CROI 2025 Abstract eBook

Abstract eBook

Poster Abstracts

970

Weekly Rifapentine and Isoniazid (3HP) vs Isoniazid Preventive Therapy (6H) Among People With HIV Dickens Onyango 1 , Jerphason Mecha 2 , Lilian N. Njagi 2 , Samson Aoro 3 , John Kinuthia 3 , Grace John-Stewart 4 , Sylvia LaCourse 4 1 Kisumu County Department of Medical Services, Public Health, and Sanitation, Kisumu, Kenya, 2 KEMRI Kenya, Nairobi, Kenya, 3 Kenyatta National Hospital, Nairobi, Kenya, 4 University of Washington, Seattle, WA, USA Background: People with HIV (PHIV) have a 30% lifetime risk of developing tuberculosis (TB) disease, which TB preventive therapy (TPT) reduces by 60%. Six-month daily isoniazid (6H) regimens are challenged by non-adherence and suboptimal completion. Shorter regimens such as 3-month weekly rifapentine and isoniazid (3HP) were introduced in Kenya in October 2022. There is a lack of programmatic data comparing the 3HP and 6H cascades. Methods: We evaluated the TPT cascade among PHIV in western Kenya, January to September 2022, when only 6H was implemented, and October 2022 to September 2023, when 3HP was the preferred regimen. Both regimens were self-administered, with monthly refills. Data were abstracted using standardized report forms for PHIV aged >15 years newly enrolled in HIV care with at least six months of follow-up. We assessed symptom screening, TPT eligibility, initiation, and completion. TPT outcomes by regimen were compared using Chi-square tests. Poisson regression was used to assess correlates of TPT non-completion. Results: Data was abstracted for 1930 PHIV with median age of 33 years (IQR=27-41). 65.8% were female (n=1269) and 19.5% (n=374) were in WHO stage 3 or 4 (advanced HIV disease [AHD]) at enrolment. Overall, 99.6% (n=1922) underwent TPT eligibility screening, of whom 6.9% (n=132) were diagnosed with TB disease; 97.5% (n=1970) were eligible for TPT. Among 1970 eligible PHIV, 88.1% (n=1577) initiated TPT, 55.4% [n=873] 3HP and 44.6% [n=704] 6H. TPT initiation was significantly higher for 3HP than 6H (89.8% vs. 84.2%; p<0.001). 3HP completion was similar to 6H (89.2% vs. 88.8%, p=0.77). Discontinuation of 3HP due to adverse effects was similar to 6H (3.1% vs. 2.3%, p=0.70). Non-completion of 6H was nearly five-fold higher (adjusted risk ratio [aRR]=4.89; 95%CI 1.91-12.48) among PHIV with AHD than those without AHD. Non-completion of 3HP was over twice higher among PHIV with AHD than those without AHD (aRR=2.36; 95% CI 1.04-5.37) and among PHIV in formal employment (aRR=2.42; 95% 1.12-5.21). Conclusions: 3HP implementation significantly increased TPT initiation. Overall, completion rates were high, adverse events leading to discontinuation were low and similar for both regimens. TPT non-completion was substantially higher among PHIV with AHD. 3HP non-completion was higher among PHIV in formal employment. While 3HP is a promising alternative to 6H, interventions are needed to support treatment completion among PHIV with AHD and those in formal employment.

969

The Impact of Rifampin Drug Interactions on TPT Completion and Safety Using High-Dose vs Standard Jinell White 1 , Federica Fregonese 2 , Rachel Lim 1 , Nancy Bedingfield 1 , Victoria Cook 3 , Fajri Gafar 2 , Diana Gibson 2 , Dina Fisher 1 1 Alberta Health Services, Calgary, Canada, 2 McGill University Health Centre Research Institute, Montreal, Canada, 3 BC Centre for Disease Control, Vancouver, Canada Background: Tuberculosis preventive treatment (TPT) has been recognized by the World Health Organization as a critical intervention to eliminate tuberculosis. Rifampin TPT is critical to this goal, given high completion rates, short treatment lengths, and low side-effects. However, rifampin treatment has limitations by drug-drug interactions (DDI) with multiple medications. Methods: A post-hoc data analysis from the 2R2 trial (Ruslami,R Lancet Resp Med 2024) on comorbidity and concomitant medications of all participants was obtained before starting TPT. Information on side effects and concomitant medication adjustments were asked at each study visit. The study population was classified as taking at least one “essential” concomitant medication or not. Essential medications were defined as 1) prescribed by a doctor; 2) could not be interrupted for the treatment duration with Rifampin 3) if interrupted would have caused potentially life threatening or debilitating consequences. We then analyzed essential medications in categories B to X, by mechanism of action for Rifampin DDI, using Lexi-drugs database. Results: 1368 participants were in the 2R2 study; 282 (21%) were classified as taking at least one concomitant “essential” medication with possible interaction with rifampin, almost half (n=128, 45%) took > 2 essential medications. 198 participants (70%) in the DDI population completed TPT treatment, with no significant differences in completion compared to the non-DDI population. Participants who took at least one dose of TPT, an adverse event (AE) resulting in permanent treatment discontinuation (protocol-defined AE) was reported for 27 (9.9%) participants in the DDI population and 58 (5.6%) in the non-DDI population. Most frequent AE, rash/allergy had similar distribution in the two populations (3%), while GI intolerance was more common in DDI population (3% vs. 1%). At follow-up, the proportion of participants who required additional unscheduled visits was higher in the DDI population and the time to the first additional visit was significantly shorter. More participants in the DDI population reported more than one symptom at the second scheduled follow up visit (GI intolerance was most reported). Conclusions: This demonstrates that DDI(s) with rifampin can be managed safely without impacting TPT completion rates of standard and high dose. Participants taking concomitant medications with possible rifampin DDI required increased clinical monitoring to achieve similar outcomes to the non-DDI population.

Poster Abstracts

971

Patient and Provider Preferences for Long-Acting Tuberculosis Preventive Therapy Marcia C. Vermeulen 1 , Renae Furl 2 , Harlan Sayles 2 , Shahanara Valawalkar 3 , Abhay Kadam 3 , Samyra R. Cox 4 , Vidya Mave 3 , Charlotte Schutz 1 , Amy Ward 1 , Joelle Dountio Ofimboudem 5 , Kimberly K. Scarsi 2 , Graeme Meintjes 1 , Susan Swindells 2 , for the Longevity Consortium 1 University of Cape Town, Cape Town, South Africa, 2 University of Nebraska Medical Center, Omaha, NE, USA, 3 The Johns Hopkins Center for Infectious Diseases in India (CIDI), Pune, India, 4 The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA, 5 Treatment Action Group, New York, NY, USA Background: Tuberculosis preventive therapy (TPT) is a key intervention for tuberculosis (TB) elimination. The introduction of long acting (LA) TPT has the

CROI 2025 306

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