The HIV space saw a historical moment last month. approval Gilead ‘s yeztugo long prevention injection for HIV.
YEZTUGO is not the first long -lasting pre -exposure prevention option. VIIV Healthcare’s APRETUDE offers long -term protection, but if you administer Gilead’s option twice a year, you can provide more convenient options to the patient. Analyst and global health authorities, along with Mizuho at the time, praised YEZTUGO for “the potential to” finish “the preparation market.”
The annual meeting of the International AIDS Association (IAS) is riding this tail wind. The meeting, which is currently being held in Ki Galli, Rwanda, is part of this field that leads to the title by Pharmas, presenting the latest development of the pipeline.
Bio space Look at some of the most interesting presentations.
Gilead widens the evidence of YEZTUGO in pregnancy and adolescents.
Thursday, Gillie I will attend Additional data on III Phase III purpose programs for YEZTUGO shows that this drug is used in other vulnerable patient groups:
According to media reports on Monday, no one of 184 pregnancy and lactating women treated with YEZTUGO according to a Monday media report in a purpose of registering CISGENDER women and youth girls in Africa, South Africa, south of Sahara, did not contract HIV. For these women, preliminary injections were safe every two years, and there was no noticeable difference in side effects compared to un pregnant women. According to Gilead, infant exposure through breastfeeding is also called “minimization.”
Meanwhile, the data of the purpose 1 and the purpose 2 shouted that the data of the purpose 2, which includes a geographical and gender population, maintained its efficacy for young people between 16 and 25 years old. In this age group, two HIVs were found after YEZTUGO treatment. Gilhee did not say the size of the patient group in this test.
Gilead also suggests modeling data that can maintain efficacy in patients with tuberculosis when provided to slightly changed medications, or other drugs that can interfere with the overall activity of the prep.
YEZTUGO is currently approved only in the United States, but Gilead is trying to secure regulatory permits around the world, including South Africa. Last week’s pharmaceutical Signed a contract With a global fund that provides HIV prevention and HIV prevention to low -income countries at the same time as high -income countries.
At the time, the spokesman did not disclose the specific price details of YEZTUGO according to the global fund partnership. Bio space It will provide Gilead a product to a program that doesn’t benefit.
VIIV discovers ‘Happiness’ patient ‘happiness’ that converts from oral preparation to APRETUDE.
It occurs Data disclosed in Pillar and Eboni implementation test The use of APRETUDE, which is a long acting preparation every month, shows that it is allowed and feasible for patients in other demographic groups, including transgender men, black women and men (MSM) with sex. APRETUDE was the first injectable long -term acting HIV preparation in the United States. 2021. VIIV is a joint venture between GSK, Pfizer and Shionogi, which focuses on HIV treatment.
End, which focuses on the Black Sys- and Transgender Women, found that APRETUDE is “very appropriate” and “executable” for HIV prevention in this population as Monday release. Meanwhile, the pillars registered MSM and transgender men, and 95%of which reported “happiness” by switching from oral prepared drugs to apretude.
VIIV has further presented data from multiple real studies and shows that the combination of cabotegravir and rilpivirine is indicated as an injectable drug. Cabe Nuba In the United States, it not only maintains the patient’s suppression of the virus, but also improves the overall experience.
For example, in the IIIB -based study, 89%of HIV patients who have reached virus suppression were selected to switch from oral pills to cabenuva. In general, patients do not have to worry about missing doses by selecting Cabenuva, so do not always have to import drugs. Cabenuva can be administered every month or every two months. brand.
Meanwhile, the results of the two -year pre -observation study of 308 patients decided to convert to Cabenuva were able to maintain virus suppression in 24 months.
Merck pushes the monthly preparation pill to the III stage.
Merck announced it on Monday It will be released III-based expression program for studying MK-8527, a New Cleo Seed reverse antidepressant potential inhibitor that can be used once and orally to prevent HIV infection.
The program includes Expressive-11, which will test Prep candidates in more than 8,500 high-risk participants in 16 countries. This test begins to register in August. Meanwhile, the Expressive-10 study will focus on women and young people in sub-Saharan Africa, and will start hiring “in the next few months” as Monday release.
According to MERCK, MK-8527’s II data, which will be announced on IAS 2025 on Wednesday, supports the development of the drug into the second half by encouraging drugs and safety results. 350 people with low risk of HIV-1 exposure participated in the mid-stage study.
The expression program shows Merck’s comeback at the end of the late preparation stadium after stopping the prevention program of ISLATRAVIR in September 2022. Stop the medication Like the MK-8527, in the second phase of November 2021, the pharmaceutical proposes Islatravir as an oral option every month to prevent HIV infection.
However, Merck continued to evaluate islatravir as a treatment option for HIV patients with another HIV drug called Doravirine. FDA last week Accepted New drugs for this combo for adults with viral HIV-1.
