ARV Procurement Working Group

Our Contacts

Business Online, Newyork, 1st block
1234 Building no 8, floor 3

Email: info@consultaid.com
Phone: 5586 554 558

APWG supports the ARV market in low- and middle-income countries through procurement, strategically managed demand and reduced fragmentation.‚Äč

DTG & 4-in1 supply

ViiV Healthcare, the innovator of DTG, obtained US FDA approval for their Tivicay® (dolutegravir (DTG)) 5 mg dispersible (disp) tablet in June 2020.
 
Mylan and Macleods developed a DTG 10 mg scored, disp tablet and filed it with the US FDA in CY2020 Q2 through a partnership with Unitaid, ViiV Healthcare, and CHAI. Mylan received FDA tentative approval in November 2020, with this approval the first generic DTG 10 mg tablets will be available in-country in CY2021 H1. Countries that plan to rapidly introduce pediatric DTG 10 mg tablets must place orders soon after approval to ensure sufficient supplies are manufactured and delivered to meet in-country demand. Advance planning can help accelerate in-country availability

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Paediatric “4 -in-1” ABC/3TC/LPV/r (30 mg/15 mg/40 mg/10 mg) Capsules and Sachets

 

Both Cipla and Mylan have developed or are in the process of developing a “4-in-1” ABC/3TC/LPV/r (30 mg/15 mg/40 mg/10 mg) heat-stable formulation. If approved, these will be the only paediatric fixed-dose combination that provides a complete regimen for use in first line for children weighing less than 20 kg.   
Cipla filed their ABC/3TC/LPV/r (30 mg/15 mg/40 mg/10 mg) granules formulation contained a capsule with the US FDA in October 2019. Concurrently, Mylan is developing a ABC/3TC/LPV/r (30 mg/15 mg/40 mg/10 mg) granule contained in a sachet and hope to file their products with the US FDA in Q1 2021. If ABC/3TC/LPV/r (30 mg/15 mg/40 mg/10 mg) CAPSULES are FDA tentatively approved by Q4 2020, then this product could be available in country in CY2021 H1. Countries are advised to issue firm purchase orders immediately upon US FDA approval.

 

 

 

Potential US FDA Approval and in-country availability Timelines for Pipeline Paediatric ABC/3TC/LPV/r (30 mg/15 mg/40 mg/10 mg) Products1 

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