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1.
Eur J Cancer Prev ; 33(3): 262-270, 2024 May 01.
Article in English | MEDLINE | ID: mdl-37933867

ABSTRACT

OBJECTIVE: To assess the costs and benefits of two algorithms for cervical cancer screening in Belgium (1) high-risk human papillomavirus (HR-HPV) primary screening and (2) HR-HPV and liquid-based cytology (LBC) co-testing. METHODS: A decision tree was adapted from published work and parameterised using HORIZON study data and Belgian cost and population data. The theoretical model represents two different screening algorithms for a cohort of 577 846 women aged 25-64 attending routine cervical screening. Scenario analyses were used to explore the impact of including vaccinated women and alternative pricing approaches. Uncertainty analyses were conducted. RESULTS: The cost per woman screened was €113.50 for HR-HPV primary screening and €101.70 for co-testing, representing a total cost of €65 588 573 and €58 775 083, respectively, for the cohort; a 10% difference. For one screening cycle, compared to HR-HPV primary, co-testing resulted in 13 173 more colposcopies, 67 731 more HR-HPV tests and 477 020 more LBC tests. Co-testing identified 2351 more CIN2+ cases per year (27% more than HR-HPV primary) and 1602 more CIN3+ cases (24% more than HR-HPV primary) than HR-HPV primary. CONCLUSION: In Belgium, a co-testing algorithm could increase cervical pre-cancer detection rates compared to HR-HPV primary. Co-testing would cost less than HR-HPV primary if the cost of the HPV test and LBC were cost-neutral compared to the current cost of LBC screening but would cost more if the cost per HPV test and LBC were the same in both co-testing and HR-HPV primary strategies.


Subject(s)
Papillomavirus Infections , Uterine Cervical Dysplasia , Uterine Cervical Neoplasms , Female , Humans , Uterine Cervical Neoplasms/diagnosis , Uterine Cervical Dysplasia/diagnosis , Cost-Benefit Analysis , Early Detection of Cancer/methods , Belgium , Cytology , Papillomaviridae , Algorithms , Mass Screening/methods
2.
Diagnostics (Basel) ; 13(24)2023 Dec 06.
Article in English | MEDLINE | ID: mdl-38132196

ABSTRACT

Detecting hypermethylation of tumour suppressor genes could provide an alternative to liquid-based cytology (LBC) triage within HPV primary cervical screening. The impact of using the QIAsure® FAM19A4/mir124-2 DNA Methylation Test (QIAGEN, N.V, Hilden, Germany) on CIN3+ diagnoses, retention, unnecessary colposcopies, and programme costs is unknown. A decision-tree model was developed to compare LBC with the QIAsure Methylation testing to guide colposcopy referral. Incorporating clinician- and self-sampling pathways the model was informed by the Dutch cervical cancer screening programme, published studies, and manufacturer data. Clinical and cost outcomes were assessed using two scenarios for DNA methylation testing and LBC relative performance. Sensitivity analyses (deterministic and probabilistic) were performed to assess model and parameter uncertainty. A range of self-sampling uptake was assessed in scenario analyses. For the screening cohort (n = 807,269) where 22.1% self-sampled, the number of unnecessary colposcopies and CIN3+ diagnoses varied according to the relative performance of methylation testing and LBC. Irrespective of relative performance, the cost per complete screen was lower and fewer people were lost to follow-up when using DNA methylation testing. The results indicate that, within an HPV primary screening programme that incorporates self-sampling, using the QIAsure Methylation Test for triage reduces the cost per screen compared to LBC.

4.
BMC Pulm Med ; 23(1): 220, 2023 Jun 21.
Article in English | MEDLINE | ID: mdl-37344852

ABSTRACT

BACKGROUND: On admission to hospital, patients with community-acquired pneumonia (CAP), undergo extensive diagnostic testing. Two high-throughput laboratory-based PCR panels which return a result in 5.5 hours (h) have been developed to test for pathogens commonly associated with upper (Respiratory 1 Panel) and lower (Respiratory 3 Panel) respiratory tract infections (GeneFirst, Oxford). These could replace multiple diagnostic tests currently used. METHODS: An online survey, completed by senior clinicians in the UK, France and Spain, was used to collect data on the diagnostic testing of immunocompetent and immunocompromised adults admitted to hospital with CAP, including the cost of diagnostics. Data were used to inform a cost-comparison model. For each country, the average cost of diagnostic testing per patient was calculated separately for immunocompetent and immunocompromised patients. The model compared three testing strategies with standard of care (SoC). In the Panel 1 strategy, the Respiratory 1 Panel was used for patients that would otherwise have tests which could be replaced by Respiratory 1 Panel, equivalent strategies for Respiratory 3 Panel and for both panels combined were assessed. RESULTS: In total, 48 surveys were completed (UK = 17; France = 15; Spain = 16). Compared with SoC, the Panel 1 + 3 strategy was most favourable, resulting in cost savings for immunocompetent and immunocompromised patients respectively, of €22.09 (£18.50) and €26.12 (£21.88) in the UK, €99.60 and €108.77 in France and €27.07 and €51.87 in Spain. CONCLUSION: In all three countries, the use of these respiratory panels could reduce the average cost of diagnostics used for patients admitted to hospital with CAP.


Subject(s)
Community-Acquired Infections , Pneumonia , Adult , Humans , Cost-Benefit Analysis , Spain , Community-Acquired Infections/diagnosis , Polymerase Chain Reaction , Hospitals , United Kingdom
5.
BMJ Open ; 13(6): e068940, 2023 06 06.
Article in English | MEDLINE | ID: mdl-37280031

ABSTRACT

OBJECTIVE: To compare the costs and effects of three sampling strategies for human papillomavirus (HPV) primary screening. DESIGN: Cost-consequence analysis from a health system perspective using a deterministic decision tree model. SETTING: England. PARTICIPANTS: A cohort of 10 000 women aged 25-65 years eligible for the National Health Service Cervical Screening Programme (NHSCSP). METHODS: The model was based on the NHSCSP HPV primary screening pathway and adapted for self-sampling. It used a 3-year cycle: routine screening (year 1) and recall screening (years 2/3). Parameter inputs were informed using published studies, NHSCSP reports and input from experts and manufacturers. Costs were from 2020/2021, British pound sterling (£). INTERVENTIONS: Three sampling strategies were implemented: (1) routine clinician-collected cervical sample, (2) self-collected first-void (FV) urine, (3) self-collected vaginal swab. The hypothetical self-sampling strategies involved mailing women a sampling kit. MAIN OUTCOME MEASURES: Primary outcomes: overall costs (for all screening steps to colposcopy), number of complete screens and cost per complete screen. SECONDARY OUTCOMES: number of women screened, number of women lost to follow-up, cost per colposcopy and total screening costs for a plausible range of uptake scenarios. RESULTS: In the base case, the average cost per complete screen was £56.81 for clinician-collected cervical sampling, £38.57 for FV urine self-sampling and £40.37 for vaginal self-sampling. In deterministic sensitivity analysis, the variables most affecting the average cost per screen were the cost of sample collection for clinician-collected sampling and the cost of laboratory HPV testing for the self-sampling strategies. Scaled to consider routine screening in England, if uptake in non-attenders increased by 15% and 50% of current screeners converted to self-sampling, the NHSCSP would save £19.2 million (FV urine) or £16.5 million (vaginal) per year. CONCLUSION: Self-sampling could provide a less costly alternative to clinician-collected sampling for routine HPV primary screening and offers opportunities to expand the reach of cervical screening to under-screened women.


Subject(s)
Papillomavirus Infections , Uterine Cervical Dysplasia , Uterine Cervical Neoplasms , Female , Humans , Uterine Cervical Neoplasms/prevention & control , Uterine Cervical Dysplasia/diagnosis , Early Detection of Cancer , Papillomavirus Infections/complications , State Medicine , Cost-Benefit Analysis , Mass Screening , Papillomaviridae , Vaginal Smears
6.
Ther Adv Infect Dis ; 8: 20499361211061645, 2021.
Article in English | MEDLINE | ID: mdl-34881023

ABSTRACT

OBJECTIVES: To assess clinical metrics and resource use of a 30-minute point-of-care test (POCT) for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) compared to laboratory-based testing. METHODS: Three English sexual health services (SHSs) were recruited as part of a study. Existing processes for CT/NG testing and treatment were assessed, and adaptions to incorporate the CT/NG POCT were developed during semi-structured interviews. Staff time and consumables data were collected by clinic staff prior to and following introduction of the POCT. RESULTS: SHSs selected patient groups for whom the CT/NG POCT would be used. Testing and treatment process data were collected for 225 patients (n = 118 POC; n = 107 standard). The percentage of patients receiving unnecessary CT treatment was 5% (5/95) and 13% (12/93) for POC and standard care respectively. The average CT/NG pathway cost varied and was on average £61.55 for POC and £50.88 for standard care. For the two SHSs where the POCT was used during a patient's visit, for standard and POC respectively, the average time to CT treatment was 10.0 and 0.0 days and to NG treatment, 0.3 and 0.0 days. CONCLUSION: Use of a 30-minute POCT at three SHSs yielded clinical benefits by reducing time to treatment and unnecessary CT treatment.

7.
Euro Surveill ; 25(43)2020 10.
Article in English | MEDLINE | ID: mdl-33124553

ABSTRACT

BackgroundWidespread ceftriaxone antimicrobial resistance (AMR) threatens Neisseria gonorrhoeae (NG) treatment, with few alternatives available. AMR point-of-care tests (AMR POCT) may enable alternative treatments, including abandoned regimens, sparing ceftriaxone use. We assessed cost-effectiveness of five hypothetical AMR POCT strategies: A-C included a second antibiotic alongside ceftriaxone; and D and E consisted of a single antibiotic alternative, compared with standard care (SC: ceftriaxone and azithromycin).AimAssess costs and effectiveness of AMR POCT strategies that optimise NG treatment and reduce ceftriaxone use.MethodsThe five AMR POCT treatment strategies were compared using a decision tree model simulating 38,870 NG-diagnosed England sexual health clinic (SHC) attendees; A micro-costing approach, representing cost to the SHC (for 2015/16), was employed. Primary outcomes were: total costs; percentage of patients given optimal treatment (regimens curing NG, without AMR); percentage of patients given non-ceftriaxone optimal treatment; cost-effectiveness (cost per optimal treatment gained).ResultsAll strategies cost more than SC. Strategy B (azithromycin and ciprofloxacin (azithromycin preferred); dual therapy) avoided most suboptimal treatments (n = 48) but cost most to implement (GBP 4,093,844 (EUR 5,474,656)). Strategy D (azithromycin AMR POCT; monotherapy) was most cost-effective for both cost per optimal treatments gained (GBP 414.67 (EUR 554.53)) and per ceftriaxone-sparing treatment (GBP 11.29 (EUR 15.09)) but with treatment failures (n = 34) and suboptimal treatments (n = 706).ConclusionsAMR POCT may enable improved antibiotic stewardship, but require net health system investment. A small reduction in test cost would enable monotherapy AMR POCT strategies to be cost-saving.


Subject(s)
Anti-Bacterial Agents , Drug Resistance, Bacterial , Gonorrhea , Point-of-Care Testing , Ambulatory Care Facilities , Anti-Bacterial Agents/economics , Anti-Bacterial Agents/pharmacology , Anti-Bacterial Agents/therapeutic use , Azithromycin/economics , Azithromycin/pharmacology , Azithromycin/therapeutic use , Ceftriaxone/economics , Ceftriaxone/pharmacology , Ceftriaxone/therapeutic use , Cost-Benefit Analysis , Drug Resistance, Bacterial/drug effects , England , Gonorrhea/drug therapy , Gonorrhea/microbiology , Humans , Neisseria gonorrhoeae/drug effects , Sexual Health
8.
BMC Health Serv Res ; 20(1): 316, 2020 Apr 16.
Article in English | MEDLINE | ID: mdl-32299437

ABSTRACT

BACKGROUND: Community-based screening may be one solution to increase testing and treatment of sexually transmitted infections in sexually active teenagers, but there are few data on the practicalities and cost of running such a service. We estimate the cost of running a 'Test n Treat' service providing rapid chlamydia (CT) and gonorrhoea (NG) testing and same day on-site CT treatment in technical colleges. METHODS: Process data from a 2016/17 cluster randomised feasibility trial were used to estimate total costs and service uptake. Pathway mapping was used to model different uptake scenarios. Participants, from six London colleges, provided self-taken genitourinary samples in the nearest toilet. Included in the study were 509 sexually active students (mean 85/college): median age 17.9 years, 49% male, 50% black ethnicity, with a baseline CT and NG prevalence of 6 and 0.5%, respectively. All participants received information about CT and NG infections at recruitment. When the Test n Treat team visited, participants were texted/emailed invitations to attend for confidential testing. Three colleges were randomly allocated the intervention, to host (non-incentivised) Test n Treat one and four months after baseline. All six colleges hosted follow-up Test n Treat seven months after baseline when students received a £10 incentive (to participate). RESULTS: The mean non-incentivised daily uptake per college was 5 students (range 1 to 17), which cost £237 (range £1082 to £88) per student screened, and £4657 (range £21,281 to £1723) per CT infection detected, or £13,970 (range £63,842 to £5169) per NG infection detected. The mean incentivised daily uptake was 19 students which cost £91 per student screened, and £1408/CT infection or £7042/NG infection detected. If daily capacity for screening were achieved (49 students/day), costs including incentives would be £47 per person screened and £925/CT infection or £2774/NG infection detected. CONCLUSIONS: Delivering non-incentivised Test n Treat in technical colleges is more expensive per person screened than CT and NG screening in clinics. Targeting areas with high infection rates, combined with high, incentivised uptake could make costs comparable. TRIAL REGISTRATION: ISRCTN58038795, Assigned August 2016, registered prospectively.


Subject(s)
Chlamydia Infections/diagnosis , Gonorrhea/diagnosis , Health Care Costs/statistics & numerical data , Mass Screening/economics , Sexually Transmitted Diseases/diagnosis , Adolescent , Chlamydia Infections/epidemiology , Chlamydia Infections/therapy , Costs and Cost Analysis , Feasibility Studies , Female , Gonorrhea/epidemiology , Gonorrhea/therapy , Humans , London/epidemiology , Male , Motivation , Prevalence , Students , Surveys and Questionnaires , Universities , Young Adult
9.
BMJ Open ; 10(11): e038505, 2020 11 19.
Article in English | MEDLINE | ID: mdl-33444184

ABSTRACT

OBJECTIVES: To assess the cost-effectiveness of universal repeat screening for syphilis in late pregnancy, compared with the current strategy of single screening in early pregnancy with repeat screening offered only to high-risk women. DESIGN: A decision tree model was developed to assess the incremental costs and health benefits of the two screening strategies. The base case analysis considered short-term costs during the pregnancy and the initial weeks after delivery. Deterministic and probabilistic sensitivity analyses and scenario analyses were conducted to assess the robustness of the results. SETTING: UK antenatal screening programme. POPULATION: Hypothetical cohort of pregnant women who access antenatal care and receive a syphilis screen in 1 year. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the cost to avoid one case of congenital syphilis (CS). Secondary outcomes were the cost to avoid one case of intrauterine fetal demise (IUFD) or neonatal death and the number of women needing to be screened/treated to avoid one case of CS, IUFD or neonatal death. The cost per quality-adjusted life year gained was assessed in scenario analyses. RESULTS: Base case results indicated that for pregnant women in the UK (n=725 891), the repeat screening strategy would result in 5.5 fewer cases of CS (from 8.8 to 3.3), 0.1 fewer cases of neonatal death and 0.3 fewer cases of IUFD annually compared with the single screening strategy. This equates to an additional £1.8 million per case of CS prevented. When lifetime horizon was considered, the incremental cost-effectiveness ratio for the repeat screening strategy was £120 494. CONCLUSIONS: Universal repeat screening for syphilis in pregnancy is unlikely to be cost-effective in the current UK setting where syphilis prevalence is low. Repeat screening may be cost-effective in countries with a higher syphilis incidence in pregnancy, particularly if the cost per screen is low.


Subject(s)
Pregnancy Complications, Infectious , Syphilis , Cost-Benefit Analysis , Female , Humans , Mass Screening , Pregnancy , Pregnancy Complications, Infectious/diagnosis , Syphilis/diagnosis , Syphilis/epidemiology , United Kingdom/epidemiology
10.
BMJ Open ; 8(9): e020394, 2018 09 10.
Article in English | MEDLINE | ID: mdl-30201794

ABSTRACT

OBJECTIVES: To quantify the costs, benefits and cost-effectiveness of three multipathogen point-of-care (POC) testing strategies for detecting common sexually transmitted infections (STIs) compared with standard laboratory testing. DESIGN: Modelling study. SETTING: Genitourinary medicine (GUM) services in England. POPULATION: A hypothetical cohort of 965 988 people, representing the annual number attending GUM services symptomatic of lower genitourinary tract infection. INTERVENTIONS: The decision tree model considered costs and reimbursement to GUM services associated with diagnosing and managing STIs. Three strategies using hypothetical point-of-care tests (POCTs) were compared with standard care (SC) using laboratory-based testing. The strategies were: A) dual POCT for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG); B) triplex POCT for CT-NG and Mycoplasma genitalium (MG); C) quadruplex POCT for CT-NG-MG and Trichomonas vaginalis (TV). Data came from published literature and unpublished estimates. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcomes were total costs and benefits (quality-adjusted life years (QALYs)) for each strategy (2016 GB, £) and associated incremental cost-effectiveness ratios (ICERs) between each of the POC strategies and SC. Secondary outcomes were inappropriate treatment of STIs, onward STI transmission, pelvic inflammatory disease in women, time to cure and total attendances. RESULTS: In the base-case analysis, POC strategy C, a quadruplex POCT, was the most cost-effective relative to the other strategies, with an ICER of £36 585 per QALY gained compared with SC when using microcosting, and cost-savings of £26 451 382 when using tariff costing. POC strategy C also generated the most benefits, with 240 467 fewer clinic attendances, 808 fewer onward STI transmissions and 235 135 averted inappropriate treatments compared with SC. CONCLUSIONS: Many benefits can be achieved by using multipathogen POCTs to improve STI diagnosis and management. Further evidence is needed on the underlying prevalence of STIs and SC delivery in the UK to reduce uncertainty in economic analyses.


Subject(s)
Clinical Laboratory Techniques/economics , Health Care Costs/statistics & numerical data , Point-of-Care Systems/economics , Sexually Transmitted Diseases/diagnosis , Sexually Transmitted Diseases/economics , Chlamydia Infections/diagnosis , Chlamydia Infections/drug therapy , Chlamydia Infections/economics , Cost Savings , Cost-Benefit Analysis , Decision Trees , Female , Gonorrhea/diagnosis , Gonorrhea/drug therapy , Gonorrhea/economics , Humans , Inappropriate Prescribing/economics , Models, Economic , Mycoplasma Infections/diagnosis , Mycoplasma Infections/drug therapy , Mycoplasma Infections/economics , Quality-Adjusted Life Years , Sexually Transmitted Diseases/drug therapy , Sexually Transmitted Diseases/transmission , Trichomonas Vaginitis/diagnosis , Trichomonas Vaginitis/drug therapy , Trichomonas Vaginitis/economics
11.
AIDS ; 29(17): 2269-78, 2015 Nov.
Article in English | MEDLINE | ID: mdl-26544700

ABSTRACT

OBJECTIVE: The objective of this study is to assess the risk of viral rebound in postpartum women on suppressive combination antiretroviral therapy (cART). METHODS: Using data from the UK Collaborative HIV Cohort (UK CHIC) study and the UK and Ireland National Study of HIV in Pregnancy and Childhood (NSHPC), women with HIV-RNA 50 copies/ml or less at delivery in 2006-2011, who started life-long cART during pregnancy (n = 321) or conceived on cART (n = 618), were matched by age, duration on cART and time period, with at least one control (non-postpartum). The cumulative probability of viral rebound (HIV-RNA >200 copies/ml) was assessed by Kaplan-Meier analysis; adjusted hazard ratios (aHRs) for the 0-3 and 3-12 months postdelivery (cases)/pseudo-delivery (controls) were calculated in Cox proportional hazards models. RESULTS: In postpartum women who conceived on cART, 5.9% [95% confidence interval (95% CI) 4.0-7.7] experienced viral rebound by 3 months, and 2.2% (1.4-3.0%) of their controls. The risk of viral rebound was higher in postpartum women than in controls during the first 3 months [aHR 2.63 (1.58-4.39)] but not during the 3-12 months postdelivery/pseudo-delivery. In postpartum women who started cART during pregnancy, 27% (22-32%) experienced viral rebound by 3 months, and 3.0% (1.6-4.4%) of their controls. The risk of viral rebound was higher in postpartum women than in controls during both postdelivery/pseudo-delivery periods [<3 months: aHR 6.63 (3.58-12.29); 3-12 months: aHR 4.05 (2.03-8.09)]. CONCLUSION: In women on suppressive cART, the risk of viral rebound is increased following delivery, especially in the first 3 months, which may be related to reduced adherence, indicating the need for additional adherence support for postpartum women.


Subject(s)
Anti-Retroviral Agents/therapeutic use , Antiretroviral Therapy, Highly Active , HIV Infections/drug therapy , HIV Infections/virology , Parturition , Postpartum Period , Viral Load , Adult , Female , HIV Infections/epidemiology , Humans , Ireland , Kaplan-Meier Estimate , Middle Aged , Pregnancy , Recurrence , Risk Assessment , United Kingdom
12.
AIDS ; 29(7): 801-9, 2015 Apr 24.
Article in English | MEDLINE | ID: mdl-25710412

ABSTRACT

OBJECTIVE: The objective of this study is to assess whether pregnancy is associated with an increased risk of liver enzyme elevation (LEE) and severe LEE in HIV-positive women on antiretroviral therapy (ART). DESIGN: Two observational studies: the UK Collaborative HIV Cohort (UK CHIC) study and the UK and Ireland National Study of HIV in Pregnancy and Childhood (NSHPC). METHODS: Combined data from UK CHIC and NSHPC were used to identify factors associated with LEE (grade 1-4) and severe LEE (grade 3-4). Women starting ART in 2000-2012 were included irrespective of pregnancy status. Cox proportional hazards were used to assess fixed and time-dependent covariates including pregnancy status, CD4 cell count, drug regimen and hepatitis B virus/hepatitis C virus (HBV/HCV) coinfection. RESULTS: One-quarter (25.7%, 982/3815) of women were pregnant during follow-up, 14.2% (n = 541) when starting ART. The rate of LEE was 14.5/100 person-years in and 6.0/100 person-years outside of pregnancy. The rate of severe LEE was 3.9/100 person-years in and 0.6/100 person-years outside of pregnancy. The risk of LEE and severe LEE was increased during pregnancy [LEE: adjusted hazard ratio (aHR) 1.66 (1.31-2.09); severe LEE: aHR 3.57 (2.30-5.54)], including in secondary analyses excluding 541 women pregnant when starting ART. Other factors associated with LEE and severe LEE included lower CD4 cell count (<250 cells/µl), HBV/HCV coinfection and calendar year. CONCLUSION: Although few women developed severe LEE, this study provides further evidence that pregnancy is associated with an increased risk of LEE and severe LEE, reinforcing the need for regular monitoring of liver biomarkers during pregnancy.


Subject(s)
Anti-Retroviral Agents/therapeutic use , Enzymes/blood , HIV Infections/pathology , Liver Function Tests , Liver/enzymology , Pregnancy Complications, Infectious/pathology , Adolescent , Adult , Female , Humans , Middle Aged , Pregnancy , United Kingdom , Young Adult
13.
J Int AIDS Soc ; 17(4 Suppl 3): 19486, 2014.
Article in English | MEDLINE | ID: mdl-25393995

ABSTRACT

INTRODUCTION: High rates of hepatotoxicity have been observed among HIV-positive pregnant women using antiretroviral therapy (ART). However, the extent to which pregnancy affects the risk of ART-induced hepatotoxicity is unclear since studies in this area have generated conflicting results. MATERIAL AND METHODS: Combined data from the UK Collaborative HIV Cohort (UK CHIC) study and the UK and Ireland National Study of HIV in Pregnancy and Childhood (NSHPC) were used. Alanine aminotransferase (ALT) data were assessed according to the Division of AIDS toxicity guidelines to identify factors associated with liver enzyme elevation (LEE) (grade 1-4). Women starting ART in 2000-11 aged 16-49 years were included irrespective of pregnancy status at ART start. Cox proportional hazards were used to assess the associations between fixed (ethnicity, exposure group, HBV/HCV co-infection, prior ART use, and age, year, pregnancy status, viral load and CD4 count at ART start) and time-dependent covariates (pregnancy status, age, year, CD4 count, viral load, duration on ART) and the risk of LEE. RESULTS: Of the 3426 women included, one-quarter (25.0%, n=857) were pregnant during follow-up and 14.4% (n=492) started ART during pregnancy. The rate of LEE was 15/100 person-years (PY) during pregnancy and 6.1/100 PY outside pregnancy. The risk of LEE was increased during pregnancy (adjusted hazard ratio (aHR) 1.61 [1.26-2.06], p<0.001), including in secondary analysis excluding 493 women pregnant when starting ART. Other factors independently associated with LEE were lower CD4 count (<250 cells/mm(3) vs. 251-350 cells/mm(3) aHR 1.25 [1.02-1.54], p=0.03), HBV/HCV co-infection (aHR 1.94 [1.58-2.39], p<0.001), HIV acquired via injecting drug use (aHR 1.61 [1.15-2.24], p=0.01 vs. heterosexually) and calendar year (aHR 1.05 [1.02-1.08], p<0.001 per one year increase). Three ART drugs were associated with increased risk of LEE (efavirenz aHR 1.27 [1.06-1.50], p-value 0.008; maraviroc 4.19 [1.34-13.1], p=0.01; and nevirapine 1.59 [1.30-1.95], p-value <0.001). Use of zidovudine was associated with decreased risk of LEE (aHR 0.74 [0.63-0.87], p<0.001) as was increasing time on an NNRTI-based regimen (aHR 0.91 [0.86-0.96], p<0.001 per additional year). CONCLUSIONS: Pregnant women were at increased risk of LEE, highlighting the importance of close monitoring of toxicity biomarkers during pregnancy.

14.
BMC Infect Dis ; 14: 127, 2014 Mar 04.
Article in English | MEDLINE | ID: mdl-24593018

ABSTRACT

BACKGROUND: Short-term zidovudine monotherapy (ZDVm) remains an option for some pregnant HIV-positive women not requiring treatment for their own health but may affect treatment responses once antiretroviral therapy (ART) is subsequently started. METHODS: Data were obtained by linking two UK studies: the UK Collaborative HIV Cohort (UK CHIC) study and the National Study of HIV in Pregnancy and Childhood (NSHPC). Treatment responses were assessed for 2028 women initiating ART at least one year after HIV-diagnosis. Outcomes were compared using logistic regression, proportional hazards regression or linear regression. RESULTS: In adjusted analyses, ART-naïve (n = 1937) and ZDVm-experienced (n = 91) women had similar increases in CD4 count and a similar proportion achieving virological suppression; both groups had a low risk of AIDS. CONCLUSIONS: In this setting, antenatal ZDVm exposure did not adversely impact on outcomes once ART was initiated for the woman's health.


Subject(s)
Anti-HIV Agents/therapeutic use , HIV Infections/drug therapy , Pregnancy Complications, Infectious/drug therapy , Pregnancy Complications, Infectious/virology , Zidovudine/therapeutic use , Adult , CD4 Lymphocyte Count , Cohort Studies , Female , HIV Infections/epidemiology , Humans , Logistic Models , Pregnancy , Pregnancy Complications, Infectious/epidemiology , Treatment Outcome , United Kingdom/epidemiology
15.
AIDS ; 27(1): 95-103, 2013 Jan 02.
Article in English | MEDLINE | ID: mdl-22713479

ABSTRACT

OBJECTIVES: To describe predictors of pregnancy and changes in pregnancy incidence among HIV-positive women accessing HIV clinical care. METHODS: Data were obtained through the linkage of two separate studies: the UK Collaborative HIV Cohort study (UK CHIC), a cohort of adults attending 13 large HIV clinics; and the National Study of HIV in Pregnancy and Childhood (NSHPC), a national surveillance study of HIV-positive pregnant women. Pregnancy incidence was measured using the proportion of women in UK CHIC with a pregnancy reported to NSHPC. Generalized estimating equations were used to identify predictors of pregnancy and assess changes in pregnancy incidence in 2000-2009. RESULTS: The number of women accessing care at UK CHIC sites increased as did the number of pregnancies. Older women were less likely to have a pregnancy [adjusted relative rate (aRR) 0.44 per 10 year increment in age, [95% confidence interval (CI) (0.41-0.46)], P < 0.001] as were women with CD4 cell count less than 200 cells/µl compared with CD4 cell count 200-350 cells/µl [aRR 0.65 (0.55-0.77), P < 0.001] and women of white ethnicity compared with women of black African ethnicity [aRR 0.67 (0.57-0.80), P < 0.001]. The likelihood that women had a pregnancy increased over the study period [aRR 1.05 (1.03-1.07), P < 0.001). The rate of change did not significantly differ according to age group, antiretroviral therapy use, CD4 group or ethnicity. CONCLUSION: The pregnancy rate among women accessing HIV clinical care increased in 2000-2009. HIV-positive women with, or planning, a pregnancy require a high level of care and this is likely to continue and increase as more women of older age have pregnancies.


Subject(s)
HIV Seropositivity/epidemiology , Infectious Disease Transmission, Vertical/statistics & numerical data , Patient Acceptance of Health Care/statistics & numerical data , Pregnancy Complications, Infectious/epidemiology , Prenatal Care/statistics & numerical data , Reproductive Behavior/statistics & numerical data , Adolescent , Adult , Aged , CD4 Lymphocyte Count , Cohort Studies , Female , Humans , Incidence , Infectious Disease Transmission, Vertical/prevention & control , Middle Aged , Predictive Value of Tests , Pregnancy , Pregnancy Complications, Infectious/prevention & control , Sentinel Surveillance , Time Factors , United Kingdom/epidemiology
16.
BMC Med Res Methodol ; 12: 110, 2012 Jul 28.
Article in English | MEDLINE | ID: mdl-22839414

ABSTRACT

BACKGROUND: The UK Collaborative HIV Cohort (UK CHIC) is an observational study that collates data on HIV-positive adults accessing HIV clinical care at (currently) 13 large clinics in the UK but does not collect pregnancy specific data. The National Study of HIV in Pregnancy and Childhood (NSHPC) collates data on HIV-positive women receiving antenatal care from every maternity unit in the UK and Ireland. Both studies collate pseudonymised data and neither dataset contains unique patient identifiers. A methodology was developed to find and match records for women reported to both studies thereby obtaining clinical and treatment data on pregnant HIV-positive women not available from either dataset alone. RESULTS: Women in UK CHIC receiving HIV-clinical care in 1996-2009, were found in the NSHPC dataset by initially 'linking' records with identical date-of-birth, linked records were then accepted as a genuine 'match', if they had further matching fields including CD4 test date. In total, 2063 women were found in both datasets, representing 23.1% of HIV-positive women with a pregnancy in the UK (n = 8932). Clinical data was available in UK CHIC following most pregnancies (92.0%, 2471/2685 pregnancies starting before 2009). There was bias towards matching women with repeat pregnancies (35.9% (741/2063) of women found in both datasets had a repeat pregnancy compared to 21.9% (1502/6869) of women in NSHPC only) and matching women HIV diagnosed before their first reported pregnancy (54.8% (1131/2063) compared to 47.7% (3278/6869), respectively). CONCLUSIONS: Through the use of demographic data and clinical dates, records from two independent studies were successfully matched, providing data not available from either study alone.


Subject(s)
HIV Infections/drug therapy , Medical Record Linkage , Pregnancy Complications, Infectious/drug therapy , Adolescent , Adult , Anti-HIV Agents/administration & dosage , Cohort Studies , Female , HIV Infections/diagnosis , HIV Infections/epidemiology , HIV Seropositivity/epidemiology , Humans , Ireland/epidemiology , Patient Acceptance of Health Care , Pregnancy , Pregnancy Complications, Infectious/diagnosis , Pregnancy Complications, Infectious/epidemiology , Pregnancy Outcome , United Kingdom/epidemiology , Women's Health , Young Adult
17.
AIDS ; 25(13): 1647-55, 2011 Aug 24.
Article in English | MEDLINE | ID: mdl-21673558

ABSTRACT

OBJECTIVES: To describe antiretroviral therapy (ART) use and clinical status, at start of and during pregnancy, for HIV-positive women receiving ART at conception, including the proportion conceiving on drugs (efavirenz and didanosine) not recommended for use in early pregnancy. METHODS: Women with a pregnancy resulting in a live-birth after 1995 (n = 1537) were identified in an observational cohort of patients receiving HIV care at 12 clinics in the UK by matching records with national pregnancy data. Treatment and clinical data were analysed for 375 women conceiving on ART, including logistic regression to identify factors associated with changing regimen during pregnancy. RESULTS: Of the 375 women on ART, 39 (10%) conceived on dual therapy, 306 (82%) on triple therapy and 30 (8%) on more than three drugs. In total, 116 (31%) women conceived on a regimen containing efavirenz or didanosine (69 efavirenz, 54 didanosine, seven both). Overall, 38% (143) changed regimen during pregnancy, of whom 44% (n = 51) had a detectable viral load around that time. Detectable viral load was associated with increased risk of regimen change [adjusted odds ratio 2.97, 95% confidence interval (CI) (1.70-5.19)], while women on efavirenz at conception were three times more likely to switch than women on other drugs [3.40, (1.84-6.25)]. Regimen switching was also associated with year at conception [0.89, (0.83-0.96)]. CONCLUSION: These findings reinforce the need for careful consideration of ART use among women planning or likely to have a pregnancy in order to reduce viral load before pregnancy and avoid drugs not recommended for early antenatal use.


Subject(s)
Anti-HIV Agents/administration & dosage , Benzoxazines/administration & dosage , Didanosine/administration & dosage , Fertilization , HIV Infections/drug therapy , Pregnancy Complications, Infectious/drug therapy , Adolescent , Adult , Alkynes , Cyclopropanes , Drug Therapy, Combination/methods , Female , HIV Infections/virology , Humans , Middle Aged , Pregnancy , Pregnancy Complications, Infectious/virology , Risk Factors , United Kingdom , Viral Load , Young Adult
18.
Enferm. infecc. microbiol. clín. (Ed. impr.) ; 28(4): 236-238, abr. 2010. tab
Article in Spanish | IBECS | ID: ibc-83988

ABSTRACT

Introducción Los objetivos de este estudio fueron estimar la prevalencia del VIH y del virus de la hepatitis C (VHC), y examinar los factores sociodemográficos y conductuales asociados a estas infecciones en usuarios de droga por vía parenteral (UDVP). Métodos Estudio transversal en UDVP seleccionados en Cataluña en 2006.ResultadosCompartir jeringuillas usadas se asoció a la infección por VIH y VHC. Las prácticas de compartir de forma indirecta y la inyección de cocaína como droga principal se asociaron al VHC, y haberse inyectado en la cárcel al VIH. Conclusión Identificar posibles factores sociodemográficos y conductuales asociados a estas infecciones puede ayudar al diseño de intervenciones preventivas específicas dirigidas a este colectivo (AU)


Introduction The objectives of this study were to estimate the prevalence of human immunodeficiency virus (HIV) and hepatitis C virus (HCV) among injection drug users (IDUs) and identify the sociodemographic and behavioral factors in this population associated with these infections. Methods Cross-sectional study in IDUs recruited in Catalonia in 2006.ResultsEver-sharing syringes was associated with both HIV and HCV infection. Indirect sharing of injecting equipment and injecting cocaine as the main drug were factors associated with HCV infection, and the fact of having injected in prison was associated with HIV infection. Conclusion Identification of sociodemographic and behavioral factors associated with these infections can be of help when designing specific preventive interventions for IDUs (AU)


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Substance Abuse, Intravenous/epidemiology , HIV Infections/epidemiology , HIV Seroprevalence , Hepatitis C/epidemiology , Prisoners , Risk-Taking , Socioeconomic Factors , Spain/epidemiology , Needle Sharing/adverse effects , Needle Sharing/statistics & numerical data , Comorbidity , Cross-Sectional Studies , Equipment Contamination
19.
Enferm Infecc Microbiol Clin ; 28(4): 236-8, 2010 Apr.
Article in Spanish | MEDLINE | ID: mdl-19695744

ABSTRACT

INTRODUCTION: The objectives of this study were to estimate the prevalence of human immunodeficiency virus (HIV) and hepatitis C virus (HCV) among injection drug users (IDUs) and identify the sociodemographic and behavioral factors in this population associated with these infections. METHODS: Cross-sectional study in IDUs recruited in Catalonia in 2006. RESULTS: Ever-sharing syringes was associated with both HIV and HCV infection. Indirect sharing of injecting equipment and injecting cocaine as the main drug were factors associated with HCV infection, and the fact of having injected in prison was associated with HIV infection. CONCLUSION: Identification of sociodemographic and behavioral factors associated with these infections can be of help when designing specific preventive interventions for IDUs.


Subject(s)
HIV Infections/epidemiology , HIV Seroprevalence , Hepatitis C/epidemiology , Substance Abuse, Intravenous/epidemiology , Adult , Comorbidity , Cross-Sectional Studies , Equipment Contamination , Female , Humans , Male , Middle Aged , Needle Sharing/adverse effects , Needle Sharing/statistics & numerical data , Prisoners , Risk-Taking , Socioeconomic Factors , Spain/epidemiology , Young Adult
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