PRESSEMITTEILUNGEN

Paris, November 25 (ots/PRNewswire) -

– REYATAZ(R) is the only boosted PI to include dosing and
medical guidance in pregnancy and postpartum in the label –

Bristol-Myers Squibb Company today announced that the European Commission approved a labelling update for REYATAZ(R) (atazanavir sulfate) based on new data generated in pregnant women living with HIV. The updated label provides dosing and medical guidance for REYATAZ/ritonavir during pregnancy and immediately following birth. The data came from study AI424-182, which evaluated the pharmacokinetic parameters, efficacy and safety of REYATAZ/ritonavir in pregnant women living with HIV. (1,2)

Worldwide, more than 3 million women living with HIV give birth every year.(3) According to European AIDS Clinical Society (EACS) treatment guidelines, some antiretroviral (ARV) drugs may be prescribed during pregnancy to reduce the mother’s viral load,(4) although their optimal dosage is mostly unknown.(5) As pregnancy can reduce the serum levels of many ARVs, it is important to know the optimal dosage.(6)

“This labelling update is important news for both physicians and women with HIV of child-bearing age in that it provides dosing and medical guidance for the use of REYATAZ/ritonavir during pregnancy and postpartum,” said Margaret Johnson, Clinical Director of HIV Services, Royal Free NHS Trust, London.

This label update is based on a multicentre, open-label, prospective, single-arm pharmacokinetic study (Study AI424-182). The study evaluated 41 pregnant women living with HIV, between 12 to 32 weeks gestation (second and third trimester of gestation) with CD4 > 200 cells/mm(3). Study participants were treated with REYATAZ with ritonavir 300/100 mg (n=20) or 400/100 mg (n=21) once daily in combination with zidovudine/lamivudine 300/150 mg twice daily; those in their second trimester received REYATAZ/ritonavir 300/100 mg.(2)

The primary objective of the study was to determine the dosing of REYATAZ/ritonavir to produce adequate drug exposure in pregnant women with HIV compared to historical data in adults living with HIV. The results showed that both doses of REYATAZ achieved minimum plasma concentrations (24 hours post-dose) during the third trimester of pregnancy, comparable to that observed historically in adults living with HIV.(2)

Secondary outcomes of the study evaluated antiviral efficacy and safety in pregnant women and their infants. Among the 39 women who completed the trial, 38 achieved an HIV RNA

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