatic impairment. Mild hepatic impairment. Females of reproductive potential should avoid pregnancy. Pregnancy (1st trimester). Lamivudine: Emergence of HBV variants associated w/ resistance in HIV-1 infected patients who receive lamivudine-containing antiretroviral regimens in the presence of concurrent HBV infection. Ped patients w/ a history of prior antiretroviral nucleoside exposure, history of pancreatitis, or other significant risk factors for the development of pancreatitis. Tenofovir: Hypophosphatemia & osteomalacia secondary to proximal renal tubulopathy in patients at risk of renal dysfunction who present w/ persistent or worsening bone or muscle symptoms. Renal impairment including acute renal failure & Fanconi syndrome. Assess serum creatinine, estimated CrCl, urine glucose, & urine protein prior to initiation & during use; assess serum P in patients w/ CKD. Closely monitor renal function in patients w/ CrCl <50 mL/min

Allergic reactions, asthenia, redistribution/accumulation of body fat; hepatitis; myopathy; dyspnea; lactic acidosis & hepatic steatosis, muscle weakness, rhabdomyolysis. Efavirenz: Abnormal coordination, ataxia, cerebellar coordination & balance disturbances, convulsions, hypoesthesia, paresthesia, neuropathy, tremor, vertigo; gynecomastia; constipation, malabsorption; flushing, palpitations; increased hepatic enzyme, hepatic failure; hypercholesterolemia; arthralgia, myalgia, myopathy; aggressive reactions, agitation, delusions, emotional lability, mania, neurosis, paranoia, psychosis, suicide, catatonia; erythema multiforme, photoallergic dermatitis, SJS; abnormal vision, tinnitus. Lamivudine: Hyperglycemia; weakness; anemia (including pure red cell aplasia & severe anemias progressing on therapy); posttreatment exacerbations of hepatitis B; anaphylaxis, urticaria; CPK elevation; alopecia, pruritus. Tenofovir: Angioedema; hypokalemia, hypophosphatemia; pancreatitis, increased amylase, abdominal pain; increased liver enzymes (commonly AST, ALT, γ-glutamyl transferase); rash; osteomalacia; acute renal failure, acute tubular necrosis, Fanconi syndrome, proximal renal tubulopathy, interstitial nephritis, nephrogenic diabetes insipidus, renal insufficiency, increased creatinine, proteinuria, polyuria.

Efavirenz: Decreased plasma conc of CYP3A or CYP2B6 substrates; atorvastatin, pravastatin, simvastatin. Increased clearance w/ CYP3A inducers (eg, phenobarb, rifampin, rifabutin). Drugs w/ known risk of Torsade de Pointes. Decreased effects of fosamprenavir, atazanavir, indinavir, lopinavir, saquinavir, maraviroc, boceprevir, elbasvir/grazoprevir, pibrentasvir/glecaprevir, simeprevir, velpatasvir, sofosbuvir/voxilaprevir, carbamazepine, phenytoin, phenobarb, bupropion, sertraline, voriconazole, itraconazole, hydroxyitraconazole, ketoconazole, posaconazole, rifabutin, proguanil, diltiazem, felodipine, nicardipine, nifedipine, verapamil, oral ethinyl estradiol/norgestimate, etonogestrel, immunosuppressants (cyclosporine, tacrolimus, sirolimus), methadone. Increased effects of ritonavir. Increased or decreased effects of warfarin. Risk of QT interval prolongation w/ macrolides (eg, clarithromycin) & artemether/lumefantrine. Decreased plasma conc of atorvastatin, pravastatin, simvastatin. NNRTIs. False +ve result in urine cannabinoid test. Tenofovir: May increase conc w/ drugs eliminated by active tubular secretion eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (eg, gentamicin), & high-doses or multiple NSAIDs. Increased conc of didanosine. Decreases conc of atazanavir. Increased conc w/ lopinavir/ritonavir, ritonavir-boosted atazanavir, or ritonavir-boosted darunavir, ofosbuvir/velpatasvir, ledispavir/sofosbuvir.

Antivirals

Rx