Cabotegravir sodium

To strengthen HIV prevention efforts, the Controlling HIV Epidemic Project (CHEP), under the Centre for Infectious Disease Research in Zambia (CIDRZ), in collaboration with the Ministry of Health and with financial support from the United States Department of State, conducted a six-day Training of Trainers (ToT) workshop on the delivery of different pre-exposure prophylaxis (PrEP) products. The training which was held in Ndola, brought together HIV healthcare specialists from CIDRZ, the Copperbelt Provincial Health Office, Ndola Teaching Hospital, Copperbelt District Health Offices, and the United States Department of State. Participants were drawn from Eastern, Western, Lusaka, and Copperbelt provinces. The training was officially opened by Copperbelt Provincial Health Director, Dr Charles Mwinuna, and focused on equipping participants with the skills required to deliver combination HIV prevention services. Particular emphasis was placed on oral PrEP, Cabotegravir (2-month injectable PrEP), Lenacapavir (6-month injectable PrEP), and the Dapivirine Vaginal Ring (DVR), a long-acting, user-controlled PrEP product designed to reduce the risk of acquiring HIV during vaginal sex. Meanwhile, Dr Paul Mwale, Copperbelt Provincial Advanced HIV Disease (AHD) and Injectable PrEP Coordinator under the Ministry of Health, led a session outlining the mandate of the HIV Prevention Programme, which aims to achieve epidemic control and end AIDS by 2030. He highlighted national targets, including reducing new HIV infections from 28,000 to 15,000 by 2026 and increasing PrEP uptake among key and priority populations to 220,000 annually, emphasising the need for accelerated efforts to meet both national and global goals. In another session, Dr Monica Chibesakunda, CIDRZ’s HIV Testing and Prevention Lead, trained participants on HIV testing services, stressing their role in both preventing new infections and linking individuals to care. She emphasised adherence to national HIV testing guidelines for PrEP initiation and the importance of providing tailored prevention services based on individual risk. Other sessions covered demand generation for PrEP, scheduling PrEP clinical visits, managing beneficiaries who missed appointments, switching beneficiaries between PrEP products, pharmacovigilance, and comprehensive data documentation. The training also addressed the link between Gender-Based Violence (GBV), Intimate Partner Violence (IPV), and HIV risk. Facilitators underscored the importance of integrating GBV and IPV screening into HIV services to support comprehensive, client-centred care. The workshop concluded with participants committing to cascade the knowledge gained and strengthen HIV prevention services, contributing to Zambia’s goal of ending AIDS as a public health threat by 2030.

The US FDA approved Idvynso (doravirine/islatravir) for Merck, marking the first non-integrase strand transfer inhibitor (INSTI), tenofovir-free, once-daily complete two-drug regimen to reach approval for HIV-1 treatment in adults. The fixed-dose combination of 100 mg doravirine and 0.25 mg islatravir is indicated as a switch regimen for virologically suppressed adults with no history of virologic treatment failure and no known resistance substitutions associated with doravirine. The approval covers use in adults with HIV-1 RNA below 50 copies per mL on a stable antiretroviral regimen for at least three months. Idvynso is a complete regimen; co-administration with other antiretrovirals is not recommended. The drug is contraindicated with strong CYP3A enzyme inducers and with lamivudine or emtricitabine, as co-administration may reduce islatravir-triphosphate concentrations and compromise efficacy. Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with doravirine-containing regimens, and one case of Drug Rash with Eosinophilia and Systemic Symptoms was observed during clinical trials. The approval is supported by Week 48 data from two randomized, active-controlled, non-inferiority Phase III trials. Trial 052 (NCT05630755) was a double-blind study in 513 virologically suppressed adults previously receiving bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), randomized 2:1 to switch to Idvynso or continue BIC/FTC/TAF. At Week 48, 1% of participants in each arm had HIV-1 RNA ≥50 copies/mL (treatment difference 0.9%, 95% CI: -1.9%, 2.9%), with 92% of Idvynso recipients maintaining viral suppression versus 94% on BIC/FTC/TAF. Trial 051 (NCT05631093) enrolled 551 participants switching from a range of antiretroviral regimens, including 64% on INSTI-based therapy. In this open-label study, 1% of Idvynso recipients versus 5% of those continuing baseline therapy had HIV-1 RNA ≥50 copies/mL at Week 48 (treatment difference -3.6%, 95% CI: -7.8%, -0.8%), with 96% versus 92% maintaining suppression. Safety profiles across both trials were comparable to comparator arms, with adverse events leading to discontinuation in 3% and 0.5% of Idvynso recipients in Trials 052 and 051, respectively. The approval adds a mechanistically distinct oral option to a treatment landscape that has been shaped predominantly by INSTI-based regimens. Gilead’s Biktarvy (BIC/FTC/TAF) and ViiV Healthcare’s Dovato (dolutegravir/lamivudine) have become the reference standards for virologically suppressed adults, while ViiV’s long-acting injectable Cabenuva (cabotegravir/rilpivirine) addresses the growing demand for less frequent dosing. Idvynso enters this field as the only approved oral two-drug regimen that avoids both INSTIs and tenofovir, a profile relevant to patients managing renal impairment, bone density concerns, or INSTI-associated metabolic effects including weight gain. Islatravir’s dual mechanism — translocation inhibition and delayed chain termination — distinguishes it from conventional NRTIs, and its activity at low doses underpins the two-drug strategy. The published Phase III data supporting the approval appeared in The Lancet HIV in 2024, including a head-to-head comparison against BIC/FTC/TAF by Mills et al. and a broader switch study by Molina et al. Islatravir’s broader role in Merck’s HIV pipeline extends beyond the approved daily formulation. The company is evaluating islatravir in combination with Gilead’s lenacapavir as a potential once-weekly oral regimen in the Phase III ISLEND-1 (NCT06630286) and ISLEND-2 (NCT06630299) trials, and in combination with the investigational NNRTI ulonivirine (MK-8507) in Phase IIb development. A separate once-monthly oral PrEP candidate, MK-8527, has entered Phase III evaluation in collaboration with the Gates Foundation, targeting HIV acquisition in women and adolescent girls in sub-Saharan Africa. These programs reflect a broader industry shift toward reducing dosing frequency while preserving or improving the tolerability profile that has defined the modern ART era. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website