CABO-LA: Switch From Oral Therapy to Long-acting Injectable Cabotegravir + Rilpivirine
Study Details
Study Description
Brief Summary
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.
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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).
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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.
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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:
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Describe percentage of patients that preferred injectable over oral therapy after 72 weeks follow up
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Evaluate the adherence of patients switching to injectable treatment
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Evaluate safety/tolerability of the injectable treatment
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Monitor the HIV viral load, of the patients every 6 months, to follow their health status
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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
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Register anthropometric changes.
Study Design
Outcome Measures
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. [72 weeks]
Level of satisfaction of HIV treatment will be measured by HIVTSQs (HIV Treatment Satisfaction Questionnaire) at day one, week 4,12, 36,52 and 72. Questionnaire produce a Treatment Satisfaction score (range: 0 to 66). The higher the score, the greater the satisfaction with treatment.
- Evaluate the level of acceptance of treatment of undetectable HIV patients who switch from oral to injectable antiretroviral treatment at 72 weeks follow up. [72 weeks]
Acceptance of treatment will be measured by ACCEPT questionnaire (Chronic Treatment Acceptance Questionnaire) at day 1, week 36 and week 72. Questionnaire score has ranges from 0 to 66. The higher the score, indicates greater acceptance
- Evaluate the level of quality of life of undetectable HIV patients who switch from oral to injectable antiretroviral treatment at 72 weeks follow up. [72 weeks]
Quality of life will be evaluated by MOS-HIV (Medical Outcomes Study HIV Health Survey) Questionnaires at day 1, weeks 4,36,60 and 72. Questionnaire score has ranges from 0 to 100. The higher the score, indicates better health
Secondary Outcome Measures
- Evaluate the adherence of patients switching to injectable treatment [72 weeks]
Patient adherence will be measured at 72 weeks, through the number of injections that the patient attends.
- Evaluate safety of the injectable treatment [From day 28 to 72 weeks]
The evaluation of safety will be monitored through incidence of All Drug related AEs and SAEs, AEs leading to discontinuations
- Describe percentage of patients who prefer injectable over oral therapy at 72 weeks follow up [72 weeks]
Patient´s preference will be described by "SOLAR preference questionnaire" at week 72 by the percentaqe of patients that prefer injectable over oral therapy
- Monitor the HIV viral load of the patients every 6 months, to follow their health status [Every 6 months until 72 weeks]
HIV-1 RNA by Copies RNA/mL will be registrered at day 1, week 20, 52, and 72.
- Monitor the lymphocytes CD4 count of the patients every 6 months, to follow their health status [Every 6 months until 72 weeks]
Absolute Values for lymphocytes CD4 Count by cells/mm3 will be registered at day 1, week 20, 52, and 72.
- Monitor the blood chemistry of the patients every 6 months, to follow their health status [Every 6 months until 72 weeks]
Blood chemistry includes creatinine, SGOT, GGT, SGPT, alkaline phosphatases and bilirrubin at day 1, week 20, 52, and 72.
- Register anthropometric changes [From day 1 to 72 weeks]
Height, weight and hip measures will be registered at day 1, week 20, 52, and 72.
Eligibility Criteria
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:
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HIV-1 positive patients, on antiretroviral therapy
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Older than 18 years of age at the time of signing the informed consent
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Undetectable HIV viral load in the last 6 months
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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:
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Previous virological failure
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Any evidence of primary resistance or the presence of any major known INI or NNRTI resistance-associated mutation by any historical resistance test result.
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Patients with decompensated pathology (physical or mental) or active opportunistic infection at the time of admission
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Concomitant use with: rifampin, carbamazepine, oxcarbazepine, phenytoin and phenobarbital or any contraindication to one of the drugs of the study
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Known hepatitis B co-infection
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
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| 1 | CICUC | Santiago | Region Metropolitana | Chile | 3830000 |
Sponsors and Collaborators
- Pontificia Universidad Catolica de Chile
- ViiV Healthcare
Investigators
- Principal Investigator: Maria E Ceballos, MD, Pontificia Universidad Catolica de Chile
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Transmission in the United States.
- A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed
- Information leaflet for professionals VOCABRIA prolonged-release injectable suspension 600 mg/3ml.
- Use of cabotegravir and rilpivirine tablets to control the planned interruption of the injection dose every 2 months with cabotegravir long-acting plus rilpivirine. ViiV Healthcare
- HIGHLIGHTS OF PRESCRIBING INFORMATION
- Information leaflet for ptofessionals Vocabria prolonged-release injectable suspension 600 mg/3ml. updated
Publications
None provided.- 220817002