GlaxoSmithKline upbeat on latest results from HIV unit ViiV
GlaxoSmithKline announced on Wednesday that specialist HIV company ViiV Healthcare, in which it is the majority owner alongside minority shareholders Pfizer and Shionogi, had reported positive week 48 results from its phase 3 ‘TANGO’ study.
The FTSE 100 pharmaceuticals giant said the TANGO study was conducted to assess whether adults living with HIV-1, who had maintained viral suppression for at least six months on a tenofovir alafenamide fumarate (TAF)-containing regimen of at least three drugs, were able to maintain similar rates of viral suppression after switching to the two-drug regimen of dolutegravir plus lamivudine in a fixed dose combination, compared to continuing the TAF-containing regimen.
It said the study met its primary endpoint for non-inferiority, based on the proportion of participants with plasma HIV-1 RNA ≥50 copies per millilitre using the FDA Snapshot algorithm at week 48.
No patients met confirmed virologic withdrawal criteria or developed treatment resistance in the dolutegravir plus lamivudine arm of the study.
The safety results for the two-drug regimen of dolutegravir plus lamivudine were consistent with the product labelling for the medicines, ViiV said.
“When we developed the TANGO study, we asked if virally suppressed people living with HIV could reduce the number of medicines in their HIV treatment regimen while maintaining viral suppression,” said ViiV head of global research and medical strategy Kimberly Smith.
“These Week 48 data clearly indicate that they can - individuals who are already on treatment can maintain viral suppression if they switch from a three-drug, TAF-containing regimen to a two-drug regimen of dolutegravir plus lamivudine.”
ViiV said the single-pill, two-drug regimen of dolutegravir plus lamivudine was authorised in the United States earlier in the year for the treatment of HIV-1 infection in adults with no antiretroviral treatment history and with no known resistance to either dolutegravir or lamivudine.
It was also authorised in Europe in July for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40 kilograms, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.