Antiretroviral Preexposure Prophylaxis for Heterosexual HIV Transmission in Botswana

In this study, 1219 HIV-uninfected, heterosexual adults in Botswana were randomly assigned to tenofovir–emtricitabine (TDF–FTC) or placebo. The TDF–FTC group had a lower incidence of HIV infection but increased rates of side effects, including a significant loss of bone density. Biomedical strategie...

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Veröffentlicht in:	The New England journal of medicine Jg. 367; H. 5; S. 423 - 434
Hauptverfasser:	Thigpen, Michael C, Kebaabetswe, Poloko M, Paxton, Lynn A, Smith, Dawn K, Rose, Charles E, Segolodi, Tebogo M, Henderson, Faith L, Pathak, Sonal R, Soud, Fatma A, Chillag, Kata L, Mutanhaurwa, Rodreck, Chirwa, Lovemore Ian, Kasonde, Michael, Abebe, Daniel, Buliva, Evans, Gvetadze, Roman J, Johnson, Sandra, Sukalac, Thom, Thomas, Vasavi T, Hart, Clyde, Johnson, Jeffrey A, Malotte, C. Kevin, Hendrix, Craig W, Brooks, John T
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	Waltham, MA Massachusetts Medical Society 02.08.2012
Schlagworte:	Adenine - adverse effects Adenine - analogs & derivatives Adenine - therapeutic use Adolescent Adult Anti-Retroviral Agents - adverse effects Anti-Retroviral Agents - therapeutic use Antibiotics. Antiinfectious agents. Antiparasitic agents Antiretroviral agents Antiretroviral drugs Antiviral agents Biological and medical sciences Bone Density - drug effects Bone mineral density Contraception Behavior - statistics & numerical data Deoxycytidine - adverse effects Deoxycytidine - analogs & derivatives Deoxycytidine - therapeutic use Disease transmission Drug Resistance, Viral Drug Therapy, Combination Emtricitabine Female Gays & lesbians General aspects HIV HIV Infections - prevention & control HIV Seropositivity HIV-1 - genetics HIV-1 - isolation & purification HIV-2 - genetics HIV-2 - isolation & purification Human immunodeficiency virus Human viral diseases Humans Infections Infectious diseases Kaplan-Meier Estimate Male Medical research Medical sciences Mens health Motivation Nausea Organophosphonates - adverse effects Organophosphonates - therapeutic use Pharmacology. Drug treatments Prophylaxis Proportional Hazards Models RNA, Viral - blood Sexual Behavior - statistics & numerical data Tenofovir Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids Viral Load Vomiting Young Adult Botswana Africa Immunopathology Antiretroviral agent Heterosexuality Transmission Retroviridae AIDS Immune deficiency Lentivirus Infection Virus Medicine Prevention Preexposure Viral disease Antiviral Human immunodeficiency virus
ISSN:	0028-4793, 1533-4406, 1533-4406
Online-Zugang:	Volltext
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Abstract	In this study, 1219 HIV-uninfected, heterosexual adults in Botswana were randomly assigned to tenofovir–emtricitabine (TDF–FTC) or placebo. The TDF–FTC group had a lower incidence of HIV infection but increased rates of side effects, including a significant loss of bone density. Biomedical strategies to prevent sexual transmission of human immunodeficiency virus (HIV) remain limited. 1 In animal models, preexposure prophylaxis with tenofovir disoproxil fumarate (TDF) or with the combination of TDF and emtricitabine (TDF–FTC) can prevent infections with HIV or hybrid simian–human immunodeficiency virus after vaginal or rectal challenge. 2 , 3 In humans, daily preexposure prophylaxis with TDF–FTC has been shown to reduce transmission of HIV by 44% among men who have sex with men 4 ; however, the findings from studies in heterosexual populations have been mixed. 5 – 8 Botswana has the world's second highest prevalence of HIV infection, estimated in 2008 to be . . .
AbstractList	In this study, 1219 HIV-uninfected, heterosexual adults in Botswana were randomly assigned to tenofovir–emtricitabine (TDF–FTC) or placebo. The TDF–FTC group had a lower incidence of HIV infection but increased rates of side effects, including a significant loss of bone density. Biomedical strategies to prevent sexual transmission of human immunodeficiency virus (HIV) remain limited. 1 In animal models, preexposure prophylaxis with tenofovir disoproxil fumarate (TDF) or with the combination of TDF and emtricitabine (TDF–FTC) can prevent infections with HIV or hybrid simian–human immunodeficiency virus after vaginal or rectal challenge. 2 , 3 In humans, daily preexposure prophylaxis with TDF–FTC has been shown to reduce transmission of HIV by 44% among men who have sex with men 4 ; however, the findings from studies in heterosexual populations have been mixed. 5 – 8 Botswana has the world's second highest prevalence of HIV infection, estimated in 2008 to be . . . BackgroundPreexposure prophylaxis with antiretroviral agents has been shown to reduce the transmission of human immunodeficiency virus (HIV) among men who have sex with men; however, the efficacy among heterosexuals is uncertain.MethodsWe randomly assigned HIV-seronegative men and women to receive either tenofovir disoproxil fumarate and emtricitabine (TDF–FTC) or matching placebo once daily. Monthly study visits were scheduled, and participants received a comprehensive package of prevention services, including HIV testing, counseling on adherence to medication, management of sexually transmitted infections, monitoring for adverse events, and individualized counseling on risk reduction; bone mineral density testing was performed semiannually in a subgroup of participants.ResultsA total of 1219 men and women underwent randomization (45.7% women) and were followed for 1563 person-years (median, 1.1 years; maximum, 3.7 years). Because of low retention and logistic limitations, we concluded the study early and followed enrolled participants through an orderly study closure rather than expanding enrollment. The TDF–FTC group had higher rates of nausea (18.5% vs. 7.1%, P<0.001), vomiting (11.3% vs. 7.1%, P=0.008), and dizziness (15.1% vs. 11.0%, P=0.03) than the placebo group, but the rates of serious adverse events were similar (P=0.90). Participants who received TDF–FTC, as compared with those who received placebo, had a significant decline in bone mineral density. K65R, M184V, and A62V resistance mutations developed in 1 participant in the TDF–FTC group who had had an unrecognized acute HIV infection at enrollment. In a modified intention-to-treat analysis that included the 33 participants who became infected during the study (9 in the TDF–FTC group and 24 in the placebo group; 1.2 and 3.1 infections per 100 person-years, respectively), the efficacy of TDF–FTC was 62.2% (95% confidence interval, 21.5 to 83.4; P=0.03).ConclusionsDaily TDF–FTC prophylaxis prevented HIV infection in sexually active heterosexual adults. The long-term safety of daily TDF–FTC prophylaxis, including the effect on bone mineral density, remains unknown. (Funded by the Centers for Disease Control and Prevention and the National Institutes of Health; TDF2 ClinicalTrials.gov number, NCT00448669.) Preexposure prophylaxis with antiretroviral agents has been shown to reduce the transmission of human immunodeficiency virus (HIV) among men who have sex with men; however, the efficacy among heterosexuals is uncertain. We randomly assigned HIV-seronegative men and women to receive either tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) or matching placebo once daily. Monthly study visits were scheduled, and participants received a comprehensive package of prevention services, including HIV testing, counseling on adherence to medication, management of sexually transmitted infections, monitoring for adverse events, and individualized counseling on risk reduction; bone mineral density testing was performed semiannually in a subgroup of participants. A total of 1219 men and women underwent randomization (45.7% women) and were followed for 1563 person-years (median, 1.1 years; maximum, 3.7 years). Because of low retention and logistic limitations, we concluded the study early and followed enrolled participants through an orderly study closure rather than expanding enrollment. The TDF-FTC group had higher rates of nausea (18.5% vs. 7.1%, P<0.001), vomiting (11.3% vs. 7.1%, P=0.008), and dizziness (15.1% vs. 11.0%, P=0.03) than the placebo group, but the rates of serious adverse events were similar (P=0.90). Participants who received TDF-FTC, as compared with those who received placebo, had a significant decline in bone mineral density. K65R, M184V, and A62V resistance mutations developed in 1 participant in the TDF-FTC group who had had an unrecognized acute HIV infection at enrollment. In a modified intention-to-treat analysis that included the 33 participants who became infected during the study (9 in the TDF-FTC group and 24 in the placebo group; 1.2 and 3.1 infections per 100 person-years, respectively), the efficacy of TDF-FTC was 62.2% (95% confidence interval, 21.5 to 83.4; P=0.03). Daily TDF-FTC prophylaxis prevented HIV infection in sexually active heterosexual adults. The long-term safety of daily TDF-FTC prophylaxis, including the effect on bone mineral density, remains unknown. (Funded by the Centers for Disease Control and Prevention and the National Institutes of Health; TDF2 ClinicalTrials.gov number, NCT00448669.). Preexposure prophylaxis with antiretroviral agents has been shown to reduce the transmission of human immunodeficiency virus (HIV) among men who have sex with men; however, the efficacy among heterosexuals is uncertain.BACKGROUNDPreexposure prophylaxis with antiretroviral agents has been shown to reduce the transmission of human immunodeficiency virus (HIV) among men who have sex with men; however, the efficacy among heterosexuals is uncertain.We randomly assigned HIV-seronegative men and women to receive either tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) or matching placebo once daily. Monthly study visits were scheduled, and participants received a comprehensive package of prevention services, including HIV testing, counseling on adherence to medication, management of sexually transmitted infections, monitoring for adverse events, and individualized counseling on risk reduction; bone mineral density testing was performed semiannually in a subgroup of participants.METHODSWe randomly assigned HIV-seronegative men and women to receive either tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) or matching placebo once daily. Monthly study visits were scheduled, and participants received a comprehensive package of prevention services, including HIV testing, counseling on adherence to medication, management of sexually transmitted infections, monitoring for adverse events, and individualized counseling on risk reduction; bone mineral density testing was performed semiannually in a subgroup of participants.A total of 1219 men and women underwent randomization (45.7% women) and were followed for 1563 person-years (median, 1.1 years; maximum, 3.7 years). Because of low retention and logistic limitations, we concluded the study early and followed enrolled participants through an orderly study closure rather than expanding enrollment. The TDF-FTC group had higher rates of nausea (18.5% vs. 7.1%, P<0.001), vomiting (11.3% vs. 7.1%, P=0.008), and dizziness (15.1% vs. 11.0%, P=0.03) than the placebo group, but the rates of serious adverse events were similar (P=0.90). Participants who received TDF-FTC, as compared with those who received placebo, had a significant decline in bone mineral density. K65R, M184V, and A62V resistance mutations developed in 1 participant in the TDF-FTC group who had had an unrecognized acute HIV infection at enrollment. In a modified intention-to-treat analysis that included the 33 participants who became infected during the study (9 in the TDF-FTC group and 24 in the placebo group; 1.2 and 3.1 infections per 100 person-years, respectively), the efficacy of TDF-FTC was 62.2% (95% confidence interval, 21.5 to 83.4; P=0.03).RESULTSA total of 1219 men and women underwent randomization (45.7% women) and were followed for 1563 person-years (median, 1.1 years; maximum, 3.7 years). Because of low retention and logistic limitations, we concluded the study early and followed enrolled participants through an orderly study closure rather than expanding enrollment. The TDF-FTC group had higher rates of nausea (18.5% vs. 7.1%, P<0.001), vomiting (11.3% vs. 7.1%, P=0.008), and dizziness (15.1% vs. 11.0%, P=0.03) than the placebo group, but the rates of serious adverse events were similar (P=0.90). Participants who received TDF-FTC, as compared with those who received placebo, had a significant decline in bone mineral density. K65R, M184V, and A62V resistance mutations developed in 1 participant in the TDF-FTC group who had had an unrecognized acute HIV infection at enrollment. In a modified intention-to-treat analysis that included the 33 participants who became infected during the study (9 in the TDF-FTC group and 24 in the placebo group; 1.2 and 3.1 infections per 100 person-years, respectively), the efficacy of TDF-FTC was 62.2% (95% confidence interval, 21.5 to 83.4; P=0.03).Daily TDF-FTC prophylaxis prevented HIV infection in sexually active heterosexual adults. The long-term safety of daily TDF-FTC prophylaxis, including the effect on bone mineral density, remains unknown. (Funded by the Centers for Disease Control and Prevention and the National Institutes of Health; TDF2 ClinicalTrials.gov number, NCT00448669.).CONCLUSIONSDaily TDF-FTC prophylaxis prevented HIV infection in sexually active heterosexual adults. The long-term safety of daily TDF-FTC prophylaxis, including the effect on bone mineral density, remains unknown. (Funded by the Centers for Disease Control and Prevention and the National Institutes of Health; TDF2 ClinicalTrials.gov number, NCT00448669.).
Author	Thomas, Vasavi T Johnson, Sandra Smith, Dawn K Henderson, Faith L Buliva, Evans Hendrix, Craig W Paxton, Lynn A Rose, Charles E Segolodi, Tebogo M Kebaabetswe, Poloko M Gvetadze, Roman J Johnson, Jeffrey A Thigpen, Michael C Mutanhaurwa, Rodreck Chirwa, Lovemore Ian Sukalac, Thom Abebe, Daniel Kasonde, Michael Malotte, C. Kevin Hart, Clyde Chillag, Kata L Brooks, John T Pathak, Sonal R Soud, Fatma A
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HIV Prevention Research Unit, CDC-Botswana, Gaborone, Botswana (P.M.K., T.M.S., F.A.S., R.M., L.I.C., M.K., D.A., E.B., S.J.); California State University–Long Beach, Long Beach (C.K.M.); and the Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (C.W.H.) – sequence: 17 givenname: Sandra surname: Johnson fullname: Johnson, Sandra organization: From the Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention (M.C.T., L.A.P., D.K.S., C.E.R., F.L.H., K.L.C., R.J.G., T.S., V.T.T., C.H., J.A.J., J.T.B.), and Northrop Grumman (S.R.P.) — both in Atlanta; HIV Prevention Research Unit, CDC-Botswana, Gaborone, Botswana (P.M.K., T.M.S., F.A.S., R.M., L.I.C., M.K., D.A., E.B., S.J.); California State University–Long Beach, Long Beach (C.K.M.); and the Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (C.W.H.) – sequence: 18 givenname: Thom surname: Sukalac fullname: Sukalac, Thom organization: From the Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention (M.C.T., L.A.P., D.K.S., C.E.R., F.L.H., K.L.C., R.J.G., T.S., V.T.T., C.H., J.A.J., J.T.B.), and Northrop Grumman (S.R.P.) — both in Atlanta; HIV Prevention Research Unit, CDC-Botswana, Gaborone, Botswana (P.M.K., T.M.S., F.A.S., R.M., L.I.C., M.K., D.A., E.B., S.J.); California State University–Long Beach, Long Beach (C.K.M.); and the Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (C.W.H.) – sequence: 19 givenname: Vasavi T surname: Thomas fullname: Thomas, Vasavi T organization: From the Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention (M.C.T., L.A.P., D.K.S., C.E.R., F.L.H., K.L.C., R.J.G., T.S., V.T.T., C.H., J.A.J., J.T.B.), and Northrop Grumman (S.R.P.) — both in Atlanta; HIV Prevention Research Unit, CDC-Botswana, Gaborone, Botswana (P.M.K., T.M.S., F.A.S., R.M., L.I.C., M.K., D.A., E.B., S.J.); California State University–Long Beach, Long Beach (C.K.M.); and the Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (C.W.H.) – sequence: 20 givenname: Clyde surname: Hart fullname: Hart, Clyde organization: From the Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention (M.C.T., L.A.P., D.K.S., C.E.R., F.L.H., K.L.C., R.J.G., T.S., V.T.T., C.H., J.A.J., J.T.B.), and Northrop Grumman (S.R.P.) — both in Atlanta; HIV Prevention Research Unit, CDC-Botswana, Gaborone, Botswana (P.M.K., T.M.S., F.A.S., R.M., L.I.C., M.K., D.A., E.B., S.J.); California State University–Long Beach, Long Beach (C.K.M.); and the Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (C.W.H.) – sequence: 21 givenname: Jeffrey A surname: Johnson fullname: Johnson, Jeffrey A organization: From the Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention (M.C.T., L.A.P., D.K.S., C.E.R., F.L.H., K.L.C., R.J.G., T.S., V.T.T., C.H., J.A.J., J.T.B.), and Northrop Grumman (S.R.P.) — both in Atlanta; HIV Prevention Research Unit, CDC-Botswana, Gaborone, Botswana (P.M.K., T.M.S., F.A.S., R.M., L.I.C., M.K., D.A., E.B., S.J.); California State University–Long Beach, Long Beach (C.K.M.); and the Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (C.W.H.) – sequence: 22 givenname: C. Kevin surname: Malotte fullname: Malotte, C. Kevin organization: From the Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention (M.C.T., L.A.P., D.K.S., C.E.R., F.L.H., K.L.C., R.J.G., T.S., V.T.T., C.H., J.A.J., J.T.B.), and Northrop Grumman (S.R.P.) — both in Atlanta; HIV Prevention Research Unit, CDC-Botswana, Gaborone, Botswana (P.M.K., T.M.S., F.A.S., R.M., L.I.C., M.K., D.A., E.B., S.J.); California State University–Long Beach, Long Beach (C.K.M.); and the Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (C.W.H.) – sequence: 23 givenname: Craig W surname: Hendrix fullname: Hendrix, Craig W organization: From the Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention (M.C.T., L.A.P., D.K.S., C.E.R., F.L.H., K.L.C., R.J.G., T.S., V.T.T., C.H., J.A.J., J.T.B.), and Northrop Grumman (S.R.P.) — both in Atlanta; HIV Prevention Research Unit, CDC-Botswana, Gaborone, Botswana (P.M.K., T.M.S., F.A.S., R.M., L.I.C., M.K., D.A., E.B., S.J.); California State University–Long Beach, Long Beach (C.K.M.); and the Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (C.W.H.) – sequence: 24 givenname: John T surname: Brooks fullname: Brooks, John T organization: From the Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention (M.C.T., L.A.P., D.K.S., C.E.R., F.L.H., K.L.C., R.J.G., T.S., V.T.T., C.H., J.A.J., J.T.B.), and Northrop Grumman (S.R.P.) — both in Atlanta; HIV Prevention Research Unit, CDC-Botswana, Gaborone, Botswana (P.M.K., T.M.S., F.A.S., R.M., L.I.C., M.K., D.A., E.B., S.J.); California State University–Long Beach, Long Beach (C.K.M.); and the Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (C.W.H.)
BackLink	http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=26184571$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/22784038$$D View this record in MEDLINE/PubMed
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CODEN	NEJMAG
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ContentType	Journal Article
Contributor	Mapiye, Darlington Johnson, Sandra Gaokgethelwe, Beryl Lockridge, Joseph Masuku, Pride Madisakwane, Luciah Majaye, Gene Cobb, Daphne Kabelo, Tshepo Maule, Kagiso Abebe, Daniel Balopi, Wangu Fonjungo, Peter Molokwane, Iris Mogatle, Karen Jackalas, Callistus Chilume, Oteng Mdlongwa, Innocent Kitso, Joseph Munamati, Lynette Kuhepa, Ihonga Khumalo, Vincent Lentswe, Mandipa Kasonde, Michael Henderson, Faith Moloi, Keodiretseng Gunda, Tshegofatso Ketlametswe, Rebecca Casillas, Paula Gucha, Tibapi Makgekgenene, Lebogang Joseph, Tshepang Kumile, Zibane Ngwaru, Gibson Kesitilwe, Kutlo Bolobilwe, Olebile Nkokodi, Pauline Gaonewe, Joyce Maposa, Shaida Modukanele, Mosetsanagape Mantimane, Ruth Kapaya, MacKintosh Ndungo, Josephine Chanda, Jonas Marumo, Kootshepile Mookodi, Potlako Chirwa, Ian Kesalopa, Koorileng Manyiwa, Early Motswasele, Naledi Nsenga, Ngoy Mogwera, Annah Dikgope, Sebokwane Mukungunurwa, Fungai Moapare, Bonny Goareng, Obuseng Norman, Jeremia Masole, Maitumelo Kagiso, Kabo Machipisa, Gladys Dikgole, Kesaobaka Molosiwa, Molefhi Mafa-Setswalo,
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Keywords	Immunopathology Antiretroviral agent Heterosexuality Transmission Retroviridae AIDS Immune deficiency Lentivirus Infection Virus Medicine Prevention Preexposure Viral disease Antiviral Human immunodeficiency virus
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Snippet	In this study, 1219 HIV-uninfected, heterosexual adults in Botswana were randomly assigned to tenofovir–emtricitabine (TDF–FTC) or placebo. The TDF–FTC group... Preexposure prophylaxis with antiretroviral agents has been shown to reduce the transmission of human immunodeficiency virus (HIV) among men who have sex with... BackgroundPreexposure prophylaxis with antiretroviral agents has been shown to reduce the transmission of human immunodeficiency virus (HIV) among men who have...
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SubjectTerms	Adenine - adverse effects Adenine - analogs & derivatives Adenine - therapeutic use Adolescent Adult Anti-Retroviral Agents - adverse effects Anti-Retroviral Agents - therapeutic use Antibiotics. Antiinfectious agents. Antiparasitic agents Antiretroviral agents Antiretroviral drugs Antiviral agents Biological and medical sciences Bone Density - drug effects Bone mineral density Contraception Behavior - statistics & numerical data Deoxycytidine - adverse effects Deoxycytidine - analogs & derivatives Deoxycytidine - therapeutic use Disease transmission Drug Resistance, Viral Drug Therapy, Combination Emtricitabine Female Gays & lesbians General aspects HIV HIV Infections - prevention & control HIV Seropositivity HIV-1 - genetics HIV-1 - isolation & purification HIV-2 - genetics HIV-2 - isolation & purification Human immunodeficiency virus Human viral diseases Humans Infections Infectious diseases Kaplan-Meier Estimate Male Medical research Medical sciences Mens health Motivation Nausea Organophosphonates - adverse effects Organophosphonates - therapeutic use Pharmacology. Drug treatments Prophylaxis Proportional Hazards Models RNA, Viral - blood Sexual Behavior - statistics & numerical data Tenofovir Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids Viral Load Vomiting Young Adult
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Title	Antiretroviral Preexposure Prophylaxis for Heterosexual HIV Transmission in Botswana
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