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GSK’s Long-Acting HIV Preventive Drug Is Safe in Pregnant Women

GSK branding. Photographer: Vivian Wan/Bloomberg (Vivian Wan/Bloomberg)

(Bloomberg) -- GSK Plc’s long-acting HIV prevention drug is as safe in pregnant women as daily pills, a boost to the company’s efforts to cement its place in the market for antivirals that patients don’t have to take each day.   

Pregnancy outcomes were similar among women who took the drug, called Apretude, and those who took daily antiviral pills, UK-based GSK said Tuesday in a statement. The drug has already been approved for prevention in other adults, and the company will seek to expand the label to include pregnant women. 

With efforts to develop a cure or a vaccine for HIV hampered by research setbacks, the race to dominate the long-acting HIV prevention and treatment space has emerged as the dominant arena for new research. Fierce competition is developing between ViiV Healthcare, majority-owned by GSK, and Gilead Sciences Inc. 

Both companies will be presenting data this week at the AIDS 2024 conference in Munich. Gilead will report highly anticipated results that follow up on data showing that Lenacapavir, its drug given every six months, prevented 100% of HIV infections in women and adolescent girls.  

If approved for prevention, Lenacapavir offer a highly effective option with the longest interval between doses. The product has the potential to leapfrog Apretude as a preventive, Bloomberg Intelligence analyst Christos Nikoletopoulos said in a note.

ViiV, co-owned by Pfizer Inc and Shionogi & Co Ltd., also plans to experiment with longer-acting treatment and preventive injections, targeting a six-month interval by the end of the decade. 

“We’ve had our long-acting treatment on the market for a couple of years now,” Kimberly Smith, head of research and development at ViiV, said in an interview. “We have the expectation that we’re going to launch our next long-acting product before they’re able to launch their first one.”

It’s a critical time to get the world back on track to meet the target of ending AIDS as a public health threat by 2030, the UNAIDS global health effort said Monday. Long-acting drugs “can protect the health of everyone living with or at risk of HIV,” the group said in a report. 

 

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