BMJ 2015;350:h717 doi: 10.1136/bmj.h717 (Published 6 February 2015)
Page 1 of 1
Research News
RESEARCH NEWS Pre-exposure prophylaxis in women fails to prevent HIV infection in African study Susan Mayor London
Pre-exposure prophylaxis with an oral or vaginal antiretroviral drug failed to reduce HIV-1 infection in a large study of young women in South Africa, Uganda, and Zimbabwe. Blood tests showed poor adherence with the treatment, which is likely to explain the lack of effect.
The study randomised 5029 women aged 18 to 45 (mean age 25.3 years) to daily treatment with 1% tenofovir vaginal gel or placebo or alternatively to oral tenofovir disoproxil fumarate, oral tenofovir emtricitabine, or placebo. The results, reported in the New England Journal of Medicine, showed that none of the drug regimens reduced rates of HIV-1 infection.1
A total of 312 women seroconverted during the follow-up of one to three years, giving an incidence of HIV infection of 5.7 cases per 100 person years. The incidence was highest in women aged under 25 (8.0 per 100 person years) and in women who were unmarried (7.2 per 100 person years). Tenofovir gel reduced the risk of HIV infection by 14.5% in comparison with placebo gel but the reduction was not statistically significant (hazard ratio 0.84 (95% confidence interval 0.61 to 1.21)). Non-significant higher rates of HIV infection rate were seen in women taking tenofovir disoproxil fumarate (49%; hazard ratio 1.49 (0.97 to 2.29)) and tenofovir emtricitabine (4.4%; hazard ratio 1.04 (0.73 to 1.49)).
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The retention rate of women in the study was high (91%), and adherence, which was based on participants’ reports and counts of unused gel applicators and pills, was estimated to be about 90%. But plasma samples from a subgroup of 647 women on active treatment showed low adherence. Tenofovir was detected in only about 30% of women randomised to oral treatment and in 25% of the gel group.
Single women under 25 were least likely to use their prophylactic treatment and were also most likely to acquire HIV during the study. “What we’ve learnt has been extremely valuable. It’s been eye opening for all of us involved in HIV prevention, particularly on trials focused on meeting the needs of women,” said the lead investigator, Jeanne Marrazzo, from the University of Washington, Seattle. “We need to better understand women’s perceived motivations for participating in a trial but, more importantly, what products they will want to use.” 1
Marrazzo JM, Ramjee G, Richardson BA, Gomez K, Mgodi N, Nair G, et al. Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med 5 Feb 2015, doi:10.1056/NEJMoa1402269.
Cite this as: BMJ 2015;350:h717 © BMJ Publishing Group Ltd 2015
Subscribe: http://www.bmj.com/subscribe
Page 1 of 1
Research News
RESEARCH NEWS Pre-exposure prophylaxis in women fails to prevent HIV infection in African study Susan Mayor London
Pre-exposure prophylaxis with an oral or vaginal antiretroviral drug failed to reduce HIV-1 infection in a large study of young women in South Africa, Uganda, and Zimbabwe. Blood tests showed poor adherence with the treatment, which is likely to explain the lack of effect.
The study randomised 5029 women aged 18 to 45 (mean age 25.3 years) to daily treatment with 1% tenofovir vaginal gel or placebo or alternatively to oral tenofovir disoproxil fumarate, oral tenofovir emtricitabine, or placebo. The results, reported in the New England Journal of Medicine, showed that none of the drug regimens reduced rates of HIV-1 infection.1
A total of 312 women seroconverted during the follow-up of one to three years, giving an incidence of HIV infection of 5.7 cases per 100 person years. The incidence was highest in women aged under 25 (8.0 per 100 person years) and in women who were unmarried (7.2 per 100 person years). Tenofovir gel reduced the risk of HIV infection by 14.5% in comparison with placebo gel but the reduction was not statistically significant (hazard ratio 0.84 (95% confidence interval 0.61 to 1.21)). Non-significant higher rates of HIV infection rate were seen in women taking tenofovir disoproxil fumarate (49%; hazard ratio 1.49 (0.97 to 2.29)) and tenofovir emtricitabine (4.4%; hazard ratio 1.04 (0.73 to 1.49)).
For personal use only: See rights and reprints http://www.bmj.com/permissions
The retention rate of women in the study was high (91%), and adherence, which was based on participants’ reports and counts of unused gel applicators and pills, was estimated to be about 90%. But plasma samples from a subgroup of 647 women on active treatment showed low adherence. Tenofovir was detected in only about 30% of women randomised to oral treatment and in 25% of the gel group.
Single women under 25 were least likely to use their prophylactic treatment and were also most likely to acquire HIV during the study. “What we’ve learnt has been extremely valuable. It’s been eye opening for all of us involved in HIV prevention, particularly on trials focused on meeting the needs of women,” said the lead investigator, Jeanne Marrazzo, from the University of Washington, Seattle. “We need to better understand women’s perceived motivations for participating in a trial but, more importantly, what products they will want to use.” 1
Marrazzo JM, Ramjee G, Richardson BA, Gomez K, Mgodi N, Nair G, et al. Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med 5 Feb 2015, doi:10.1056/NEJMoa1402269.
Cite this as: BMJ 2015;350:h717 © BMJ Publishing Group Ltd 2015
Subscribe: http://www.bmj.com/subscribe
