100% effectiveness, Gilead AIDS prevention drugs achieved amazing experimental results, and the company's share price rose by more than 8%
On June 20 local time, Gilead Scientific, an American biopharmaceutical company, announced on its official website that its "Lenacapavir" (Lenacapavir) has shown 100% effectiveness in HIV prevention.
These results bring Gilead closer to introducing a new form of pre exposure prophylaxis (PrEP) and expanding its HIV business. Affected by this news, Gilead Scientific (GILD) in US stock trading has significantly risen. As of the close of June 20th local time, Gilead Scientific Journal was $68.49, an increase of 8.46%, with a market value of $85.33 billion, the highest level since early April.
The latest released results are a phase 3 double-blind randomized trial called "PURPOSE 1" aimed at evaluating the safety and efficacy of Lenacapavir and Descovy on over 5300 16-25 year old women at 25 sites in South Africa and 3 sites in Uganda.
More than 5300 participants were randomly assigned to receive Lenacaavir, Descovy, and Truvada for pre exposure prevention of HIV (PrEP) in a ratio of 2:2:1.
It is understood that Descovy and Truvada are oral medications taken once a day.
Lenacapavir is a shell inhibitor, administered every six months through subcutaneous injection. The results showed that out of 2134 women in the Lenacapavir group, there were 0 cases of HIV infection. This prompted the Independent Data Monitoring Committee to recommend Gilead to unblind the Phase III trial and provide treatment to everyone in the study. Other participants received standard daily pills.
Jared Baeten, Vice President of HIV Clinical Development at Gilead, said, "What the world needs is for people to have more PrEP choices so they can choose the options that best suit them."
Before applying for approval from the Food and Drug Administration, Gilead Company needs to first replicate these results. The company expects to share data from an ongoing phase III study targeting men who have sexual intercourse with men later this year or early next year. If these results are also positive, the company can use lenacaavir for PrEP listing as early as the end of 2025.
More than a decade ago, Truvada from Gilead became the first approved PrEP, suitable for people who do not have HIV but are at high risk of infection. Daily tablets dominate the market, but pharmaceutical companies are now focusing on developing injections with longer action times.
PrEP reduces the risk of HIV infection through sexual activity by 99%, and the risk of infection through injection drug use by 74% (if taken correctly). However, according to data from the Centers for Disease Control and Prevention, only slightly over one-third of people in the United States who can benefit from PrEP take it.
Health policy makers and advocates hope that longer acting options can reach those who cannot or are unwilling to take pills every day and better prevent the spread of the virus, which has caused approximately one million new infections worldwide in 2022.
Bruce Richman, founding executive director of the non-profit organization Prevention of Access Campaign, said, "We really need more choices than daily pills because oral pills won't end the pandemic. We need to ensure that people have choices that are suitable for their lifestyle."
In 2021, the FDA approved the first injectable PrEP. This drug, Apretude, is administered by medical professionals every two months or six times a year. According to its manufacturer ViiV, approximately 11000 people use Apretude.
Tim Oliver, a 28 year old public health worker in New York, said he doesn't mind going to see a doctor to receive his Apretude injection. But he added that some of his friends told him they would rather continue taking pills every day than receive injections. Choosing a longer duration of action may be more attractive to patients.
RBC Capital Markets analyst Brian Abrams predicts that Gilead's injections will significantly increase the number of people interested in HIV prevention drugs. He estimates peak sales to be close to $2 billion. Gilead's newer PrEP tablets, Descovy, generated approximately $2 billion in revenue last year.
Activists have urged Geely to ensure that people in low - and middle-income dominated countries can access lenacaavir. The company has long been criticized for the price of HIV drugs. The use of Descovy has a list price of $26000 per year.
In a statement disclosing the results of the lenacapavir trial, Gilead said that it planned to share updates on how to plan to address the access of people to drugs in these countries with high HIV incidence rate.
Comments
Post a Comment