48-week Efficacy and Safety of Switching to Bictegravir/ Emtricitabine/Tenofovir alafenamide in Virologically Suppressed People Living with HIV aged > 65 years
Introduction
Globally the number of people living with HIV (PLWH) aged >50 years exceeded 4.2 million in 2013, with the highest burden reported in sub-Saharan Africa (2.5 million) followed by Western/Central Europe and North America and the Asia-Pacific region. As older individuals are at increased risk of comorbidities and may experience challenges with polypharmacy, ensuring the safety and tolerability of ART in this population is crucial.
Aim
To assess the efficacy and safety of switching older people with HIV to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)
Patient Profile
- HIV patients with > 65 years age
- Treatment with elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide (E/C/F/TAF) or F/TDF plus a third agent
- Plasma HIV-1 RNA<50 copies/ml before and at screening
- An estimated glomerular filtration rate calculated using the Cockcroft-Gault equation (eGFRCG) > 30 ml/min
Methods
- Ongoing phase 3b, multicenter, open-label, single-arm study
- N= 90 HIV patients with > 65 years age
- Patients were switched from their preceding therapy to receive oral B/F/TAF (50/200/ 25 mg) once daily for 96 weeks
- Clinic visits were scheduled at baseline (day1) and at the end of weeks 4, 12, 24, 36 and 48
Endpoints
- The primary endpoint: The percentage of participants with HIV RNA\50 copies/ml at week 24 as defined by the US Food and Drug Administration Snapshot algorithm (Snapshot)
- Secondary endpoints: The proportion of participants with HIV RNA\50 copies/ml at week 48 (Snapshot) and the safety and tolerability of B/F/TAF, as assessed by adverse events (AEs), through week 48
Results
Primary Efficacy Endpoint at week 48
- B/F/TAF for the treatment of virologically suppressed PLWH aged > 65 years, we observed high rates of viral suppression
- No participants had HIV-1 RNA > 50 copies/ml at either time point
- The number and percentage of CD4+ cells were maintained during 48 weeks’ treatment with B/F/TAF
Safety
- B/F/ TAF was well tolerated
- Overall incidence and types of drug-related adverse events (AEs), was consistent with that expected with B/F/TAF based on previous studies
- Serious AEs (SAEs) were reported in seven participants (8.1%); all were considered unrelated to study medication
- No participants developed proximal tubulopathy, including Fanconi syndrome
- At week 48, median changes from baseline in weight and estimated glomerular filtration rate were +0.1 kg and - 6.0 ml/min respectively
- Median total cholesterol, low-density lipoprotein, high-density lipoprotein (HDL), total cholesterol: HDL ratio and triglyceride levels all declined from baseline to week 48
- No hepatic SAEs, and no hepatic, bone or renal AEs resulted in discontinuation of the study drug
| Summary of adverse events | Incidence, n (%) |
| Any adverse event | 70 (81.4) |
| Grade 3–4 adverse event | 7(8.1) |
| Any drug-related adverse event | 9(10.5) |
| Grade 3–4 drug-related adverse event | 0 |
| Any serious adverse event | 7(8.1) |
| Drug-related serious adverse event | 0 |
| Adverse event leading to premature | 3 (3.5) a |
| discontinuation of study drug |
|
| Treatment-emergent adverse events reported in > 3% of participants | |
| Bronchitis | 8(9.3) |
| Arthralgia | 6(7.0) |
| Hypertension | 5(5.8) |
| Nasopharyngitis | 5(5.8) |
| Back pain | 3(3.5) |
| Depression | 3 (3.5) |
| Diarrhea | 3 (3.5) |
| Dizziness | 3 (3.5) |
| Hypercholesterolemia | 3 (3.5) |
| Myalgia | 3(3.5) |
| Sciatica | 3(3.5) |
| Upper respiratory tract infection | 3(3.5) |
| Visual impairment | 3(3.5) |
a One participant had an adverse event of abdominal discomfort (grade 2), considered related to study drug; one had a serious adverse event of alcohol withdrawal (grade 3), considered not related to study drug; one had an adverse event of benzodiazepine withdrawal (grade 2), considered not related to study drug
- Patient-reported treatment satisfaction was higher at week 48 with B/F/TAF versus the preswitch baseline regimens
- Health-related quality of life was maintained from baseline through week 48.
- Median adherence to the study drug was 98.6%
Conclusion
Switching to B/F/TAF was effective and well tolerated in virologically suppressed adults aged > 65 years through 48 weeks
Reference
Infect Dis Ther .9th March 2021. https://doi.org/10.1007/s40121-021-00419-5
