Dear Patrick, dear Dr. Vasee,  hope this email finds you well!

 

I wanted to double check if you have any updates on Remdesivir shipment and also kindly ask to provide the information on the manufacturer of Acalabrutinib as our NRA needs this to add this medication to the list of registered drugs.

We will hopefully have the requested documents by the end of next week.

 

I apologize for using my non-work email for technical reasons and I'm copying the previous correspondence in the email.

Thank you for your kind support!

 

Respectfully,

Alisa Tsuladze, MPH

 

Health Policy Division

Policy Department

Ministry of Internally Displaced persons from

Occupied Territories, Labor, Health and Social Affairs of Georgia

 

_______________________________________________________

 

From: LYDON, Patrick [mailto:lydonp@who.int]
Sent: Tuesday, September 15, 2020 1:10 PM
To: DARA, Masoud; Tengiz Tsertsvadze; SATHIYAMOORTHY, Vaseeharan
Cc: solidaritytrials; Tamar Gabunia; Ekaterine Adamia; Alisa Tsuladze
Subject: RE: [EXT] Solidarity trial

 

Dear Prof Tsertsvadze,

Thank you for your message. I’m including Dr Vasee on this exchange in order to clarify the situation on Remdesivir for Georgia.

For Acalabrutinib, we need to have the assurance that you have gotten both ethics and regulatory approvals of the revised protocol (V.15). Can you share these documents with us?
All the very best

Patrick

 

From: DARA, Masoud <daram@who.int>
Sent: 14 September 2020 20:00
To: Tengiz Tsertsvadze <tt@aidscenter.ge>
Cc: LYDON, Patrick <lydonp@who.int>; solidaritytrials <solidaritytrials@who.int>; M Georgia <tgabunia@moh.gov.ge>; Ekaterine Adamia <eadamia@moh.gov.ge>; Alisa Tsuladze <atsuladze@moh.gov.ge>
Subject: RE: [EXT] Solidarity trial

 

Dear professor Tsertsvadze,

 

Thank you for you message. I am doing fine. I hope you and colleagues in Georgia are also doing fine in these trying times. Supply of medicines under Solidarity trial is led by our headquarters colleagues. Mr Lydon copied here can kindly add.

 

Thanks and regards,

Masoud

 

 

Dr Masoud Dara

Coordinator, Communicable Diseases

Division of Country Health Programmes

World Health Organization Regional Office for Europe

UN City, Marmorvej 51, 2100 Copenhagen, Denmark

Email: daram@who.int | Website: www.euro.who.int

 

 

 

 

From: Tengiz Tsertsvadze <tt@aidscenter.ge>
Sent: Monday, September 14, 2020 7:04 PM
To: DARA, Masoud <daram@who.int>
Cc: LYDON, Patrick <lydonp@who.int>; solidaritytrials <solidaritytrials@who.int>; M Georgia <tgabunia@moh.gov.ge>; Ekaterine Adamia <eadamia@moh.gov.ge>; Alisa Tsuladze <atsuladze@moh.gov.ge>
Subject: [EXT] Solidarity trial

 

Dear Dr. Dara,  

 

I hope this email finds you well. Once again we would like to express our sincere gratitude for selecting Georgia to participate in WHO sponsored “Solidarity” trial.

 

As you are well aware the initial protocol of the “Solidarity” trial envisioned to study efficacy of Remdesivir, hydroxychloroquine and Lopinavir/Ritonavir ± Interferon β1a in hospitalized patients with moderate or severe COVID-19.

 

On June 17, 2020, WHO removed hydroxychloroquine from the above-mentioned trial, and on July 4, 2020, Lopinavir/Ritonavir was also removed. On August 6, 2020, the “Solidarity” research executive broad issued a recommendation to evaluate the clinical efficacy of the additional drug Acalabrutinib as part of this study. Currently, “Solidarity” trial includes following medications: Remdisivir, Acalabrutinib and β interferon.

 

In line with WHO recommendation we removed the use of hydroxychloroquine and Lopinavir/Ritonavir outside of clinical trials in our national COVID-19 treatment protocol. As a result Interferon β1a is the only medication in the country which we can use for COVID-19 patients at present. Therefore provision of Remdesivir and Acalabrutinib within the “Solidarity” trial is a matter of urgency for us.  

 

We would highly appreciate it if you could consider the above mentioned serious circumstance and facilitate a timely provision of Remdesivir and Acalabrutinib to Georgia as soon as possible.  

 

Thank you in advance for your kind consideration and we look forward to your response.

 

Best regards,

 

Tengiz Tsertsvadze