INDICATIONS AND USAGE
TRUVADA is indicated in combination with other antiretroviral agents (such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of HIV-1 infection in adults.
Additional important information regarding the use of TRUVADA for the treatment of HIV-1 infection:
- It is not recommended that TRUVADA be used as a component of a triple nucleoside regimen.
- TRUVADA should not be coadministered with ATRIPLA™, EMTRIVA, VIREAD or lamivudine-containing products (see WARNINGS).
- In treatment experienced patients, the use of TRUVADA should be guided by laboratory testing and treatment history (see MICROBIOLOGY).
Description of Clinical Studies
Clinical Study 934 supports the use of TRUVADA tablets for the treatment of HIV-1 infection. Additional data in support of the use of TRUVADA are derived from Study 903, in which lamivudine and tenofovir disoproxil fumarate were used in combination in treatment-naïve adults, and clinical Study 303 in which EMTRIVA and lamivudine demonstrated comparable efficacy, safety and resistance patterns as part of multidrug regimens. For additional information about these studies, please consult the prescribing information for VIREAD and EMTRIVA.
Study 934: EMTRIVA + VIREAD + Efavirenz Compared with zidovudine/lamivudine + Efavirenz
Data through 48 weeks are reported for Study 934, a randomized, open-label, active-controlled multicenter study comparing EMTRIVA + VIREAD administered in combination with efavirenz versus zidovudine/lamivudine fixed-dose combination administered in combination with efavirenz in 511 antiretroviral-naïve patients. Patients had a mean age of 38 years (range 18–80), 86% were male, 59% were Caucasian and 23% were Black. The mean baseline CD4 cell count was 245 cells/mm3 (range 2–1191) and median baseline plasma HIV-1 RNA was 5.01 log10 copies/mL (range 3.56–6.54). Patients were stratified by baseline CD4 count (< or ≥ 200 cells/mm3); 41% had CD4 cell counts <200 cells/mm3 and 51% of patients had baseline viral loads >100,000 copies/mL. Treatment outcomes through 48 weeks for those patients who did not have efavirenz resistance at baseline are presented in Table 7.
Table 7 Outcomes of Randomized Treatment at Week 48 (Study 934) | Outcome at Week 48 | EMTRIVA + VIREAD
+ EFV
(N=244) | AZT/3TC
+ EFV
(N=243) |
|---|
| | % | % |
|---|
| ResponderPatients achieved and maintained confirmed HIV-1 RNA <400 copies/mL through Week 48. | 84% | 73% |
| Virologic failureIncludes confirmed viral rebound and failure to achieve confirmed <400 copies/mL through Week 48. | 2% | 4% |
| Rebound | 1% | 3% |
| Never suppressed | 0% | 0% |
| Change in antiretroviral regimen | 1% | 1% |
| Death | <1% | 1% |
| Discontinued due to adverse event | 4% | 9% |
| Discontinued for other reasonsIncludes lost to follow-up, patient withdrawal, noncompliance, protocol violation and other reasons. | 10% | 14% |
The difference in the proportion of patients 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 study. In addition, 80% and 70% of patients in the EMTRIVA + VIREAD group and the zidovudine/lamivudine group, respectively, achieved and maintained HIV-1 RNA <50 copies/mL. The mean increase from baseline in CD4 cell count was 190 cells/mm3 in the EMTRIVA + VIREAD group and 158 cells/mm3 in the zidovudine/lamivudine group.
Through 48 weeks, 7 patients in the EMTRIVA + VIREAD group and 5 patients in the zidovudine/lamivudine group experienced a new CDC Class C event.
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DOSAGE AND ADMINISTRATION
The dose of TRUVADA is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken orally with or without food.
Dose Adjustment for Renal Impairment
Significantly increased drug exposures occurred when EMTRIVA or VIREAD were administered to patients with moderate to severe renal impairment (see EMTRIVA or VIREAD Package Insert). Therefore, the dosing interval of TRUVADA should be adjusted in patients with baseline creatinine clearance 30–49 mL/min using the recommendations in Table 10. These dosing interval recommendations are based on modeling of single-dose pharmacokinetic data in non-HIV infected subjects. The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate renal impairment, therefore clinical response to treatment and renal function should be closely monitored in these patients (see WARNINGS).
No dose adjustment is necessary for patients with mild renal impairment (creatinine clearance 50–80 mL/min). Routine monitoring of calculated creatinine clearance and serum phosphorus should be performed for these patients (see WARNINGS).
Table 10 Dosage Adjustment for Patients with Altered Creatinine Clearance | Creatinine Clearance (mL/min)Calculated using ideal (lean) body weight |
|---|
| ≥50 | 30–49 | <30
(Including Patients
Requiring
Hemodialysis) |
|---|
Recommended Dosing
Interval | Every 24 hours | Every 48 hours | TRUVADA should not
be administered. |
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HOW SUPPLIED
TRUVADA is available as tablets. Each tablet contains 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate (which is equivalent to 245 mg of tenofovir disoproxil). The tablets are blue, capsule-shaped, film-coated, debossed with "GILEAD" on one side and with "701" on the other side. Each bottle contains 30 tablets (NDC 61958-0701-1) and a desiccant (silica gel canister or sachet) and is closed with a child-resistant closure.
Store at 25 °C (77 °F), excursions permitted to 15–30 °C (59–86 °F) (see USP Controlled Room Temperature).
- Keep container tightly closed
- Dispense only in original container
- Do not use if seal over bottle opening is broken or missing.
Gilead Sciences, Inc.
Foster City, CA 94404
May 2007
TRUVADA, EMTRIVA, and VIREAD are registered trademarks of Gilead Sciences, Inc. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other trademarks referenced herein are the property of their respective owners.
© 2007 Gilead Sciences, Inc. All rights reserved.
21-752-GS-20
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