23rd Jul 2024 12:07
(Alliance News) - GSK PLC on Tuesday reported "positive" data for testing on three different treatments by ViiV Healthcare, its majority-owned specialist HIV company.
The London-based pharmaceutical company firstly said ViiV Healthcare has shared 48-week findings from the phase 4 Paso Doble clinical trial investigating the two-drug regimen Dovato compared with the three-drug regimen Biktarvy for HIV.
Dovato comprises dolutegravir and lamivudine, while the Biktarvy regimen consists of bictegravir, emtricitabine and tenofovir alafenamide fumarate.
The trial, GSK said, focused on patients "who are virologically suppressed and who could benefit from treatment optimisation".
The 48-week results showed that virologically suppressed adults with HIV, if they switched to the Dovato regimen, demonstrated non-inferior efficacy in maintaining viral suppression compared with switching to Biktarvy.
Secondly GSK said ViiV, in which Pfizer Inc and Shionogi & Co Ltd also hold minority interests, announced positive data for HIV drug Apretude, or cabotegravir LA for PrEP, in pregnant people.
The new maternal safety and pregnancy outcomes and pharmacokinetic findings came from the HIV Prevention Trials Network's 084 open label extension, which evaluated cisgender women in sub-Saharan Africa who became pregnant while using Apretude for HIV pre-exposure prophylaxis, or PrEP.
"The findings showed that [Apretude] was generally well tolerated among pregnant women, and PK findings demonstrated that cabotegravir levels were maintained above those associated with HIV protection throughout the overall pregnancy period," GSK said.
Finally, GSK and ViiV announced phase 1 study results and in vitro data for VH4524184 or VH184, an investigational integrase strand transfer inhibitor or INSTI.
ViiV, GSK said, shared positive in vitro findings showing that VH184 retained its antiviral activity and could be effective in countering second-generation INSTI resistance.
Analysis of the phase 1 study, meanwhile, showed that PK and safety data supported the further development of VH184.
"The study showed VH184 achieved drug levels in the blood that could potentially exhibit sufficient antiviral activity against the clinically derived INSTI mutations seen in vitro," GSK explained.
GSK shares were trading 0.6% higher at 1,534.13p on Tuesday afternoon in London.
By Emma Curzon, Alliance News reporter
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