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.