Subject: FW: Request
From: Ekaterine Adamia <[email-masked]>
To: Tamar Gabunia <[email-masked]>
Date: Mon, 04 Mar 2019 13:18:52 +0000

From: David Sergeenko
Sent: 20 February, 2019 19:41
To: Ekaterine Adamia <[email-masked]>
Subject: FW: Request

სალამი ეკა

თუ შეიძლება მომწერე, რა სტატუსი გვაქვს "ვოსევი" სთან დაკავშირებით

მადლობა

დათო

From: Maia Lagvilava <[email-masked]>
Date: Tuesday, January 15, 2019 7:07 PM
To: Graeme Robertson <[email-masked]>
Cc: Sean Barr <[email-masked]>, "Hulia Hakki (Contractor" <[email-masked]>, Sopo Belkania <[email-masked]>, Davit Sergeenko <[email-masked]>, Amiran Gamkrelidze <[email-masked]>
Subject: RE: Request

Dear Graeme,

I Hope this finds you well. As per your suggestion we would like to provide with estimate requirements of Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) for a period of one calendar year within Georgian HCV elimination program:

According to AASLD and EASL guidelines Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) is recommended for following categories of patients:

·         Patients with ALL HCV genotypes with or without cirrhosis who failed on previous treatment with NS5A inhibitors containing regimens

·         Patients with HCV genotype 3 with or without cirrhosis who failed on previous treatment with Sofosbuvir-containing regimens (without NS5A inhibitor) or Pegylated Interferon/Ribavirin regimens

Based on the main international guidelines it remains controversial which regimen:  Sofosbuvir/Velpatasvir (Epclusa) or Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) is treatment of choice for HCV genotype 3 naïve patients with cirrhosis.

After consultations with Prof. Stephan Zeuzeum (University of Frankfurt) and other experts, we agreed to use Sofosbuvir/Velpatasvir (Epclusa) for treatment of HCV genotype 3 naïve patients with cirrhosis who failed on previous treatment.

Taking in consideration above mentioned the estimated number of unresponsive patients requiring treatment with Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) will be around 900 patients (2 700 bottles of Vosevi) p/year.  As this number is

rough and these calculations may need adjustment later on, at the first stage, we consider to start administration of Vosevi for the treatment of already known unresponsive patients (about 250 patients) with this diagnosis (about 750 bottles of Vosevi) and place another order later.

Sincerely,

Maia Lagvilava, MD, MHA

Deputy Minister

144 A. Tsereteli ave.

0119 Tbilisi, Georgia

Tel: (+995 32) 251 00 27 (0503)

E-mail: [email-masked]

From: Graeme Robertson [mailto:[email-masked]]
Sent: Wednesday, November 14, 2018 4:46 PM
To: Maia Lagvilava <[email-masked]>
Cc: Sean Barr <[email-masked]>; Hulia Hakki (Contractor) <[email-masked]>
Subject: RE: Request
Importance: High

Dear Maia,

We can certainly make this happen. I would also suggest that whilst Vosevi (sof/vel/vox) is not registered in Georgia we should supply you with this product to take care of any other patients that may have not responded to other courses of treatment.

I will work with Sean and advise you, we will require an official import permit and purchase order to ship you a small supply of Vosevi for these patients. If you could send these documents over at your earliest convenience we can start the process

Thank you and best wishes

Graeme

Graeme.A Robertson

Senior Director,  Africa & CIS

Access Operations & Emerging Markets

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From: Maia Lagvilava [mailto:[email-masked]]
Sent: 14 November 2018 09:26
To: Graeme Robertson
Subject: Request

Dear Graeme,

Hope you are doing well. We need your support and have a request – for only very high level patient that has a chronic HCV status and has been treated twice with different mediations, first in 2013 PedINT/RBV, 24 week, relapse and in 2015 in frames of our program SOF/PegINT/RBV – 12 relapse. There is a recommendation from the physician to conduct the treatment with SOF/VEL/VOX 3 bottles in total.

Is it possible just only for this patient to provide 3 bottles of the above mentioned medication.

We are raising this topic because of its utmost priority and will greatly appreciate your support.

Looking forward to your kind reply.

Best regards,

Maia Lagvilava, MD, MHA

Deputy Minister

144 A. Tsereteli ave.

0119 Tbilisi, Georgia

Tel: (+995 32) 251 00 27 (0503)

E-mail: [email-masked]

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