FDA’s new paediatric weight band for atazanavir

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The US Federal Drug Administration (FDA) has approved a new paediatric weight band for atazanavir oral powder. Healio reports that the revised label includes dosing recommendations for patients at least 3 months of age who weigh a minimum of 5 kg. Atazanavir (Reyataz, Bristol-Myers Squibb) was previously recommended for patients in the same age group who weighed at least 10 kg.

According to the FDA, the regimen must be taken in combination with the oral solution, ritonavir (Norvir, AbbVie). The daily dosage for patients who weigh 5kg to less than 15kg is 200mg (four packets) of atazanavir plus 80mg of ritonavir. Doses may be lowered to 150mg (three packets) of atazanavir, but only in patients weighing 5kg to less than 10kg who do not tolerate the recommended dose and have not previously received an HIV protease inhibitor. In this case, patients must be closely monitored.

The safety profile of the oral powder was similar to the capsule form of Reyataz, which was observed in clinical studies. The most frequent Grade 3 to 4 laboratory abnormalities associated with the oral powder in pediatric patients weighing 5kg to less than 35kg were increases in amylase (33%), neutropenia (9%), serum glutamic pyruvic transaminase/alanine aminotransferase ratios (9%), lipase (8%) and elevated bilirubin (>2.6 times the upper limit of the normal range; 16%). All other incidences of abnormalities occurred with a frequency of less than 3%, according to the FDA.


Also, Sangamo BioSciences has reported updated clinical data from the ZFP Therapeutic® Program for HIV/AIDS at the 2015 Interscience Conference of Antimicrobial Agents and Chemotherapy. Sangamo Biosciences’ efforts to develop genetic therapies for HIV have had some early success, with two of three participants in one cohort maintaining control of the virus for an extended period during which they were not taking standard antiretroviral (ARV) treatment. The biotech company is conducting a Phase I/II study, known as SB-728-1101, of its genetic treatment, called SB-728-T.

Cohort 3 includes three HIV-positive participants who received a genetic treatment in which their own CD4 and CD8 immune cells were drawn out, genetically modified to resist HIV, and then infused back into their bodies. This treatment was different from what was given to other participants in the study because it included modified CD8 cells instead of just modified CD4s. All of the study participants received a treatment called Cytoxan preconditioning before they received the modified cells in order to prime the body to better accept the immune cell infusion.

After undergoing the genetic treatment, the members of Cohort 3 all stopped taking ARVs. Two of them have maintained control of HIV for longer than 16 weeks.

“The ability of subjects treated in Cohort 3 to suppress and sustain control of viral load, combined with durable increases in CD4 and CD8 cells, provide support for our hypothesis of an immunologic mechanism of action for SB-728,” Dr Dale Ando, Sangamo’s vice president of therapeutic development and chief medical officer, said in a press release. “The prolonged positive effects observed in these Cohort 3 subjects have not been seen before with other treatments and have encouraged us to enroll and treat an additional five subjects with this regimen.”

Full Healio report
Aidsmeds material

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