Skip to main content
Erschienen in: AIDS and Behavior 7/2016

13.05.2015 | Original Paper

Pre-exposure Prophylaxis Adherence Measured by Plasma Drug Level in MTN-001: Comparison Between Vaginal Gel and Oral Tablets in Two Geographic Regions

verfasst von: Alexandra M. Minnis, Ariane van der Straten, Parichat Salee, Craig W. Hendrix

Erschienen in: AIDS and Behavior | Ausgabe 7/2016

Einloggen, um Zugang zu erhalten

Abstract

Despite strong evidence that daily oral pre-exposure prophylaxis (PrEP) reduces HIV risk, effectiveness across studies has varied. Inconsistent adherence constitutes one explanation. Efforts to examine adherence are limited when they rely on self-reported measures. We examined recent adherence as measured by plasma tenofovir (TFV) concentration in participants of MTN-001, a phase 2 cross-over trial comparing oral tablet and vaginal gel formulations of TFV among 144 HIV-uninfected women at sites in the United States (U.S.) and sub-Saharan Africa (SSA). Adherence to daily product use was higher in the U.S. than in the SSA sites. Within region, however, adherence was similar between products. In the U.S., gel adherence was higher among married women, and lower among women using male condoms and injectable contraceptives. At the SSA sites, gel adherence was lower for younger women. Inconsistent adherence points to challenges in use of daily PrEP, even during a trial of short duration.
Literatur
1.
Zurück zum Zitat Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Rose CE, Segolodi TM, et al. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. New Engl J Med. 2012;367(5):423–34.CrossRefPubMed Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Rose CE, Segolodi TM, et al. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. New Engl J Med. 2012;367(5):423–34.CrossRefPubMed
2.
Zurück zum Zitat Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. New Engl J Med. 2012;367(5):399–410.CrossRefPubMedPubMedCentral Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. New Engl J Med. 2012;367(5):399–410.CrossRefPubMedPubMedCentral
3.
Zurück zum Zitat Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. New Engl J Med. 2010;363(27):2587–99.CrossRefPubMedPubMedCentral Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. New Engl J Med. 2010;363(27):2587–99.CrossRefPubMedPubMedCentral
4.
Zurück zum Zitat Centers for Disease C, Prevention. Update to interim guidance for preexposure prophylaxis (PrEP) for the prevention of HIV infection: PrEP for injecting drug users. MMWR. Morb Mortal Wkly Rep. 2013;62(23):463–5. Centers for Disease C, Prevention. Update to interim guidance for preexposure prophylaxis (PrEP) for the prevention of HIV infection: PrEP for injecting drug users. MMWR. Morb Mortal Wkly Rep. 2013;62(23):463–5.
5.
Zurück zum Zitat Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010;329(5996):1168–74.CrossRefPubMedPubMedCentral Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010;329(5996):1168–74.CrossRefPubMedPubMedCentral
6.
Zurück zum Zitat Van Damme L, Corneli A, Ahmed K, Agot K, Lombaard J, Kapiga S, et al. Preexposure prophylaxis for HIV infection among African women. New Engl J Med. 2012;367(5):411–22.CrossRefPubMedPubMedCentral Van Damme L, Corneli A, Ahmed K, Agot K, Lombaard J, Kapiga S, et al. Preexposure prophylaxis for HIV infection among African women. New Engl J Med. 2012;367(5):411–22.CrossRefPubMedPubMedCentral
7.
Zurück zum Zitat Marrazzo J, Ramjee G, Nair G, Palanee T, Mkhize B, Nakabiito C, et al. Pre-exposure prophylaxis for HIV in women: daily oral tenofovir, oral tenofoviremtricitabine, or vaginal tenofovir gel in the VOICE Study (MTN 003). Conference on retroviruses and opportunistic infections, Atlanta, GA, 2013. Marrazzo J, Ramjee G, Nair G, Palanee T, Mkhize B, Nakabiito C, et al. Pre-exposure prophylaxis for HIV in women: daily oral tenofovir, oral tenofoviremtricitabine, or vaginal tenofovir gel in the VOICE Study (MTN 003). Conference on retroviruses and opportunistic infections, Atlanta, GA, 2013.
8.
Zurück zum Zitat Rees H, Delany-Moretlwe S, Baron D, Lombard C, Gray G, Myer L et al. FACTS 001 phase III trial of pericoital tenofovir 1% gel for HIV prevention in women. In: Abstract #26LB presented at CROI, Seattle, WA, 2015. Rees H, Delany-Moretlwe S, Baron D, Lombard C, Gray G, Myer L et al. FACTS 001 phase III trial of pericoital tenofovir 1% gel for HIV prevention in women. In: Abstract #26LB presented at CROI, Seattle, WA, 2015.
9.
Zurück zum Zitat van der Straten A, Van Damme L, Haberer JE, Bangsberg DR. Unraveling the divergent results of pre-exposure prophylaxis trials for HIV prevention. AIDS. 2012;26(7):F13–9.CrossRefPubMed van der Straten A, Van Damme L, Haberer JE, Bangsberg DR. Unraveling the divergent results of pre-exposure prophylaxis trials for HIV prevention. AIDS. 2012;26(7):F13–9.CrossRefPubMed
10.
Zurück zum Zitat van der Straten A, Montgomery ET, Hartmann M, Minnis A. Methodological lessons from clinical trials and the future of microbicide research. Curr HIV/AIDS Rep. 2013;10(1):89–102.CrossRefPubMed van der Straten A, Montgomery ET, Hartmann M, Minnis A. Methodological lessons from clinical trials and the future of microbicide research. Curr HIV/AIDS Rep. 2013;10(1):89–102.CrossRefPubMed
11.
Zurück zum Zitat Koenig LJ, Lyles C, Smith DK. Adherence to antiretroviral medications for HIV pre-exposure prophylaxis: lessons learned from trials and treatment studies. Am J Prev Med. 2013;44(1 Suppl 2):S91–8.CrossRefPubMed Koenig LJ, Lyles C, Smith DK. Adherence to antiretroviral medications for HIV pre-exposure prophylaxis: lessons learned from trials and treatment studies. Am J Prev Med. 2013;44(1 Suppl 2):S91–8.CrossRefPubMed
12.
Zurück zum Zitat Van Damme L, Corneli A, Ahmed K, Agot K, Lombaard J, Kapiga S, et al. The FEM-PrEP Trial of Emtricitabine/Tenofovir Disoproxil Fumarate (Truvada) among African Women. Conference on retroviruses and opportunistic infections, Seattle, WA, 2012. Van Damme L, Corneli A, Ahmed K, Agot K, Lombaard J, Kapiga S, et al. The FEM-PrEP Trial of Emtricitabine/Tenofovir Disoproxil Fumarate (Truvada) among African Women. Conference on retroviruses and opportunistic infections, Seattle, WA, 2012.
13.
Zurück zum Zitat Haberer JE, Baeten JM, Campbell J, Wangisi J, Katabira E, Ronald A, et al. Adherence to antiretroviral prophylaxis for HIV prevention: a substudy cohort within a clinical trial of serodiscordant couples in East Africa. PLoS Med. 2013;10(9):e1001511.CrossRefPubMedPubMedCentral Haberer JE, Baeten JM, Campbell J, Wangisi J, Katabira E, Ronald A, et al. Adherence to antiretroviral prophylaxis for HIV prevention: a substudy cohort within a clinical trial of serodiscordant couples in East Africa. PLoS Med. 2013;10(9):e1001511.CrossRefPubMedPubMedCentral
14.
Zurück zum Zitat Koblin BA, Andrasik M, Austin J. Preparing for the unexpected: the pivotal role of social and behavioral sciences in trials of biomedical HIV prevention interventions. J Acquir Immune Defic Syndr. 2013;63(Suppl 2):S183–6.CrossRefPubMedPubMedCentral Koblin BA, Andrasik M, Austin J. Preparing for the unexpected: the pivotal role of social and behavioral sciences in trials of biomedical HIV prevention interventions. J Acquir Immune Defic Syndr. 2013;63(Suppl 2):S183–6.CrossRefPubMedPubMedCentral
15.
Zurück zum Zitat Ware NC, Wyatt MA, Haberer JE, Baeten JM, Kintu A, Psaros C, et al. What’s love got to do with it? Explaining adherence to oral antiretroviral pre-exposure prophylaxis for HIV-serodiscordant couples. J Acquir Immune Defic Syndr. 2012;59(5):463–8.CrossRefPubMed Ware NC, Wyatt MA, Haberer JE, Baeten JM, Kintu A, Psaros C, et al. What’s love got to do with it? Explaining adherence to oral antiretroviral pre-exposure prophylaxis for HIV-serodiscordant couples. J Acquir Immune Defic Syndr. 2012;59(5):463–8.CrossRefPubMed
16.
Zurück zum Zitat Gorbach PM, Kelly CW, Borgerding JA, Ramjee G, Tembo T, Kumwenda N, et al. Effects of partnership change on microbicide gel adherence in a clinical trial (HPTN 035). AIDS Behav. 2013;18(5):855–61.CrossRef Gorbach PM, Kelly CW, Borgerding JA, Ramjee G, Tembo T, Kumwenda N, et al. Effects of partnership change on microbicide gel adherence in a clinical trial (HPTN 035). AIDS Behav. 2013;18(5):855–61.CrossRef
17.
Zurück zum Zitat Minnis AM, Gandham S, Richardson BA, Guddera V, Chen BA, Salata R, et al. Adherence and acceptability in MTN 001: a randomized cross-over trial of daily oral and topical tenofovir for HIV prevention in women. AIDS Behav. 2013;17(2):737–47.CrossRefPubMedPubMedCentral Minnis AM, Gandham S, Richardson BA, Guddera V, Chen BA, Salata R, et al. Adherence and acceptability in MTN 001: a randomized cross-over trial of daily oral and topical tenofovir for HIV prevention in women. AIDS Behav. 2013;17(2):737–47.CrossRefPubMedPubMedCentral
18.
Zurück zum Zitat Dayton R, Lanham M, Wilcher R. Engaging male partners in women’s microbicide use. FHI 360, 2014. Dayton R, Lanham M, Wilcher R. Engaging male partners in women’s microbicide use. FHI 360, 2014.
19.
Zurück zum Zitat Montgomery CM, Lees S, Stadler J, Morar NS, Ssali A, Mwanza B, et al. The role of partnership dynamics in determining the acceptability of condoms and microbicides. AIDS Care. 2008;20(6):733–40.CrossRefPubMed Montgomery CM, Lees S, Stadler J, Morar NS, Ssali A, Mwanza B, et al. The role of partnership dynamics in determining the acceptability of condoms and microbicides. AIDS Care. 2008;20(6):733–40.CrossRefPubMed
20.
Zurück zum Zitat Gengiah TN, Moosa A, Naidoo A, Mansoor LE. Adherence challenges with drugs for pre-exposure prophylaxis to prevent HIV infection. Int J Clin Pharm. 2013;36(1):70–85.CrossRefPubMedPubMedCentral Gengiah TN, Moosa A, Naidoo A, Mansoor LE. Adherence challenges with drugs for pre-exposure prophylaxis to prevent HIV infection. Int J Clin Pharm. 2013;36(1):70–85.CrossRefPubMedPubMedCentral
21.
Zurück zum Zitat van der Straten A, Stadler J, Montgomery E, Hartmann M, Magazi B, Mathebula F, et al. Women’s experiences with oral and vaginal pre-exposure prophylaxis: the VOICE-C qualitative study in Johannesburg, South Africa. PLoS One. 2014;9(2):e89118.CrossRefPubMedPubMedCentral van der Straten A, Stadler J, Montgomery E, Hartmann M, Magazi B, Mathebula F, et al. Women’s experiences with oral and vaginal pre-exposure prophylaxis: the VOICE-C qualitative study in Johannesburg, South Africa. PLoS One. 2014;9(2):e89118.CrossRefPubMedPubMedCentral
22.
Zurück zum Zitat Hendrix CW, Chen BA, Guddera V, Hoesley C, Justman J, Nakabiito C, et al. MTN-001: randomized pharmacokinetic cross-over study comparing tenofovir vaginal gel and oral tablets in vaginal tissue and other compartments. PLoS One. 2013;8(1):e55013.CrossRefPubMedPubMedCentral Hendrix CW, Chen BA, Guddera V, Hoesley C, Justman J, Nakabiito C, et al. MTN-001: randomized pharmacokinetic cross-over study comparing tenofovir vaginal gel and oral tablets in vaginal tissue and other compartments. PLoS One. 2013;8(1):e55013.CrossRefPubMedPubMedCentral
23.
Zurück zum Zitat Donnell D, Baeten J, Hendrix C, Bumpus N, Bangsberg D, Haberer J, et al., editors. Tenofovir drug levels indicate PrEP use is strongly correlated with HIV-1 protective effects. 19th Conference on retroviruses and opportunistic infections, Seattle, WA, 2012. Donnell D, Baeten J, Hendrix C, Bumpus N, Bangsberg D, Haberer J, et al., editors. Tenofovir drug levels indicate PrEP use is strongly correlated with HIV-1 protective effects. 19th Conference on retroviruses and opportunistic infections, Seattle, WA, 2012.
24.
Zurück zum Zitat Schwartz JL, Rountree W, Kashuba AD, Brache V, Creinin MD, Poindexter A, et al. A multi-compartment, single and multiple dose pharmacokinetic study of the vaginal candidate microbicide 1 % tenofovir gel. PLoS One. 2011;6(10):e25974.CrossRefPubMedPubMedCentral Schwartz JL, Rountree W, Kashuba AD, Brache V, Creinin MD, Poindexter A, et al. A multi-compartment, single and multiple dose pharmacokinetic study of the vaginal candidate microbicide 1 % tenofovir gel. PLoS One. 2011;6(10):e25974.CrossRefPubMedPubMedCentral
25.
Zurück zum Zitat Grant R, editor. Completed observation of the randomized placebo-controlled phase of iPrEx: daily oral FTC/TDF pre-exposure HIV prophylaxis among men and trans women who have sex with men. Sixth IAS Conference, Rome, Italy, 2011. Grant R, editor. Completed observation of the randomized placebo-controlled phase of iPrEx: daily oral FTC/TDF pre-exposure HIV prophylaxis among men and trans women who have sex with men. Sixth IAS Conference, Rome, Italy, 2011.
26.
Zurück zum Zitat United Nations Children’s Fund. Towards an AIDS-free generation—children and AIDS: sixth stocktaking report. New York: United Nations Children’s Fund, UNICEF; 2013. United Nations Children’s Fund. Towards an AIDS-free generation—children and AIDS: sixth stocktaking report. New York: United Nations Children’s Fund, UNICEF; 2013.
27.
Zurück zum Zitat Montgomery ET, Chidanyika A, Chipato T, van der Straten A. Sharing the trousers: gender roles and relationships in an HIV-prevention trial in Zimbabwe. Cult Health Sex. 2012;14(7):795–810.CrossRefPubMed Montgomery ET, Chidanyika A, Chipato T, van der Straten A. Sharing the trousers: gender roles and relationships in an HIV-prevention trial in Zimbabwe. Cult Health Sex. 2012;14(7):795–810.CrossRefPubMed
28.
Zurück zum Zitat Plummer ML, Watson-Jones D, Lees S, Baisley K, Matari S, Changalucha J, et al. A qualitative study of participant adherence in a randomized controlled trial of herpes suppressive therapy for HIV prevention in Tanzania. AIDS Care. 2010;22(4):499–508.CrossRefPubMed Plummer ML, Watson-Jones D, Lees S, Baisley K, Matari S, Changalucha J, et al. A qualitative study of participant adherence in a randomized controlled trial of herpes suppressive therapy for HIV prevention in Tanzania. AIDS Care. 2010;22(4):499–508.CrossRefPubMed
Metadaten
Titel
Pre-exposure Prophylaxis Adherence Measured by Plasma Drug Level in MTN-001: Comparison Between Vaginal Gel and Oral Tablets in Two Geographic Regions
verfasst von
Alexandra M. Minnis
Ariane van der Straten
Parichat Salee
Craig W. Hendrix
Publikationsdatum
13.05.2015
Verlag
Springer US
Erschienen in
AIDS and Behavior / Ausgabe 7/2016
Print ISSN: 1090-7165
Elektronische ISSN: 1573-3254
DOI
https://doi.org/10.1007/s10461-015-1081-3

Weitere Artikel der Ausgabe 7/2016

AIDS and Behavior 7/2016 Zur Ausgabe

Leitlinien kompakt für die Innere Medizin

Mit medbee Pocketcards sicher entscheiden.

Seit 2022 gehört die medbee GmbH zum Springer Medizin Verlag

Update Innere Medizin

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.