VIREAD-treated subjects whose HIV-1 expressed 3 or more zidovudine resistance-associated substitutions that included either the M41L or L210W reverse transcriptase substitution showed reduced responses to VIREAD therapy; however, these responses were still improved compared with placebo. The mean baseline CD4Achievement of plasma HIV-1 RNA concentrations of less than 400 copies/mL at Week 144 was similar between the two treatment groups for the population stratified at baseline on the basis of HIV-1 RNA concentration (> or ≤100,000 copies/mL) and CD4Through 144 weeks, 11 subjects in the VIREAD group and 9 subjects in the stavudine group experienced a new CDC Class C event.Data through 144 weeks are reported for Study 934, a randomized, open-label, active-controlled multicenter trial comparing emtricitabine + VIREAD administered in combination with efavirenz versus zidovudine/lamivudine fixed-dose combination administered in combination with efavirenz in 511 antiretroviral-naïve subjects. 6-fold those observed in humans caused bone toxicity. The trials assessed
milk at low levels. weaning of the offspring.Long-term oral carcinogenicity studies of TDF in mice and
similar incidence in both arms, and included dizziness, diarrhea, and nausea.
subject received treatment with a single 300-mg dose of 3TC and TMP 160 mg/SMX
tenofovir. Reproduction studies with orally
Commonly reported side effects of tenofovir include: abdominal pain, depression, nausea, vomiting, and vesicobullous reaction. Patients infected with HBV who
comparative controlled study in which 600 treatment-naive subjects received TDF
Please see the full prescribing information
If overdose occurs, the patient should be monitored and standard
mean elimination half-life (t½) ranged from 5 to 7 hours in most single-dose
therapy. If you
The median EC50 values
Subjects had a mean Child-Pugh score of 7, a mean MELD score of 12, mean HBV DNA of 5.8 logAt 48 weeks, 31/44 (70%) and 12/26 (46%) VIREAD-treated subjects achieved an HBV DNA < 400 copies/mL (69 IU/mL), and normalized ALT, respectively. between 3TC and interferon alfa in a trial of 19 healthy male subjects [see Trimethoprim/Sulfamethoxazole: 3TC and TMP/SMX were coadministered to 14 HIV-1positive
to 2000 mg per kg, producing plasma levels of 35 to 45 times those in humans at
Similar trends were observed in chronic hepatitis B infected adolescent subjects aged 12 years to less than 18 years. Ann Pharmacother 38 (2004): 1969-7027.
You can ask your healthcare provider for information about this vaccine.This leaflet summarizes the most important information about VIREAD. HIV-1 clades A, B, C, D, E, F, G, and O (EC50 values ranged from 0.5 μM to
registry to monitor fetal outcomes in women exposed to CIMDUO [see Instruct women with HIV-1 infection not to breastfeed
3TC was not antagonistic to all tested anti-HIV agents. postnatal transmission of HIV-1 infection.3TC is excreted into human milk. termination after incorporation of the nucleotide analogue.TDF is an acyclic nucleoside phosphonate diester analog
Mean change in absolute CD4Through Week 24, one subject in the VIREAD group and no subjects in the placebo arm experienced a new CDC Class C event.Study 0102 was a Phase 3, randomized, double-blind, active-controlled trial of VIREAD 300 mg compared to HEPSERA 10 mg in 375 HBeAg- (anti-HBe+) subjects with compensated liver function, the majority of whom were nucleoside-naïve. If
Increases in serum creatinine, BUN, glycosuria, proteinuria, phosphaturia, and/or calciuria and decreases in serum phosphate were observed to varying degrees in these animals.
mg twice daily) and 2.1 to 5.2 mcg per mL (300 mg twice daily).Studies in pregnant rats showed that 3TC is transferred
variable, and can occur many months after initiation of treatment.In HIV-infected patients, redistribution/accumulation of
laboratory follow-up for at least several months after stopping treatment. risk of overall major birth defects for 3TC compared to the background rate for
drug and may not reflect the rates observed in practice.The most common adverse reactions seen in a double-blind
Clinically relevant fractures (excluding fingers and toes) were reported in 4 subjects in the VIREAD group and 6 subjects in the d4T group.
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