Closing the Gap: Emerging On‑Demand and Injectable PrEP Options to Empower Women’s HIV Prevention

Injectable PrEP Lenacapavir Faces Efficacy Gaps While Demand Grows for Alternate Access

Breaking news in HIV prevention shows that injectable lenacapavir as pre-exposure prophylaxis (PrEP) generated strong interest among women, yet it did not achieve a statistically notable reduction in HIV infections compared with population incidence in the current trials.

The delivery,administered as two injections per year,remains a focal point for prevention strategies. Early data highlight notable differences in injection-site reactions between lenacapavir and placebo: nodules appeared in many recipients, whereas placebo injections yielded almost no nodules. Specifically, nodules were observed in about 60% of treated individuals at the time of injection, 40% at six months, and just over 20% at 12 months. Pain and swelling at the injection site were similar between the lenacapavir and placebo groups.

Discussions around real-world impact extend beyond efficacy. In the PURPOSE 1 trial, young women showed a preference for the twice-yearly injection, with many planning to continue through periods of exposure.Results from PURPOSE 5, which includes cis migrant women in France, are awaited to better understand outcomes across diverse populations.

Experts note that while lenacapavir represents a significant innovation, many women still require a choice among prevention options. The field is also exploring other innovations, from monthly oral tablets to vaginal inserts. A south African study presented at a recent IAS conference highlighted that offering a range of PrEP methods could better cover prevention needs for women.

Access to PrEP: a long walk, far from the goal

The trajectory of PrEP adoption remains uneven despite its proven potential. Oral PrEP was recognized as effective in 2015, but ten years later, only 21.2 million PrEP courses had been initiated worldwide, equating to about 37% of UNAIDS targets for 2025.In France, 124,000 people had started PrEP by june 30, 2025, with no formal target previously set.

While innovative methods spark optimism, economic and political barriers hinder widespread, enduring access. The health and humanitarian imperative remains clear: scale up access to a practical mix of PrEP options and ensure real-world effectiveness through implementation and evaluation in diverse settings.

Efforts like the ANRS-EllesPrEP initiative are pushing to operationalize PrEP in sexual health centers across Paris and Seine-Saint-Denis, focusing on women from sub-Saharan Africa who bear a disproportionate burden of HIV risk.

Aspect	Key Facts
dosing pattern	Two injections per year for lenacapavir PrEP; ongoing exposure required.
Injection-site reactions (nodules)	Observed in ~60% at injection, ~40% at 6 months, >20% at 12 months; placebo injections had almost no nodules.
Overall efficacy vs population incidence	Did not show a statistically significant risk reduction relative to population incidence in the reported trials.
Uptake worldwide	21.2 million prep initiations worldwide (≈37% of target for 2025).
Français uptake (as of 30 Jun 2025)	Approximately 124,000 individuals initiated prep in france.
Key programs	ANRS-EllesPrEP initiative aims to implement PrEP in Paris and Seine-Saint-Denis with a focus on sub-Saharan African women.

Looking ahead, researchers and advocates emphasize the need for varied prevention offerings. Along with injectable options, monthly oral regimens such as new agents are under study, and innovations like vaginal inserts offer alternative routes to PrEP. The overarching goal remains clear: broaden access and tailor prevention to diverse real-world contexts.

For readers seeking trusted context, organizations like the World Health Organization and the U.S. Centers for Disease Control and Prevention provide ongoing guidance on PrEP availability, choices, and best practices. Learn more at WHO and CDC, and explore global targets and progress at UNAIDS.

As the field advances, a multi-method approach appears essential: expanding access, enabling patient choice, and continuously evaluating effectiveness in real-world settings. The hope is that diverse options will translate into meaningful reductions in HIV infections for women worldwide.

Disclaimer: This article provides health information and is not a substitute for professional medical advice.Consult a healthcare provider for personal PrEP decisions.

Engage with the news

• What factors would influence your decision to choose injectable PrEP over other forms of PrEP?
• What barriers do you see in improving PrEP access for women in your community, and how could programs address them?

Share this updates with colleagues and friends to spark informed discussions about PrEP options and access challenges.

To hide from partners or family.

Closing the Gap: Emerging On‑demand and Injectable prep Options to Empower Women’s HIV prevention

Archyde.com – published 2026‑01‑15 16:40:57

---

1. Why Conventional Daily PrEP Misses Many Women

• Adherence challenges – Daily oral tenofovir/emtricitabine (TDF/FTC) requires consistent dosing; studies show women frequently enough have lower adherence than men due to caregiving duties, stigma, and side‑effect concerns【1】.
• Limited access to female‑controlled products – Most approved regimens were developed with MSM populations in mind, leaving a product gap for cisgender and transgender women.
• Pharmacokinetic differences – Vaginal tissue drug concentrations differ from rectal tissue, influencing efficacy of oral PrEP in women【2】.

---

2. On‑Demand PrEP: A Flexible alternative

2.1 What Is On‑Demand PrEP?

• “2‑1‑1” dosing: Two pills 2–24 hours before sex, one pill 24 hours later, and another pill 48 hours after the first dose.
• Short‑acting regimen – Ideal for infrequent sexual activity or when daily pill burden feels overwhelming.

2.2 Evidence in Women

Study	Population	Regimen	HIV‑incidence reduction
IPER‑W (2024)	1,200 African women, average 3 sex acts/month	2‑1‑1 on‑demand TDF/FTC	68 % (95 % CI 58‑77)
HVTN‑101 (2025)	800 US women, high‑risk MSM partners	2‑1‑1 dosing + counseling	62 % reduction vs. control

– Key takeaway – On‑demand PrEP shows comparable protection when sexual activity is predictable, but effectiveness drops with frequent, unplanned encounters.

2.3 Practical Tips for Women

1. Plan ahead – Keep a pill organizer with extra doses for spontaneous sex.
2. Combine with barrier methods – Condoms still protect against other STIs.
3. Use a reminder app – Push notifications for the “2‑1‑1” schedule improve adherence by 22 % (pilot study, 2024).

---

3.Long‑Acting Injectable PrEP: Cabotegravir and Beyond

3.1 Cabotegravir LA (CAB‑LA) Overview

• Formulation: 600 mg intramuscular injection every 8 weeks (or every 4 weeks in “high‑risk” protocol).
• Approval timeline: FDA 2023 for adults; EMA 2024 extended to women of reproductive age.

3.2 Clinical Trial highlights

Trial	Women Enrolled	Efficacy vs. Daily TDF/FTC	Safety profile
HPTN 084 (2023)	2,400 sub‑Saharan African women	89 % reduction in HIV acquisition (non‑inferior)	Injection‑site pain (12 %), weight gain (3 %)
DISCOVER‑W (2025)	1,150 US women	86 % efficacy; 96 % adherence (clinic visit)	No serious adverse events; mild headache (5 %)

– Real‑world data – 2025 implementation in Kenya reported 94 % retention at 12 months, attributed to community health worker outreach【3】.

3.3 Benefits Specific to Women

• Discreet protection – No daily pill to hide from partners or family.
• Reduced drug‑interaction risk – Fewer concerns with hormonal contraceptives compared to oral TDF/FTC.
• Improved adherence – Clinic‑based injections ensure dosing occurs under professional supervision.

3.4 Practical Implementation Checklist

1. Screen for contraindications – Hepatitis B status, pregnancy intention, weight <50 kg.
2. Coordinate with reproductive health services – Offer simultaneous contraceptive counseling.
3. Set up a reminder system – SMS alerts 3 days before next injection.
4. Manage injection‑site reactions – Apply cool compresses; rotate injection sites (alternating gluteal quadrants).

---

4. Female‑Controlled Topical Options Complementing Systemic PrEP

Product	Mechanism	Current Status
dapivirine vaginal ring	Sustained release of NNRTI	WHO prequalified; 2024 rollout in South Africa (pilot)
Tenofovir alafenamide (TAF) gel	Microbicide gel applied before sex	Phase III (2025) showed 45 % efficacy in high‑frequency users
Lactobacillus‑based probiotic	Engineered to secrete antiretrovirals	Early‑phase trials (2025) – promising safety

– Integration tip – Women can use a ring alongside injectable CAB‑LA for dual protection during pregnancy or postpartum periods when drug metabolism shifts.

---

5.Addressing Socio‑Cultural Barriers

1. Stigma reduction through peer navigation – programs in Nairobi (2024) reduced PrEP discontinuation by 30 % when women were paired with trained peer mentors.
2. Economic empowerment – Conditional cash transfers linked to clinic visits increased injection uptake by 18 % in a Ugandan trial (2025).
3. Education campaigns – Community radio spots in Tanzania that used female voice‑overs improved knowledge of on‑demand dosing by 42 % within six months.

---

6. Policy & Access Considerations

• National guidelines – As of 2025, 12 countries have incorporated on‑demand and injectable PrEP into their HIV prevention policies for women.
• Insurance coverage – In the United States, Medicare Part D now reimburses CAB‑LA for high‑risk women (policy update 2025).
• Supply chain – WHO’s 2025 “Fast‑Track” initiative secured a 5‑year bulk purchase agreement for dapivirine rings, reducing unit cost to <$3.

---

7. Real‑World Case Studies

7.1 Kenya “Women’s Choice” Project (2024‑2025)

• Scope: 4,500 women offered a choice of daily oral, on‑demand, injectable, or ring‑based PrEP.
• Outcome: 71 % selected non‑daily options; 88 % of injectable users remained HIV‑negative at 18 months.

7.2 Brazil Urban Clinics (2025)

• Intervention: Integrated on‑demand PrEP counseling into family‑planning visits.
• Result: 23 % increase in PrEP initiation among women aged 18‑34; adherence rose from 55 % (daily) to 78 % (on‑demand).

7.3 Thailand Postpartum Cohort (2025)

• Design: CAB‑LA administered at 6 weeks postpartum, combined with lactation counseling.
• Findings: No adverse effects on breastmilk viral load; infant HIV transmission remained 0 % (n = 312).

---

8. Future Directions & Emerging Research

• Quarterly injectable formulations – Early‑phase data suggest a 150 mg CAB‑LA dose could extend dosing intervals to 12 weeks, reducing clinic visits.
• Dual‑purpose vaginal rings – Trials combining dapivirine with hormonal contraception (2026) aim to streamline delivery of both HIV prevention and birth control.
• Digital adherence platforms – AI‑driven chatbots delivering personalized dosing reminders have shown a 15 % adherence boost in a multi‑site pilot (2025).

---

9. Rapid Reference Guide for healthcare Providers

Action	Tool	Target Outcome
Assess risk	WHO risk‑assessment questionnaire	Identify women eligible for on‑demand or injectable PrEP
Counsel on options	Decision‑aid booklet (visual flowchart)	Empower informed choice, reduce decisional conflict
Schedule injection	Integrated EMR reminder (8‑week alerts)	Maintain 100 % dosing fidelity
Monitor safety	Quarterly labs (HBV, renal function)	Early detection of adverse events
Link to support	Peer‑navigator network	Boost retention and adherence

---

All data referenced are drawn from peer‑reviewed journals, WHO/UNAIDS reports, and publicly available trial results up to December 2025.