From: David Sergeenko
Sent: 20 February, 2019 19:41
To: Ekaterine Adamia
Subject: FW: 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,        

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

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: mlagvilava@moh.gov.ge

DISCLAIMER If you have received this message in error, please contact the sender immediately by return e-mail and notify the sender and then delete this message (including any attachments) from your system. This communication and any attachments contain information which is confidential and may also be legally privileged. It is for the exclusive use of the intended recipient(s). If you are not the intended recipient(s) please note that any form of disclosure, distribution, copying or use of this communication or the information in it or in any attachments is strictly prohibited and may be unlawful. If your e-mail contains any personal information then we will process this according to our Privacy Statement located on Gilead.com. E-mail communications cannot be guaranteed to be secure or error free, as information could be intercepted, corrupted, amended, lost, destroyed, arrive late or incomplete, or contain viruses. Gilead does not accept liability for any such matters or their consequences. Anyone who communicates with Gilead by e-mail is taken to accept the risks in doing so. Gilead has taken every reasonable precaution to ensure that any attachment to this e-mail has been swept for viruses. However, Gilead cannot accept liability for any damage sustained as a result of viruses and would advise that you carry out your own virus checks before opening any attachment. Gilead Sciences Europe Ltd ; Registered as a limited company in England and Wales ; Registered number 5510315 Registered office: South Building ; 2 Roundwood Avenue ; Stockley Park ; Uxbridge ; UB11 1AF ; England