Clinical questions and Second round evaluation of clinical data submitted in response to questions Question 1 The FDC is a 22 mm x 11 mm, film coated tablet. The depth and circumference have not been stated in the clinical component of the dossier. The Sponsor is requested to supply the depth and circumference measurements. ViiV Healthcare response For Triumeq Tablets, the typical thickness is 7.6 mm and the approximate maximum circumference is 54.6 mm. For Kivexa Tablets, the typical thickness is 8.3 mm (as stated in our response to Question #2) and the approximate maximum circumference is 51 mm. In addition, Atripla, another fixed-dose combination HIV product marketed in Australia has similar dimensions: Atripla (EFV/TDF/FTC FDC): 20 mm x 10.4 mm. Evaluator comment Response accepted. Triumeq is a relatively large tablet which may cause some patients difficulty. Question 2 What are the dimensions of Kivexa tablets and Tivicay tablets? ViiV Healthcare response The dimensions of Kivexa and Tivicay tablets are provided below: Kivexa: 20.3 mm by 8.9 mm; typical thickness is 8.3 mm Tivicay: 9 mm round tablet; typical thickness is 4.7 mm. Evaluator comment Response accepted. Question 3 Does the Triumeq tablet swell in the presence of water? ViiV Healthcare response Triumeq Tablets do not swell in water. An experiment was performed where tablets from three batches were placed in water at room temperature and the dimensions were compared after 1, 3 and 10 minutes. No increases in dimensions (length, width and thickness) were observed. The tablets disintegrate by erosion in water, which would not be expected to cause difficulties in swallowing the tablets. Evaluator comment Response accepted. The information is reassuring. Question 4 The only submitted study in which the FDC was administered was ING114580, in which 54 healthy adults were administered 1 tablets and 12 were administered 2 tablets.
Clinical questions and Second round evaluation of clinical data submitted in response to questions Question 1 The FDC is a 22 mm x 11 mm, film coated tablet. The depth and circumference have not been stated in the clinical component of the dossier. The Sponsor is requested to supply the depth and circumference measurements. ViiV Healthcare response For Triumeq Tablets, the typical thickness is 7.6 mm and the approximate maximum circumference is 54.6 mm. For Kivexa Tablets, the typical thickness is 8.3 mm (as stated in our response to Question #2) and the approximate maximum circumference is 51 mm. In addition, Atripla, another fixed-dose combination HIV product marketed in Australia has similar dimensions: Atripla (EFV/TDF/FTC FDC): 20 mm x 10.4 mm. Evaluator comment Response accepted. Triumeq is a relatively large tablet which may cause some patients difficulty. Question 2 What are the dimensions of Kivexa tablets and Tivicay tablets? ViiV Healthcare response The dimensions of Kivexa and Tivicay tablets are provided below: Kivexa: 20.3 mm by 8.9 mm; typical thickness is 8.3 mm Tivicay: 9 mm round tablet; typical thickness is 4.7 mm. Evaluator comment Response accepted. Question 3 Does the Triumeq tablet swell in the presence of water? ViiV Healthcare response Triumeq Tablets do not swell in water. An experiment was performed where tablets from three batches were placed in water at room temperature and the dimensions were compared after 1, 3 and 10 minutes. No increases in dimensions (length, width and thickness) were observed. The tablets disintegrate by erosion in water, which would not be expected to cause difficulties in swallowing the tablets. Evaluator comment Response accepted. The information is reassuring. Question 4 The only submitted study in which the FDC was administered was ING114580, in which 54 healthy adults were administered 1 tablets and 12 were administered 2 tablets.
auspar-dolutegravir-sodium-abacavir-sulfate-lamivudine-150519-cer.docx