Subjects had a mean age of 7.9 years (range 0.3–21), 49% were male, 15% Caucasian, 61% Black and 24% Hispanic. Subjects had a median baseline HIV-1 RNA of 4.6 log10 copies/mL (range 1.7–6.4) and a mean baseline CD4+ cell count of 745 cells/mm3 (range 2–2650). Through 48 weeks of therapy, the overall proportion of subjects who achieved and sustained an HIV-1 RNA <400 copies/mL was 86%, and <50 copies/mL was 73%. The mean increase from baseline in CD4+ cell count was 232 cells/mm3 (-945, +1512). The adverse reaction profile observed during these clinical trials was similar to that of adult subjects, with the exception of the occurrence of anemia and higher frequency of hyperpigmentation in children [See Adverse Reactions (6)].

The pharmacokinetics of emtricitabine were studied in 20 neonates born to HIV-1-positive mothers. Each mother received prenatal and intrapartum combination antiretroviral therapy. Neonates received up to 6 weeks of zidovudine prophylactically after birth. The neonates were administered two short courses of emtricitabine oral solution (each 3 mg/kg once daily × 4 days) during the first 3 months of life. Emtricitabine exposures in neonates were similar to the exposures achieved in subjects ages 3 months to 17 years [See Clinical Pharmacology (12.3)]. During the two short dosing periods on emtricitabine there were no safety issues identified in the treated neonates. All neonates were HIV-1 negative at the end of the trial; the efficacy of emtricitabine in preventing or treating HIV-1 could not be determined.

How Supplied/Storage and Handling
Capsules

The size 1 hard gelatin capsules with a blue cap and white body contain 200 mg of emtricitabine, are printed with "200 mg" in black on the cap and "GILEAD" and the corporate logo in black on the body, and are available in unit of use bottles (closed with induction sealed child-resistant closures) of:

•30 capsules (NDC 61958–0601–1).
Store at 25 °C (77 °F); excursions permitted to 15 °C–30 °C (59 °F–86 °F).

Oral Solution

The oral solution is a clear, orange to dark orange liquid, contains 10 mg/mL of emtricitabine, and is available in unit of use plastic, amber bottles (closed with child resistant closures and packaged with a marked dosing cup) of:

•170 mL (NDC 61958–0602–1).
Store refrigerated, 2 °C–8 °C (36 °F–46 °F). Emtriva oral solution should be used within 3 months if stored by the patient at 25 °C (77 °F); excursions permitted to 15 °C–30 °C (59 °F–86 °F).

Patient Counseling Information
See FDA-approved patient labeling (Patient Information).

Information for Patients
Patients should be advised that:

•Emtriva is not a cure for HIV-1 infection and patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. Patients should remain under the care of a physician when using Emtriva.
•Patients should avoid doing things that can spread HIV to others.
◦Do not share needles or other injection equipment.
◦Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
◦Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual