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  • Oxford University Press (OUP)  (14)
  • 1
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    Prevalence and Evolution of Renal Impairment in People Living With HIV in Rural Tanzania
    Oxford University Press (OUP) ; 2018
    In:  Open Forum Infectious Diseases Vol. 5, No. 4 ( 2018-04-01)
    Details
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 5, No. 4 ( 2018-04-01)
    Abstract: We assessed the prevalence, incidence, and predictors of renal impairment among people living with HIV (PLWHIV) in rural Tanzania. Methods In a cohort of PLWHIV aged ≥15 years enrolled from January 2013 to June 2016, we assessed the association between renal impairment (estimated glomerural filtration rate & lt; 90 mL/min/1.73 m2) at enrollment and during follow-up with demographic and clinical characteristcis using logistic regression and Cox proportional hazards models. Results Of 1093 PLWHIV, 172 (15.7%) had renal impairment at enrollment. Of 921 patients with normal renal function at baseline, 117 (12.7%) developed renal impairment during a median follow-up (interquartile range) of 6.2 (0.4–14.7) months. The incidence of renal impairment was 110 cases per 1000 person-years (95% confidence interval [CI], 92–132). At enrollment, logistic regression identified older age (adjusted odds ratio [aOR] , 1.79; 95% CI, 1.52–2.11), hypertension (aOR, 1.84; 95% CI, 1.08–3.15), CD4 count & lt;200 cells/mm3 (aOR, 1.80; 95% CI, 1.23–2.65), and World Health Organization (WHO) stage III/IV (aOR, 3.00; 95% CI, 1.96–4.58) as risk factors for renal impairment. Cox regression model confirmed older age (adjusted hazard ratio [aHR], 1.85; 95% CI, 1.56–2.20) and CD4 count & lt;200 cells/mm3 (aHR, 2.05; 95% CI, 1.36–3.09) to be associated with the development of renal impairment. Conclusions Our study found a low prevalence of renal impairment among PLWHIV despite high usage of tenofovir and its association with age, hypertension, low CD4 count, and advanced WHO stage. These important and reassuring safety data stress the significance of noncommunicable disease surveillance in aging HIV populations in sub-Saharan Africa.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    URL: Article
    DOI: 10.1093/ofid/ofy072
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2018
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  • 2
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    Prevalence and Outcomes of Hepatitis B Coinfection and Associated Liver Disease Among Antiretroviral Therapy-Naive Individuals in a Rural Tanzanian Human Immunodeficiency Virus Cohort
    Oxford University Press (OUP) ; 2016
    In:  Open Forum Infectious Diseases Vol. 3, No. 3 ( 2016-05-01)
    Details
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 3, No. 3 ( 2016-05-01)
    Abstract: Background.  We evaluated the prevalence of chronic hepatitis B virus (HBV) infection and liver fibrosis/cirrhosis in human immunodeficiency virus (HIV)-infected individuals enrolled in a rural Tanzanian prospective cohort and assessed hepatic fibrosis progression 12–24 months after antiretroviral treatment (ART) initiation. Methods.  All ART-naive HIV-infected adults ≥15-year-old enrolled in the Kilombero and Ulanga Antiretroviral Cohort who started ART between 2005 and 2015 were included. Pre-ART factors associated with significant liver fibrosis (aspartate aminotransferase-to-platelet ratio index [APRI] & gt;1.5) and cirrhosis (APRI & gt; 2.0) were identified using logistic regression. Results.  Of 3097 individuals screened, 227 (7.3%; 95% CI, 6.4–8.2) were hepatitis B surface antigen (HBsAg) positive. Before ART initiation, 9.1% individuals had significant liver fibrosis and 5.3% had cirrhosis. Human immunodeficiency virus/HBV-coinfected individuals were more likely to have an APRI score indicating significant fibrosis (14.2% vs 8.7%, P = .03) and cirrhosis (9.2% vs 4.9%, P = .03) than HBV-uninfected patients. CD4 cell count & lt;200 cell/μL and alcohol consumption were independently associated with pre-ART APRI score, indicating significant fibrosis and cirrhosis in multivariable analyses. Among individuals with elevated APRI measurements pre- and 12–24 months post-ART initiation, 53 of 57 (93.0%) of HIV-monoinfected and 4 of 5 (80.0%) of HIV/HBV-coinfected had a regression to APRI & lt; 1.5. Conclusions.  Hepatic fibrosis and cirrhosis were common in our cohort, especially among HIV/HBV-coinfected individuals. The APRI improved in most patients. Pre-ART HBsAg screening and early onset of tenofovir-based ART for HIV/HBV-coinfection should be prioritized in sub-Saharan Africa.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    URL: Article
    DOI: 10.1093/ofid/ofw162
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2016
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  • 3
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    Evaluating Diversity in Randomized Clinical Trials of Dolutegravir-Based Antiretroviral Therapy Regimens: Pooled 48-Week Analyses by Race, Sex, and Regional Subgroups
    Oxford University Press (OUP) ; 2022
    In:  Open Forum Infectious Diseases Vol. 9, No. 8 ( 2022-08-02)
    Details
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 9, No. 8 ( 2022-08-02)
    Abstract: In HIV clinical trials, proportions of Black and female participants achieving virologic suppression (VS) are often lower compared with White and male participants. As the antiretroviral therapy (ART) landscape continues to evolve, addressing existing challenges in clinical trial diversity will be critical to effectively translate results into clinical practice. Here, we pooled data to evaluate the efficacy and safety of dolutegravir (DTG)-containing regimens by race, sex, and regional subgroups. Methods Three pooled analyses were conducted using 48-week results from phase 3/3b trials: DTG 3-drug vs non-DTG-containing 3- or 4-drug regimens in ART-naive participants (ARIA, FLAMINGO, SINGLE, SPRING-2), DTG-containing 2-drug vs 3-drug regimens in ART-naive participants (GEMINI-1, GEMINI-2), and DTG 3-drug vs non-DTG-containing 3- or 4-drug regimens in ART-experienced participants (SAILING, DAWNING). Proportions of participants with VS, safety, and change from baseline in CD4+ cell count were analyzed. Results Proportions of participants achieving VS were high among those receiving DTG vs comparator regimens. Proportions of participants achieving VS were generally lower in Black (vs non-Black), female (vs male), and US (vs non-US) subgroups. No new safety signals emerged from any subgroup in pooled analyses. Conclusions These analyses confirm that, across subgroups, DTG has robust efficacy and a good safety profile at week 48 relative to comparator regimens. Achieving VS may vary by participant characteristics, highlighting the urgent need for enrollment to reflect the demographics of global HIV populations more accurately. Future studies should strive to support participants throughout the trial to ensure optimal representation, inclusion, and retention.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    URL: Article
    DOI: 10.1093/ofid/ofac304
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 4
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    1285. Systematic Literature Review of Real-world Experience with the 2-Drug Regimen Dolutegravir and Lamivudine in People with HIV Who Would Not Have Met Inclusion Criteria for the Phase 3 Clinical Program
    Oxford University Press (OUP) ; 2022
    In:  Open Forum Infectious Diseases Vol. 9, No. Supplement_2 ( 2022-12-15)
    Details
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 9, No. Supplement_2 ( 2022-12-15)
    Abstract: In phase 3 randomized controlled trials (RCTs), dolutegravir/lamivudine (DTG/3TC) demonstrated durable efficacy in treatment-naive (GEMINI-1/-2) and virologically suppressed switch (TANGO, SALSA) participants. Eligibility criteria for these RCTs included no history of treatment failure or any major nucleoside reverse transcriptase inhibitor or integrase inhibitor–associated mutations, no hepatitis B virus (HBV) or need for hepatitis C virus (HCV) therapy, and viral load (VL) & lt; 500,000 c/mL at screening (GEMINI) or & lt; 50 c/mL for & gt; 6 months (TANGO, SALSA). We analyzed real-world evidence (RWE) for DTG + 3TC use in people with HIV (PWH) with baseline characteristics not consistent with these inclusion criteria. Methods We conducted a systematic literature review according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement. RWE studies that reported on DTG + 3TC use in PWH were retrieved from Ovid MEDLINE®, Embase®, PubMed, Cochrane library, and relevant international conference proceedings from January 2013 to February 2022. Results This review includes 122 publications from 103 RWE studies of 44 unique cohorts (N=8034; 42 cohorts outside the United States; Tables 1-2, Figure). In the 1 study that described outcomes in PWH with previous virologic failure (VF; N=194), probability of VF at 1 year was low (0.4% or 1.2%, depending on VF criteria). In cohorts with & gt; 10 PWH with baseline resistance that reported outcomes (mostly M184V/I; 4 cohorts, N=211), VF was low (ranging from 0%-5.4% at ∼1 year), and the difference in VF between those with or without M184V/I was not significant in 3 of 4 cohorts. A treatment-emergent resistance mutation (M41L, not selected by DTG or 3TC) was observed in 1 PWH with evidence of baseline resistance. None of the 35 PWH with HBV experienced VF, and 89% (16/18) of treatment-naive PWH with baseline VL & gt; 500,000 c/mL achieved virologic suppression at Week 24. There were no studies describing effectiveness outcomes in PWH with HCV who were receiving DTG/3TC. Conclusion DTG + 3TC has been used in PWH with various baseline characteristics, including RCT exclusion criteria. Outcomes from published RWE in these subgroups further support the clinical data demonstrating the high effectiveness and barrier to resistance of DTG + 3TC. Disclosures Jihad Slim, MD, FACP, abbvie- speaker bureau: Honoraria|Gilead Speaker Bureau: Honoraria|Janssen Speaker Bureau: Honoraria|Merck Speaker Bureau: Honoraria Douglas Ward, MD, ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Honoraria Stefan Schneider, MD, GlaxoSmithKline: Grant/Research Support|Janssen: Grant/Research Support|ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Grant/Research Support Madhusudan Kabra, BPharm, MSc, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare: Employee Gustavo Verdier, BSc, BPharm, MBA, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare ULC: Salary Clifford B. Jones, BSc MSc MB ChB, GSK: Stocks/Bonds|viiv healthcare: Employee Emilio Letang, MD, MPH, PhD, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare: Employee.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    URL: Article
    DOI: 10.1093/ofid/ofac492.1116
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 5
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    Recognition and management of clinically significant drug–drug interactions between antiretrovirals and co-medications in a cohort of people living with HIV in rural Tanzania: a prospective questionnaire-based study
    Oxford University Press (OUP) ; 2021
    In:  Journal of Antimicrobial Chemotherapy Vol. 76, No. 10 ( 2021-09-15), p. 2681-2689
    Details
    In: Journal of Antimicrobial Chemotherapy, Oxford University Press (OUP), Vol. 76, No. 10 ( 2021-09-15), p. 2681-2689
    Abstract: The extent to which drug–drug interactions (DDIs) between antiretrovirals (ARVs) and co-medications are recognized and managed has not been thoroughly evaluated in limited-resource settings. Objectives This prospective questionnaire-based study aimed to determine the prevalence and risk factors for unrecognized/incorrectly managed DDIs in people living with HIV followed-up at the Chronic Diseases Clinic of Ifakara (CDCI) and enrolled in the Kilombero and Ulanga Antiretroviral Cohort (KIULARCO). Methods We prospectively included ARV-treated adults receiving ≥1 co-medication coming for a follow-up visit at the CDCI between March and July 2017. Using a structured questionnaire, physicians were requested to identify potentially clinically significant DDIs in the prescribed treatment, to provide recommendations for their management and to indicate any hurdles to implement the recommendations. Prescriptions were subsequently screened for DDIs using the Liverpool DDIs database. Identified clinically significant DDIs and their recommended management according to the DDIs database were compared with the information provided in the questionnaires. Results Among 334 participants, the median age was 47 years (IQR = 40–56 years), 69% were female and 82% had ≥1 non-communicable disease (NCD). Overall, 129 participants had ≥1 clinically relevant DDI, which was not recognized and/or incorrectly managed in 56 participants (43%). Of those, 6 (11%) were due to limited monitoring options or medication affordability issues. In the multivariable logistic regression, the presence of ≥1 NCD was associated with an increased risk for unrecognized/incorrect DDI management (OR = 15.8; 95% CI = 1.8–139.6). Conclusions Recognition/appropriate management of DDIs is suboptimal, highlighting the need for educational programmes, pharmacovigilance activities and increased access to medications and monitoring options. This should become a focus of HIV programmes given the increasing burden of NCDs in sub-Saharan Africa.
    Type of Medium: Online Resource
    ISSN: 0305-7453 , 1460-2091
    URL: Article
    DOI: 10.1093/jac/dkab254
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
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  • 6
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    Determinants of virological failure and antiretroviral drug resistance in Mozambique
    Oxford University Press (OUP) ; 2015
    In:  Journal of Antimicrobial Chemotherapy Vol. 70, No. 9 ( 2015-09), p. 2639-2647
    Details
    In: Journal of Antimicrobial Chemotherapy, Oxford University Press (OUP), Vol. 70, No. 9 ( 2015-09), p. 2639-2647
    Type of Medium: Online Resource
    ISSN: 0305-7453 , 1460-2091
    URL: Article
    DOI: 10.1093/jac/dkv143
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2015
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  • 7
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    Persistent High Burden and Mortality Associated With Advanced HIV Disease in Rural Tanzania Despite Uptake of World Health Organization “Test and Treat” Guidelines
    Oxford University Press (OUP) ; 2022
    In:  Open Forum Infectious Diseases Vol. 9, No. 12 ( 2022-12-02)
    Details
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 9, No. 12 ( 2022-12-02)
    Abstract: Information about burden, characteristics, predictors, and outcomes of advanced human immunodeficiency virus disease (AHD) is scarce in rural settings of sub-Saharan Africa. Human immunodeficiency virus (HIV) infections and associated deaths remain high despite specific guidelines issued by the World Health Organization (WHO). Methods Burden of AHD and 6-month death/loss to follow-up (LTFU) were described among 2498 antiretroviral therapy (ART)–naive nonpregnant people with HIV (PWH) aged & gt;15 years enrolled in the Kilombero Ulanga Antiretroviral Cohort in rural Tanzania between 2013 and 2019. Baseline characteristics associated with AHD and predictors of death/LTFU among those with AHD were analyzed using multivariate logistic and Cox regression, respectively. Results Of the PWH, 62.2% had AHD at diagnosis (66.8% before vs 55.7% after national uptake of WHO “test and treat” guidelines in 2016). At baseline, older age, male sex, lower body mass index, elevated aminotransferase aspartate levels, severe anemia, tachycardia, decreased glomerular filtration rate, clinical complaints, impaired functional status, and enrollment into care before 2018 were independently associated with AHD. Among people with AHD, incidence of mortality, and LTFU were 16 and 34 per 100 person-years, respectively. WHO clinical stage 3 or 4, CD4 counts & lt;100 cells/µL, severe anemia, tachypnea, and liver disease were associated with death/LTFU. Conclusions More than 50% of PWH enrolled in our cohort after test and treat implementation still had AHD at diagnosis. Increasing HIV testing and uptake and implementation of the WHO-specific guidelines on AHD for prevention, diagnosis, treatment of opportunistic infections, and reducing the risks of LTFU are urgently needed to reduce morbidity and mortality.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    URL: Article
    DOI: 10.1093/ofid/ofac611
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 8
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    Cryptococcal Antigenemia in Immunocompromised Human Immunodeficiency Virus Patients in Rural Tanzania: A Preventable Cause of Early Mortality
    Oxford University Press (OUP) ; 2015
    In:  Open Forum Infectious Diseases Vol. 2, No. 2 ( 2015-04-01)
    Details
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 2, No. 2 ( 2015-04-01)
    Abstract: Background.  Cryptococcal meningitis is a leading cause of death in people living with human immunodeficiency virus (HIV)/acquired immune deficiency syndrome. The World Health Organizations recommends pre-antiretroviral treatment (ART) cryptococcal antigen (CRAG) screening in persons with CD4 below 100 cells/µL. We assessed the prevalence and outcome of cryptococcal antigenemia in rural southern Tanzania. Methods.  We conducted a retrospective study including all ART-naive adults with CD4 & lt;150 cells/µL prospectively enrolled in the Kilombero and Ulanga Antiretroviral Cohort between 2008 and 2012. Cryptococcal antigen was assessed in cryopreserved pre-ART plasma. Cox regression estimated the composite outcome of death or loss to follow-up (LFU) by CRAG status and fluconazole use. Results.  Of 750 ART-naive adults, 28 (3.7%) were CRAG-positive, corresponding to a prevalence of 4.4% (23 of 520) in CD4 & lt;100 and 2.2% (5 of 230) in CD4 100–150 cells/µL. Within 1 year, 75% (21 of 28) of CRAG-positive and 42% (302 of 722) of CRAG-negative patients were dead or LFU (P & lt;.001), with no differences across CD4 strata. Cryptococcal antigen positivity was an independent predictor of death or LFU after adjusting for relevant confounders (hazard ratio [HR], 2.50; 95% confidence interval [CI] , 1.29–4.83; P = .006). Cryptococcal meningitis occurred in 39% (11 of 28) of CRAG-positive patients, with similar retention-in-care regardless of meningitis diagnosis (P = .8). Cryptococcal antigen titer & gt;1:160 was associated with meningitis development (odds ratio, 4.83; 95% CI, 1.24–8.41; P = .008). Fluconazole receipt decreased death or LFU in CRAG-positive patients (HR, 0.18; 95% CI, .04–.78; P = .022). Conclusions.  Cryptococcal antigenemia predicted mortality or LFU among ART-naive HIV-infected persons with CD4 & lt;150 cells/µL, and fluconazole increased survival or retention-in-care, suggesting that targeted pre-ART CRAG screening may decrease early mortality or LFU. A CRAG screening threshold of CD4 & lt;100 cells/µL missed 18% of CRAG-positive patients, suggesting guidelines should consider a higher threshold.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    URL: Article
    DOI: 10.1093/ofid/ofv046
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2015
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  • 9
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    Minimally Invasive Tissue Sampling: A Tool to Guide Efforts to Reduce AIDS-Related Mortality in Resource-Limited Settings
    Oxford University Press (OUP) ; 2021
    In:  Clinical Infectious Diseases Vol. 73, No. Supplement_5 ( 2021-12-15), p. S343-S350
    Details
    In: Clinical Infectious Diseases, Oxford University Press (OUP), Vol. 73, No. Supplement_5 ( 2021-12-15), p. S343-S350
    Abstract: Available information on the causes of death among people living with human immunodeficiency virus (PLHIV) in low- and middle-income countries (LMICs) remains scarce. We aimed to provide data on causes of death in PLHIV from two LMICs, Brazil and Mozambique, to assess the impact of clinical misdiagnosis on mortality rates and to evaluate the accuracy of minimally invasive tissue sampling (MITS) in determining the cause of death in PLHIV. Methods We performed coupled MITS and complete autopsy on 164 deceased PLHIV (18 children, 36 maternal deaths, and 110 adults). HIV antibody levels and HIV RNA viral loads were determined from postmortem serum samples. Results Tuberculosis (22.7%), toxoplasmosis (13.9%), bacterial infections (13.9%), and cryptococcosis (10.9%) were the leading causes of death in adults. In maternal deaths, tuberculosis (13.9%), bacterial infections (13.9%), cryptococcosis (11.1%), and cerebral malaria (8.3%) were the most frequent infections, whereas viral infections, particularly cytomegalovirus (38.9%), bacterial infections (27.8%), pneumocystosis (11.1%), and HIV-associated malignant neoplasms (11.1%) were the leading cause among children. Agreement between the MITS and the complete autopsy was 100% in children, 91% in adults, and 78% in maternal deaths. The MITS correctly identified the microorganism causing death in 89% of cases. Conclusions Postmortem studies provide highly granular data on the causes of death in PLHIV. The inaccuracy of clinical diagnosis may play a significant role in the high mortality rates observed among PLHIV in LMICs. MITS might be helpful in monitoring the causes of death in PLHIV and in highlighting the gaps in the management of the infections.
    Type of Medium: Online Resource
    ISSN: 1058-4838 , 1537-6591
    URL: Article
    DOI: 10.1093/cid/ciab789
    RVK:
    XA 10000
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
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  • 10
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    Strengthening HIV therapy and care in rural Tanzania affects rates of viral suppression
    Oxford University Press (OUP) ; 2017
    In:  Journal of Antimicrobial Chemotherapy Vol. 72, No. 7 ( 2017-07), p. 2069-2074
    Details
    In: Journal of Antimicrobial Chemotherapy, Oxford University Press (OUP), Vol. 72, No. 7 ( 2017-07), p. 2069-2074
    Type of Medium: Online Resource
    ISSN: 0305-7453 , 1460-2091
    URL: Article
    DOI: 10.1093/jac/dkx095
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2017
    detail.hit.zdb_id: 1467478-6
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