Progress towards an HIV cure depends on strengthening four critical systems: lab equipment, sustainable funding, policy & programs, and training.
What Does It Take to Conduct HIV Cure Research?
Long-Acting HIV Treatment Pipeline
AVAC has begun to track the research pipeline for long-acting HIV treatment (LA-ART). A rapidly expanding pipeline for LA-ART has the potential to introduce new regimens with dosing frequencies that range from weeks to months to, eventually, years. The benefits of LA-ART include reduced drug dosing, frequency, and number of drugs, with the potential for associated decreases in the cost of medications and the burden on health systems. New drug classes could close treatment gaps in children, adolescents, and those with high viremia, comorbidities and resistance. Ongoing clinical research will hopefully further demonstrate whether there are trade-offs (treatment failures or resistance) between LA-ART and highly effective daily oral ART. In addition to the new long-acting products, simplified single-tablet daily regimens are also in development.
Speeding Up Access to PrEP
Time from efficacy results to key milestones
The timeline for hitting key milestones in product introduction is moving faster for injectable LEN than for any previous PrEP products, starting from the announcement of efficacy results in Phase III trials. LEN’s accelerated timeline compared to oral PrEP, DVR, and CAB reflects a field-wide effort to learn lessons from previous PrEP rollout and not repeat the mistakes of the past.
Where We Are Now with LEN for PrEP
This timeline tracks the regulatory approval process for lenacapavir (LEN) for HIV prevention from late 2024 through early 2026. Key milestones include FDA Priority Review status, FDA approval in June 2025, expected subsequent approvals from European regulators and WHO, and Global Fund and PEPFAR commitment to roll out LEN to three million people over the next three years.
Decline in PEPFAR Supported PrEP
Official characterizations of the HIV response as “doing very good” warrant a closer look at the data. AVAC’s analysis of PEPFAR prevention figures shows PrEP initiations declined 41% in one year, with women and men each seeing drops exceeding 50%. Data on key populations remains unavailable.
Potential Demand for LEN for PrEP
The top 16 PrEP markets, based on 2024 oral PrEP initiations and the possible 2026 injectable market, assuming 60% of new PrEP users choose an injectable, as seen in implementation studies.
An Overview of Lenacapavir for PrEP Trials
Change in PrEP Initiations from 2024 to 2025 in Five Countries
Between the period January-September 2024 to January-September 2025, PrEP initiations fell between 13% and 66% in selected high-volume PrEP countries where ministries of health (MoH) were able to provide data. Among the five countries depicted, four saw significant decline in PrEP uptake. All four relied on PEPFAR PrEP programs and were disrupted by stop work orders (SWO).
Dapivirine Vaginal Ring Regulatory Approval
Regulatory approvals, pending decisions, and appeals as of January 2026. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.
Cabotegravir Regulatory Approval
Regulatory approvals and those pending for cabotegravir as of January 2026. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.