The Food and Drug Administration (FDA) has approved Temixys (lamivudine and tenofovir disoproxil fumarate; Celltrion) tablets for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients weighing ≥35kg.
Temixys combines lamivudine (3TC) and tenofovir disoproxil fumarate (TDF), which are 2 nucleoside reverse transcriptase inhibitors.
The approval was supported by 2 bioavailability trials showing similarity in exposures between Temixys and the reference products, Epivir (lamivudine) and Viread (tenofovir disoproxil fumarate). Trial 903 was a double-blind, active-controlled multicenter study (N=600) that compared TDF 300mg + 3TC 300mg + efavirenz (EFV) 600mg vs stavudine (d4T) 40mg + 3TC 300mg + EFV 600mg in antiretroviral-naive patients. Results showed achievement of plasma HIV-1 RNA <400 copies/mL at week 144 was similar between the treatment arms for the population stratified by baseline HIV-1 RNA concentration and CD4+ cell count.
Through week 144, 62% of TDF- and 58% of d4T-treated patients achieved and maintained confirmed HIV-1 RNA <50 copies/mL. A mean increase of 263 cells/mm3 and 283 cells/mm3 from baseline CD4+ cell count was seen for the TDF and d4T arms, respectively. The most common adverse reactions were headache, pain, depression, diarrhea, and rash.
Prior to initiation and during treatment, patients should be tested for hepatitis B virus (HBV) infection. Also, estimated creatinine clearance, urine glucose, and urine protein should be obtained. Temixys is not recommended for patients with renal impairment (ie, CrCl <50 mL/min) or in patients with end-stage renal disease (ESRD) requiring hemodialysis.
Temixys will be available as 300mg/300mg fixed-dose tablets in 30-count bottles.
For more information call (844) 837-6511 or visit Celltrion.com.