Cabotegravir sodium

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

To strengthen HIV prevention strategies in defence force medical facilities, the CIDRZ Defence Force Prevention Project partnered with the Defence Force Medical Services (DFMS) of Zambia with the support from Department of War at the U.S Embassy Zambia organised a Pre-Exposure Prophylaxis (PrEP) training for healthcare workers serving in Defence Force facilities. The training, which took place in Kabwe District, covered both the widely available daily oral PrEP and novel long-acting injectable PrEP options, including Cabotegravir and Lenacapavir. Dr Chimika Phiri, the Ministry of Health HIV Prevention Focal Point Person, attended and officiated the training on behalf of the Ministry. The CIDRZ team was led by Dr Michael Kabongo, while Lt. Col. Evans Kabaso led the DFMS team. Thirty healthcare providers from 12 initial Defence Force sites across the country participated in the training, preparing for the imminent launch of PrEP services in the coming weeks. Additional trainings are planned to cover the remaining sites as part of the national rollout plan.