Umesh K, Senior Vice President – Global Business Operations, Aurobindo 

– pALD the fixed dose combination for young children is now available to at least 123 LMICs countries. MPP talks to Umesh K, Senior Vice President – Global Business Operations, at Aurobindo on their quality approved product.

  1. Why did Aurobindo decide to develop ALD fixed dose combination paediatric HIV medicine?

Aurobindo Pharma’s ARV mission is to provide wide range of high-quality antiretroviral drugs for both adults and children living with HIV with high accessibility to over 125 countries at affordable prices. In order to contribute to UNAIDS ambitious goal of achieving 95-95-95 by 2030, Aurobindo pharma is expanding through state-of-the-art manufacturing facilities and currently providing latest treatment options to more than 3 million people in low- and middle-income countries (LMICs). Aurobindo has, for long, prioritised the development and commercialisation of paediatric HIV products as required. So, it was only logical for us to develop pALD – (abacavir-60mg, lamivudine-30 mg, dolutegravir 5-mg) fixed dose combination paediatric dispersible tablet medicine which is a reflection and assurance of our commitment to support the HIV program throughout the patient lifecycle. Aurobindo has a paediatric dolutegravir voluntary licence with ViiV Healthcare, UK enabling development and supply of pALD in at least 123 LMICs.

  1. How will this treatment help the treatment of paediatric HIV?

The dispersible fixed dose combination of abacavir, dolutegravir and lamivudine is identified by WHO as a priority ART option for children living with HIV, and the generic approval for Aurobindo’s pALD will help to enable broad and affordable supply in LMICs. This combination has been included in the WHO HIV treatment guideline as 1st line treatment for paediatric HIV patients. The pALD dispersible tablet is recommended for the treatment of paediatric patients weighing 6 kg to <25 kg is administered once a day by dissolving in water. The strawberry cream flavour and the significantly smaller pill size enhances the ease of administration in children. Backed by science the superior efficacy of this drug, advantages on the palatability, dose adjustable strength and a wider weight band can contribute to making pALD more accessible and manageable for children and caregivers.

  1. In what way can MPP assist in making pALD available?

Aurobindo appreciates the initiatives spearheaded by MPP for making the most advanced HIV and other critical care medicines affordable and accessible to a wider, larger population through its voluntary licensing efforts. This includes, MPP’s contribution to GAP-f pDTG/pALD Task Team efforts to disseminate information in support of a smooth transition to this optimal new fixed-dose combination.  [Click here to access quarterly updated information reporting by MPP on Paediatric DTG Products.]

  1. How will Aurobindo work with others to ensure rapid uptake?

We are extremely glad that, with this approval for pALD, more than a million children could benefit from this product thereby helping to increase the treatment coverage of children in 123 countries. Though slow adoption and the pace of transition can be a challenge on the ground, it will be our collective endeavour to make pALD accessible across the licensed territory by stepping up advocacy efforts in the countries.

Key areas for collaboration include:

  • Regulatory affairs for facilitating the India approvals through support from MPP and other policy making groups.
  • On Development & Commercialisation, regular updates on the product availability timelines are provided to all stakeholders such as NRAs, Procurement multilateral agencies like PEPFAR/The Global Fund/ MOH s of various countries, Policy makers and Patient support groups for in-country demand generation, faster adoption etc.
  • We will continue our focus, collaborative efforts and partnerships with various international organisations as well as the National Health authorities to fast track the inclusion of pALD into the paediatric treatment guidelines.

As quoted by Helen McDowell, Head of Government Affairs & Global Public Health, ViiV Healthcare, “ViiV is proud to have partnered with CHAI, Unitaid and Aurobindo over the last three years to accelerate the development and availability of generic age-appropriate HIV treatment in resource-limited settings. The generic pALD approval is an important step forward in ensuring children living with HIV can access appropriate care and reinforces our commitment to leave no person living with HIV behind.”