HIV-1 Incidence, Adherence, and Drug Resistance in Individuals Taking Daily Emtricitabine/Tenofovir Disoproxil Fumarate for HIV-1 Pre-Exposure Prophylaxis : Pooled Analysis From 72 Global Studies
© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America..
BACKGROUND: Oral pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (F/TDF) has high efficacy against HIV-1 acquisition. Seventy-two prospective studies of daily oral F/TDF PrEP were conducted to evaluate HIV-1 incidence, drug resistance, adherence, and bone and renal safety in diverse settings.
METHODS: HIV-1 incidence was calculated from incident HIV-1 diagnoses after PrEP initiation and within 60 days of discontinuation. Tenofovir concentration in dried blood spots (DBS), drug resistance, and bone/renal safety indicators were evaluated in a subset of studies.
RESULTS: Among 17,274 participants, there were 101 cases with new HIV-1 diagnosis (0.77 per 100 person-years; 95% CI 0.63-0.94). In 78 cases with resistance data, 18 (23%) had M184I or V, one (1.3%) had K65R, and three (3.8%) had both mutations. In 54 cases with tenofovir concentration data from DBS, 45 (83.3%), 2 (3.7%), 6 (11.1%), and 1 (1.9%) had average adherence of <2, 2-3, 4-6, and ≥7 doses/week, respectively, and the corresponding incidence was 3.9 (95% CI 2.9-5.3), 0.24 (0.060-0.95), 0.27 (0.12-0.60), and 0.054 (0.008-0.38) per 100 person-years. Adherence was low in younger participants, Hispanic/Latinx and Black participants, cisgender women, and transgender women. Bone and renal adverse event incidence rates were 0.69 and 11.8 per 100 person-years, respectively, consistent with previous reports.
CONCLUSIONS: Leveraging the largest pooled analysis of global PrEP studies to date, we demonstrate that F/TDF is safe and highly effective, even with less than daily dosing, in diverse clinical settings, geographies, populations, and routes of HIV-1 exposure.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2024 |
|---|---|
| Enthalten in: |
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America - (2024) vom: 14. März |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Landovitz, Raphael J [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Emtricitabine |
|---|
| Anmerkungen: |
Date Revised 14.03.2024 published: Print-Electronic Citation Status Publisher |
|---|
| doi: |
10.1093/cid/ciae143 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM369738160 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM369738160 | ||
| 003 | DE-627 | ||
| 005 | 20240315234400.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240315s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1093/cid/ciae143 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1330.xml |
| 035 | |a (DE-627)NLM369738160 | ||
| 035 | |a (NLM)38484128 | ||
| 035 | |a (PII)ciae143 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Landovitz, Raphael J |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a HIV-1 Incidence, Adherence, and Drug Resistance in Individuals Taking Daily Emtricitabine/Tenofovir Disoproxil Fumarate for HIV-1 Pre-Exposure Prophylaxis |b Pooled Analysis From 72 Global Studies |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Revised 14.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status Publisher | ||
| 520 | |a © The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America. | ||
| 520 | |a BACKGROUND: Oral pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (F/TDF) has high efficacy against HIV-1 acquisition. Seventy-two prospective studies of daily oral F/TDF PrEP were conducted to evaluate HIV-1 incidence, drug resistance, adherence, and bone and renal safety in diverse settings | ||
| 520 | |a METHODS: HIV-1 incidence was calculated from incident HIV-1 diagnoses after PrEP initiation and within 60 days of discontinuation. Tenofovir concentration in dried blood spots (DBS), drug resistance, and bone/renal safety indicators were evaluated in a subset of studies | ||
| 520 | |a RESULTS: Among 17,274 participants, there were 101 cases with new HIV-1 diagnosis (0.77 per 100 person-years; 95% CI 0.63-0.94). In 78 cases with resistance data, 18 (23%) had M184I or V, one (1.3%) had K65R, and three (3.8%) had both mutations. In 54 cases with tenofovir concentration data from DBS, 45 (83.3%), 2 (3.7%), 6 (11.1%), and 1 (1.9%) had average adherence of <2, 2-3, 4-6, and ≥7 doses/week, respectively, and the corresponding incidence was 3.9 (95% CI 2.9-5.3), 0.24 (0.060-0.95), 0.27 (0.12-0.60), and 0.054 (0.008-0.38) per 100 person-years. Adherence was low in younger participants, Hispanic/Latinx and Black participants, cisgender women, and transgender women. Bone and renal adverse event incidence rates were 0.69 and 11.8 per 100 person-years, respectively, consistent with previous reports | ||
| 520 | |a CONCLUSIONS: Leveraging the largest pooled analysis of global PrEP studies to date, we demonstrate that F/TDF is safe and highly effective, even with less than daily dosing, in diverse clinical settings, geographies, populations, and routes of HIV-1 exposure | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a HIV-1 | |
| 650 | 4 | |a emtricitabine | |
| 650 | 4 | |a pre-exposure prophylaxis | |
| 650 | 4 | |a tenofovir disoproxil fumarate | |
| 700 | 1 | |a Tao, Li |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Juan |e verfasserin |4 aut | |
| 700 | 1 | |a de Boer, Melanie |e verfasserin |4 aut | |
| 700 | 1 | |a Carter, Christoph |e verfasserin |4 aut | |
| 700 | 1 | |a Das, Moupali |e verfasserin |4 aut | |
| 700 | 1 | |a Baeten, Jared M |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Albert |e verfasserin |4 aut | |
| 700 | 1 | |a Hoover, Karen W |e verfasserin |4 aut | |
| 700 | 1 | |a Celum, Connie |e verfasserin |4 aut | |
| 700 | 1 | |a Grinsztejn, Beatriz |e verfasserin |4 aut | |
| 700 | 1 | |a Morris, Sheldon |e verfasserin |4 aut | |
| 700 | 1 | |a Wheeler, Darrell P |e verfasserin |4 aut | |
| 700 | 1 | |a Mayer, Kenneth H |e verfasserin |4 aut | |
| 700 | 1 | |a Golub, Sarit A |e verfasserin |4 aut | |
| 700 | 1 | |a Bekker, Linda-Gail |e verfasserin |4 aut | |
| 700 | 1 | |a Diabaté, Souleymane |e verfasserin |4 aut | |
| 700 | 1 | |a Hoornenborg, Elske |e verfasserin |4 aut | |
| 700 | 1 | |a Myers, Janet |e verfasserin |4 aut | |
| 700 | 1 | |a Leech, Ashley A |e verfasserin |4 aut | |
| 700 | 1 | |a McCormack, Sheena |e verfasserin |4 aut | |
| 700 | 1 | |a Chan, Philip A |e verfasserin |4 aut | |
| 700 | 1 | |a Sweat, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Matthews, Lynn T |e verfasserin |4 aut | |
| 700 | 1 | |a Grant, Robert |e verfasserin |4 aut | |
| 700 | 0 | |a Global F/TDF PrEP Study Team |e verfasserin |4 aut | |
| 700 | 1 | |a Beyrer, Chris |e investigator |4 oth | |
| 700 | 1 | |a Brown, Joelle |e investigator |4 oth | |
| 700 | 1 | |a Clark, Jesse |e investigator |4 oth | |
| 700 | 1 | |a Colson, Paul |e investigator |4 oth | |
| 700 | 1 | |a Eakle, Robyn |e investigator |4 oth | |
| 700 | 1 | |a Farley, Jason |e investigator |4 oth | |
| 700 | 1 | |a Flash, Charlene A |e investigator |4 oth | |
| 700 | 1 | |a Gallardo, Jorge |e investigator |4 oth | |
| 700 | 1 | |a Gottlieb, Geoffrey |e investigator |4 oth | |
| 700 | 1 | |a Grangeiro, Alexandre |e investigator |4 oth | |
| 700 | 1 | |a Heffron, Renee |e investigator |4 oth | |
| 700 | 1 | |a Hosek, Sybil |e investigator |4 oth | |
| 700 | 1 | |a Hull, Mark |e investigator |4 oth | |
| 700 | 1 | |a Idoko, John |e investigator |4 oth | |
| 700 | 1 | |a Inwani, Irene |e investigator |4 oth | |
| 700 | 1 | |a Koenig, Helen |e investigator |4 oth | |
| 700 | 1 | |a Kurth, Ann |e investigator |4 oth | |
| 700 | 1 | |a Lee, Shui-Shan |e investigator |4 oth | |
| 700 | 1 | |a Mayer, Kenneth |e investigator |4 oth | |
| 700 | 1 | |a Mboup, Souleymane |e investigator |4 oth | |
| 700 | 1 | |a Meyer, Jaimie |e investigator |4 oth | |
| 700 | 1 | |a Mills, Anthony |e investigator |4 oth | |
| 700 | 1 | |a Mujugira, Andrew |e investigator |4 oth | |
| 700 | 1 | |a Pala, Pietro |e investigator |4 oth | |
| 700 | 1 | |a Phoenix, John |e investigator |4 oth | |
| 700 | 1 | |a Piatt, Janice |e investigator |4 oth | |
| 700 | 1 | |a Russell, Darren |e investigator |4 oth | |
| 700 | 1 | |a Sanders, Eduard |e investigator |4 oth | |
| 700 | 1 | |a Scott, Rachel |e investigator |4 oth | |
| 700 | 1 | |a Sevelius, Jae |e investigator |4 oth | |
| 700 | 1 | |a Shang, Hong |e investigator |4 oth | |
| 700 | 1 | |a Siegel, Marc |e investigator |4 oth | |
| 700 | 1 | |a Swaminathan, Shobha |e investigator |4 oth | |
| 700 | 1 | |a Tamayo, Vivian |e investigator |4 oth | |
| 700 | 1 | |a Tan, Darrell |e investigator |4 oth | |
| 700 | 1 | |a Taylor, Allan |e investigator |4 oth | |
| 700 | 1 | |a Vuylsteke, Bea |e investigator |4 oth | |
| 773 | 0 | 8 | |i Enthalten in |t Clinical infectious diseases : an official publication of the Infectious Diseases Society of America |d 1992 |g (2024) vom: 14. März |w (DE-627)NLM012603007 |x 1537-6591 |7 nnns |
| 773 | 1 | 8 | |g year:2024 |g day:14 |g month:03 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1093/cid/ciae143 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |j 2024 |b 14 |c 03 | ||