PrEP Study 2/4 50% 55/69 80% had TDF TDF2 81% had FTC VOICEc 12/51 (TDF group) 24% 50/145 (TDF group) 34% 17/57 (FTC-TDF group) 30% 45/132 (TDF-FTC group) 22% a This measure includes drug detection using plasma. The study also assessed Tenofovir (TFV) detection using peripheral blood mononuclear cells (PBMC) and hair samples. The three specimens that did not have detectable TFV levels in plasma did have detectable TFV levels in either hair and/or PBMC samples. Results from plasma are presented here as this method was most similar to methods used by other studies. b FEM-PrEP defined drug detection as per milliliter. ≥10 nanograms c Results from the VOICE trial presented here come from the Marrazzo et al., 2015 Supplementary Appendix Table S6B and reflect the number of women in each study arm that had detectable drug levels at their first quarterly visit. Marrazzo et al. also reports that among a random sample of participants assigned to active study drug (Ns not reported), Tenofovir was detected in 30% of participants assigned to TDF and in 29% of participants assigned to TDF-FTC. For meta-analysis, the reported proportion of participants from the random sample was used as the marker of overall trial-level adherence.
PrEP Study TDF2 2/4 50% 55/69 80% had TDF 81% had FTC VOICEc 12/51 (TDF group) 17/57 (FTC-TDF group) 24% 30% 50/145 (TDF group) 45/132 (TDF-FTC group) 34% 22% a This measure includes drug detection using plasma. The study also assessed Tenofovir (TFV) detection using peripheral blood mononuclear cells (PBMC) and hair samples. The three specimens that did not have detectable TFV levels in plasma did have detectable TFV levels in either hair and/or PBMC samples. Results from plasma are presented here as this method was most similar to methods used by other studies. b FEM-PrEP defined drug detection as ≥10 nanograms per milliliter. c Results from the VOICE trial presented here come from the Marrazzo et al., 2015 Supplementary Appendix Table S6B and reflect the number of women in each study arm that had detectable drug levels at their first quarterly visit. Marrazzo et al. also reports that among a random sample of participants assigned to active study drug (Ns not reported), Tenofovir was detected in 30% of participants assigned to TDF and in 29% of participants assigned to TDF-FTC. For meta-analysis, the reported proportion of participants from the random sample was used as the marker of overall trial-level adherence.
QAD_2016_04_27_FONNER_AIDS-D-16-00026_SDC1.docx