Favourable opinion for reimbursement in the treatment of HIV-1 infection only in adults and adolescents above 12 years of age weighing at least 40 kg:
who are treatment-naive, with a CD4 count of more than 200/mm3, a viral load (VL) of less than 500,000 copies/mL and with no known or suspected resistance to either of the two drugs;
previously treated, with a stable VL < 50 copies/mL for at least one year, a CD4 count of more than 350/mm3 and with no known or suspected resistance to either of the two drugs.
Unfavourable opinion for reimbursement in the other situations covered by the MA indication.
Clinical Benefit
Substantial
The clinical benefit of DOVATO (dolutegravir/lamivudine) is substantial only in adults and adolescents above 12 years of age weighing at least 40 kg:
who are treatment-naive, with a CD4 count of more than 200/mm3, a viral load (VL) of less than 500,000 copies/mL and with no known or suspected resistance to either of the two drugs;
previously treated, with a stable VL < 50 copies/mL for at least one year, a CD4 count of more than 350/mm3 and with no known or suspected resistance to either of the two drugs.
Insufficient
The clinical benefit is insufficient to justify public funding cover in the other populations of the MA.
Clinical Added Value
minor
Updating of the reimbursement scope in view of the long-term follow-up data from the GEMINI 1 and 2 studies and in line with current HAS recommendations, does not modify the clinical added value level of DOVATO (dolutegravir/lamivudine) according to the opinion of 8 January 2020:
minor clinical added value (CAV IV) in the treatment of HIV-1 infection in adults and adolescents above 12 years of age who are treatment-naive, with a CD4 count of more than 200/mm3, a VL of < 500,000 copies/mL and with no known or suspected resistance to either of the two drugs,
no clinical added value (CAV V) in the treatment of patients infected with HIV-1, who are previously treated and virologically suppressed, compared to the proprietary medicinal product JULUCA.
no clinical added value
Updating of the reimbursement scope in view of the long-term follow-up data from the GEMINI 1 and 2 studies and in line with current HAS recommendations, does not modify the clinical added value level of DOVATO (dolutegravir/lamivudine) according to the opinion of 8 January 2020:
minor clinical added value (CAV IV) in the treatment of HIV-1 infection in adults and adolescents above 12 years of age who are treatment-naive, with a CD4 count of more than 200/mm3, a VL of < 500,000 copies/mL and with no known or suspected resistance to either of the two drugs,
no clinical added value (CAV V) in the treatment of patients infected with HIV-1, who are previously treated and virologically suppressed, compared to the proprietary medicinal product JULUCA.
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