Subject: FW: Drugs for Hep C program-Georgia
From: Ekaterine Adamia <[email-masked]>
To: Amiran Gamkrelidze <[email-masked]>, "[email-masked]" <[email-masked]>, "[email-masked]" <[email-masked]>, Vakho Kerashvili <[email-masked]>, "[email-masked]" <[email-masked]>, Maia Butsashvili <[email-masked]>, tamar kavteladze <[email-masked]>, "[email-masked]" <[email-masked]>
Cc: Tamar Gabunia <[email-masked]>, Giorgi Tsotskolauri <[email-masked]>
Date: Mon, 09 Sep 2019 12:42:33 +0000

მოგესალმებით,

გაცნობებთ, რომ ხვალ, 10 სექტემბერს, 17:00-18:00 სთ ჩანიშნულია ტელეკონფერენცია ბატონ ფრანცისკო ავერჰოფთან, C ჰეპატიტის სამკურნალო სქემებში ჰარვონის გამოყენების საკითხებთან დაკავშირებით.

გთხოვთ, მიიღოთ მონაწილეობა (იხ. ქვემოთ წერილი).

პატივისცემით,

ეკა

ეკატერინე ადამია

საზოგადოებრივი ჯანმრთელობის დაცვისა

და პროგრამების სამმართველოს უფროსი

საქართველოს ოკუპირებული ტერიტორიებიდან დევნილთა,

შრომის, ჯანმრთელობისა და სოციალური დაცვის სამინისტრო

თბილისი, წერეთლის გამზირი 144

მობ: (+995) 577 282825

ტელ: (+322) 5100381110

From: Tatia Kuchuloria [mailto:[email-masked]]
Sent: 6 September, 2019 12:59
To: Tamar Gabunia <[email-masked]>
Cc: Ekaterine Adamia <[email-masked]>; Irinka Tskhomelidze <[email-masked]>; Koscelski, Anna (CDC/DDID/NCHHSTP/DVH) <[email-masked]>; Lia Gvinjilia <[email-masked]>; Nasrullah, Muazzam (CDC/DDID/NCHHSTP/DVH) <[email-masked]>; Shadaker Shaun (CDC/DDID/NCHHSTP/DVH) <[email-masked]>; Glass Nancy (CDC/DDID/NCHHSTP/DVH) <[email-masked]>; Averhoff, Francisco (CDC/DDID/NCHHSTP/DVH) <[email-masked]>
Subject: Re: Drugs for Hep C program-Georgia

Dear Dr. Gabunia,

Dr. Francisco Averhoff and his team can make a zoom call on September 10 at 17:00-18:00 Tbilisi time. If this date and time is convenient for you, below please find zoom links for the given date/time to invite relevant parties.

Join Zoom from PC, Mac, iOS or Android:
https://echo.zoom.us/j/3545388816?pwd=dUFmQW51eDE0dEdwWThsTWtGbmhodz09

Password: 123123

Joining by phone ONLY:
+1 646 558 8656 US (New York)
+1 669 900 6833 US (San Jose)
Meeting ID: 354 538 8816
Find your local number: https://zoom.us/u/adIyNk9ueH
Press *6 to mute your line when not speaking

To join via video from Video Conferencing System:

Join by SIP
[email-masked]

Join by H.323
162.255.37.11 (US West)
162.255.36.11 (US East)
Meeting ID: 354 538 8816
Password: 586473

Best regards,

Tatia

Tinatin Kuchuloria MD, PhD, MSc

თინათინ ქუჩულორია

Scientific Coordinator

Georgia Hepatitis C Elimination Program

CDC South Caucasus Office

9 M. Asatiani  str.  0177 Tbilisi, Georgia

Tel: (995 32) 224 46 58

Mobile: +995 595 227778

On Wednesday, September 4, 2019, 09:18:56 AM GMT+4, Tamar Gabunia <[email-masked]> wrote:

Dear Francisco

Many thanks for your prompt reply. Much appreciated. Below I’ve enclosed a letter from Professor Tsertsvadze that he kindly asked me to convey to you before our discussion. We’ll get back to you regarding the date.

With kind regards.

Tamar

Dear Dr. Averhoff,

I hope everything is fine. With this email we would like to discuss with you an important issue related to hepatitis C treatment protocol of Georgia’s HCV elimination program.

As you know at present two DAAs: Sofosbuvir/Ledipasvir (Harvoni) and Sofosbuvir/Velpatasvir (Epclusa) are available within our program. According to national treatment protocol:

Sofosbuvir/Ledipasvir (Harvoni) is used for treatment of following categories of patients:

•             Genotype 1 and genotype 4 treatment naïve patients (without or with cirrhosis, including decompensated cirrhosis)

•             Genotype 1 and genotype 4 treatment experienced (Interferon/Ribavirin, Protease inhibitor) patients (without or with cirrhosis, including decompensated cirrhosis)

Sofosbuvir/Velpatasvir (Epclusa) is used for following categories of patients:

•             Genotype 2 and genotype 3 treatment naïve patients (without or with cirrhosis, including decompensated cirrhosis)

•             Genotype 2 and genotype 3 treatment experienced (Interferon/Ribavirin, Sofosbuvir, NS5A inhibitor) patients (without or with cirrhosis, including decompensated cirrhosis)

•             Genotype 1 and genotype 4 treatment experienced (Sofosbuvir, NS5A inhibitor) patients (without or with cirrhosis, including decompensated cirrhosis)

Please be informed that at the last meeting (on August 19th) of national hepatitis C elimination program committee, replacement of Harvoni with Epclusa was discussed.

As you know first round (without retreatment) Harvoni-based regimens resulted to a very high overall SVR rate – 98.5% and it was not expected that Epclusa-based regimens would further raise overall cure rate. Preliminary data on Epclusa-based treatment outcomes have already showed it (overall cure rate - up to 96%). Epclusa-based treatment was definitely justified for genotype 2 and genotype 3 patients, since in most of the regimens treatment with Epclusa compared to Harvoni was Ribavirin free. However for genotype 1 patients treatment with Harvoni does not also require Ribavirin. Therefore we did not consider as an advantage to replace Harvoni with Epclusa for genotype 1 patients.

The only advantage of Epclusa is that compared to Harvoni, it is a pan-genotypic DAA that allows to remove genotyping test from pretreatment diagnostic algorithm and it can be used for all patients regardless of genotype.

However as you know Georgia’s HCV elimination program also envisions (and it was approved by scientific committee) to study HCV reinfection after successful treatment and in this case we are anyway doing genotyping test to distinguish true reinfection case (if discordant genotype if detected) from late relapse (if concordant genotype detected).

Also genotyping test will be still needed for genotype 3 Sofosbuvir experienced patients (without or with compensated cirrhosis) for selecting a correct treatment regimen - a 24-week combination of Epclusa plus Ribavirin (according to treatment guidelines).

Taking into account all above-mentioned we think that from the clinical standpoint it would be more comfortable to have a diverse arsenal of DAAs within the program and leave both Harvoni (for genotype 1 patients) and Epclusa (for genotype 2 and 3 patients) in our treatment protocol.

We would appreciate if you can provide us your recommendations on abovementioned. If despite of our suggestions you strongly recommend using Epclusa for all genotypes and removing Harvoni from treatment algorithms, we will update treatment protocol as well as medication forecast for 2020 to be submitted to GIlead will be done accordingly by the ministry of health.

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

From: Averhoff, Francisco (CDC/DDID/NCHHSTP/DVH) [mailto:[email-masked]]
Sent: Tuesday, September 3, 2019 4:31 PM
To: Tamar Gabunia <[email-masked]>
Cc: Ekaterine Adamia <[email-masked]>; Irinka Tskhomelidze <[email-masked]>; Tatia Kuchuloria <[email-masked]>; Koscelski, Anna (CDC/DDID/NCHHSTP/DVH) <[email-masked]>
Subject: Re: Drugs for Hep C program-Georgia

Dear Tamar, I would be very happy to participate in a discussion. Would next week be ok? Or could do this week as well, please advise, I am including Anna who knows my calendar well, and I can be flexible, best FA

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From: Tamar Gabunia <[email-masked]>
Sent: Tuesday, September 3, 2019 7:51:06 AM
To: Averhoff, Francisco (CDC/DDID/NCHHSTP/DVH) <[email-masked]>
Cc: Ekaterine Adamia <[email-masked]>; Irinka Tskhomelidze <[email-masked]>; Tatia Kuchuloria <[email-masked]>
Subject: Drugs for Hep C program-Georgia

Dear Francisco

I hope this e-mail will find you doing well. I am writing to ask for your advice on the following. As you may know we are in the process of developing the next year forecast for Hep C drugs. The National program leaders consider both options (1) full transition to Epclusa only regimen and (2) use Harvoni for genotype 1 patients and Epclusa for 2 and 3 as it is right now. The latter is the preferred option for the clinical team here. However, Dr Tengiz and others are willing to discuss more pros and cons of both options. Would you mind to assist with this discussion and facilitate decision making. We could have a conference call at your convenience sometime soon.

Many thanks and looking forward.

პატივისცემით,

თამარ გაბუნია

მინისტრის მოადგილე

Sincerely,

Tamar Gabunia, MD, MPH

Deputy Minister