Subject: Re: Drugs for Hep C program-Georgia
From: "Averhoff, Francisco (CDC/DDID/NCHHSTP/DVH)" <[email-masked]>
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]>
Date: Wed, 04 Sep 2019 14:58:03 +0000

Dear Dr. Tamar thank you for below, well noted. Best FA

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From: Tamar Gabunia <[email-masked]>

Sent: Wednesday, September 4, 2019 1:18:47 AM

To: Averhoff, Francisco (CDC/DDID/NCHHSTP/DVH) <[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 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