Through 48 weeks in the Emtriva group, 5 subjects (1.7%) experienced a new CDC Class C event, compared to 7 subjects (2.5%) in the stavudine group.

Treatment-Experienced Adult Patients
Study 303

Study 303 was a 48 week, open-label, active-controlled multicenter clinical trial comparing Emtriva (200 mg once daily) to lamivudine, in combination with stavudine or zidovudine and a protease inhibitor or NNRTI in 440 adult subjects who were on a lamivudine-containing triple-antiretroviral drug regimen for at least 12 weeks prior to trial entry and had HIV-1 RNA ≤400 copies/mL.

Subjects were randomized 1:2 to continue therapy with lamivudine (150 mg twice daily) or to switch to Emtriva (200 mg once daily). All subjects were maintained on their stable background regimen. Subjects had a mean age of 42 years (range 22–80), 86% were male, 64% Caucasian, 21% African-American and 13% Hispanic. Subjects had a mean baseline CD4+ cell count of 527 cells/mm3 (range 37–1909), and a median baseline plasma HIV-1 RNA of 1.7 log10 copies/mL (range 1.7–4.0).

The median duration of prior antiretroviral therapy was 27.6 months. Treatment outcomes are presented in Table 12 below.

Table 12 Outcomes of Randomized Treatment at Week 48 (Study 303) Outcomes Emtriva
+ ZDV/d4T
+ NNRTI/PI
(N=294) Lamivudine
+ ZDV/d4T
+ NNRTI/PI
(N=146)
*
Subjects achieved and maintained confirmed HIV RNA <400 copies/mL (<50 copies/mL) through Week 48.
†
Includes subjects who failed to achieve virologic suppression or rebounded after achieving virologic suppression.
‡
Includes lost to follow-up, subject withdrawal, non-compliance, protocol violation and other reasons.
Responder* 77% (67%) 82% (72%)
Virologic Failure† 7% 8%
Death 0% <1%
Discontinuation Due to Adverse Event 4% 0%
Discontinuation for Other Reasons‡ 12% 10%
Subjects achieved and maintained confirmed HIV RNA <400 copies/mL (<50 copies/mL) through Week 48.
†
Includes subjects who failed to achieve virologic suppression or rebounded after achieving virologic suppression.

The mean increase from baseline in CD4+ cell count was 29 cells/mm3 for the Emtriva arm and 61 cells/mm3 for the lamivudine arm.

Through 48 weeks, in the Emtriva group 2 subjects (0.7%) experienced a new CDC Class C event, compared to 2 subjects (1.4%) in the lamivudine group.

Pediatric Patients
In three open-label, non-randomized clinical trials, emtricitabine was administered to 169 HIV-1 infected treatment-naive and experienced (defined as virologically suppressed on a lamivudine containing regimen for which emtricitabine was substituted for lamivudine) subjects between 3 months and 21 years of age. Subjects received once-daily Emtriva oral solution (6 mg/kg to a maximum of 240 mg/day) or Emtriva capsules (a single 200 mg capsule once daily) in combination with at least two other antiretroviral agents.