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The Food and Drug Administration has approved the combination of lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) known as Temixys for treatment of HIV-1 when used with other antiretrovirals. The approval is for adult and pediatric patients with HIV-1 who weigh at least 35 kg.
The approval is based on data through 144 weeks in a double-blind, active-controlled, multicenter trial in 600 antiretroviral-naive patients. The trial compared TDF/3TC plus efavirenz (EFV) with 3TC/EFV plus stavudine (d4T). The results showed similar responses at 144 weeks between both groups: 62% of patients taking TDF/3TC/EFV and 58% of patients taking d4T/3TC/EFV achieved and maintained fewer than 50 copies/mL of HIV-1 RNA.
The most common adverse events include headache, pain, depression, rash, and diarrhea. Prior to initiating treatment, patients should be tested for hepatitis B virus because there have been reports of 3TC-resistant strains of hepatitis B virus associated with treatment of HIV-1 with 3TC-containing regimens in coinfected patients. Patients should also be tested for estimated creatinine clearance, urine glucose, and urine protein because TDF/3TC is not recommended for patients with renal impairment.
The full prescribing information can be found on the FDA website.
The Food and Drug Administration has approved the combination of lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) known as Temixys for treatment of HIV-1 when used with other antiretrovirals. The approval is for adult and pediatric patients with HIV-1 who weigh at least 35 kg.
The approval is based on data through 144 weeks in a double-blind, active-controlled, multicenter trial in 600 antiretroviral-naive patients. The trial compared TDF/3TC plus efavirenz (EFV) with 3TC/EFV plus stavudine (d4T). The results showed similar responses at 144 weeks between both groups: 62% of patients taking TDF/3TC/EFV and 58% of patients taking d4T/3TC/EFV achieved and maintained fewer than 50 copies/mL of HIV-1 RNA.
The most common adverse events include headache, pain, depression, rash, and diarrhea. Prior to initiating treatment, patients should be tested for hepatitis B virus because there have been reports of 3TC-resistant strains of hepatitis B virus associated with treatment of HIV-1 with 3TC-containing regimens in coinfected patients. Patients should also be tested for estimated creatinine clearance, urine glucose, and urine protein because TDF/3TC is not recommended for patients with renal impairment.
The full prescribing information can be found on the FDA website.
The Food and Drug Administration has approved the combination of lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) known as Temixys for treatment of HIV-1 when used with other antiretrovirals. The approval is for adult and pediatric patients with HIV-1 who weigh at least 35 kg.
The approval is based on data through 144 weeks in a double-blind, active-controlled, multicenter trial in 600 antiretroviral-naive patients. The trial compared TDF/3TC plus efavirenz (EFV) with 3TC/EFV plus stavudine (d4T). The results showed similar responses at 144 weeks between both groups: 62% of patients taking TDF/3TC/EFV and 58% of patients taking d4T/3TC/EFV achieved and maintained fewer than 50 copies/mL of HIV-1 RNA.
The most common adverse events include headache, pain, depression, rash, and diarrhea. Prior to initiating treatment, patients should be tested for hepatitis B virus because there have been reports of 3TC-resistant strains of hepatitis B virus associated with treatment of HIV-1 with 3TC-containing regimens in coinfected patients. Patients should also be tested for estimated creatinine clearance, urine glucose, and urine protein because TDF/3TC is not recommended for patients with renal impairment.
The full prescribing information can be found on the FDA website.