Log in or register to see all Alerts
New HTA Decisions in Germany
June 2020
Drug name
DOVATO® (dolutegravir lamivudine)
Company
ViiV Healthcare
Decision date
04/11/2019
Therapeutic area
Infections
Therapeutic sub area
HIV and AIDS
G-BA decision date
01/02/2020
Orphan Drug?
No
Decision
Minor additional benefit
Indication
Treatment naive adults who are infected with HIV-1 Main comparator therapy: -Rilpivirine in combination with Tenofovir disoproxil /alafenamid plus emtricitabine or in combination with abacavir plus lamivudine -Dolutegravir in combination with Tenofovir disoproxil / alafenamid plus emtricitabine or in combination with abacavir plus lamivudine
Decision
No additional benefit
Indication
Pre-treated adults infected with HIV-1 with or without changeover indication Main comparator therapy: Individual antiretroviral therapy independent of the pre-treatment (s) and under consideration of the reason for the therapy change (in particular therapy failure due to a virological failure and possibly concomitant resistance or due to side effects)
Decision
No additional benefit
Indication
Therapy naive adolescents who are infected with HIV-1 Main comparator therapy: -Rilpivirine in combination with Tenofovir alafenamid plus emtricitabine or in combination with abacavir plus lamivudine -Dolutegravir in combination with Tenofovir alafenamid plus emtricitaine or in combination with abacavir plus lamivudine
Decision
No additional benefit
Indication
Pre-treated adolescents who are infected with HIV-1 Main comparator therapy: Individual antiretroviral therapy independent of the pre-treatment (s) and under consideration of the reason for the therapy change (in particular therapy failure due to a virological failure and possibly concomitant resistance or due to side effects)
Decision Detail
Main studies: GEMINI-1 and -2, ASPIRE Main driver of decisions: Treatment with dolutegravir lamivudine in treatment naïve adults led to a reduction in adverse effects and there was indication of a slight benefit for gastrointestinal disorders. There was also a positive change in key biomarkers but this was not sufficient to derive a certain added benefit. For pre-treated adults, there was no statistically significant benefit in major endpoints of morbidity, mortality of safety. IQWiG did not feel the company provided appropriate evidence to show a benefit for the adolescent indications.
Summary
IQWiG concluded that there was evidence of a slight benefit of dolutegravir lamivudine over comparators for treatment naïve adults, but there was no additional benefit for pre-treated adults, or adolescents (either pre-treated or treatment naive).