Antiretroviral Prophylaxis for HIV Prevention in Heterosexual Men and Women
In this study of 4758 HIV-1–serodiscordant heterosexual couples in Kenya and Uganda, daily antiretroviral prophylaxis (with tenofovir or emtricitabine–tenofovir) in the HIV-1–negative partner significantly decreased the risk of HIV infection. The use of antiretroviral medications for the prevention...
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| Published in: | The New England journal of medicine Vol. 367; no. 5; pp. 399 - 410 |
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| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
Waltham, MA
Massachusetts Medical Society
02-08-2012
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| Subjects: | |
| Online Access: | Get full text |
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| Abstract | In this study of 4758 HIV-1–serodiscordant heterosexual couples in Kenya and Uganda, daily antiretroviral prophylaxis (with tenofovir or emtricitabine–tenofovir) in the HIV-1–negative partner significantly decreased the risk of HIV infection.
The use of antiretroviral medications for the prevention of HIV type 1 (HIV-1) transmission is a promising strategy for reducing the spread of HIV-1.
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Antiretroviral treatment for persons infected with HIV-1 provides important clinical benefits and substantially reduces infectiousness.
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Antiretroviral prophylaxis is a potential HIV-1–prevention strategy for those not yet infected with HIV-1, administered either as postexposure prophylaxis after high-risk occupational or nonoccupational exposure or as preexposure prophylaxis in those with ongoing HIV-1 exposure.
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The rationale for antiretroviral prophylaxis in persons with ongoing exposure is based on its efficacy in infants exposed to HIV-1 during birth and . . . |
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| AbstractList | In this study of 4758 HIV-1–serodiscordant heterosexual couples in Kenya and Uganda, daily antiretroviral prophylaxis (with tenofovir or emtricitabine–tenofovir) in the HIV-1–negative partner significantly decreased the risk of HIV infection.
The use of antiretroviral medications for the prevention of HIV type 1 (HIV-1) transmission is a promising strategy for reducing the spread of HIV-1.
1
–
4
Antiretroviral treatment for persons infected with HIV-1 provides important clinical benefits and substantially reduces infectiousness.
5
–
7
Antiretroviral prophylaxis is a potential HIV-1–prevention strategy for those not yet infected with HIV-1, administered either as postexposure prophylaxis after high-risk occupational or nonoccupational exposure or as preexposure prophylaxis in those with ongoing HIV-1 exposure.
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9
The rationale for antiretroviral prophylaxis in persons with ongoing exposure is based on its efficacy in infants exposed to HIV-1 during birth and . . . Antiretroviral preexposure prophylaxis is a promising approach for preventing human immunodeficiency virus type 1 (HIV-1) infection in heterosexual populations. We conducted a randomized trial of oral antiretroviral therapy for use as preexposure prophylaxis among HIV-1-serodiscordant heterosexual couples from Kenya and Uganda. The HIV-1-seronegative partner in each couple was randomly assigned to one of three study regimens--once-daily tenofovir (TDF), combination tenofovir-emtricitabine (TDF-FTC), or matching placebo--and followed monthly for up to 36 months. At enrollment, the HIV-1-seropositive partners were not eligible for antiretroviral therapy, according to national guidelines. All couples received standard HIV-1 treatment and prevention services. We enrolled 4758 couples, of whom 4747 were followed: 1584 randomly assigned to TDF, 1579 to TDF-FTC, and 1584 to placebo. For 62% of the couples followed, the HIV-1-seronegative partner was male. Among HIV-1-seropositive participants, the median CD4 count was 495 cells per cubic millimeter (interquartile range, 375 to 662). A total of 82 HIV-1 infections occurred in seronegative participants during the study, 17 in the TDF group (incidence, 0.65 per 100 person-years), 13 in the TDF-FTC group (incidence, 0.50 per 100 person-years), and 52 in the placebo group (incidence, 1.99 per 100 person-years), indicating a relative reduction of 67% in the incidence of HIV-1 with TDF (95% confidence interval [CI], 44 to 81; P<0.001) and of 75% with TDF-FTC (95% CI, 55 to 87; P<0.001). Protective effects of TDF-FTC and TDF alone against HIV-1 were not significantly different (P=0.23), and both study medications significantly reduced the HIV-1 incidence among both men and women. The rate of serious adverse events was similar across the study groups. Eight participants receiving active treatment were found to have been infected with HIV-1 at baseline, and among these eight, antiretroviral resistance developed in two during the study. Oral TDF and TDF-FTC both protect against HIV-1 infection in heterosexual men and women. (Funded by the Bill and Melinda Gates Foundation; Partners PrEP ClinicalTrials.gov number, NCT00557245.). BackgroundAntiretroviral preexposure prophylaxis is a promising approach for preventing human immunodeficiency virus type 1 (HIV-1) infection in heterosexual populations.MethodsWe conducted a randomized trial of oral antiretroviral therapy for use as preexposure prophylaxis among HIV-1–serodiscordant heterosexual couples from Kenya and Uganda. The HIV-1–seronegative partner in each couple was randomly assigned to one of three study regimens — once-daily tenofovir (TDF), combination tenofovir–emtricitabine (TDF–FTC), or matching placebo — and followed monthly for up to 36 months. At enrollment, the HIV-1–seropositive partners were not eligible for antiretroviral therapy, according to national guidelines. All couples received standard HIV-1 treatment and prevention services.ResultsWe enrolled 4758 couples, of whom 4747 were followed: 1584 randomly assigned to TDF, 1579 to TDF–FTC, and 1584 to placebo. For 62% of the couples followed, the HIV-1–seronegative partner was male. Among HIV-1–seropositive participants, the median CD4 count was 495 cells per cubic millimeter (interquartile range, 375 to 662). A total of 82 HIV-1 infections occurred in seronegative participants during the study, 17 in the TDF group (incidence, 0.65 per 100 person-years), 13 in the TDF–FTC group (incidence, 0.50 per 100 person-years), and 52 in the placebo group (incidence, 1.99 per 100 person-years), indicating a relative reduction of 67% in the incidence of HIV-1 with TDF (95% confidence interval [CI], 44 to 81; P<0.001) and of 75% with TDF–FTC (95% CI, 55 to 87; P<0.001). Protective effects of TDF–FTC and TDF alone against HIV-1 were not significantly different (P=0.23), and both study medications significantly reduced the HIV-1 incidence among both men and women. The rate of serious adverse events was similar across the study groups. Eight participants receiving active treatment were found to have been infected with HIV-1 at baseline, and among these eight, antiretroviral resistance developed in two during the study.ConclusionsOral TDF and TDF–FTC both protect against HIV-1 infection in heterosexual men and women. (Funded by the Bill and Melinda Gates Foundation; Partners PrEP ClinicalTrials.gov number, NCT00557245.) |
| Author | Ondrejcek, Lisa Lingappa, Jairam R Krows, Meighan Haugen, Harald Nakku-Joloba, Edith Hendrix, Craig Odoyo, Josephine Kakia, Aloysious Mujugira, Andrew Katabira, Elly Mugo, Nelly R Donnell, Deborah Ngure, Kenneth Wangisi, Jonathan Emmanuel-Ogier, Mira Campbell, James D Kidoguchi, Lara Cohen, Craig R Were, Edwin Haberer, Jessica E Twesigye, Rogers Gabona, Fridah Tappero, Jordan W Tumwesigye, Elioda Thomas, Katherine K Coombs, Robert W Bangsberg, David Ronald, Allan Stevens, Wendy S Farquhar, Carey Ndase, Patrick Celum, Connie Apaka, Cosmas Tamooh, Harrison Revall, Jennifer Morrison, Susan Kiarie, James Mucunguzi, Akasiima Bumpus, Namandjé N Fife, Kenneth H Bukusi, Elizabeth A John-Stewart, Grace Panteleeff, Dana Baeten, Jared M Frenkel, Lisa |
| Author_xml | – sequence: 1 givenname: Jared M surname: Baeten fullname: Baeten, Jared M organization: The authors' affiliations are listed in the Appendix – sequence: 2 givenname: Deborah surname: Donnell fullname: Donnell, Deborah organization: The authors' affiliations are listed in the Appendix – sequence: 3 givenname: Patrick surname: Ndase fullname: Ndase, Patrick organization: The authors' affiliations are listed in the Appendix – sequence: 4 givenname: Nelly R surname: Mugo fullname: Mugo, Nelly R organization: The authors' affiliations are listed in the Appendix – sequence: 5 givenname: James D surname: Campbell fullname: Campbell, James D organization: The authors' affiliations are listed in the Appendix – sequence: 6 givenname: Jonathan surname: Wangisi fullname: Wangisi, Jonathan organization: The authors' affiliations are listed in the Appendix – sequence: 7 givenname: Jordan W surname: Tappero fullname: Tappero, Jordan W organization: The authors' affiliations are listed in the Appendix – sequence: 8 givenname: Elizabeth A surname: Bukusi fullname: Bukusi, Elizabeth A organization: The authors' affiliations are listed in the Appendix – sequence: 9 givenname: Craig R surname: Cohen fullname: Cohen, Craig R organization: The authors' affiliations are listed in the Appendix – sequence: 10 givenname: Elly surname: Katabira fullname: Katabira, Elly organization: The authors' affiliations are listed in the Appendix – sequence: 11 givenname: Allan surname: Ronald fullname: Ronald, Allan organization: The authors' affiliations are listed in the Appendix – sequence: 12 givenname: Elioda surname: Tumwesigye fullname: Tumwesigye, Elioda organization: The authors' affiliations are listed in the Appendix – sequence: 13 givenname: Edwin surname: Were fullname: Were, Edwin organization: The authors' affiliations are listed in the Appendix – sequence: 14 givenname: Kenneth H surname: Fife fullname: Fife, Kenneth H organization: The authors' affiliations are listed in the Appendix – sequence: 15 givenname: James surname: Kiarie fullname: Kiarie, James organization: The authors' affiliations are listed in the Appendix – sequence: 16 givenname: Carey surname: Farquhar fullname: Farquhar, Carey organization: The authors' affiliations are listed in the Appendix – sequence: 17 givenname: Grace surname: John-Stewart fullname: John-Stewart, Grace organization: The authors' affiliations are listed in the Appendix – sequence: 18 givenname: Aloysious surname: Kakia fullname: Kakia, Aloysious organization: The authors' affiliations are listed in the Appendix – sequence: 19 givenname: Josephine surname: Odoyo fullname: Odoyo, Josephine organization: The authors' affiliations are listed in the Appendix – sequence: 20 givenname: Akasiima surname: Mucunguzi fullname: Mucunguzi, Akasiima organization: The authors' affiliations are listed in the Appendix – sequence: 21 givenname: Edith surname: Nakku-Joloba fullname: Nakku-Joloba, Edith organization: The authors' affiliations are listed in the Appendix – sequence: 22 givenname: Rogers surname: Twesigye fullname: Twesigye, Rogers organization: The authors' affiliations are listed in the Appendix – sequence: 23 givenname: Kenneth surname: Ngure fullname: Ngure, Kenneth organization: The authors' affiliations are listed in the Appendix – sequence: 24 givenname: Cosmas surname: Apaka fullname: Apaka, Cosmas organization: The authors' affiliations are listed in the Appendix – sequence: 25 givenname: Harrison surname: Tamooh fullname: Tamooh, Harrison organization: The authors' affiliations are listed in the Appendix – sequence: 26 givenname: Fridah surname: Gabona fullname: Gabona, Fridah organization: The authors' affiliations are listed in the Appendix – sequence: 27 givenname: Andrew surname: Mujugira fullname: Mujugira, Andrew organization: The authors' affiliations are listed in the Appendix – sequence: 28 givenname: Dana surname: Panteleeff fullname: Panteleeff, Dana organization: The authors' affiliations are listed in the Appendix – sequence: 29 givenname: Katherine K surname: Thomas fullname: Thomas, Katherine K organization: The authors' affiliations are listed in the Appendix – sequence: 30 givenname: Lara surname: Kidoguchi fullname: Kidoguchi, Lara organization: The authors' affiliations are listed in the Appendix – sequence: 31 givenname: Meighan surname: Krows fullname: Krows, Meighan organization: The authors' affiliations are listed in the Appendix – sequence: 32 givenname: Jennifer surname: Revall fullname: Revall, Jennifer organization: The authors' affiliations are listed in the Appendix – sequence: 33 givenname: Susan surname: Morrison fullname: Morrison, Susan organization: The authors' affiliations are listed in the Appendix – sequence: 34 givenname: Harald surname: Haugen fullname: Haugen, Harald organization: The authors' affiliations are listed in the Appendix – sequence: 35 givenname: Mira surname: Emmanuel-Ogier fullname: Emmanuel-Ogier, Mira organization: The authors' affiliations are listed in the Appendix – sequence: 36 givenname: Lisa surname: Ondrejcek fullname: Ondrejcek, Lisa organization: The authors' affiliations are listed in the Appendix – sequence: 37 givenname: Robert W surname: Coombs fullname: Coombs, Robert W organization: The authors' affiliations are listed in the Appendix – sequence: 38 givenname: Lisa surname: Frenkel fullname: Frenkel, Lisa organization: The authors' affiliations are listed in the Appendix – sequence: 39 givenname: Craig surname: Hendrix fullname: Hendrix, Craig organization: The authors' affiliations are listed in the Appendix – sequence: 40 givenname: Namandjé N surname: Bumpus fullname: Bumpus, Namandjé N organization: The authors' affiliations are listed in the Appendix – sequence: 41 givenname: David surname: Bangsberg fullname: Bangsberg, David organization: The authors' affiliations are listed in the Appendix – sequence: 42 givenname: Jessica E surname: Haberer fullname: Haberer, Jessica E organization: The authors' affiliations are listed in the Appendix – sequence: 43 givenname: Wendy S surname: Stevens fullname: Stevens, Wendy S organization: The authors' affiliations are listed in the Appendix – sequence: 44 givenname: Jairam R surname: Lingappa fullname: Lingappa, Jairam R organization: The authors' affiliations are listed in the Appendix – sequence: 45 givenname: Connie surname: Celum fullname: Celum, Connie organization: The authors' affiliations are listed in the Appendix |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=26184569$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/22784037$$D View this record in MEDLINE/PubMed |
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| Snippet | In this study of 4758 HIV-1–serodiscordant heterosexual couples in Kenya and Uganda, daily antiretroviral prophylaxis (with tenofovir or... Antiretroviral preexposure prophylaxis is a promising approach for preventing human immunodeficiency virus type 1 (HIV-1) infection in heterosexual... BackgroundAntiretroviral preexposure prophylaxis is a promising approach for preventing human immunodeficiency virus type 1 (HIV-1) infection in heterosexual... |
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| Title | Antiretroviral Prophylaxis for HIV Prevention in Heterosexual Men and Women |
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