Dataset Information

Increasing body mass index or weight does not appear to influence the association between efavirenz-based antiretroviral therapy and implant effectiveness among HIV-positive women in western Kenya.

ABSTRACT: OBJECTIVE:Our objective was to evaluate if increasing body mass index (BMI) or weight influences the association between efavirenz-based antiretroviral therapy (ART) and implant effectiveness. STUDY DESIGN:We conducted a secondary cohort analysis of HIV-positive women aged 15 to 45?years enrolled in HIV care in western Kenya using an implant from January 2011 to December 2015. Implant use, ART regimen and weight were documented at each clinic visit and height at enrollment. We categorized BMI as underweight, normal weight, overweight or obese, and weight as <70 kg or ?70 kg. Our primary outcome was incident pregnancy diagnosed clinically. We used crude and adjusted Poisson models with robust standard errors to account for covariates and repeated observations to estimate adjusted incident rate ratios (aIRRs). RESULTS:In this analysis, 12,960 women contributed a total of 11,285 woman-years of observation time while using an implant, with a median of 6.6?months. The aIRRs comparing efavirenz- to nevirapine-based ART groups did not increase as BMI increased; the aIRRs were 2.0 (1.1-3.6) for underweight, 1.9 (1.5-2.5) for normal, 3.1 (1.6-6.0) for overweight and 2.1 (0.6-6.9) for obese women. The aIRRs comparing efavirenz- to nevirapine-based ART groups did not increase as weight increased; the aIRRs were 2.0 (1.6-2.6) for weight <70 kg and 2.1 (1.0-4.5) for weight ?70 kg. CONCLUSION:Higher BMI or weight did not appear to modify the relationship between efavirenz use and implant effectiveness. IMPLICATIONS:Programs should not recommend differential counseling for women with higher BMI or weight who concomitantly use implants and efavirenz.

SUBMITTER: Patel RC

PROVIDER: S-EPMC6778013 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Increasing body mass index or weight does not appear to influence the association between efavirenz-based antiretroviral therapy and implant effectiveness among HIV-positive women in western Kenya.

Patel Rena C RC Jakait Beatrice B Thomas Katherine K Yiannoutsos Constantin C Onono Maricianah M Bukusi Elizabeth A EA Wools-Kaloustian Kara K KK Cohen Craig R CR

Contraception 20190624 4

<h4>Objective</h4>Our objective was to evaluate if increasing body mass index (BMI) or weight influences the association between efavirenz-based antiretroviral therapy (ART) and implant effectiveness.<h4>Study design</h4>We conducted a secondary cohort analysis of HIV-positive women aged 15 to 45 years enrolled in HIV care in western Kenya using an implant from January 2011 to December 2015. Implant use, ART regimen and weight were documented at each clinic visit and height at enrollment. We cat ...[more]

PMID: 31247193

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Project description:IntroductionDolutegravir (DTG) is widely used for antiretroviral therapy (ART). We compared weight and blood pressure trends and examined the association between high blood pressure and weight gain among people living with HIV (PLHIV) switching to or starting DTG-based, efavirenz (EFV)-based and ritonavir-boosted atazanavir (ATV/r)-based ART in Zimbabwe.MethodsPLHIV aged 18 years or older who started or switched to DTG, EFV or ATV/r-based ART between January 2004 and June 2022 at Newlands Clinic in Harare, Zimbabwe, were eligible. Weight was measured at all visits (Seca floor scales); blood pressure only at clinician-led visits (Omron M2 sphygmomanometer). We used Bayesian additive models to estimate trends in weight gain and the proportion with high blood pressure (systolic >140 mmHg or diastolic >90 mmHg) in the first 2 years after starting or switching the regimen. Finally, we examined whether trends in the proportion with high blood pressure were related to weight change.ResultsWe analysed 99,969 weight and 35,449 blood pressure records from 9487 adults (DTG: 4593; EFV: 3599; ATV/r: 1295). At 24 months after starting or switching to DTG, estimated median weight gains were 4.54 kg (90% credibility interval 3.88-5.28 kg) in women and 3.71 kg (3.07-4.45 kg) in men, around twice that observed for ATV/r and over four-times the gain observed for EFV. Prevalence of high blood pressure among PLHIV receiving DTG-based ART increased from around 5% at baseline to over 20% at 24 months, with no change in PLHIV receiving EFV- or ATV/r-based ART. High blood pressure in PLHIV switching to DTG was associated with weight gain, with stronger increases in the proportion with high blood pressure for larger weight gains.ConclusionsAmong PLHIV starting ART or switching to a new regimen, DTG-based ART was associated with larger weight gains and a substantial increase in the prevalence of high blood pressure. Routine weight and blood pressure measurement and interventions to lower blood pressure could benefit PLHIV on DTG-based ART. Further studies are needed to elucidate the mechanisms and reversibility of these changes after discontinuation of DTG.

Project description:IntroductionHigh levels of adherence to antiretroviral therapy (ART) are central to HIV management. The objective of this study was to compare multiple measures of adherence and investigate factors associated with adherence among HIV-infected children in western Kenya.MethodsWe evaluated ART adherence prospectively for six months among HIV-infected children aged ≤14 years attending a large outpatient HIV clinic in Kenya. Adherence was reported using caregiver report, plasma drug concentrations and Medication Event Monitoring Systems (MEMS®). Kappa statistics were used to compare adherence estimates with MEMS®. Logistic regression analyses were performed to assess the association between child, caregiver and household characteristics with dichotomized adherence (MEMS® adherence ≥90% vs. <90%) and MEMS® treatment interruptions of ≥48 hours. Odds ratios (ORs) and 95% confidence intervals (95% CIs) were calculated.ResultsAmong 191 children, mean age at baseline was 8.2 years and 55% were female. Median adherence by MEMS® was 96.3% and improved over the course of follow-up (p<0.01), although 49.5% of children had at least one MEMS® treatment interruption of ≥48 hours. Adherence estimates were highest by caregiver report, and there was poor agreement between MEMS® and other adherence measures (Kappa statistics 0.04-0.37). In multivariable logistic regression, only caregiver-reported missed doses in the past 30 days (OR 1.25, 95% CI 1.14-1.39), late doses in the past seven days (OR 1.14, 95% CI 1.05-1.22) and caregiver-reported problems with getting the child to take ART (OR 1.10, 95% CI 1.01-1.20) were significantly associated with dichotomized MEMS® adherence. The caregivers reporting that ART made the child sick (OR 1.12, 95% CI 1.01-1.25) and reporting difficulties in the community that made giving ART more difficult (e.g. stigma) (OR 1.14, 95% CI 1.02-1.27) were significantly associated with MEMS® treatment interruptions in multivariable logistic regression.ConclusionsNon-adherence in the form of missed and late doses, treatment interruptions of more than 48 hours and sub-therapeutic drug levels were common in this cohort. Adherence varied significantly by adherence measure, suggesting that additional validation of adherence measures is needed. Few factors were consistently associated with non-adherence or treatment interruptions.

Project description:ObjectiveWe evaluated the pharmacokinetics of double-dose levonorgestrel (LNG) implants to overcome the drug-drug interaction with efavirenz-based antiretroviral therapy (ART).Study designWe conducted a nonrandomized, open-label, parallel-group, longitudinal pharmacokinetic study among Ugandan women ages 18-45 years. Participants with HIV on ART containing efavirenz 600 mg received 300 mg of LNG implants (Jadelle®, Bayer, New Zealand): 300LNG+ART group. We compared our outcomes with women without HIV using standard dose, 150 mg of LNG implants: 150LNG group. The implant was placed on day zero in both groups, and we quantified plasma LNG concentrations over 48 weeks post implant insertion. LNG pharmacokinetic parameters were estimated using noncompartmental techniques. Our primary outcome was the geometric mean ratio with 90% confidence intervals of LNG area under the concentration-time curve over 24 weeks (AUC0-24w) between groups. Demographic data were described as median (interquartile range). A secondary outcome compared between-group percent of LNG concentrations ≥300 pg/mL, a minimum threshold selected a priori based on observed pregnancies in Ugandan women on standard-dose LNG implants plus efavirenz.ResultsWe enrolled 27 women in the 300LNG+ART group (34 [28.0 to 40.5] years and 61.0 [49.8-66.0] kg) and 19 women in the 150LNG group (33 [30.0 to 34.5] years and 64.9 [59.0 to 74.5] kg). LNG AUC0-24w was 34% lower for 300LNG+ART versus 150LNG (geometric mean 9998 vs. 15,231 pg*week/mL, respectively [geometric mean ratio 0.66 (90% confidence intervals, 0.54 to 0.80)]). The percentage of participants with LNG concentrations ≥300 pg/mL was not statistically different between groups at week 24 (300LNG+ART: 74.1%; 150LNG: 89.5%; p = 0.27).ConclusionDouble-dose LNG implant did not completely overcome the drug-drug interaction with efavirenz.ImplicationIn women using ART containing efavirenz, placing two implant systems (300 mg) did not normalize LNG pharmacokinetics compared with the standard-dose implant (150 mg), and some women had evidence of ovulatory activity. Alternative ART without drug-drug interactions, such as dolutegravir, is recommended with contraceptive implants.

Dataset Information

Increasing body mass index or weight does not appear to influence the association between efavirenz-based antiretroviral therapy and implant effectiveness among HIV-positive women in western Kenya.

Publications

Increasing body mass index or weight does not appear to influence the association between efavirenz-based antiretroviral therapy and implant effectiveness among HIV-positive women in western Kenya.

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