Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women

Baeten, Jared M.; Palanee‐Phillips, Thesla; Brown, Elizabeth R.; Schwartz, Katie; Soto-Torres, Lydia; Govender, Vaneshree; Mgodi, Nyaradzo; Kiweewa, Flavia Matovu; Nair, Gonasagrie; Mhlanga, Felix; Siva, Samantha; Bekker, Linda Gail; Jeenarain, Nitesha; Gaffoor, Zakir; Martinson, Francis; Makanani, Bonus; Pather, Arendevi; Naidoo, Logashvari; Husnik, Marla; Richardson, Barbra A.; Parikh, Urvi M.; Mellors, John W.; Marzinke, Mark A.; Hendrix, Craig W.; Straten, Ariane Van Der; Ramjee, Gita; Chirenje, Zvavahera M.; Nakabiito, Clemensia; Taha, Taha E.; Jones, Judith; Mayo, Ashley J.; Scheckter, Rachel; Berthiaume, Jennifer; Livant, Edward; Jacobson, Cindy; Ndase, Patrick; White, Rhonda; Patterson, Karen; Germuga, Donna; Galaska, Beth; Bunge, Katherine; Singh, Devika; Szydlo, Daniel; Montgomery, Elizabeth; Mensch, Barbara S.; Torjesen, Kristine; Grossman, Cynthia; Chakhtoura, Nahida; Nel, Annaléne; Rosenberg, Zeda F.; McGowan, Ian; Hillier, Sharon L.

doi:10.1097/01.ogx.0000489577.60775.40

Cited by 51 publications

(61 citation statements)

References 19 publications

(27 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Divergence in the trial groups did not, however, increase over time. This result is in contrast to that observed in the ASPIRE trial (A Study to Prevent Infection with a Ring for Extended Use), 10 a multicenter, randomized, double-blind, placebocontrolled, phase 3 safety and effectiveness trial of a vaginal matrix ring containing dapivirine for the prevention of HIV-1 infection in women, in which the benefit from the dapivirine vaginal ring was apparent only after the first 12 months -a finding that was attributed to participants needing time to become comfortable with using the ring. Analysis according to age group showed a 37% lower rate of HIV-1 acquisition with the dapivirine ring than with the placebo ring among women older than 21 years of age and a 15% lower rate among those 21 years of age or younger (the age effect was not significant).…”

Section: Discussioncontrasting

confidence: 92%

“…The E138A substitution is a polymorphism of HIV-1 subtype C, and although it is associated with rilpivirine and etravirine, two close analogues of dapivirine, 17 it is not associated with nevirapine and efavirenz, which are the more widely used NNRTIs in sub-Saharan Africa. The data are consistent with the data from the ASPIRE trial, 10 which also showed no significant difference between the dapivirine group and the placebo group in the numbers of participants with NNRTI mutations suggesting antiviral resistance.…”

Section: Discussionsupporting

confidence: 87%

“…Analysis according to age group showed a 37% lower rate of HIV-1 acquisition with the dapivirine ring than with the placebo ring among women older than 21 years of age and a 15% lower rate among those 21 years of age or younger (the age effect was not significant). In the ASPIRE trial, 10 age was shown to be significantly related to protection against HIV-1 infection, with no protection observed among participants 18 to 21 years of age and with a 56% lower rate observed among participants older than 21 years of age. The lower level of protection that was observed among younger women may be due to physiologic differences in the genital tract of younger women, lower adherence to ring use, adjusted chi-square test.…”

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

Safety and Efficacy of a Dapivirine Vaginal Ring for HIV Prevention in Women

et al. 2016

Self Cite

View full text Add to dashboard Cite

BACKGROUNDThe incidence of human immunodeficiency virus (HIV) infection remains high among women in sub-Saharan Africa. We evaluated the safety and efficacy of extended use of a vaginal ring containing dapivirine for the prevention of HIV infection in 1959 healthy, sexually active women, 18 to 45 years of age, from seven communities in South Africa and Uganda. METHODSIn this randomized, double-blind, placebo-controlled, phase 3 trial, we randomly assigned participants in a 2:1 ratio to receive vaginal rings containing either 25 mg of dapivirine or placebo. Participants inserted the rings themselves every 4 weeks for up to 24 months. The primary efficacy end point was the rate of HIV type 1 (HIV-1) seroconversion. RESULTSA total of 77 participants in the dapivirine group underwent HIV-1 seroconversion during 1888 person-years of follow-up (4.1 seroconversions per 100 person-years), as compared with 56 in the placebo group who underwent HIV-1 seroconversion during 917 person-years of follow-up (6.1 seroconversions per 100 person-years). The incidence of HIV-1 infection was 31% lower in the dapivirine group than in the placebo group (hazard ratio, 0.69; 95% confidence interval [CI], 0.49 to 0.99; P = 0.04). There was no significant difference in efficacy of the dapivirine ring among women older than 21 years of age (hazard ratio for infection, 0.63; 95% CI, 0.41 to 0.97) and those 21 years of age or younger (hazard ratio, 0.85; 95% CI, 0.45 to 1.60; P = 0.43 for treatment-by-age interaction). Among participants with HIV-1 infection, nonnucleoside reverse-transcriptase inhibitor resistance mutations were detected in 14 of 77 participants in the dapivirine group (18.2%) and in 9 of 56 (16.1%) in the placebo group. Serious adverse events occurred more often in the dapivirine group (in 38 participants [2.9%]) than in the placebo group (in 6 [0.9%]). However, no clear pattern was identified. CONCLUSIONSAmong women in sub-Saharan Africa, the dapivirine ring was not associated with any safety concerns and was associated with a rate of acquisition of HIV-1 infection that was lower than the rate with placebo. (Funded by the International Partnership for Microbicides; ClinicalTrials.gov number, NCT01539226.)

show abstract

Section: Discussioncontrasting

confidence: 92%

Section: Discussionsupporting

confidence: 87%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Safety and Efficacy of a Dapivirine Vaginal Ring for HIV Prevention in Women

et al. 2016

Self Cite

View full text Add to dashboard Cite

show abstract

“…Dapivirine is the only microbicide used in human in the form of vaginal rings and believed to be nontoxic [123]. The phase III clinical trials (the ASPIRE study) showed a 27% reduction in HIV-1 acquisition upon using dapivirine vaginal rings [124]. The protection efect was more pronounced in the women aged 21 or more; however, no signiicant protection was observed for women under age 21 [10].…”

Section: Dapivirinementioning

confidence: 99%

Microbicides for the Prevention of HPV, HIV-1, and HSV-2: Sexually Transmitted Viral Infections

Sattar¹,

.²,

Aslam³

et al. 2017

Fundamentals of Sexually Transmitted Infections

View full text Add to dashboard Cite

Sexually transmited diseases (STDs) can be transmited through genital-genital, orogenital, or anogenital contacts and remain to be a public health concern worldwide. Approximately one million people around the world are believed to be newly infected with sexually transmited infections (STIs) each day. Numerous causative agents including bacteria, viruses, protozoa, yeast, and fungi are responsible for STIs; however, viruses exhibit more serious risks, probabilities and outcomes of STDs than other organisms. The most lethal viral STIs are human immunodeiciency virus-1 (HIV), herpes simplex viruses 1 and 2 (HSV-1 and HSV-2), and human papillomavirus (HPV), which are responsible for major sexually transmited viral infections including AIDS, herpes simplex, and genital warts, respectively. Despite the fact that several prevention strategies such as vaccination, abstinence from sex, limiting sex partners, the use of condoms and a range of therapeutic drugs have drastically reduced the risk of contracting STIs, these three infections continue to spread at an alarming rate. The high incidence and lack of efective vaccine, instigated scientists to look for alternate, cheap, and eicient strategies for controlling these deadly viruses. Microbicide are relatively new approach that may be helpful in preventing STIs transmission when applied inside the genitals before intercourse. Like other interventions, microbicides are used as prophylactic measures against STIs. Therefore, an excellent safety and eicacy proile analysis is mandatory before their approval for human use. Although no safe and eicacious microbicide is yet available, many candidates including nonoxynol-9, Savvy, cellulose sulfate, Carraguard, VivaGel, tenofovir gel, and PRO 2000 have shown promising in vitro activity and many more are under development. However, very few of them have moved to large-scale phase III trials. This chapter aims to provide a brief overview of various microbicides along with their mechanism of actions and recent updates on safety and efectiveness trials.

show abstract

“…According to UNAIDS data [1], there has been a significant decline and stabilization in the number of new HIV infections since 2012, but Sub-Saharan Africa is still severely affected and more precisely in this region of the world women comprise more than half of all people living with HIV. In particular, in 2016, South Africa had an estimated 7.03 million of people living with HIV [2], and an incidence rate of up to 4 per 100 women-years [3,4]. The most significant advance in medical management of HIV infection includes two recommendations [5].…”

Section: Introductionmentioning

confidence: 99%

A model of HIV/AIDS population dynamics including ARV treatment and pre-exposure prophylaxis

Nsuami

Witbooi

2018

Adv Differ Equ

View full text Add to dashboard Cite

Antiretroviral treatment (ART) and oral pre-exposure prophylaxis (PrEP) have recently been used efficiently in management of HIV infection. Pre-exposure prophylaxis consists in the use of an antiretroviral medication to prevent the acquisition of HIV infection by uninfected individuals. We propose a new model for the transmission of HIV/AIDS including ART and PrEP. Our model can be used to test the effects of ART and of the uptake of PrEP in a given population, as we demonstrate through simulations. The model can also be used to estimate future projections of HIV prevalence. We prove global stability of the disease-free equilibrium. We also prove global stability of the endemic equilibrium for the most general case of the model, i.e., which allows for PrEP individuals to default. We include insightful simulations based on recently published South-African data. MSC: 92D30; 34K20

show abstract

Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women

Cited by 51 publications

References 19 publications

Safety and Efficacy of a Dapivirine Vaginal Ring for HIV Prevention in Women

Safety and Efficacy of a Dapivirine Vaginal Ring for HIV Prevention in Women

Microbicides for the Prevention of HPV, HIV-1, and HSV-2: Sexually Transmitted Viral Infections

A model of HIV/AIDS population dynamics including ARV treatment and pre-exposure prophylaxis

Contact Info

Product

Resources

About