ocol violation and other reasons.
Responder† 84% 73% 71% 58%
Virologic failure‡ 2% 4% 3% 6%
Rebound 1% 3% 2% 5%
Never suppressed 0% 0% 0% 0%
Change in antiretroviral regimen 1% 1% 1% 1%
Death <1% 1% 1% 1%
Discontinued due to adverse event 4% 9% 5% 12%
Discontinued for other reasons§ 10% 14% 20% 22%
Subjects who were responders at Week 48 or Week 96 (HIV-1 RNA <400 copies/mL) but did not consent to continue in the trial after Week 48 or Week 96 were excluded from analysis.
†
Subjects achieved and maintained confirmed HIV-1 RNA <400 copies/mL through Weeks 48 and 144.
‡
Includes confirmed viral rebound and failure to achieve confirmed <400 copies/mL through Weeks 48 and 144.
§
Includes lost to follow-up, subject withdrawal, noncompliance, protocol violation and other reasons.
Through Week 48, 84% and 73% of subjects in the Emtriva + tenofovir DF group and the zidovudine/lamivudine group, respectively, achieved and maintained HIV-1 RNA <400 copies/mL (71% and 58% through Week 144). The difference in the proportion of subjects who achieved and maintained HIV-1 RNA <400 copies/mL through 48 weeks largely results from the higher number of discontinuations due to adverse events and other reasons in the zidovudine/lamivudine group in this open-label trial. In addition, 80% and 70% of subjects in the Emtriva + tenofovir DF group and the zidovudine/lamivudine group, respectively, achieved and maintained HIV-1 RNA <50 copies/mL through Week 48 (64% and 56% through Week 144). The mean increase from baseline in CD4+ cell count was 190 cells/mm3 in the Emtriva + tenofovir DF group and 158 cells/mm3 in the zidovudine/lamivudine group at Week 48 (312 and 271 cells/mm3 at Week 144).
Through 48 weeks, 7 subjects in the Emtriva + tenofovir DF group and 5 subjects in the zidovudine/lamivudine group experienced a new CDC Class C event (10 and 6 subjects through 144 weeks).
Study 301A
Study 301A was a 48 week double-blind, active-controlled multicenter clinical trial comparing Emtriva (200 mg once daily) administered in combination with didanosine and efavirenz versus stavudine, didanosine and efavirenz in 571 antiretroviral naive adult subjects. Subjects had a mean age of 36 years (range 18–69), 85% were male, 52% Caucasian, 16% African-American and 26% Hispanic. Subjects had a mean baseline CD4+ cell count of 318 cells/mm3 (range 5–1317) and a median baseline plasma HIV-1 RNA of 4.9 log10 copies/mL (range 2.6–7.0). Thirty-eight percent of subjects had baseline viral loads >100,000 copies/mL and 31% had CD4+ cell counts <200 cells/mL. Treatment outcomes are presented in Table 11 below.
Table 11 Outcomes of Randomized Treatment at Week 48 (Study 301A) Outcomes Emtriva
+ Didanosine
+ Efavirenz
(N=286) Stavudine
+ Didanosine
+ Efavirenz
(N=285)
*
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* 81% (78%) 68% (59%)
Virologic Failure† 3% 11%
Death 0% <1%
Discontinuation Due to Adverse Event 7% 13%
Discontinuation for Other Reasons‡ 9% 8%
Subje
