[Ip-health] with attachment copied: Urgent: Sign on Letter to ViiV on ARVs for kids! Need organisational sign ons by end of day Wednesday

Katy ATHERSUCH Katy.ATHERSUCH at geneva.msf.org
Tue Jul 17 07:33:47 PDT 2018


Dear All,

Further to Shailly's email, I am copying the text of the letter to sign on to here below, as IP Health list does not send attachments. Please send your ORGANIZATIONAL SIGN ON to Jessica.burry at geneva.msf.org and HTB-AccessIntern at newyork.msf.org (cc'd) by COB this Wednesday (17 July).

Many thanks
----------------------------------------

Deborah Waterhouse 
CEO, Viiv Healthcare 
United Kingdom 
July 19th, 2018 

Request to urgently step up efforts to ensure widespread access to dolutegravir for children 

Dear Mrs. Waterhouse, 

We are writing to express our concerns about the on-going delays in making the key pediatric HIV medicine dolutegravir available. On November 17, 2017, the global HIV community welcomed the commitment from Viiv at the Rome Pediatric HIV meeting, to make dolutegravir pediatric formulations available at the cost of production in low and middle-income countries until generics become available, but we have yet to see concrete steps to ensure this will happen. 

The vast majority of the 2.1 million children living with HIV do not have access to life-saving treatment or continue to receive suboptimal treatment. These children would benefit from dolutegravir-based regimens that have fewer side effects and a stronger barrier to resistance. 

However, despite Viiv's public promise, there has been little advancement to date, a full eight months later, to make this promise a reality. Viiv has barely started filing for registration of its available pediatric formulations, with dossiers submitted in only three countries in sub-Saharan Africa. This is particularly problematic because Viiv refuses to sell pediatric dolutegravir to countries where the medicine is not yet registered, even though the use of import waivers is a common practice accepted by most pharmaceutical companies for importation of unregistered ARVs in to countries where they are needed. 

Given the preference from the Pediatric ARV Drug Optimization group for dolutegravir as the best option for children, and their recommendation to move towards alignment with adult treatment options, it is expected that the next World Health Organization HIV guidelines update will include dolutegravir as part of first-line treatment for children living with HIV. However, dolutegravir dosing is still not available for younger children; pediatric formulations are not available in countries where they are needed; and pediatric 5 mg dispersible tablets and the fixed-dose combination of ABC/3TC/DTG do not exist at all. As a result, 40% of children who are on HIV treatment continue to receive sub-optimal nevirapine-based regimens, putting them at risk of increased side effects, resistance and treatment failure, thereby increasing their risk of contracting opportunistic infections such as tuberculosis (TB), and dying. 

Viiv must commit to take immediate, concerted actions in order uphold its 2017 promise. We, the undersigned, demand that Viiv undertake the following actions, in order to ensure access to affordable pediatric formulations: 

1. R&D - Expedite finalization of dosing studies for younger children to allow simplified dosing for Lower- and Middle-Income Countries, and the development/registration of 5mg dispersible tablets. 

2. REGISTRATION - start filing dossiers for existing pediatric dolutegravir for 10 mg and 25 mg tablets, prioritizing countries with high HIV-prevalence, using WHO's Collaborative Registration process for participating countries. Viiv should subsequently publish the registration status (both filed and approved) by country online. 

3. PROCUREMENT - Make dolutegravir 10 mg and 25 mg tablets available for procurement by countries where registration is not complete by using importation waivers for unregistered medicines. 

We call on Viiv to urgently take these steps and revise its policies and practices in order to allow countries to purchase and use pediatric dolutegravir formulations as quickly as possible. 

If Viiv follows these actions, it will signal its stated dedication to helping improve the lives of ALL people living with HIV. 

We look forward to your response by the eve of the International AIDS Conference, along with timelines for the actions outlined above. 

Sincerely, 

Cc Bill Collier, Head of Pediatric Strategy 
Helen McDowell, Director of Government Affairs, Access & Patient Advocacy 

-----Original Message-----
From: Ip-health [mailto:ip-health-bounces at lists.keionline.org] On Behalf Of Shailly GUPTA
Sent: mardi 17 juillet 2018 15:25
Cc: Jessica BURRY; HTB Access Intern-Allyson Stieber
Subject: [Ip-health] Urgent: Sign on Letter to ViiV on ARVs for kids! Need organisational sign ons by end of day Wednesday



Dear All,



As the International AIDS Conference is around the corner, we will take the opportunity to put pressure on Viiv regarding the lack of access to pediatric dolutegravir(DTG).   There are too many delays and excuses - now Viiv needs to take action.



Access to dolutegravir for children living with HIV is critical to provide improved and optimal treatment options for children who often suffer from side effects and difficulty adhering to other regimens. Both the WHO's paediatric antiretroviral drug optimization (PADO) group and the Paediatric HIV Treatment Initiative (PHTI) have indicated dolutegravir as a priority ARV and that access should be accelerated for children.



Viiv has barely even  started to register peds formulations of dolutegravir in Lower Middle Income Countries (filed in 3 in sub-Saharan Africa, registered in Brazil, Turkey and Israel), and for countries where they are not registered, they do not allow procurement.  For the youngest kids, the dosing info is still pending, and they have not even filed to register their 5 mg dispersible tablet in any country - and all of this despite their public commitments to allowing access to dolutegravir for peds.

Please see the attached letter for more details, for sign-on by organizations / institutions only please.  We will send the letter to Viiv on Friday, so please let us know if your organization will sign-on to this request by end of the day tomorrow (Wed July 18).  We hope it won't be a difficult decision for groups to take to sign on to a letter on access to peds ARVs!



Please reply to Jessica Burry (Jessica.burry at geneva.msf.org<mailto:Jessica.burry at geneva.msf.org>) and Allyson  Stieber (HTB-AccessIntern at newyork.msf.org<mailto:HTB-AccessIntern at newyork.msf.org>),



Thanks!



Best regards



MSF Access Campaign



Shailly Gupta
Press & Communications Officer
MSF Access Campaign
Médecins Sans Frontières
Ph: +41 22 849 9334
M: +41 79 203 13 02
Skype: Shailly.17 |Twitter: @shaillytweeting





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