{"id":52049,"date":"2025-07-28T12:00:44","date_gmt":"2025-07-28T12:00:44","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=52049"},"modified":"2025-08-06T12:48:01","modified_gmt":"2025-08-06T12:48:01","slug":"switching-to-injectable-cab-rpv-la-with-detectable-viral-load","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/52049","title":{"rendered":"IAS 2025: Switching to injectable CAB\/RPV-LA with detectable viral load: results from the OPERA cohort"},"content":{"rendered":"

\"\"Simon Collins, HIV i-Base<\/strong><\/p>\n

IAS 2025 included results from two studies from the large US OPERA cohort in people who started injectable CAB\/RPV-LA when their viral load was still detectable. [1, 2]<\/strong><\/p>\n

It also included results from the ANRS IMPALA study which looked at the same approach in a randomised study in Uganda, Kenya and South Africa. [3]<\/p>\n

These results are important because even though CAB\/RPV-LA is only approved as a switch option in people with viral load <50 copies\/mL on oral ART, it is perhaps most likely to benefit people whose viral load is still detectable due to adherence difficulties with oral treatment.<\/p>\n

Results in 368 people were presented by Ricky Hsu from AIDS Healthcare Foundation, New York in an oral presentation.<\/p>\n

The OPERA cohort includes medical records of almost 152,000 adults living with HIV attending more than 100 clinics across the US. Of these, 3304 (less than 3%) started CAB\/RPV-LA between January 2021 and December 2023 and were not enrolled in a clinical study \u2013 and 368\/3304 (11%) started injectable ART with viral load >50 copies\/mL on oral therapy.<\/p>\n

Baseline characteristics, only provided for these 368 participants, included 27% older than 50 years, 30% women, 57% African-American, 18% Hispanic, 49% gay and bisexual men and 63% were living in the US South.<\/p>\n

Clinical characteristics included 29% with BMI >30, 80% had a comorbidity and one-third had a history that included an AIDS-defining infection. There was a median 9 years since HIV diagnosis (IQR: 3 to 17) with time on current oral ART of 17 months (IQR: 8 to 37 months). This was INSTI-based in 68%, PI-based in 9%, NNRTI-based in 8% and >1 of these core drugs was used by 12%. These details are important because of the potential of resistance at baseline to injectable ART. Although detectable, the median viral load was still low: 120 copies\/mL (IQR: 61 to 2535) and the median CD4 count was roughly 575 cells\/mm3<\/sup> (IQR: 350 to 800).<\/p>\n

Adherence results were based on a window of one week either side of the planned injection time, but were complicated by the presentation combining monthly and twice-monthly schedules. Roughly 80% of people started on a two-monthly injection schedule which increased to 93% by the end of follow-up.<\/p>\n

Adherence was reported at 90% for the first two injections, with 37\/368 people taking longer than 67 days before the second injection. Only 59% of subsequent injections were categorised as being on time, with 33% being either at 38-52 days (monthly) or 68-112 days (two-monthly), and 38\/368 participants missed an injection completely.<\/p>\n

Overall, only 258 of the total 368 participants (70%) remained on injectable ART for a median of 12 cumulative months (IQR: 8 to 19 months).<\/p>\n

Virological results were also complicated by missing data. Only 306\/368 had a viral load test result within six months and of these, 259\/306 had at least one viral load result <50 copies\/mL and 30\/313 (12%) with any viral load result never suppressed to <50 copies\/mL.<\/p>\n

Only three participants were reported to have confirmed viral failure defined, although this was only among those with viral load results available. Viral failure was defined as two consecutive results >200 copies\/mL. These three cases were presented in detail. All 3\/3 achieved undetectable viral load at some point. Of these, 2\/3 rebounded with two-class resistance and the third resuppressed on monthly CAB\/RPV-LA using an unusual high-dose (600\/900 mg) with fostemsavir.<\/p>\n

The study concluded that 259 participants achieved undetectable viral load within 6 months of starting CAB\/RPV-LA.<\/p>\n

This was 70% by ITT analysis rather than the 85% reported based on available data, and understanding the outcomes for the remaining 30% is more difficult.<\/p>\n

A second analysis from the OPERA cohort included a subset of 105 women from the above study presented as a poster. [2]<\/p>\n

In this group, the median viral load when switching to injectable ART was 1090 copies\/mL (IQR: 89 to 24,700). Of these, 69\/105 (65%) were on CAB\/RPV-LA at the time of the analysis after a median follow-up of 19 months (IQR: 13 to 25). Roughly 39% received all injections on time, 33% had at least one delayed injection and 17% missed at least one injection. Of note, only 66 women had at least one viral load test available for the analysis and this included several cases of viral failure after a median of 13 months (IQR: 9 to 17).<\/p>\n

Comment<\/h3>\n

The results are encouraging for people who switch with a relatively low viral load and who are able to adhere to the schedule of injections.<\/strong><\/p>\n

However, the lack of viral load data for many of the participants is a significant limitation of both studies, especially as viral load should be routinely checked at every visit. Collecting this real-world data is also complicated by this being a vulnerable population, who for other complex reasons may not have a stable connection to HIV care.<\/strong><\/p>\n

This makes it important to clearly define the denominator in each analysis and to compare long-term outcomes from long-acting injections compared to similar people who continue on failing oral ART.\u00a0<\/strong><\/p>\n

Although a growing number of people achieved and maintained undetectable viral load, many of whom are likely to have had a complex HIV history, these are still very small numbers \u2013 similar to other studies reporting outcomes from people with detectable viral load when switching to CAB\/RPV-LA. [4, 5, 6]<\/span><\/strong><\/p>\n

It is therefore good that ViiV is currently recruiting for the randomised phase 3b CROWN study in Spain and the US. This open-label study will enrol adolescents and adults with viral load >1000 to <100,000 copies\/mL and documented adherence difficulties with oral ART. [7]<\/strong><\/p>\n

CID also published results of another US cohort switching to all injectable ART in people struggling with adherence to oral ART. [8]<\/p>\n

References<\/p>\n

    \n
  1. Hsu R et al. Real-world effectiveness of CAB+RPV LA in individuals with HIV viremia at therapy initiation. IAS 2025. 13-17 July 2025. Oral abstract.
    \nhttps:\/\/conference.ias2025.org\/media-1144-art-strategies (webinar, login required)<\/a><\/li>\n
  2. Altamirano J et al. Clinical outcomes among women in the OPERA cohort initiating CAB+RPV LA with viral loads \u2265 50 copies\/mL. IAS 2025), 13-17 July, Kigali. Poster abstract WEPEB036.
    \n    https:\/\/programme.ias2025.org\/Abstract\/Abstract\/?abstractid=2079<\/a><\/li>\n
  3. IAS 2025: Long-acting CAB\/RPV in people with suboptimal adherence: IMPALA study results at 48 weeks. HTB July 2025.
    \n    https:\/\/i-base.info\/htb\/51876<\/a><\/li>\n
  4. Spinelli MA et al. HIV Viral Suppression With Use of Long-Acting Antiretroviral Therapy in People With and Without Initial Viremia. JAMA. 2025;333(16):1451\u20131453. doi:10.1001\/jama.2025.0109
    \n    https:\/\/pubmed.ncbi.nlm.nih.gov\/40048173<\/a><\/li>\n
  5. Sension MG et al. Cabotegravir + Rilpivirine Long-Acting Injections for HIV Treatment in the US: Real World Data from the OPERA Cohort. Infect Dis Ther. 2023;12:2807-2817.
    \n    https:\/\/pubmed.ncbi.nlm.nih.gov\/37966701<\/a><\/li>\n
  6. Hickey MD et al. Suppression Rates at 48 Weeks in People With HIV Starting Long-Acting Cabotegravir\/Rilpivirine With Initial Viremia. Clin Infect Dis. 2025 Apr 30;80(4):864-870. doi: 10.1093\/cid\/ciae500.
    \n    https:\/\/pubmed.ncbi.nlm.nih.gov\/39367871<\/a><\/li>\n
  7. Clinicaltrials.gov. A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1
    \n    https:\/\/clinicaltrials.gov\/study\/NCT06694805<\/a><\/li>\n
  8. Switching to long-acting injectable ART with detectable viral load in people struggling with oral ART. HTB 8 August 2025).
    \n    https:\/\/i-base.info\/htb\/52279<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base IAS 2025 included results from two studies from the large US OPERA cohort in people who started injectable CAB\/RPV-LA when their viral load was still detectable. [1, 2] It also included results from the ANRS IMPALA …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,3,41],"tags":[344],"class_list":["post-52049","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","category-treatment-strategies","tag-ias-13th-kigali"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/52049","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=52049"}],"version-history":[{"count":29,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/52049\/revisions"}],"predecessor-version":[{"id":52284,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/52049\/revisions\/52284"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=52049"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=52049"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=52049"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}