From : Maia Nikoleishvili <mnikoleishvili@moh.gov.ge>
To : SPARC <sparc@gilead.com>
Subject : FW: Sovaldi AE report from Armenia_AE5_2017-0303964 and AE6_2017-0303965
Cc : Farhana Haque <Farhana.Haque@gilead.com>; sbelkania@moh.gov.ge; Mariana Mkurnali
Received On : 13.11.2017 16:29
Attachments :

Dear Colleagues,
Please, find the e-mail below from Armenian contact point regarding the latest AE reports (AE-5 - 2017-0303964 and AE6 - 2017-0303965). Some details are clarified. The original filled AE5 and AE6 reports are also attached.

Kind regards,
Maia
 


-----Original Message-----
From: Naira Romanova
To: 'Maia Nikoleishvili'
Date: Mon, 13 Nov 2017 15:15:42 +0400
Subject: RE: FW: Sovaldi AE report from Armenia

Dear Maia,

 

I in response to your request from 02.11.2017 on AEs clarifications, I would like to provide answers to A5 and A6 reports:

 

Concerning A5 report

The treatment start date is changed it was written on report 02.07.2017 but should be 08.06.2017. Patient started treatment on 08.06.2017, from 31.06.2017 to 13.07.2017  treatment was stopped  because of patients condition. Treatment restarted on 13.07.2017 again. On 31.08.2017 patient was tested and the results shown HCV negative but because of liver condition and decomposition treatment was stopped. Patient was later hospitalized and died on 12.08.2017. HC  Treating doctor  got aware about the patient death several days after the death.

 

Concerning A6 report

Patient started treatment on 14.06 and was on treatment for 3 months without stopping the medication intake.

On 27.08..2017 doctor got aware that patient died some days ago because of hemodialysis complication (concomitant disease from 2012).

 

And the A3 report clarification was sent to you on Friday.

 

The other rest of requested AE clarifications doctor will provide during this week. As soon as I get the information will send them to you.

 

Kind regards,

Naira