Table 4. Pharmacokinetic and non-pharmacokinetic adherence measures among five participants who had at least one sample with undetectable drug in the US CDC PrEP safety study.
Detectable tenofovir in biological measures of drug exposure | Count data for non-biological measures of drug exposure | Most likely Interpretation | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Participant | Hair (level ng/mg hair) | Plasma on hair collection date (ng/mL) | Plasma on PBMC collection date (ng/mL) | PBMC on hair collection date (fmol/sample) | PBMC if done on date other than hair | MEMS openings 90 days before hair (%) | MEMS openings 90 days before PBMC (%) | Self-report by ACASI using VAS (%) | Pill counts in 90 days before hair | Pill counts in 90 days before PBMC | - |
1 | Yes (0.026) | Yes (48.3) | PBMCs, plasma and hair collected on same date | No (BLQ) | n/a | 92.2 | 92.2 | 90 | 95.5 | 95.5 | False negative PBMC result or remote dosing (suggested by hair) with dosing holiday (PBMC BLQ) and then very recent dosing before clinic visit (plasma elevated) |
2 | Yes (0.042) | Yes (99.5) | No (BLQ) | n/a | No (BLQ) (58 days before hair) | 68.9 | 1.1 | 100 | 73.3 | N/A | Low/no adherence before PBMC collection date, but higher adherence before hair collection date |
3 | Yes (0.069) | Yes (446) | No (BLQ) | n/a | Yes (52.48 fmol/sample, 103 days after hair) | 34.4 | 31.1 | 90 | 86.0 | 38.8 | Adherence throughout the duration with waning adherence in the last few days prior to PBMC sampling, or false negative plasma test. |
4 | No (BLQ) | Yes (188) | Yes (87.4) | n/a | Yes (43.62 fmol/sample, 91 days after hair) | 42.2 | 75.6 | 90 | 82.4 | 80.2 | False negative hair result, or, less likely, recent adherence without remote adherence. |
5 | Yes (0.011) | No (BLQ) | No (BLQ) | n/a | No (BLQ) (32 days after hair) | 0 | 0 | 70 | 1.6 | 21.9 | Remote adherence without recent adherence. |
PBMC = peripheral blood mononuclear cells, MEMS = medication electronic monitoring system; ACASI = audio computer-assisted self-interview; VAS = visual analog scale; BLQ = below lower limit of quantification