GlaxoSmithKline upbeat on HIV treatment test results in women
GlaxoSmithKline announced on Monday that the independent data safety monitoring board of ViiV Healthcare had recommended the early unblinding of the HIV Prevention Trials Network (HPTN) ‘084’ study, evaluating the safety and efficacy of investigational, long-acting, injectable ‘cabotegravir’ for HIV prevention in women.
FTSE 100
7,895.85
16:59 19/04/24
FTSE 350
4,341.08
17:09 19/04/24
FTSE All-Share
4,296.41
17:08 19/04/24
GSK
1,599.00p
17:08 19/04/24
Pharmaceuticals & Biotechnology
21,247.91
17:09 19/04/24
The FTSE 100 company is majority owner of HIV specialist ViiV, with Pfizer and Shionogi as minority shareholders.
It said that, following a prespecified interim analysis, the board indicated that cabotegravir met the primary objective of demonstrating superiority when compared to the current standard of care for women, being daily oral emtricitabine and tenofovir disoproxil fumarate 200 mg and 300 mg (FTC/TDF) tablets.
The study showed cabotegravir was 89% more effective than daily oral FTC/TDF for pre-exposure prophylaxis.
GSK said the early study unblinding for superior efficacy in the prevention trial in women followed results reported earlier in the year year from a companion study, HPTN 083, that also established long-acting cabotegravir's superiority to daily oral pre-exposure prophylaxis in preventing HIV among men who have sex with men, and transgender women who have sex with men.
“It's thrilling to collaborate with the NIH and the Bill & Melinda Gates Foundation to conduct such an important study in HIV prevention in women and deliver ground-breaking results confirming the superior efficacy of long-acting cabotegravir for pre-exposure prophylaxis,” said ViiV’s head of research and development Kimberly Smith.
“Women need more effective choices for HIV prevention.
“If approved, long-acting cabotegravir will provide an option that reduces the number of annual dosing days from 365 to six.”
In addition, Smith said long-acting cabotegravir could be “discretely administered”, and may empower women to reduce their risk of HIV acquisition without the need for negotiation with their sexual partner.
“The results of HPTN 084 confirm long-acting cabotegravir's potential as an HIV prevention option that can meet these needs.”
The HPTN 084 study, with 3,223 participants in 20 sites across seven countries in sub-Saharan Africa, being Botswana, Kenya, Malawi, South Africa, eSwatini, Uganda and Zimbabwe, was the first study of long-acting injectable therapy for HIV prevention among women.
The data showed that there was a “statistically significant advantage” for the women who received cabotegravir compared with the women who received FTC/TDF.
While both were highly effective at preventing HIV in the study population, cabotegravir was superior.
Among the 38 women in the trial who acquired HIV, four were randomised to the long-acting cabotegravir arm and 34 were randomised to the daily, oral FTC/TDF arm, which translated to an HIV incidence rate of 0.21% in the cabotegravir group and 1.79% in the FTC/TDF group.
Detailed results from HPTN 084 would be presented at an upcoming scientific meeting, GlaxoSmithKline said.
ViiV Healthcare was planning to use the data from both HPTN studies for future regulatory submissions.
Cabotegravir had not yet been approved for the treatment or prevention of HIV as a single agent by regulatory authorities anywhere in the world.
At 0853 GMT, shares in GlaxoSmithKline were up 0.83% at 1,410.2p.