Tenofovir Gel for the Prevention of Herpes Simplex Virus Type 2 Infection
Salim S Abdool Karim, Quarraisha Abdool Karim, Ayesha B M Kharsany, Cheryl Baxter, Anneke C Grobler, Lise Werner, Angela Kashuba, Leila E Mansoor, Natasha Samsunder, Adrian Mindel, Tanuja N Gengiah, CAPRISA 004 Trial Group, Q Abdool Karim, S S Abdool Karim, J A Fröhlich, A B M Kharsany, K P Mlisana, C Baxter, L E Mansoor, N A Arulappan, S Maarschalk, H Humphries, G Parker, J Richards, J Upton, S Sibeko, B Mdluli, N Miya, L Mtongana, N Naicker, Z Omar, D Sokal, D D Chetty, F Dlamini, S D Gumede, Z Gumede, N E Khambule, N Langa, B T Madlala, N Madlala, N Mkhize, Z L Mkhize, M Mlotshwa, C Ndimande, N Ngcobo, C Ntshingila, B Phungula, T E Vumase, N B Biyela, N Dladla, T Dlamini, C T Khwela, N Mayisela, M R Mlaba, J Mchunu, Z Msimango, D Nkosi, T Shange, L Chelini, T N Gengiah, A Gray, B Maharaj, G I Masinga, A Naidoo, M Upfold, B Moodley, Y Naidoo, C Ngcobo, T Nzimande, L Zondi, A C Grobler, D Taylor, L Werner, N Yende, R Lallbahadur, M Mdladla, K Naidoo, T Nala, C Pillay, P Sikakane, T Zondo, T Govender, N Mvandaba, F van Loggerenberg, I van Middelkoop, J Naicker, V Naranbhai, N Ndlovu, N Samsunder, S Sidhoo, P Tshabalala, J Ledwaba, L Morris, J Fisher, K MacQueen, L R Luthuli, F Ntombela, P F Chonco, D P Magagula, P C Majola, T Ndlovu, L Ngobese, N Ngubane, N M Zwane, N Bhengu, P Buthelezi, P D Lembethe, B F Mazibuko, S F Mdluli, W N Mkhize, S P Ndlovu, S Ngubane, R M Ogle, R B Xulu, S A Barnabas, T Malembe, Y T Miya, A Mqadi, S Sibisi, B Zulu, Q Abdool Karim, S S Abdool Karim, L Claypool, J Manning, J Spieler, H Gabelnick, B Okole, C Montague, J Rooney, W Cates, L Dorflinger, D Taylor, S Combes, C Katz, L McNeil, A Troxler, K Mayer, E Bukusi, M Chen, K Dickson, C Lombard, S Self, Salim S Abdool Karim, Quarraisha Abdool Karim, Ayesha B M Kharsany, Cheryl Baxter, Anneke C Grobler, Lise Werner, Angela Kashuba, Leila E Mansoor, Natasha Samsunder, Adrian Mindel, Tanuja N Gengiah, CAPRISA 004 Trial Group, Q Abdool Karim, S S Abdool Karim, J A Fröhlich, A B M Kharsany, K P Mlisana, C Baxter, L E Mansoor, N A Arulappan, S Maarschalk, H Humphries, G Parker, J Richards, J Upton, S Sibeko, B Mdluli, N Miya, L Mtongana, N Naicker, Z Omar, D Sokal, D D Chetty, F Dlamini, S D Gumede, Z Gumede, N E Khambule, N Langa, B T Madlala, N Madlala, N Mkhize, Z L Mkhize, M Mlotshwa, C Ndimande, N Ngcobo, C Ntshingila, B Phungula, T E Vumase, N B Biyela, N Dladla, T Dlamini, C T Khwela, N Mayisela, M R Mlaba, J Mchunu, Z Msimango, D Nkosi, T Shange, L Chelini, T N Gengiah, A Gray, B Maharaj, G I Masinga, A Naidoo, M Upfold, B Moodley, Y Naidoo, C Ngcobo, T Nzimande, L Zondi, A C Grobler, D Taylor, L Werner, N Yende, R Lallbahadur, M Mdladla, K Naidoo, T Nala, C Pillay, P Sikakane, T Zondo, T Govender, N Mvandaba, F van Loggerenberg, I van Middelkoop, J Naicker, V Naranbhai, N Ndlovu, N Samsunder, S Sidhoo, P Tshabalala, J Ledwaba, L Morris, J Fisher, K MacQueen, L R Luthuli, F Ntombela, P F Chonco, D P Magagula, P C Majola, T Ndlovu, L Ngobese, N Ngubane, N M Zwane, N Bhengu, P Buthelezi, P D Lembethe, B F Mazibuko, S F Mdluli, W N Mkhize, S P Ndlovu, S Ngubane, R M Ogle, R B Xulu, S A Barnabas, T Malembe, Y T Miya, A Mqadi, S Sibisi, B Zulu, Q Abdool Karim, S S Abdool Karim, L Claypool, J Manning, J Spieler, H Gabelnick, B Okole, C Montague, J Rooney, W Cates, L Dorflinger, D Taylor, S Combes, C Katz, L McNeil, A Troxler, K Mayer, E Bukusi, M Chen, K Dickson, C Lombard, S Self
Abstract
Background: Globally, herpes simplex virus type 2 (HSV-2) infection is the most common cause of genital ulcer disease. Effective prevention strategies for HSV-2 infection are needed to achieve the goals of the World Health Organization global strategy for the prevention and control of sexually transmitted infections.
Methods: We assessed the effectiveness of pericoital tenofovir gel, an antiviral microbicide, in preventing HSV-2 acquisition in a subgroup of 422 HSV-2-negative women enrolled in the Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004 study, a double-blind, randomized, placebo-controlled trial. Incident HSV-2 cases were identified by evidence of seroconversion on an HSV-2 IgG enzyme-linked immunosorbent assay between study enrollment and exit. A confirmatory analysis was performed by Western blot testing.
Results: The HSV-2 incidence rate was 10.2 cases per 100 person-years (95% confidence interval [CI], 6.8 to 14.7) among 202 women assigned to tenofovir gel, as compared with 21.0 cases per 100 person-years (95% CI, 16.0 to 27.2) among 222 women assigned to placebo gel (incidence rate ratio, 0.49; 95% CI, 0.30 to 0.77; P=0.003). The HSV-2 incidence rate among the 25 women with vaginal tenofovir concentrations of 10,000 ng per milliliter or more was 5.7 cases per 100 person-years, as compared with 15.5 cases per 100 person-years among the 103 women with no detectable vaginal tenofovir (incidence rate ratio, 0.37; 95% CI, 0.04 to 1.51; P=0.14). As confirmed by Western blot testing, there were 16 HSV-2 seroconversions among women assigned to tenofovir gel as compared with 36 among those assigned to the placebo gel (incidence rate ratio, 0.45; 95% CI, 0.23 to 0.82; P=0.005).
Conclusions: In this study in South Africa, pericoital application of tenofovir gel reduced HSV-2 acquisition in women. (Funded by the U.S. Agency for International Development and others; ClinicalTrials.gov number, NCT00441298.).
Figures
Source: PubMed