MedPath

Lamivudine and Dolutegravir

Generic Name
Lamivudine and Dolutegravir
Indication

用于治疗感染人类免疫缺陷病毒1型(HIV-1)的成人和12岁以上青少年(体重至少40kg),且对整合酶抑制剂或拉米夫定无已知或可疑耐药患者。

ViiV Healthcare Showcases Long-Acting HIV Innovations and Pipeline Advances at CROI 2025

• Real-world data presented at CROI 2025 demonstrates zero HIV acquisitions and high persistence with Apretude (cabotegravir LA) for PrEP across diverse populations, reinforcing its effectiveness in HIV prevention. • Long-term follow-up data from multiple studies confirms the sustained efficacy and safety of Cabenuva (cabotegravir + rilpivirine LA) as a complete treatment regimen for people living with HIV. • Late-breaking phase IIb data reveals promising results for an investigational broadly neutralizing antibody (VH3810109) in combination with cabotegravir LA, potentially expanding long-acting treatment options.

GSK's Portfolio Resilience: Cancer and HIV Gains Offset RSV Vaccine Decline

• GSK experienced a significant 51% decline in Arexvy RSV vaccine sales to £590 million in 2024, following restricted US recommendations limiting use to adults 75 and older. • Strong performance in oncology with 72% sales growth to £408 million, driven by Jemperli and Ojjaara, while HIV portfolio showed double-digit growth through Cabenuva, Apretude, and Dovato. • Despite vaccine challenges, GSK upgraded its long-term sales forecast to £40 billion by 2031, supported by pipeline progress and planned launches in respiratory, oncology, and infectious diseases.

FDA Accepts Gilead's Lenacapavir for HIV Prevention with Priority Review

• The FDA has accepted Gilead's NDA for lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, as pre-exposure prophylaxis (PrEP). • Lenacapavir demonstrated 100% risk reduction in cisgender women and 96% risk reduction in a diverse population, compared to background HIV incidence. • The FDA has granted priority review with a target action date of June 19, 2025, potentially making it the first twice-yearly HIV prevention option. • Gilead is also pursuing global access, including submissions to the EMA and voluntary licensing agreements to facilitate availability in low- and middle-income countries.

Dovato Shows Comparable Efficacy to Three-Drug Regimen in Advanced HIV

• A post-hoc analysis of the DOLCE study indicates that Dovato, a two-drug regimen, demonstrates similar efficacy to a three-drug therapy in achieving viral suppression in adults with advanced HIV. • The study, involving approximately 230 antiretroviral treatment-naïve individuals, showed Dovato was non-inferior in attaining viral suppression compared to the three-drug regimen at 48 weeks. • Safety profiles were comparable between the Dovato and three-drug regimen arms, with similar rates of serious adverse events and immune reconstitution inflammatory syndrome. • These findings support Dovato's use in treatment-naïve adults living with HIV, even those with low CD4 counts and high viral loads, reinforcing the efficacy and safety of a two-drug approach.

Dovato Demonstrates High Efficacy in Treatment-Naive Individuals with Advanced HIV

• ViiV Healthcare's Dovato (DTG/3TC) shows comparable efficacy to a three-drug regimen in treatment-naive adults with advanced HIV, according to the DOLCE study. • The DOLCE study included participants with low CD4 counts (≤200 cells/mL) and high viral loads, demonstrating Dovato's effectiveness in severe immunosuppression cases. • At week 48, 82% of individuals in the Dovato group achieved a viral load <50 copies/mL, compared to 80% in the three-drug regimen group, establishing non-inferiority. • These findings reinforce the efficacy and safety of Dovato as a two-drug regimen, offering a potentially simpler treatment option for people living with HIV.

ViiV Healthcare Triples HIV Prevention Drug Supply for Low-Income Nations

• ViiV Healthcare announces plans to provide 2 million doses of long-acting cabotegravir (Apretude) at not-for-profit pricing for low and middle-income countries through 2026. • The GSK-backed company has already initiated drug rollout in several nations including Zambia, Malawi, Zimbabwe, with plans to expand to nine additional countries by year-end. • This expansion of HIV prevention access aligns with ViiV's broader initiatives, including support for generic drug development through the Medicines Patent Pool agreement.
© Copyright 2025. All Rights Reserved by MedPath