Effects of the Transition from Bottle to PTP Packaging of Bictegravir/Emtricitabine/Tenofovir Alafenamide on Medication Management

Technical Summary: Effects of the Transition from Bottle to PTP Packaging of Bictegravir/Emtricitabine/Tenofovir Alafenamide on Medication Management

Problem Statement
In Japan, oral medications are predominantly supplied in press-through packaging (PTP), whereas many antiretroviral agents (ARVs) have traditionally been distributed in bottle packaging. This discrepancy creates a distinct visual and functional profile for HIV medications compared to other daily drugs. Patients often transfer ARVs from their original bottles into pill organizers to address concerns regarding portability, privacy, and HIV-related stigma. However, manufacturers recommend storing Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in its original packaging to maintain product quality and moisture protection. In 2022, B/F/TAF became the first ARV in Japan to offer PTP packaging alongside the traditional bottle format. The study addresses the need to evaluate how this transition from bottle to PTP packaging influences daily medication management practices, patient perceptions, and satisfaction among people living with HIV (PLWH) in a real-world clinical setting.

Methodology
This was a single-center, prospective, questionnaire-based study conducted at Hiroshima City Hiroshima Citizens Hospital. The study population consisted of 15 male participants who had been receiving bottle-packaged B/F/TAF for at least three months and continued treatment for at least three months after the transition to PTP packaging in December 2025.

Data collection involved two anonymous, paper-based surveys:

1. Pre-transition Survey: Administered while patients were using bottle packaging, assessing medication management practices (specifically storage habits), adherence (self-reported missed doses in the previous month), and satisfaction with the packaging.
2. Post-transition Survey: Administered at least three months after the switch to PTP packaging, assessing the same metrics.

Demographic and clinical data (age, sex, infection duration, viral load, CD4+ count) were retrospectively collected from electronic medical records. The study utilized descriptive statistics for analysis, presenting continuous variables as medians with interquartile ranges and categorical variables as numbers and percentages. No inferential statistical analyses were performed. Free-text responses were qualitatively analyzed and categorized by common themes.

Key Contributions and Results
The study provides empirical data on the shift in patient behavior and perception following the packaging transition:

• Patient Satisfaction: Satisfaction with packaging increased significantly. Only 33.3% (5/15) of participants reported being satisfied with bottle packaging, compared to 80.0% (12/15) with PTP packaging.
• Medication Storage Practices: The transition reduced the need for patients to transfer medication to alternative containers. Before the transition, 40.0% (6/15) of participants transferred B/F/TAF to pill organizers. After the transition, this figure dropped to 13.3% (2/15). Consequently, 86.7% of participants stored the medication in its original PTP packaging post-transition.
• Perceived Usability: Participants perceived PTP packaging as easier to carry and allowing for easier confirmation of remaining tablets compared to bottles.
• Qualitative Feedback:
  • Bottle Packaging: Criticisms focused on the noise generated when carrying the bottle and difficulty in opening the container.
  • PTP Packaging: Positive feedback highlighted the smaller printed medication name (beneficial for privacy) and the absence of noise during transport.
• Adherence: While participants perceived PTP packaging as less likely to result in missed doses, the actual number of self-reported missed doses remained largely unchanged between the two survey periods (13/15 reported no missed doses in both surveys).

Significance and Claims
The paper claims that the transition to PTP packaging for B/F/TAF may improve patient satisfaction by addressing specific concerns regarding portability and privacy. By aligning the packaging of ARVs with the standard PTP format used for other medications in Japan, the study suggests that patients are less compelled to transfer medications to alternative containers. This reduction in transfer behavior is significant because it supports adherence to manufacturer recommendations for storing B/F/TAF in its original packaging to ensure product stability.

The authors conclude that while packaging changes can positively influence patient-centered outcomes and daily management practices, medication adherence remains a complex behavior influenced by multiple factors beyond packaging type. The study emphasizes that for patient-centered HIV care, greater consideration should be given to packaging types, particularly as many other antiretroviral agents remain in bottle formats. The authors acknowledge limitations, including the small sample size, the single-center nature of the study, the exclusive male participant pool, and the short-term evaluation period, cautioning against broad generalization of these findings.