{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Massud I"],"funding":["CDC intramural funds","CDC HHS"],"pagination":["384"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC10974356"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["16(3)"],"pubmed_abstract":["Pre-exposure prophylaxis (PrEP) with a weekly oral regimen of antiretroviral drugs could be a suitable preventative option for individuals who struggle with daily PrEP or prefer not to use long-acting injectables. We assessed in macaques the efficacy of weekly oral tenofovir alafenamide (TAF) at doses of 13.7 or 27.4 mg/kg. Macaques received weekly oral TAF for six weeks and were exposed twice-weekly to SHIV vaginally or rectally on day 3 and 6 after each dose. Median TFV-DP levels in PBMCs following the 13.7 mg/kg dose were 3110 and 1137 fmols/10<sup>6</sup> cells on day 3 and 6, respectively. With the 27.4 mg/kg dose, TFV-DP levels were increased (~2-fold) on day 3 and 6 (6095 and 3290 fmols/10<sup>6</sup> cells, respectively). Both TAF doses (13.7 and 27.4 mg/kg) conferred high efficacy (94.1% and 93.9%, respectively) against vaginal SHIV infection. Efficacy of the 27.4 mg/kg dose against rectal SHIV infection was 80.7%. We estimate that macaque doses of 13.7 and 27.4 mg/kg are equivalent to approximately 230 and 450 mg of TAF in humans, respectively. Our findings demonstrate the effectiveness of a weekly oral PrEP regimen and suggest that a clinically achievable oral TAF dose could be a promising option for non-daily PrEP."],"journal":["Pharmaceutics"],"pubmed_title":["Weekly Oral Tenofovir Alafenamide Protects Macaques from Vaginal and Rectal Simian HIV Infection."],"pmcid":["PMC10974356"],"funding_grant_id":["intramural funds"],"pubmed_authors":["Mitchell J","Nishiura K","Massud I","Ruone S","Heneine W","Lipscomb J","Dobard CW","Dinh C","Garcia-Lerma JG","Holder A","Khalil GM"],"additional_accession":[]},"is_claimable":false,"name":"Weekly Oral Tenofovir Alafenamide Protects Macaques from Vaginal and Rectal Simian HIV Infection.","description":"Pre-exposure prophylaxis (PrEP) with a weekly oral regimen of antiretroviral drugs could be a suitable preventative option for individuals who struggle with daily PrEP or prefer not to use long-acting injectables. We assessed in macaques the efficacy of weekly oral tenofovir alafenamide (TAF) at doses of 13.7 or 27.4 mg/kg. Macaques received weekly oral TAF for six weeks and were exposed twice-weekly to SHIV vaginally or rectally on day 3 and 6 after each dose. Median TFV-DP levels in PBMCs following the 13.7 mg/kg dose were 3110 and 1137 fmols/10<sup>6</sup> cells on day 3 and 6, respectively. With the 27.4 mg/kg dose, TFV-DP levels were increased (~2-fold) on day 3 and 6 (6095 and 3290 fmols/10<sup>6</sup> cells, respectively). Both TAF doses (13.7 and 27.4 mg/kg) conferred high efficacy (94.1% and 93.9%, respectively) against vaginal SHIV infection. Efficacy of the 27.4 mg/kg dose against rectal SHIV infection was 80.7%. We estimate that macaque doses of 13.7 and 27.4 mg/kg are equivalent to approximately 230 and 450 mg of TAF in humans, respectively. Our findings demonstrate the effectiveness of a weekly oral PrEP regimen and suggest that a clinically achievable oral TAF dose could be a promising option for non-daily PrEP.","dates":{"release":"2024-01-01T00:00:00Z","publication":"2024 Mar","modification":"2026-04-08T19:00:54.522Z","creation":"2025-04-04T19:11:14.498Z"},"accession":"S-EPMC10974356","cross_references":{"pubmed":["38543278"],"doi":["10.3390/pharmaceutics16030384"]}}