Lenacapavir, injectable twice a year, is developed by US-based biopharmaceutical company Gilead Sciences, Inc.
An HIV-preventive drug showed 100 per cent efficacy and “no safety
concerns” in women, according to a study published in The New England Journal
of Medicine.
Lenacapavir, injectable twice a year, is developed by the US-based
biopharmaceutical company Gilead Sciences, Inc. as a pre-exposure prophylaxis
(PrEP) drug. These drugs prevent the spread of infection in people not yet
exposed to the disease-causing agent.
The study, a phase-3 trial involving teenage girls and young women
in South Africa and Uganda, showed that lenacapavir “demonstrated zero (HIV)
infections” and “100 per cent efficacy,” Gilead Sciences, Inc. said in a
statement.
HIV, or human immunodeficiency virus, spreads from the body fluids
of an infected person. Untreated, the infection can progress to AIDS or
acquired immunodeficiency syndrome over years.
In the PURPOSE 1 trial, 5,338 participants, who were HIV-negative,
to begin with, were divided into three groups - 2,134 receiving lenacapavir
injections 26 weeks apart; 2,136 receiving the daily oral tablet Descovy
(F/TAF); and 1,068 receiving the daily oral tablet Truvada (F/TDF).
Researchers, including those from the Desmond Tutu HIV Centre,
University of Cape Town, South Africa, observed a total of 55 infections - zero
in the Lenacapavir group, 39 in the Desovy group and 16 in the Truvada group.
“No participants receiving twice-yearly lenacapavir acquired HIV
infection,” the study authors wrote.
The most common adverse effects were injection-site reactions
experienced by close to 70 per cent of the participants in the Lenacapavir
group. However, there were “no serious injection-site reactions,” according to
the statement.
“These stellar results show that twice-yearly lenacapavir for
PrEP, if approved, could offer a highly effective, tolerable and discreet
choice that could potentially improve PrEP uptake and persistence, helping us
to reduce HIV in cisgender women globally,” first author Linda-Gail Bekker,
Director of the Desmond Tutu HIV Center at the University of Cape Town, South
Africa, said in the statement.
Results of PURPOSE 2 trial, involving cisgender men, transgender
men, transgender women and gender non-binary individuals in countries,
including Latin American ones, South Africa and Thailand, are expected in late
2024 or early 2025, the statement said.
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