Indications: Treatment of HIV-1 infection

Contra-indications: History of clinically-significant hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme, or toxic skin reactions) to efavirenz; concurrent use of bepridil, cisapride, midazolam, triazolam, voriconazole, ergot alkaloids (includes dihydroergotamine, ergotamine, ergonovine, methylergonovine), St John's wort, pimozide.

Renal impairment: Moderate-to-severe renal impairment (CrCl <50 ml/minute): (Use not recommended).

Hepatic Impairment Mild hepatic impairment (Child- Pugh class A): Use with caution. Moderate or severe hepatic impairment (Child-Pugh class B, C): Not recommended.

Side Effects: The complete adverse reaction profile of combination therapy has not been established. The

following adverse effects were noted in clinical trials with combination therapy:

Most common: Endocrine & metabolic: Hypercholesterolemia.

Less common: Central nervous system: Depression, fatigue, dizziness, headache, anxiety, insomnia, somnolence, abnormal dreams Dermatologic: Rash. Endocrine & metabolic: Triglycerides increased, hyperglycemia. Gastrointestinal: Nausea, diarrhea, serum amylase increased, vomiting.

Hematologic: Neutropenia. Hepatic: AST increased, ALT increased, alkaline phosphatase increased.

Neuromuscular & skeletal: Creatine increased. Renal: Hematuria. Respiratory: Sinusitis, upper respiratory infection, nasopharyngitis. rare (Limited to important or life-threatening): Glycosuria.

Dose: Adult: Note: Prior to initiation, patients should be tested for hepatitis B infection, and baseline estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be assessed in all patients. HIV infection: Oral: One tablet once daily.

Note: Recommended as an initial regimen for antiretroviral-naive patients.