> ## Content Index > Fetch the complete content index at: https://dotsexual.com/llms.txt > Use this file to discover other available public pages before exploring further. # Long-Acting PrEP Injection Windows: Missed-Dose Rules, Access Data and Country Status (2026) - URL: https://dotsexual.com/long-acting-prep-injection-windows-cabotegravir-lenacapavir-access-2026/ - Published: 2026-10-31T06:30:00.000Z - Updated: 2026-10-31T06:30:00.000Z - Description: Two long-acting PrEP injections, two very different late windows: cabotegravir tolerates plus or minus 7 days around the two-month date, lenacapavir plus or minus 14 days around week 26 with an oral bridge. Plus the IDWeek 2026 finding that 41% never received an injection. - Author: Dot Research Desk - Tags: Research, Country Guides, How Long? Quick Answer (Checked 31 October 2026) Two data sets published in late October changed the practical questions: at IDWeek 2026 (21-24 October, Washington, D.C.) a Ryan White clinic study found that of **170** people prescribed long-acting injectable HIV PrEP, **70 (41.2%) never received an injection**, with **54.3%** lacking a pharmacy benefit and **41.4%** denied prior authorization ([*AJMC*](https://www.ajmc.com/view/insurance-barriers-block-4-in-10-from-injectable-hiv-prep?ref=dotsexual.com)), while NICE's appraisal committee reconvenes on **3 November 2026** on whether the NHS should fund twice-yearly lenacapavir at all ([*The Pharmaceutical Journal*](https://pharmaceutical-journal.com/article/news/nice-rejects-long-acting-hiv-prevention-treatment-lenacapavir-for-nhs-use?ref=dotsexual.com)). Here is the clock data those stories omit: 1. **Injectable PrEP Has Narrow, Explicitly Documented Late Windows:** per the [National HIV PrEP Curriculum](https://www.hivprep.uw.edu/go/hiv-prep-fundamentals/follow-up-monitoring-on-prep/core-concept/all?ref=dotsexual.com) and the [CDC lenacapavir recommendation (MMWR, 18 September 2025)](https://www.cdc.gov/mmwr/volumes/74/wr/mm7435a1.htm?ref=dotsexual.com), cabotegravir (*Apretude*) is **±7 days** around the 2-month date, and lenacapavir (*Yeztugo*) is **±2 weeks** around the 26-week date. Inside the window, you are on schedule. Outside it, you need an oral bridge. 2. **The Bridge and Re-Start Rules Differ by Drug:** if a *Yeztugo* dose will be **≥14 days late**, the labelled fallback is oral lenacapavir **300 mg once every 7 days** (started 26-28 weeks after the last injection, for up to 6 months), then the injection is resumed **within 7 days of the last oral dose**. If a cabotegravir dose is **more than 4 weeks late**, the loading schedule is repeated (two 600 mg injections one month apart). Missing *both* lenacapavir oral lead-in days pushes estimated time-to-protection to **21-28 days**. 3. **Two Long-Acting Injections Do Not Cover Everything Else:** lenacapavir and cabotegravir prevent HIV only. Condoms still decide gonorrhoea, chlamydia and syphilis risk (see [STI Test Window Periods](https://dotsexual.com/sti-test-window-periods-when-to-test-and-retest/)), and neither drug has any effect on pregnancy risk, so the [Broken or Slipped Condom & Unprotected Exposure Action Responder on /tools/](https://dotsexual.com/tools/#ds-emergency-tool) still governs emergency contraception, DoxyPEP and HIV PEP decisions. Long-acting PrEP is the fastest-moving story in sexual health right now, and it is currently being decided on two clocks at once. The clinical clock finished: [IDWeek 2026 ran 21-24 October in Washington, D.C.](https://www.ajmc.com/view/insurance-barriers-tied-to-missed-long-acting-prep-starts?ref=dotsexual.com), and the access data from that meeting is still circulating. The coverage clock is still running: NICE's second appraisal meeting on NHS funding for twice-yearly lenacapavir is scheduled for **3 November 2026** (three days from now), after its September draft said the drug's cost-effectiveness estimates were "above the range" the committee can accept. Most coverage of long-acting PrEP is about approvals and prices. Almost nobody writes down the part that decides whether a person stays protected: **the exact number of days a shot can be late before the schedule has to be re-loaded, and what you take in between**. This guide documents those windows, the on-demand oral alternative, and the access workarounds, using the CDC recommendation, the US National HIV PrEP Curriculum, product labelling and the trial data behind each drug ([CDC PrEP Clinical Guidance](https://www.cdc.gov/hiv/clinicians/prevention/prescribe-prep.html/?ref=dotsexual.com); [*NEJM*](https://www.nejm.org/doi/full/10.1056/NEJMoa2215025?ref=dotsexual.com)). ## 1\. The five protection clocks, compared line by line Every PrEP option has a different relationship with time: how long before protection, how much lateness the evidence tolerates, and how quickly protection decays after you stop. Those three numbers are what "adherence" means in practice: | Regimen | Time to Protection After Starting | How Much Lateness Is Tolerated | Stopping / "Tail" Behaviour | Guideline Status by Region | | --------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | | **Daily oral F/TDF** *(Truvada and generics; emtricitabine 200 mg / tenofovir DF 300 mg)* | **7 days** of daily dosing for receptive anal sex; **21 days** for receptive vaginal sex ([CDC-derived guidance summarised by i-Base](https://i-base.info/htb/51432?ref=dotsexual.com)). | Forgiving day-to-day: UK BHIVA-derived guidance reports four or more doses per week still sustains very high tissue levels ([i-Base PrEP guide](https://i-base.info/guides/prep/introduction-and-access?ref=dotsexual.com)). | Continue for **2 days** (event-driven) to **28 days** (after the last exposure) depending on regimen and protocol. | First-line everywhere: US, UK (free at sexual health clinics), EU, Canada, Australia (PBS), generic supply widely available. | | **Event-driven "2-1-1" oral F/TDF** *(on-demand / coitally timed)* | **2 hours** after the two-pill loading dose taken before sex (the reason the schedule exists). | Two pills 2-24 h before sex, one pill 24 h and one pill 48 h after the first two-pill dose ([CDC](https://www.cdc.gov/hiv/clinicians/prevention/prescribe-prep.html/?ref=dotsexual.com)). Requires planning sex around the first dose. | Stops when the last pill is taken; no tail. | **Off-label and explicitly not FDA-approved or CDC-recommended**, but included in IAS-USA (since 2018), BASHH/BHIVA and EACS guidance, and RACGP-based Australian practice; studied only in adult gay and bisexual men; avoid with active hepatitis B (flare risk). | | **Cabotegravir LA 600 mg IM** *(Apretude; gluteal injection every 2 months)* | Protective levels reached within about **7 days of the first injection**; some clinics hand out oral PrEP for those first 7 days if exposure is imminent ([Ward 86 protocol](https://gettingtozerosf.org/wp-content/uploads/2025/11/Ward-86-long-acting-PrEP-protocol%5FNov%5F2025.pdf?ref=dotsexual.com)). | **±7 days** around the 2-month date is the accepted window. If a dose will be **\>7 days late**: start daily oral PrEP on the missed date (oral cabotegravir bridging is in the product information for up to 2 months but is rarely stocked, so F/TDF is the usual bridge; F/TAF should not bridge vaginal-acquisition risk). | Long tail: measurable drug persists after the last injection, which is why HIV RNA testing is recommended at initiation and why "stop and forget" is unsafe without a plan. | FDA-approved (US); NHS England commissioned since 3 February 2026 (NICE TA1106) for people who cannot use oral PrEP, delivered in specialist clinics; approved in Australia in 2022 with limited public funding. | | **Lenacapavir 927 mg SC** *(Yeztugo; two 1.5 mL abdominal injections every 6 months, after oral lead-in)* | Limited data suggest protective levels **2 hours after the Day 2 oral 600 mg lead-in**; **if both lead-in days are missed, estimated time to protection is 21-28 days** ([CDC MMWR](https://www.cdc.gov/mmwr/volumes/74/wr/mm7435a1.htm?ref=dotsexual.com)). | **±2 weeks** around the 26-week date. If the dose will be **≥14 days late**: oral lenacapavir **300 mg every 7 days** (start 26 weeks after the last injection, no later than 28 weeks), for up to 6 months, then re-inject within 7 days of the last oral dose. | CDC advises patients that after stopping, levels decline across roughly **18 months** and **offer no protection after 6 months**, i.e. another PrEP method must be started at the 6-month mark. | FDA-approved 18 June 2025; EU approved (EMA/EU-M4all); TGA registered in Australia 13 January 2026 with public funding unresolved; MHRA licensed *Yeytuo* in the UK in December 2025, with **NICE funding decision still open (committee reconvenes 3 November 2026)**. | | **Dapivirine vaginal ring** *(monthly non-iso ring, Nelfina)* | Used continuously with monthly replacement; protection is tied to correct ongoing placement rather than a loading period. | Monthly change; no per-act timing decisions. | Short intravaginal half-life; protection falls quickly after removal. | WHO-recommended additional choice for cisgender women (endorsed alongside the 2025 injectable guidance); not a general option for people at risk through anal sex. | ## 2\. What the IDWeek 2026 access data showed, number by number The clinical efficacy of these drugs is no longer the weak link. In PURPOSE 1, **0 HIV infections occurred among 2,134 participants** randomised to lenacapavir (against 55 incident infections overall across 5,338 participants who were HIV-negative at baseline), and the CDC summarised that as **100% efficacy versus background incidence in cisgender women**. In PURPOSE 2 (2,179 lenacapavir recipients, mostly cisgender men, transgender women, transgender men and non-binary people who have sex with men) there were **2 infections, so 99.9% stayed HIV-negative**, a 96% reduction versus background incidence and **89% more effective than daily F/TDF** in the same trial ([trial summary](https://lovefoundation.or.th/en/twice-yearly-hiv-prevention-injection-phase-3/?ref=dotsexual.com); [narrative review, *Current Therapeutic Research*](https://link.springer.com/article/10.1007/s40506-024-00281-2?ref=dotsexual.com); [CDC MMWR](https://www.cdc.gov/mmwr/volumes/74/wr/mm7435a1.htm?ref=dotsexual.com)). What the 2026 IDWeek poster measured was the distance between a prescription and an arm. Among 170 patients prescribed long-acting injectable PrEP at a large Ryan White-funded St. Louis clinic: - **100 (58.8%) received an injection; 70 (41.2%) did not.** Among the 54.3% of non-recipients with no pharmacy benefit and the 41.4% with a prior-authorization denial, the blocker was paperwork, not willingness ([*AJMC*, 22 October 2026](https://www.ajmc.com/view/insurance-barriers-tied-to-missed-long-acting-prep-starts?ref=dotsexual.com)). - **Benefit design decided the outcome.** 94% of recipients had a *pharmacy* benefit versus 34% of non-recipients; 57% of non-recipients had no or unknown benefit type versus 1% of recipients. Medicaid covered 24.3% of non-recipients and 7.0% of recipients; Missouri Medicaid does not cover long-acting injectable PrEP at all. Roughly **9× better 12-month care engagement** followed from getting the drug (aOR 8.94; 95% CI 2.89-27.69). - **12 days (IQR 6-23)** passed between prescription and first injection even among people who succeeded, and **17% of those recipients were late for at least one subsequent injection** while **17% went back to oral PrEP** (15.7%, or 13 of 83, switched from cabotegravir to lenacapavir mid-schedule). The study recorded **one HIV seroconversion**: a patient with intermittent oral-PrEP adherence who had been denied coverage for the injection in the preceding year ([study reporting, 28 October 2026](https://gayety.com/injectable-prep-insurance-barriers-st-louis-study?ref=dotsexual.com)). Read together: the "late window" is not a theoretical section of a guideline. 17% of people who got the drug were late at least once, and a missed 7-day (cabotegravir) or 14-day (lenacapavir) window is the point at which an oral bridge stops being optional. ## 3\. What to do when the drug is prescribed but blocked 1. **Ask which benefit the injection is billed under.** The St. Louis data show the pharmacy benefit vs medical benefit distinction decided most outcomes. A prescriber's office can request a *pharmacy-benefit* claim pathway (including brand/generic substitution of the oral lead-in tablets), which is often a different, faster appeal than a medical-benefit prior authorisation. 2. **Check the no-cost-sharing route before paying cash.** In the US, PrEP is a USPSTF grade-A preventive service, so compliant private plans must cover CDC-recommended regimens without cost sharing; manufacturer assistance can reduce commercially insured out-of-pocket cost to as little as $0 and provides lenacapavir free to qualifying uninsured patients ([Gilead access statement](https://www.gilead.com/news/news-details/2025/yeztugo-lenacapavir-is-now-the-first-and-only-fda-approved-hiv-prevention-option-offering-6-months-of-protection?ref=dotsexual.com)). 3. **Do not let an approval gap become a protection gap.** A daily F/TDF or F/TAF prescription is the standard interim step (clinics in the study did exactly this when injections were delayed), and it is also the correct fallback if you are travelling through the injection window. The list price of an approved-but-unfunded drug is not a reason to be unprotected for three months. 4. **Set a calendar alarm at last dose + 4 weeks before the window closes**, not on the due date. Cabotegravir gives you ±7 days, lenacapavir ±2 weeks; those are the only margin you get. 5. **Test on the schedule the drug requires, not the schedule you prefer.** For lenacapavir the CDC path is a laboratory antigen/antibody test within 7 days before each injection (with HIV RNA testing as an alternative at initiation); for cabotegravir, antigen/antibody plus HIV RNA at initiation. Routine STI screening on PrEP is generally **every 3 months** for bacterial STIs and at least **every 6 months** for HIV. See [STI Test Window Periods: When to Test and Retest](https://dotsexual.com/sti-test-window-periods-when-to-test-and-retest/) or run the [STI & HIV Test Window-Period Explorer](https://dotsexual.com/tools/#ds-window-tool) and, if a clinic visit is not possible, [Confidential Postal STI Testing Routes by Country](https://dotsexual.com/confidential-postal-sti-testing-routes-by-country/). ## 4\. Price and availability by country (checked 31 October 2026) | Country / Region | Twice-Yearly Lenacapavir Status | Two-Monthly Cabotegravir Status | Oral F/TDF Access and Typical Cost Route | | ---------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | | **United States** | FDA-approved 18 June 2025 as *Yeztugo*; list price $28,218 per person-year; copay card to $0 for many commercially insured patients and free drug for qualifying uninsured people. | Approved and covered as a preventive service by compliant plans; medical-benefit billing is the common friction point. | Generic F/TDF widely available; $0 copay for most insured users under the preventive-services rule; Title X/340B and manufacturer programmes for the uninsured. | | **United Kingdom (England & Wales)** | MHRA licensed *Yeytuo* December 2025, so private use is lawful; **NICE draft guidance (9 September 2026) recommends against NHS funding** on cost-effectiveness grounds, with the **committee reconvening 3 November 2026** and a commercial access deal still possible. | Commissioned for NHS England since 3 February 2026 after NICE guidance, restricted to people who cannot use oral PrEP, delivered in specialist sexual health clinics (reported scale: roughly 1,000 people per year in early implementation). | Free at NHS sexual health clinics for anyone who would benefit (risk-based eligibility no longer required); event-based 2:1:1 and 2:7 schedules appear in UK clinical guidance ([i-Base](https://i-base.info/guides/prep/introduction-and-access?ref=dotsexual.com)). | | **Australia** | TGA registered lenacapavir for PrEP on 13 January 2026; **not yet publicly listed**, and advocacy bodies (Health Equity Matters, the National HIV Strategy) are pressing for a Pharmaceutical Benefits Scheme listing and an equitable rollout. | Approved since 2022, with limited funded access; the Global PrEP Tracker recorded no cumulative injectable initiations against roughly 80,254 oral PrEP initiations. | Listed on the PBS; state access schemes and bulk-billed sexual health clinics are the usual routes; event-based dosing is endorsed in Australian general-practice guidance. | | **European Union** | Approved via EMA/EU-M4all review; national reimbursement decisions vary country by country, which is the main practical difference between an approval and an injection appointment. | Approved; funded in several northern and western European health systems, usually restricted to oral-PrEP-ineligible people. | EACS guidance supports daily and 2:1:1 F/TDF; generics priced from a few euros per month in most markets, often free in public sexual health services. | | **High-incidence, resource-limited settings (120 licensed countries)** | Royalty-free voluntary licences with six generic manufacturers; modelled generic price $35-46 per person-year ($25 at 5-10 million users), branded supply at no profit in the interim via PEPFAR/Global Fund agreements. Independent reviewers note registration and manufacturing delays mean generics may not arrive before 2027-2028 in some markets ([*Lancet*\-region commentary, PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC12959828/?ref=dotsexual.com); [Forbes, 16 April 2026](https://www.forbes.com/sites/judystone/2026/04/16/breakthrough-hiv-drug-is-out-of-reach-for-many-who-need-it-most/?ref=dotsexual.com)). | Limited; the practical option in most of these settings remains oral PrEP and combination prevention. | WHO-recommended and widely available as generic F/TDF, funded through national programmes and PEPFAR-supporting mechanisms. | ## 5\. What long-acting PrEP does not do - **It does not prevent other STIs.** Bacterial STI incidence has not fallen in the long-acting PrEP era, which is why 3-monthly rectal, pharyngeal and urine testing exists in every guideline (see [What a Standard STI Panel Includes, and Misses](https://dotsexual.com/what-standard-sti-panel-includes-misses-partner-scripts/)) and why [doxycycline PEP within 72 hours](https://dotsexual.com/doxypep-after-sex-72-hour-sti-prevention-rules-by-country/) is a separate decision from PrEP dosing. - **It does not affect pregnancy risk, and pregnancy does not affect its dosing in the way oral contraception rules do.** No hormonal interaction is documented for either injectable; the contraception clocks live in [Emergency Contraception Pills & Copper IUD Rules by Country](https://dotsexual.com/emergency-contraception-pills-copper-iud-rules-by-country/) and [the missed-pill 3/12/24-hour windows guide](https://dotsexual.com/birth-control-pill-clock-change-missed-pill-3-12-24-hour-windows-2026/). - **It is not post-exposure prophylaxis.** An injection received today does not compress the 72-hour PEP clock from an exposure last night. If sex already happened without protection and you are not yet on PrEP, run the [Broken or Slipped Condom & Unprotected Exposure Action Responder on /tools/](https://dotsexual.com/tools/#ds-emergency-tool): HIV PEP is a 72 h (ideally 2 h) question, and it is decided by hours, not by what you plan to start next month. - **It does not remove the need for a negative HIV test before every dose.** Injecting a long-acting drug into someone with undetected HIV creates a real resistance problem, which is the reason the 7 days-old laboratory test requirement exists at all, and why the "self-start before the appointment" model is the one thing clinics consistently advise against for injectables. ## Frequently asked questions **How many days late can a cabotegravir injection be?** Seven. The accepted window is 7 days before or after the 2-month date. Past that, daily oral PrEP is started on the missed date as a bridge, and beyond 4 weeks late the two-dose loading schedule is repeated with a month between doses, with an HIV test before resuming. **What if my twice-yearly lenacapavir shot is delayed?** Inside 2 weeks of the 26-week date you are on schedule. Longer, take oral lenacapavir 300 mg once weekly (started at 26 weeks after the last injection, never later than 28 weeks) for up to 6 months, then have the injection within 7 days of the last tablet. If you cannot get oral lenacapavir, another PrEP form is prescribed until injections resume. **Do I need condoms with an injection every six months?** For HIV, no, provided the schedule is maintained and STI testing continues. For gonorrhoea, chlamydia and syphilis, yes, or a documented testing-plus-DoxyPEP plan. The injection has zero effect on those bacteria. **Is event-based 2-1-1 PrEP "less protected" than the injection?** The two schedules were not compared head to head in a single trial. 2-1-1 has 2 hours of lead time and is confined to anal sex in adult gay and bisexual men (and not recommended in the US guideline at all), while the injectables trade that planning burden for an appointment-window burden and a long pharmacokinetic tail. Trials reported 96-100% efficacy versus background incidence for lenacapavir and superior efficacy for cabotegravir over daily oral dosing, but real-world protection is dominated by whether a person can complete the schedule they chose. **Where can I complain about a denial?** Ask the prescribing clinic to file a peer-to-peer appeal and a plan-level exception citing the USPSTF grade-A preventive-services requirement, and, in the UK, ask the sexual health service about its individual funding request process while the NICE appraisal remains open. ## Sources and evidence notes 1. **US Centers for Disease Control and Prevention.** Clinical Recommendation for the Use of Injectable Lenacapavir as HIV Preexposure Prophylaxis, United States, 2025\. *MMWR* 74(35), 18 September 2025\. [MMWR report](https://www.cdc.gov/mmwr/volumes/74/wr/mm7435a1.htm?ref=dotsexual.com). 2. **US Centers for Disease Control and Prevention.** Clinical Guidance for PrEP (2-1-1 off-label dosing, eligibility, hepatitis B caution). [CDC PrEP Clinical Guidance](https://www.cdc.gov/hiv/clinicians/prevention/prescribe-prep.html/?ref=dotsexual.com). 3. **Ramakrishnan A, Mukwekwerere E, Cardoza N, et al.** Long-acting injectable PrEP: interest vs. access in an Ending the HIV Epidemic priority state. Poster P-931, IDWeek 2026, Washington, D.C., 21-24 October 2026\. Summarised by [*AJMC* (22 Oct 2026)](https://www.ajmc.com/view/insurance-barriers-tied-to-missed-long-acting-prep-starts?ref=dotsexual.com), [*AJMC* video interview](https://www.ajmc.com/view/insurance-barriers-block-4-in-10-from-injectable-hiv-prep?ref=dotsexual.com) and [Gayety (28 Oct 2026)](https://gayety.com/injectable-prep-insurance-barriers-st-louis-study?ref=dotsexual.com). 4. **University of Washington, National HIV PrEP Curriculum.** Follow-Up Care and Monitoring on HIV PrEP: CAB-LA and LEN-SQ dosing windows, oral bridging, time-to-protection. [hivprep.uw.edu](https://www.hivprep.uw.edu/go/hiv-prep-fundamentals/follow-up-monitoring-on-prep/core-concept/all?ref=dotsexual.com). Practical implementation detail: [Ward 86 Long-Acting PrEP Protocol (Nov 2025)](https://gettingtozerosf.org/wp-content/uploads/2025/11/Ward-86-long-acting-PrEP-protocol%5FNov%5F2025.pdf?ref=dotsexual.com). 5. **NICE draft guidance on lenacapavir for PrEP (9 September 2026)** and NHS funding status; committee to reconvene 3 November 2026\. [*The Pharmaceutical Journal*](https://pharmaceutical-journal.com/article/news/nice-rejects-long-acting-hiv-prevention-treatment-lenacapavir-for-nhs-use?ref=dotsexual.com); [*FiercePharma*](https://www.fiercepharma.com/pharma/draft-guidance-uk-cost-arbiter-nice-rebuffs-gileads-twice-year-prep-med-national-coverage?ref=dotsexual.com); [*The Pharma Letter*](https://www.thepharmaletter.com/pharma-news/nice-draft-recommendation-against-lenacapavir-for-prep-slammed?ref=dotsexual.com). 6. **i-Base.** Getting oral and injectable HIV PrEP in the UK (access, quick-start double first dose, four-doses-per-week adherence, 2:1:1 and 2:7 schedules, cabotegravir commissioning). [i-base.info](https://i-base.info/guides/prep/introduction-and-access?ref=dotsexual.com); guideline comparison: [i-Base 2025 analysis](https://i-base.info/htb/51432?ref=dotsexual.com). 7. **Gilead Sciences.** [Gilead FDA approval and US access statement (18 June 2025)](https://www.gilead.com/news/news-details/2025/yeztugo-lenacapavir-is-now-the-first-and-only-fda-approved-hiv-prevention-option-offering-6-months-of-protection?ref=dotsexual.com); [PEPFAR partnership release](https://www.gilead.com/news/news-details/2025/gilead-announces-partnership-with-pepfar-to-deliver-twice-yearly-lenacapavir-for-hiv-prevention-for-up-to-two-million-people-in-primarily-low--and-lower-middle-income-countries?ref=dotsexual.com). 8. **PURPOSE 1 and PURPOSE 2 trial data summaries.** [Trial results explainer (0/2,134 and 2/2,179 infections)](https://lovefoundation.or.th/en/twice-yearly-hiv-prevention-injection-phase-3/?ref=dotsexual.com); [narrative review of the clinical programme, *Current Therapeutic Research*](https://link.springer.com/article/10.1007/s40506-024-00281-2?ref=dotsexual.com); [global-access commentary](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12959828/?ref=dotsexual.com); [pricing analysis (16 April 2026)](https://www.forbes.com/sites/judystone/2026/04/16/breakthrough-hiv-drug-is-out-of-reach-for-many-who-need-it-most/?ref=dotsexual.com). 9. **Australia.** [TGA registration reporting, 13 January 2026](https://www.starobserver.com.au/news/long-acting-hiv-prep-drug-lenacapavir-approved-but-access-is-vital-say-health-bodies/240475?ref=dotsexual.com); [Health Equity Matters analysis](https://www.healthequitymatters.org.au/resources/lenacapavir-and-the-future-of-prep-in-australia?ref=dotsexual.com); [PrEPWatch country page (updated 13 July 2026)](https://www.prepwatch.org/countries/australia/?ref=dotsexual.com). *Evidence checked: 31 October 2026\. Written by the Dot Sexual Research Desk (*[*Dot*](https://dotsexual.com/about/)*), with our method documented at* [*How We Research*](https://dotsexual.com/how-we-research/)*. Educational only: PrEP requires HIV testing and a prescriber, and dosing changes are made with the clinic that prescribed them. Corrections policy:* [*Corrections*](https://dotsexual.com/corrections/)*.*