Yusuf Hassan Wada

This session highlights the current data for LA-ART implementation and new agents for HIV, as well as barriers. Discussions were centred on clinical studies and the best approaches for implementation from the NADIA, VISEND and 2SD clinical trials and the needs of key and affected populations.

Prof. Chloe Orkin highlighted the current data on long-acting ART (which is sadly not universally available yet). FLAIR study shows that starting treatment directly with injectables is non-inferior & as safe. However, the SOLAR study showed only 53% of health care providers (HCP) preferred to start ART with injectables. Dr Iskandar Azwa presented the benefit and accessibility of ART to all populations. He presented data from studies exploring factors associated with interest in LA-CAB/RPV in 688 people with HIV & 120 HCPs. Treatment implementation and lessons learnt from NADIA, VISEND and 2SD clinical trials were discussed by Dr Lloyd Mulenga as he summarized studies in Africa. Dr. Gulick provided an overview of the HIV drug pipeline as he highlighted that there are 34 drugs approved for the treatment of HIV within (1987-2022). He discussed investigational drugs in the pipeline at different phases (Islatravir, Elsulfavirin and Lenacapavir). Patients on Islatravir sadly presented a decrease in CD4 T cell counts limiting it from moving forward for LA-ART.

This session addressed an important question LA-ART is surely a game-changing addition to the existing therapy. Understudied populations, including pregnant women, adolescents and people with detectable viral loads due to poor adherence is lacking and very much needed. Robust implementation science studies on the preferences and concerns of users and ways of integrating LA-ART into client-preferred models of care for treatment and prevention are needed to ensure effective implementation in LMIC. There is also a need for additional innovations of Cabotegravir as it’s only recommended for people who are suppressed.

Kombatende Sikombe

In this session, we heard from Chloe Orkin, Iskandar Azwa, Lloyd Mulenga and Roy Gulick on findings of several drug trials for Long-acting antiretroviral treatment of HIV (LA-ART) around the world. We heard about the different generic formulations in different trial phases, virologic failure at different time points, HCW preferences.

Virologic failure in phase 3 trials (Carisel, ATLAS2M, SOLAR, etc.) usually occurred in week 48. HCWs preferred SWI despite OLI being equally effective. ATLAS, FLAIR, and ATLAS-2M phase 3 trials highlighted LA-ART opportunities and challenges, clinical and implementation considerations for LMIC countries, and prohibitive cost. Virological failure risk factors include BMI, RBV resistance, and HIV subtype. PLHIV need less frequent LA-ART dosing, which reduces side effects and pill burden. 66% of PLHIV agreed to try LART in one trial. 86% of HCW said they could offer injectables to malabsorption, GI, or non-swallowing patients. Key pops who can't negotiate other prevention strategies prefer LART, especially FSW. LA-ART provides choice, privacy, and less dosing. It's convenient for those that work and travel. Large injectables can't be self-administered, and most data includes adherents. Tenofavir resistance was seen in the Vicend study like NADIA, but not with DTG, which had better results at 1000c/ml and no resistance at week 48. LMICs simplified second-line regimens. Switching regimens is easy and has no consequences, but Malawi showed reemergence of DTG resistance, and these people had no frequent viral loads. In 35 years, 34 drugs have been approved- more options. Annual LA-ART microneedle patches are being researched.

It's important to expand access to HIV treatments beyond resource-rich countries. Implementation science gaps include non-participation in trials. Unsuppressed participants, pregnant and lactating women, adolescents, and LMICs must be included in trials. The session reminded us that DSD was rolled out to stable patients, not unsuppressed patients. LA-ART should be careful not to repeat past mistakes. Panelists wondered if LA-ARTs could be rolled out equitably to poorer countries with more health system challenges when high-income countries reported health system and infrastructure challenges. LA-ART requires bimonthly clinic visits, so we must redesign health systems.