Switch From Oral Therapy to Long-acting Injectable Cabotegravir + Rilpivirine

Official title

Level of Satisfaction and Quality of Life in People Living With HIV in Chile, Who Switch From Oral Therapy to Long-acting Injectable Cabotegravir + Rilpivirine

Overview

This protocol will assess the level of satisfaction, acceptance of treatment and quality of life of patients with undetectable HIV who voluntarily change from oral to injectable antiretroviral treatment at 72 weeks of follow-up.

Detailed description

Foreign studies have shown that long-acting (LA) injectable Cabotegravir + Rilpivirine is effective and well tolerated in the long term, demonstrating non-inferiority in relation to oral antiretroviral therapy. One of the main advantages described is that patients report a better quality of life and greater satisfaction with their new antiretroviral therapy.

Currently in Chile, HIV patients have only access to oral antiretroviral therapy as part of their health coverage, either in public ( FONASA) or at private ( ISAPRES). Several issues regarding oral antiretroviral therapy have been detected, including: a) patients who have been in treatment for a long time, often complain of being tired of taking 1 or more pills daily, which might directly affect adherence and success of treatment, b) some patients complain about gastrointestinal intolerance, associated with oral therapy; and c) patients who have to travel abroad for longer than a month, have problems to get an extra dose, in order to adhere to their antiretroviral treatment.

That is why, the possibility of receiving a bimonthly injectable antiretroviral therapy, becomes an attractive alternative for our patients.

Studies evaluating efficacy and security of LA-injectable Cabotegravir + rilpivirine were ATLAS, ATLAS-2M and FLAIR. ATLAS and ATLAS-2M only included 26 and 45 Latin American patients (Argentina and Mexico) from a total of 616 and 1045 participants, respectively. FLAIR study did not include Latin American individuals. Since the majority of patients included in the registration studies were not of Hispanic or Latino ethnicities, it is important to evaluate, in population living in Chile, the real-life impact of Cabotegravir + Rilpivirine injectable treatment on the level of satisfaction, in experienced patients and how it will affect them in the long-term period.

Injectable therapy with Cabotegravir + Rilpivirine needs to be administered by a third person, in an authorized place for such procedures, and requires refrigeration. For this reason, starting the program as a part of a study facilitates the logistic implementation of such program.

The objective of this study is to evaluate, in real life, the level of satisfaction, acceptance of treatment, and quality of life in a group of HIV patients treated in HIV consultation at Red Salud UC-Christus, in Santiago de Chile, who switch to LA injectable therapy Cabotegravir + Rilpivirine, during a 72 weeks follow-up. In order to measure these items, the investigators will use validated instruments (questionnaires).

III. Hypotheses The change from oral to injectable antiretroviral therapy in HIV patients is associated with a high level of satisfaction, good acceptance of treatment, and better quality of life, without affecting adherence to treatment, keeping undetectable HIV viral load an stable CD4 count, and with few serious adverse effects related to injectable therapy.

IV. Objectives Primary Objective: Evaluate the level of satisfaction, acceptance of treatment, and quality of life of undetectable HIV patients who switch from oral to injectable antiretroviral treatment at 72 weeks follow up

Secondary Objectives:

1. Describe percentage of patients that preferred injectable over oral therapy after 72 weeks follow up 2. Evaluate the adherence of patients switching to injectable treatment 3. Evaluate safety/tolerability of the injectable treatment 4. Monitor the HIV viral load, of the patients every 6 months, to follow their health status 5. Monitor the CD4 count of the patients every 6 months, to follow their health status 6 Monitor blood chemistry of the patients every 6 months, to follow their health status

7\. Register anthropometric changes.

Primary outcome measures

• Evaluate the level of satisfaction of undetectable HIV patients who switch from oral to injectable antiretroviral treatment at 72 weeks follow up. [Time frame: 72 weeks]
• Evaluate the level of acceptance of treatment of undetectable HIV patients who switch from oral to injectable antiretroviral treatment at 72 weeks follow up. [Time frame: 72 weeks]
• Evaluate the level of quality of life of undetectable HIV patients who switch from oral to injectable antiretroviral treatment at 72 weeks follow up. [Time frame: 72 weeks]

Secondary outcome measures (7)

• Evaluate the adherence of patients switching to injectable treatment [Time frame: 72 weeks]
• Evaluate safety of the injectable treatment [Time frame: From day 28 to 72 weeks]
• Describe percentage of patients who prefer injectable over oral therapy at 72 weeks follow up [Time frame: 72 weeks]
• Monitor the HIV viral load of the patients every 6 months, to follow their health status [Time frame: Every 6 months until 72 weeks]
• Monitor the lymphocytes CD4 count of the patients every 6 months, to follow their health status [Time frame: Every 6 months until 72 weeks]
• Monitor the blood chemistry of the patients every 6 months, to follow their health status [Time frame: Every 6 months until 72 weeks]
• Register anthropometric changes [Time frame: From day 1 to 72 weeks]

Eligibility criteria

Inclusion criteria

All patients who, according to the recommendations for use, can receive LA- injectable Cabotegravir +Rilpivirine therapy will be invited to participate in the study.

Recommendations for use:

• HIV-1 positive patients, on antiretroviral therapy
• Older than 18 years of age at the time of signing the informed consent
• Undetectable HIV viral load in the last 6 months
• Willing to switch from oral to injectable therapy

Exclusion criteria

These criteria are defined for those patients who, according to the recommendations for use, cannot receive the therapy:

• Previous virological failure
• Any evidence of primary resistance or the presence of any major known INI or NNRTI resistance-associated mutation by any historical resistance test result.
• Patients with decompensated pathology (physical or mental) or active opportunistic infection at the time of admission
• Concomitant use with: rifampin, carbamazepine, oxcarbazepine, phenytoin and phenobarbital or any contraindication to one of the drugs of the study
• Known hepatitis B co-infection
• Pregnancy (There is insufficient data for people who become pregnant on CAB or those planning to conceive because available pregnancy PK data are limited (n = 3), and data on clinical outcomes in pregnancy are extremely limited. Therefore, CAB is Not Recommended for pregnant or nonpregnant people initiating or restarting ART or for those whose current regimen is not well tolerated and/or not fully suppressive)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Chile · 1 center

• CICUC — Santiago

Publications

• Scarsi KK, Swindells S. The Promise of Improved Adherence With Long-Acting Antiretroviral Therapy: What Are the Data? J Int Assoc Provid AIDS Care. 2021 Jan-Dec;20:23259582211009011. doi: 10.1177/23259582211009011. PMID 33902356
• Swindells S, Andrade-Villanueva JF, Richmond GJ, Rizzardini G, Baumgarten A, Masia M, Latiff G, Pokrovsky V, Bredeek F, Smith G, Cahn P, Kim YS, Ford SL, Talarico CL, Patel P, Chounta V, Crauwels H, Parys W, Vanveggel S, Mrus J, Huang J, Harrington CM, Hudson KJ, Margolis DA, Smith KY, Williams PE, Spreen WR. Long-Acting Cabotegravir and Rilpivirine for Maintenance of HIV-1 Suppression. N Engl J M PMID 32130809
• Overton ET, Richmond G, Rizzardini G, Jaeger H, Orrell C, Nagimova F, Bredeek F, Garcia Deltoro M, Swindells S, Andrade-Villanueva JF, Wong A, Khuong-Josses MA, Van Solingen-Ristea R, van Eygen V, Crauwels H, Ford S, Talarico C, Benn P, Wang Y, Hudson KJ, Chounta V, Cutrell A, Patel P, Shaefer M, Margolis DA, Smith KY, Vanveggel S, Spreen W. Long-acting cabotegravir and rilpivirine dosed every 2 m PMID 33308425
• Jaeger H, Overton ET, Richmond G, Rizzardini G, Andrade-Villanueva JF, Mngqibisa R, Hermida AO, Thalme A, Belonosova E, Ajana F, Benn PD, Wang Y, Hudson KJ, Espanol CM, Ford SL, Crauwels H, Margolis DA, Talarico CL, Smith KY, van Eygen V, Van Solingen-Ristea R, Vanveggel S, Spreen WR. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 96-week r PMID 34648734
• Orkin C, Oka S, Philibert P, Brinson C, Bassa A, Gusev D, Degen O, Garcia JG, Morell EB, Tan DHS, D'Amico R, Dorey D, Griffith S, Thiagarajah S, St Clair M, Van Solingen-Ristea R, Crauwels H, Ford SL, Patel P, Chounta V, Vanveggel S, Cutrell A, Van Eygen V, Vandermeulen K, Margolis DA, Smith KY, Spreen WR. Long-acting cabotegravir plus rilpivirine for treatment in adults with HIV-1 infection: 96-w PMID 33794181
• Cutrell AG, Schapiro JM, Perno CF, Kuritzkes DR, Quercia R, Patel P, Polli JW, Dorey D, Wang Y, Wu S, Van Eygen V, Crauwels H, Ford SL, Baker M, Talarico CL, Clair MS, Jeffrey J, White CT, Vanveggel S, Vandermeulen K, Margolis DA, Aboud M, Spreen WR, van Lunzen J. Exploring predictors of HIV-1 virologic failure to long-acting cabotegravir and rilpivirine: a multivariable analysis. AIDS. 2021 Jul 1 PMID 33730748
• Cooper V, Clatworthy J, Harding R, Whetham J; Emerge Consortium. Measuring quality of life among people living with HIV: a systematic review of reviews. Health Qual Life Outcomes. 2017 Nov 15;15(1):220. doi: 10.1186/s12955-017-0778-6. PMID 29141645
• Wu AW, Hanson KA, Harding G, Haider S, Tawadrous M, Khachatryan A, Pashos CL, Simpson KN. Responsiveness of the MOS-HIV and EQ-5D in HIV-infected adults receiving antiretroviral therapies. Health Qual Life Outcomes. 2013 Mar 12;11:42. doi: 10.1186/1477-7525-11-42. PMID 23497257

Identifiers

NCT: NCT05835635 · 220817002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗