With this letter I would like to request your assistance in obtaining "Vosevi" for continuing treatment for Giorgui Tevdorashvili, 66 years old, male patient. As communicated earlier during the treatment initiation, the patient is diagnosed with chronic hepatitis C. He received two courses of different medications in 2013 Peg INT/RBV, 24 week, relapse and in 2015 in frames of our program SOF/Peg INT/RBV – 12 week. After the second relapse, he started treatment with SOF/VEL/VOX + RBV800mg, on 17 December 2018. At 4 weeks of treatment, PCR HCV RNA became detectable.

Attending physicians in consultations with international experts (Prof. Geoffrey Dusheiko, Prof. Karla Thornthon), within the ECHO project recommended to continue treatment with SOF/VEL/VOX (Vosevi) + RBV 1200 mg – 24 weeks, given that HCV RNA is undetectable.

Please kindly note that no special import permit or marketing authorization is required in the case of import of unlicensed medicinal product for individual needs of natural person. Company donating medicinal product should indicate in the invoice the receiver in the country of import - person`s name and surname, which will present at customs Form 100 to receive the medicine (Form 100 is issued by the physician for the particular patient (name and surname shall be indicated) – this is not a prescription, as prescription could be issued in Georgia only in the case of licensed medicines, Form 100 is applicable in the case of unlicensed medicines, it describes in details diagnosis and medicines necessary for the treatment of the person).

Import permits are not required also in the case of import of medicinal products for an exhibition, symposium, conference, forums, and congress - as a sample, without the right to sell; for such cases the purpose of the import should be clearly stated in the shipment documents.

Sincerely,

Deputy Minister

Tamar Gabunia