In a move that will make it easier for toddlers suffering with HIV to ingest their medication and save their lives, the Drug Controller General of India (DCGI) has finally given its nod to the child-friendly and heat-stable pellet formulation of the HIV drug lopinavir/ ritonavir (lPv/r) that can be mixed into a child’s food.
The pellets will replace the syrup comprising the drugs lPv/r which was till last year given to children up to age of three with HIV and AIDS under the National Aids Control Programme or NACO.
Manufactured by the Indian generic pharma Cipla ltd, the pellets will help achieve the World Health Organisation (WHO)’s guidelines which recommend immediate initiation of ART for all HIV-positive children younger than 5 years.
Earlier, the drug regulator had rejected Cipla’s application for registration of the HIV drug pellet formulation, citing unavailability of data on trials among Indian population. The company had sought a waiver for clinical trials among the Indian paediatric population stating that it conducted the same in Uganda and Kenya and had already been supplying the drug pellets outside India.
On May 25, an expert committee of the DCGI, the top drug regulatory authority permitted the pellet formulation of the HIV drug lPV/r to be registered.
“New innovations like these make it easy for families to administer the lifesaving treatment, yet infants living with HIV in India are the last to receive access to the lPV/r pellet due to regulatory delays. With more children actually swallowing the medicines, there will be more survivors. These innovations represent very important progress in the fight to end AIDS in children,” said Paul lhungdim of the Delhi Network of Positive People (DNP+).
“India is taking a step in the right direction by approving the use of lPV/r pellets for young children with HIV/AIDS. We now hope that more new antiretroviral drug combinations for children will be registered in India in the future so they can have more options,” said Dr Isaac Chikwanha, HIV medical advisor for MSF’s Access Campaign.
“The lack of child-friendly HIV formulations is one of the major reasons why there is such a large treatment gap between adults and children, and is also why we consider paediatric HIV to be a ‘neglected disease.’ luckily, even better medicines will soon be available, including ‘4-in-1’ fixed-dose combinations that DNDi is developing with Cipla ltd,” said Dr Suman Rijal, head, DNDi India.
Cipla stopped manufacturing syrup in 2015 stating that it has a foul-tasting that not only contains 40 per cent alcohol but also requires cold-chain transport.