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Estimation of Clinical, Immunological and Virological Failure of First Line Antiretroviral Treatment in Kinshasa, Democratic Republic of Congo
Erick Ntambwe Kamangu
Open Access Library Journal (OALib Journal) , 2018, DOI: 10.4236/oalib.1104560
Abstract:
Background: The prevalence of Human Immunodeficiency Virus (HIV) infection was 1.2% in the Democratic Republic of Congo, according to the Demographic Health Study report in 2014. In 2012, the severe failure rate to first-line ART in Kinshasa was estimated at more than 16%. Objective: The objective of this study is to determine the rate of clinical, immunological and virological failure in first-line treatment in Kinshasa. Methodology: At the 6th month of Antiretroviral Treatment (ART), 138 patients from a follow-up cohort of 8 centers in Kinshasa were received for paraclinical evaluations and analyses. The clinical and paraclinical parameters were recorded on the individual patient sheets as well as the survey forms. Clinical parameters, viral load and CD4 were evaluated at the 6th month of ART. Results: One hundred and thirty-eight (138) patients had returned for follow-up treatment, 81 women and 57 men. The average age of patients is 37 ± 12 years. The dominant age groups are those of 26 to 35 years and 36 to 45 years with 39 patients (28.3%) each, followed by those of 18 to 25 years (21.7%). One hundred and twenty-five (125) patients (90.5%) were in clinical stage 3 and 13 (9.5%) in clinical stage 4 according to the WHO classification. CD4 levels ranged from 98 to 1050 cells/mm3 and a median value of 560 cells/mm3. The median value of the patients’ VLs was 0.90 log10 copies of RNA/ml with respective minimum and maximum values of 0 and 4.82 log10 copies of RNA/ml. The virological failure rate was 24.6%. Conclusions: The rate of virological failure of first-line antiretroviral treatment of patients under treatment in Kinshasa is 24.6% for the year 2015.
Implementation of an In-House Quantitative Real-Time PCR for Determination of HIV Viral Load in Kinshasa
Erick Ntambwe Kamangu, Adawaye Chatte, Raphael Boreux, Richard Lunganza Kalala, Georges Lelo Mvumbi, Patrick Demol, Dolores Vaira, Pierre Marie Hayette
Open Access Library Journal (OALib Journal) , 2014, DOI: 10.4236/oalib.1100855
Abstract: Background: Measurement of Viral Load (VL) is the most reliable mean for evaluating virological monitoring of the Human Immunodeficiency Virus (HIV) infection. It allows determination of the amount of virus present in a given volume. Due to the constraints of costs, the VL is not often requested for patient’s follow-up in countries with limited resources. Hence the objective of this study is to implement an in-house Quantitative Real-Time PCR to assess the VL of HIV infected patients in Kinshasa. Methods: One hundred and fifty five patients positive for HIV type 1, naive of Antiretroviral Therapy (ART) and eligible for treatment were included in the study. Five milliliter of blood was collected in a tube with anticoagulant. One milliliter of plasma was sent to the laboratory for analysis. After RNA extraction, a Quantitative Real time PCR was performed on a portion of the region of the Long Terminal Repeat (LTR) of the virus. Results: Of 155 samples received for determination of VL by Quantitative Real-Time PCR, 153 were successfully amplified according to the protocol. The median VL was 301052.97 copies/ml or 5.48 log10. Conclusions: The results of VL were used to assess the feasibility of the Real-Time Quantitative PCR. It turns a simple, reliable and less expensive alternative for the diagnosis and virological monitoring of HIV patients under ART.
Sustained virological response on second-line antiretroviral therapy following virological failure in HIV-infected patients in rural South Africa
A Schoffelen,A Wensing,H Tempelman,S Geelen
Journal of the International AIDS Society , 2012, DOI: 10.7448/ias.15.6.18254
Abstract: Purpose of the study: Over the last decade, a massive roll-out of antiretroviral drugs in resource-limited settings has taken place. In general, good virological responses on first-line antiretroviral therapy (ART) are achieved in most HIV-infected patients residing there. Still, a growing number of patients experience virological failure over time, resulting in an increasing need for second-line regimens [1]. This study describes the clinical, immunological and virological efficacy of protease inhibitor (PI)-based second-line ART in a clinic in rural South Africa. Methods: An observational cohort study was performed on 210 patients (including 39 children) who initiated PI-based second-line ART at least 12 months prior to data collection. Biannual clinical, immunological and virological monitoring was performed. Primary endpoints were adequate virological response (HIV-RNA<400 copies/ml), full virological suppression (HIV-RNA<50 copies/ml), virological failure (HIV-RNA>1000 after initial virological response) and on-going viremia (HIV-RNA never<400 copies/ml for more than six months). Data were analyzed by an on-treatment (OT) and intention-to-treat (ITT) approach. Results: Median duration of follow-up after switch to second-line treatment was 21 months [IQR 14–37]. 150/210 patients (71%, ITT) were in care and on treatment at the end of follow-up and 16/210 (8%, ITT) had died. After twelve months, an adequate virological response was seen in 106/143 patients (74%, OT), of which 86/143 (60%, OT) experienced full virological suppression and 20/143 (14%, OT) showed persisting low-level viremia (HIV-RNA between 50 and 400 copies/ml). Furthermore, virological responses remained stable after 24 months of second-line ART. Virological efficacy was similar amongst adult and pediatric patients. Median increase in CD4 counts from switch until end of follow-up was 145 cells/mm3 [IQR 1–397] in adults. As in first-line ART, we observed a lack of correlation between virological treatment failure and WHO-defined immunological failure in PI-based therapy. Conclusions: Promising virological outcomes are achieved with PI-based, second-line antiretroviral therapy in adult and pediatric patients in rural South Africa. Results were sustainable during the two-year follow-up period with a high retention rate, although persisting low-level viremia occurred in a subset of patients. The observed viro-immunological dissociation emphasizes the need for virological monitoring.
Virological Response in Cerebrospinal Fluid to Antiretroviral Therapy in a Large Italian Cohort of HIV-Infected Patients with Neurological Disorders  [PDF]
Maria Letizia Giancola,Patrizia Lorenzini,Antonella Cingolani,Francesco Baldini,Simona Bossolasco,Teresa Bini,Laura Monno,Giovanna Picchi,Antonella d’Arminio Monforte,Paola Cinque,Valerio Tozzi,Andrea Antinori
AIDS Research and Treatment , 2012, DOI: 10.1155/2012/708456
Abstract: The aim of the present study was to analyse the effect of antiretroviral (ARV) therapy and single antiretroviral drugs on cerebrospinal fluid (CSF) HIV-RNA burden in HIV-infected patients affected by neurological disorders enrolled in a multicentric Italian cohort. ARVs were considered “neuroactive” from literature reports. Three hundred sixty-three HIV-positive patients with available data from paired plasma and CSF samples, were selected. One hundred twenty patients (33.1%) were taking ARVs at diagnosis of neurological disorder. Mean CSF HIV-RNA was significantly higher in na?ve than in experienced patients, and in patients not taking ARV than in those on ARV. A linear correlation between CSF HIV-RNA levels and number of neuroactive drugs included in the regimen was also found ( ?? = ? 0 . 4 4 , ?? < 0 . 0 0 1 ). Low -plasma HIV-RNA and the lack of neurocognitive impairment resulted in independently associated to undetectable HIV-RNA. Taking nevirapine or efavirenz, or regimen including NNRTI, NNRTI plus PI or boosted PI, was independently associated to an increased probability to have undetectable HIV-RNA in CSF. The inclusion of two or three neuroactive drugs in the ARV regimen was independently associated to undetectable viral load in CSF. Our data could be helpful in identifying ARV regimens able to better control HIV replication in the CNS sanctuary, and could be a historical reference for further analyses. 1. Introduction One of the major concerns about antiretroviral (ARV) therapy is the question of whether current ARV regimens are effective in suppressing HIV-1 replication in the central nervous system (CNS) as well as in plasma. CNS is considered one of the anatomic reservoirs of HIV replication, sites in which the cellular HIV replication has a longer half-life [1, 2]. HIV dynamics in CNS and plasma can evolve independently, leading to virologic compartmentalization of HIV infection in the CNS [3]. It is well known that HIV can evolve and replicate in neurological compartment independently from plasma and the virological response in these two different compartments can be quite different [3–5]. Moreover, a residual HIV replication in CNS and persistent intrathecal immune activation can be detected also in patients on ARV [6, 7]. To assess the replication of HIV in CNS is not easy. The levels of HIV-1 RNA in cerebrospinal fluid (CSF) has been considered an indirect measure to assess active infection in brain tissue and a biological marker of HIV infection, as well as in plasma [8]. The diagnostic and prognostic role of the detection of HIV-1
Involvement of the Genetic Diversity of HIV-1 in the Virological Treatment Failure of First Line Antiretroviral in Kinshasa  [PDF]
Erick Ntambwe Kamangu, Richard Lunganza Kalala, Georges Lelo Mvumbi, Dolores Vaira, Marie-Pierre Hayette
World Journal of AIDS (WJA) , 2017, DOI: 10.4236/wja.2017.71003
Abstract: Background: Genetic diversity of human immunodeficiency virus affects the treatment and the emergence of resistance. Some subtypes would develop resistance more frequently than others. The aim of this study is to determine the rate of virological treatment failure and the involvement of genetic diversity and different mutations in this failure in Kinshasa. Methods: Of the 153 Antiretroviral-naive patients who were included in the cohort, 138 patients have been received for the appointment of the 6th month. Clinical parameters were recorded on individual patient charts. The determination of Viral Load (VL) was done at the Laboratory of Molecular Biology. Clinical and biological parameters of the 6th month were compared with those taken at baseline of the cohort to determine the evolution of patients under treatment. Results: At the consultation of the 6th month, 138 patients (90.2%) had returned out of the 153 included. Eighty-one (58.7%) patients were women and 57 (41.3%) men. The age of patients is between 18 and 65 with an average of 37 years. Ten deaths (6.5%) and 5 (3.3%) lost have been reported. One hundred twenty-five patients (90.5%) were in clinical stage 3 and 13 (9.5%) in clinical stage 4. The median CD4 T cells is 560 cells mm3. The median VLs of patients was 0.90 log10 RNA copies/ml. Of the 34 patients in virological failure, 8 (23.5%) are minimal failure, 23 (67.7%) in moderate failure and 3 (8.8%) in severe failure. According to the Pearson’s test, VLs at 6th months were highly correlated with that of inclusion, with V75 and K70 mutations for NRTIs, with V108 mutation for NNRTI well as the virological failure of treatment. Conclusion: Our results confirmed the hypothesis that high Viral Load at the start of the treatment is a poor prognosis for the development of therapy. Transmitted mutations are involved in treatment failure.
Simplified Assessment of Antiretroviral Adherence and Prediction of Virological Efficacy in HIV-Infected Patients in Cambodia  [PDF]
Olivier Segeral,Yoann Madec,Boroath Ban,Vara Ouk,Chan Roeurn Hak,Clotilde Le Tiec,Eric Nerrienet,Cécile Goujard,Anne Marie Taburet,Jean Francois Delfraissy,Arnaud Fontanet
AIDS Research and Treatment , 2010, DOI: 10.1155/2010/142076
Abstract: Background. Adherence to antiviral therapy is important for HIV-infected people living in low- and middle-income countries, because of poor access to alternative regimens. Methods. We conducted a cross-sectional survey of adherence in Cambodian patients enrolled in the ESTHER program and treated with WHO first-line regimen for at least 6 months. The survey was based on a self-report questionnaire, drug assay, MCV measurement, visual analog scale, and viral load HIV RNA. Results. Two hundred fifty-nine patients treated for a median of 16 months participated in the survey. At inclusion in the program, 158 patients (61%) were ARV-na?ve. The virological success rate was 71% overall and 81% in previously ARV-naive patients. Considered individually, the measures suggested perfect adherence in 71% to 93% of patients. In multivariate analysis adjusted for sex and therapeutic status before HAART initiation, only the biological markers were associated with virological efficacy. Self-funded treatment before entry to the program was highly predictive of virological failure. Conclusion. Adherence was excellent in these Cambodian patients. Biological markers were predictive of virological efficacy. MCV might thus serve as a simple alternative for assessing adherence and predicting virological efficacy among patients receiving AZT- or d4T-based regimens. 1. Introduction Since highly active antiretroviral therapy (HAART) became widely available in industrialized countries, mortality and morbidity among patients living with HIV/AIDS have been substantially reduced [1]. Recently, access to ARV has improved in low- and middle-income countries.In late 2007, three million people in such countries were receiving HAART [2]. Numerous initiatives have shown that countries such as Brazil, Thailand, and Senegal can provide HAART on a large scale by using produced generic drugs [3–5], and that smaller programs can provide HAART in local healthcare centres [6–10]. These cohort studies also demonstrated the efficacy of World Health Organization-(WHO-)recommended first-line HAART regimens, mainly thanks to excellent adherence to treatment [10–12]. It is particularly important to assess adherence during HAART programs, mainly owing to the limited availability of alternative regimens [13]. Indeed, poor adherence can lead to the emergence of drug resistance [14–16], notably to first-line nonnucleoside reverse transcriptase inhibitor (NNRTI-)based regimens recommended by WHO. In countries with poor access to laboratory monitoring (CD4 cell count and viral load), it has been suggested
Sustained Virological Response on Second-Line Antiretroviral Therapy following Virological Failure in HIV-Infected Patients in Rural South Africa  [PDF]
Annelot F. Schoffelen, Annemarie M. J. Wensing, Hugo A. Tempelman, Sibyl P. M. Geelen, Andy I. M. Hoepelman, Roos E. Barth
PLOS ONE , 2013, DOI: 10.1371/journal.pone.0058526
Abstract: Objective This study aims to describe the virological, immunological and clinical efficacy of protease inhibitor (PI)-based second-line antiretroviral therapy (ART) in rural South Africa. Methods An observational cohort study was performed on 210 patients (including 39 children) who initiated PI-based second-line therapy at least 12 months prior to data collection. Biannual clinical, immunological and virological monitoring was performed. Primary endpoints were adequate virological response (plasma HIV-1 RNA<400 copies/ml), full virological suppression (plasma HIV-1 RNA<50 copies/ml) and treatment failure (virological failure (plasma HIV-1 RNA>1000 after initial virological response) or on-going viremia (plasma HIV-1 RNA never<400 copies/ml for more than six months)). Data were analyzed by an on-treatment (OT) and intention-to-treat (ITT) approach. Analyses were primarily performed on the group of patients who switched following first-line virological failure. Results Median duration of follow-up after switch to second-line treatment was 20 months [IQR 11–35]. 191 patients had switched to second-line ART due to first-line virological failure. 139/191 of them (72.8%, ITT) were in care and on treatment at the end of follow-up and 11/191 (5.8%, ITT) had died. After twelve months, an adequate virological response was seen in 92/128 patients (71.9%, OT), of which 78/128 (60.9%, OT) experienced full virological suppression. Virological response remained stable after 24 months. Virological efficacy was similar amongst adult and pediatric patients. As in first-line ART, we observed a lack of correlation between virological failure and WHO-defined immunological failure. Conclusions Good virological outcomes following first-line failure can be achieved with PI-based, second-line antiretroviral therapy in both adult and pediatric patients in rural South Africa. Retention rates were high and virological outcomes were sustainable during the two-year follow-up period, although persisting low-level viremia occurred in a subset of patients. The observed viro-immunological dissociation emphasizes the need for virological monitoring.
Factors Predicting Discordant Virological and Immunological Responses to Antiretroviral Therapy in HIV-1 Clade C Infected Zulu/Xhosa in South Africa  [PDF]
Boris Julg, Danielle Poole, Musie Ghebremichael, Carmen Castilla, Marcus Altfeld, Henry Sunpath, Richard A. Murphy, Bruce D. Walker
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0031161
Abstract: Factors predicting suboptimal CD4 cell recovery have been studied in HIV clade-B infected US and European populations. It is, however, uncertain to what extent these results are applicable to HIV clade-C infected African populations. Multivariate analysis using logistic regression and longitudinal analyses using mixed models were employed to assess the impact of age, gender, baseline CD4 cell count, hemoglobin, body mass index (BMI), tuberculosis and other opportunistic co-infections, and frequencies of regimen change on CD4 cell recovery at 12 and 30 months and on overtime change in CD4 cells among 442 virologically suppressed South Africans. Despite adequate virological response 37% (95% CI:32%–42%) and 83% (95% CI:79%–86%) of patients on antiretroviral therapy failed to restore CD4 cell counts ≥200 cells/mm3 after 12 and ≥500 cells/mm3 after 30 months, respectively, in this South African cohort. Critical risk factors for inadequate recovery were older age (p = 0.001) and nadir CD4 cell count at ART initiation (p<0.0001), while concurrent TB co-infection, BMI, baseline hemoglobin, gender and antiretroviral regimen were not significant risk factors. These data suggest that greater efforts are needed to identify and treat HAART-eligible patients prior to severe CD4 cell decline or achievement of advanced age.
Impact of antiretroviral dosing frequency and daily pill burden on virological success rates in patients of the ICoNA cohort starting their first ART
A Ammassari,P Lorenzini,C Mussini,A Cozzi-Lepri
Journal of the International AIDS Society , 2012, DOI: 10.7448/ias.15.6.18233
Abstract: Complexity of antiretroviral treatment (ART) is a reason for non-adherence and may impact treatment outcome. The association between daily dosing and pill burden and chance of virological success (VS) of first ART has been rarely assessed. 3,674 na ve patients who started treatment after January 2000 were identified from the ICoNA cohort. Number of daily doses and pills were estimated on the basis of the drugs used to rank first ART complexity: 1–2 daily pills once a day (low-pills QD [lpQD]); 3–6 daily pills QD (high-pills QD [hpQD]); 2–5 daily pills BID (low-pills BID [lpBID]); >6 daily pills BID (high-pills BID [hpBID]). VS was the date of first HIV RNA <50 cp/ml. Follow-up was censored at the date of VS or last available HIV RNA. Kaplan-Meier curves estimated probability of achieving VS according to ART complexity. Univariable and multivariable Cox regression stratified by clinical site was used to identify variables associated with VS. ITT principle was applied, using competing risk approach for death. Population: male 75%; median age 37 y (IQR, 32–44); HIV transmission heterosexual 43%, homosexual 33%, drug use 16%; Italian origin 86%; CDC group C 17%; median pre-ART CD4 and log HIV-RNA were 271/mm3 (range, 0–1672) and 4.84 cp/ml (1.70–6.38), respectively. Regimens were started in ‘00–‘02 24%,‘03–‘05 17%,‘06–‘08 17%,‘09–‘12 42% and based on NNRTI in 40%, PI/r 43%, PI 8%, other ART 10%. Frequencies in complexity ranks were: 19% lpQD, 23% hpQD, 32% lpBID, 26% hpBID. VS was achieved by 85% of patients with an overall median time to VS of 5.6 months (95% CI: 5.4–5.8). Median months to VS were shorter with decreasing complexity: hpBID 6.5; lpBID 6.0; hpQD 5.3, lpQD 4.5. Kaplan-Meier curves are shown (Figure). After stratifying for clinical site and adjusting for age, gender, origin, transmission route, CDC group C, HCV/HBV infection, years of HIV, pre-cART CD4 and HIV-RNA, type of regimen a significantly reduced likelihood of achieving VS was found for ART complexity (hpQD: HR 0.76 95% CI 60–0.96; lpBID: 0.74, 0.59–0.94) when compared with lpQD. The chance of VS was higher in people starting ART more recently (RH 1.28 [95% CI 1.09–1.51] for ‘03–‘05; RH 1.64 [1.27–2.10] for ‘09–‘12; vs. ‘00–‘02) and was lower in people with previous AIDS (RH 0.85 [0.73–0.98]). Once-a-day dosing of ART, especially when combined with low daily pill burden, seems to be one of main factors contributing to the higher rate of success of ART in recent years.
The Cost-Effectiveness of Directly Observed Highly-Active Antiretroviral Therapy in the Third Trimester in HIV-Infected Pregnant Women  [PDF]
Caitlin J. McCabe,Sue J. Goldie,David N. Fisman
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0010154
Abstract: In HIV-infected pregnant women, viral suppression prevents mother-to-child HIV transmission. Directly observed highly-active antiretroviral therapy (HAART) enhances virological suppression, and could prevent transmission. Our objective was to project the effectiveness and cost-effectiveness of directly observed administration of antiretroviral drugs in pregnancy.
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