Stakeholder and Provider Views Regarding Pericoital Contraceptive Pills in India and Uganda

Cover, Jane; Drake, Jennifer Kidwell; Kyamwanga, Imelda T.; Turyakira, Eleanor; Dargan, Tanya; Harner-Jay, Claudia

doi:10.1111/j.1728-4465.2013.00368.x

Cited by 3 publications

(3 citation statements)

References 14 publications

(15 reference statements)

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“…Importantly, one study demonstrated that the pregnancy prevention efficacy of on-demand oral levonorgestrel was similar to that seen with typical use of daily oral contraceptive pills ( Halpern et al., 2014 ). Key stakeholders and health care providers also agree that an event-driven method fills an important gap in women’s reproductive health products ( Cover et al., 2013a ). An on-demand topical prevention product has the potential to provide greater flexibility to meet end user’s needs, potentially leading to increased overall uptake.…”

Section: Discussionmentioning

confidence: 99%

A phase I study to assess safety, pharmacokinetics, and pharmacodynamics of a vaginal insert containing tenofovir alafenamide and elvitegravir

Thurman

Ouattara

Yousefieh

et al. 2023

Front. Cell. Infect. Microbiol.

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BackgroundNew multi-purpose prevention technology (MPT) products are needed to prevent human immunodeficiency virus (HIV) and herpes simplex virus type 2 (HSV2). In this study, we evaluated a fast-dissolve insert that may be used vaginally or rectally for prevention of infection.ObjectiveTo describe the safety, acceptability, multi-compartment pharmacokinetics (PK), and in vitro modeled pharmacodynamics (PD) after a single vaginal dose of an insert containing tenofovir alafenamide (TAF) and elvitegravir (EVG) in healthy women.MethodsThis was a Phase I, open-label, study. Women (n=16) applied one TAF (20mg)/EVG (16mg) vaginal insert and were randomized (1:1) to sample collection time groups for up to 7 days post dosing. Safety was assessed by treatment-emergent adverse events (TEAEs). EVG, TAF and tenofovir (TFV) concentrations were measured in plasma, vaginal fluid and tissue, and TFV-diphosphate (TFV-DP) concentration in vaginal tissue. PD was modeled in vitro by quantifying the change in inhibitory activity of vaginal fluid and vaginal tissue against HIV and HSV2 from baseline to after treatment. Acceptability data was collected by a quantitative survey at baseline and post treatment.ResultsThe TAF/EVG insert was safe, with all TEAEs graded as mild, and acceptable to participants. Systemic plasma exposure was low, consistent with topical delivery, while high mucosal levels were detected, with median TFV vaginal fluid concentrations exceeding 200,000 ng/mL and 1,000 ng/mL for up to 24 hours and 7 days post dosing, respectively. All participants had vaginal tissue EVG concentrations of > 1 ng/mg at 4 and 24 hours post dosing. The majority had tissue TFV-DP concentrations exceeding 1000 fmol/mg by 24 – 72 hours post dosing. Vaginal fluid inhibition of HIV-1 and HSV-2 in vitro significantly increased from baseline and was similarly high at 4 and 24 hours post dosing. Consistent with high tissue TFV-DP concentrations, p24 HIV antigen production from ectocervical tissues infected ex vivo with HIV-1 significantly decreased from baseline at 4 hours post dosing. HSV-2 production from tissue also decreased post treatment.ConclusionsA single dose of TAF/EVG inserts met PK benchmarks, with PK data supporting an extended window of high mucosal protection. PD modeling supports mucosal protection against both HIV-1 and HSV-2. The inserts were safe and highly acceptable.Clinical trial registrationClinicalTrials.gov, identifier NCT03762772.

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Section: Discussionmentioning

confidence: 99%

A phase I study to assess safety, pharmacokinetics, and pharmacodynamics of a vaginal insert containing tenofovir alafenamide and elvitegravir

Thurman

Ouattara

Yousefieh

et al. 2023

Front. Cell. Infect. Microbiol.

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“…Furthermore, compliance might be easier given that pill use is triggered by a specific event, and the pill could be used discreetly, without the cooperation or knowledge of a partner, which is not the case for other coital-dependent methods (i.e., condoms). Most critically, there is evidence that women are already using currently available levonorgestrel (LNG) products off-label (i.e., emergency contraception pills (ECP)) as their main form of contraception (Cover et al 2013b;Vandermark Moore and Chan 2019).…”

Section: Introductionmentioning

confidence: 99%

“…Most critically, there is evidence that women are already using currently available levonorgestrel (LNG) products off‐label (i.e., emergency contraception pills (ECP)) as their main form of contraception (Cover et al. 2013b; Vandermark Moore and Chan 2019).…”

Section: Introductionmentioning

confidence: 99%

Feasibility and Acceptability of LNG 1.5 mg as an On‐Demand Pericoital Contraceptive in Ghana

McCann,

Liang,

Ramarao

et al. 2023

Studies in Family Planning

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Globally, there is a need for more family planning method options as currently, available options do not adequately meet the needs of women, specifically those who have infrequent sex. Levonorgestrel (LNG) 1.5 mg is widely available as emergency contraception pills (ECP), and recent research has shown that certain women take it as their main form of contraception. Furthermore, limited studies have found repeat, on‐demand use safe and efficacious.This 12‐month prospective, single‐arm, interventional study in Ghana tested whether a single LNG 1.5 mg on‐demand or pericoital (“around the time of sex”) dose contraceptive was acceptable to women who have infrequent sex and if pharmacy provision was feasible. The study sample (1,890) comprised women of reproductive age recruited from urban areas, having infrequent sex (i.e., coital frequency ≤ 6× per month), and not using any other modern methods except condoms or ECP at the time of study inclusion.Results indicated that there is demand and acceptability for a pericoital pill and that pharmacy provision is feasible. Furthermore, precoital use of the pill had high levels of satisfaction and was popular with new users. Adding LNG 1.5 mg for pericoital use to the family planning method mix has the potential to address an important segment of the population currently underserved, decrease unwanted pregnancies, and increase modern contraceptive prevalence rates.

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What some women want? On-demand oral contraception

et al. 2014

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Stakeholder and Provider Views Regarding Pericoital Contraceptive Pills in India and Uganda

Cited by 3 publications

References 14 publications

A phase I study to assess safety, pharmacokinetics, and pharmacodynamics of a vaginal insert containing tenofovir alafenamide and elvitegravir

A phase I study to assess safety, pharmacokinetics, and pharmacodynamics of a vaginal insert containing tenofovir alafenamide and elvitegravir

Feasibility and Acceptability of LNG 1.5 mg as an On‐Demand Pericoital Contraceptive in Ghana

What some women want? On-demand oral contraception

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