VIIV HEALTHCARE PTY LTD

DOLCE study shows Dovato (DTG/3TC) is effective and safe for treatment-naive adults with advanced HIV, comparable to a 3-drug regimen, even in those with low CD4 counts and high viral loads.

Studies on cabotegravir + rilpivirine long-acting, dolutegravir, dolutegravir/lamivudine, fostemsavir, and pipeline drugs, focusing on efficacy, safety, adherence, and real-world outcomes.

GSK's RSV vaccine Arexvy sales dropped 72% in Q3 due to narrower US recommendations and COVID-19 vaccination prioritization. Pfizer's Abrysvo sales declined only 5%, suggesting Pfizer's ascendency in the RSV vaccine market. GSK's overall vaccine sales fell 15%, leading to a revised forecast of low-single-digit percentage gains. Despite this, GSK's overall revenues increased 2% to $8 billion, supported by HIV drugs and specialty medicines.

GSK focuses on vaccines and medicines in infectious diseases, HIV, respiratory/immunology, and oncology. Their pipeline progresses through clinical phases to assess safety and efficacy, aiming for regulatory approval. GSK also explores opportunities in human genetics and genomics, emphasizing the immune system's science.

Gilead Sciences seeks to expedite local registration of its six-monthly anti-HIV injection in South Africa, offering it at no-profit prices to 18 countries, including SA. Generic versions will be available in 2027 for 120 high-HIV-rate countries. Lenacapavir, the drug in the injection, has shown 100% protection for HIV-negative women and 96% reduction in HIV infection risk for other groups. SAHPRA, though understaffed, aims to expedite reviews using EU-M4All, potentially reducing review times from over a year to seven months. The National Department of Health considers publishing a request for information before SAHPRA approval to save time. Price negotiations and market demand will be crucial for the drug's affordability and accessibility.

Gilead and MSD advance their once-weekly HIV treatment to Phase II trials after a 48-week study showed 94.2% of patients maintained viral loads below 50 copies m/L. The treatment combines MSD’s islatravir with Gilead’s lenacapavir, offering a long-acting alternative to daily HIV medications like Gilead’s Biktarvy.

GSK and ViiV's Apretude shows over 99% effectiveness in preventing HIV in real-world studies, with high adherence and no HIV diagnoses in Trio Health cohort. Apretude, the first long-acting PrEP, aims to extend dosing intervals beyond two months, while Gilead's lenacapavir shows 100% efficacy in women and 96% in diverse populations, targeting a twice-yearly injection.

PILLAR trial findings show CAB LA for PrEP reduces stigma and anxiety in MSM and TGM, with high acceptability and convenience, despite minor injection site reactions.

Lenacapavir, a long-acting HIV injection given twice yearly, dominated discussions at the fifth HIV Research for Prevention Conference (HIVR4P) in Lima, Peru. The conference also highlighted other studies, including an injectable combining contraception and HIV protection, a three-month vaginal ring, and real-world findings from Zambia's rollout of long-acting injectable cabotegravir. Lenacapavir reduced HIV infections by 96% in a gender-diverse population, according to the PURPOSE 2 trial. Regulatory filings for lenacapavir are expected globally by the end of 2024.