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Evaluation of the Nigerian national antiretroviral (ARV) treatment training programme
O Odutolu, P Okonkwo, M O Folayan, C B Uwakwe, R A Audu, O M Jolayemi, R A Audu, M Osagbemi
SAHARA J (Journal of Social Aspects of HIV/AIDS Research Alliance) , 2006,
Abstract: There is an understanding that greater availability of HIV treatment for the 40.3 million people currently infected with HIV is a humanitarian imperative that could prolong the lives of millions, restore economic productivity, and stabilise societies in some of the world's hardest-hit regions. The Nigerian government recognises that the country has the third highest burden of infection, with people living with HIV estimated to total 4.0 million, and so in 2002 commenced the implementation of one of Africa's largest antiretroviral (ARV) treatment programmes. A successful ARV programme requires that all components of a functional management system be put in place for effective and efficient functioning. This would include logistics, human resources, financial planning, and monitoring and evaluation systems, as well as sustainable institutional capacities. The Nigerian national ARV treatment training programme was conceived to meet the human resource needs in hospitals providing ARV therapy. This paper reports on the evaluation of the training programme. It examines knowledge and skills gained, and utilisation thereof. Recommendations are made for improved training effectiveness and for specific national policy on training, to meet the demand for scaling up therapy to the thousands who need ARV.
A clinical assessment of antiretroviral-treated patients Referred from the private sector to the South African government antiretroviral (ARV) programme: a retrospective analysis
R Gounden
Southern African Journal of HIV Medicine , 2011,
Abstract: Objectives. A comparison of the effects of highly active antiretroviral therapy (HAART) on the immunological, virological and clinical status of two groups of patients in the South African government antiretroviral (ARV) programme in KwaZulu-Natal, viz. patients previously treated with ARVs in the private sector and then entering the government programme (private group), and ARV-na ve patients entering the programme directly (government group). Methods. A retrospective, cohort study was performed by reviewing records of 58 former private sector patients and 98 patients initiated on ARV treatment in the government sector. Treatment regimens, CD4 cell counts, viral loads and regimen modifications were analysed. Results. The study found that use of various classes of ARV drugs varied between the private sector and the government sector. Median distribution of CD4 cell count increased from 158.5 to 419 cells/μl for the private group (42 patients (72.4%)) and from 101 to 358 cells/μl for the government group (95 patients (96.9%)), over an average time span ranging from 29 to 30 months. Median viral load decreased in the private group (29 patients (50%)) and the government group (66 patients (67.3%)) to approximately 3.22 log copies/ml (25 copies/ml) over an average time span ranging from 27 to 29 months. The rate of change of CD4 cell count (p=0.47) and viral load (p=0.097) between the two groups was not significantly different. Conclusion. This study showed that even for patients with prior experience with ARVs, virological and immunological success is still achievable with the use of standardised HAART regimens in the government programme.
Factors associated with clinical, immunological and virological responses in protease-inhibitor-experienced brazilian children receiving highly active antiretroviral therapy containing Lopinavir-Ritonavir
Machado, Daisy Maria;Gouvêa, Aída de Fátima Barbosa;Cardoso, Maria Regina;Beltr?o, Suênia Vasconcelos;Cunegundes, Kelly Simone;Bononi, Fabiana;Almeida, Fernanda;Cavalheiro, Kaline;Angelis, Daniela Souza Araújo de;Succi, Regina Célia de Menezes;
Brazilian Journal of Infectious Diseases , 2007, DOI: 10.1590/S1413-86702007000100006
Abstract: this study evaluates clinical, virological and immunological responses to antiretroviral (arv) therapy based on lopinavir/ritonovir (lpv/r) in previously protease -inhibitor-experienced children. the study included 29 brazilian children (median age = 5.91 years) who had failed previous arv therapy and had begun a regimen based on lpv/r. at 12 months follow-up, a good virological response to lpv/r therapy was defined as achieving an undetectable viral load or as a decrease in plasma hiv rna levels to > 1 log. a good immunological response was defined as an increase in cd4+ cell count from baseline sufficient to attain a better cdc immune stage classification. the number of infectious episodes 12 months before and 12 months after beginning lpv/r was assessed. sixteen (55.2%) and 19 (65.5%) of 29 patients exhibited good virological and immunological responses, respectively. baseline cd4+ values (>500) predicted both virological and immunological responses (p<0.05). older children were less likely to develop an immunological response (p<0.001) than younger children. nine children receiving 3 arv drugs plus lpv/r showed an immunological response (100%) compared to 10/20 (50%) children receiving 2 drugs plus lpv/r (p=0.01). a lower number (n<5) of infectious episodes was noted after 12 months follow-up in children using the lpv/r regimen (p=0.006). there was a positive correlation between children whose baseline cd4+ values were greater than 500 cells/mm3 and virological responses. although virological responses to therapy were seen in about half the children (55.2%), the use of haart containing lpv/r provided clinical and immmunological benefits.
HIV integrase variability and genetic barrier in antiretroviral na?ve and experienced patients
Antonio Piralla, Stefania Paolucci, Roberto Gulminetti, Giuditta Comolli, Fausto Baldanti
Virology Journal , 2011, DOI: 10.1186/1743-422x-8-149
Abstract: IN variability was analyzed and compared with reverse transcriptase (RT) and protease (PR) variability in 41 treatment na?ve and 54 RT inhibitor (RTI) and protease inhibitor (PRI) experienced patients from subjects infected with subtype B and non-B strains. In addition, four HIV-2 strains were analyzed in parallel. Frequency and distribution of IN mutations were compared between HAART-na?ve and RTI/PI-experienced patients; the genetic barrier for 27 amino acid positions related to INI susceptibility was calculated as well.Primary mutations associated with resistance to INI were not detected in patients not previously treated with this class of drug. However, some secondary mutations which have been shown to contribute to INI resistance were found. Only limited differences in codon usage distribution between patient groups were found. HIV-2 strains from INI na?ve patients showed the presence of both primary and secondary resistance mutations.Exposure to antivirals other than INI does not seem to significantly influence the emergence of mutations implicated in INI resistance. HIV-2 strain might have reduced susceptibility to INI.Raltegravir (MK-0518; Isentress, Merck) was the first integrase (IN) inhibitor approved for treatment of HIV infection [1], while other compounds such as GS-9137 [2], S-1360 [3], and L-870,810 [4] are at different stages of development. Raltegravir (RAL) has shown potent and durable antiretroviral activity in both treatment na?ve [5,6] and highly experienced HIV-1-infected individuals. Due to its novel mechanism of action, RAL was shown to be effective also against HIV-1 strains resistant to reverse transcriptase (RT), protease (PR) and entry inhibitors, both in vitro [7] and in vivo [8,9]. However, it has been observed that failure of highly active antiretroviral therapy (HAART) including RAL might be related to the emergence of drug-resistant virus variants [10-15], and amino acid changes associated with resistance to integrase inhibitors (I
Observational epidemiological study to identify the clinical profile of na ve patients starting antiretroviral (ARV) therapy in Spain
A Ocampo,P Viciana,H Hevia,F Ledesma
Journal of the International AIDS Society , 2012, DOI: 10.7448/ias.15.6.18298
Abstract: Purpose of the study: To identify the proportion of patients starting ARV treatment with NNRTIs or with a PI/r and to explore and compare their clinical profile establishing different factors whereby physicians select the initial ARV treatment in a Spanish clinical setting. Methods: An observational study was conducted in two different phases. In Phase I a cross-sectional registration was conducted for patients who initiated ARV treatment in a 6-month period in 65 Spanish hospitals. In Phase II clinical and social-demographic features were collected retrospectively of patients who visited HIV clinics between August and November 2010 who had started ARV treatment containing an NNRTIs or a PI/r in Phase I. Summary of results: In Phase I, 1,687 subjects who initiated ARV treatment were registered, of which 53% started with an NNRTI-based regimen whereas 42% started with a PI/r-based regimen. Two percent of the treatment initiations occurred in a clinical trial. In Phase II, 642 patients were paired consecutively and retrospectively. The group of patients was composed of predominantly male subjects (81% vs 19%). The median time between diagnosis and the start of ARV treatment was 3.6±5.3 years. At the initiation of treatment, 72% of patients had a CD4 count below 350 cells/μl. Although treatment based on NNRTIs in na ve patients is the most frequent option in Spain, the analysis of clinical profiles shows that PI/r-based therapy is more often used than NNRTIs with statistical significance in patients with high viral load, Fig. A (≥100.000 copies/ml) (58% vs 42%; OR:1,75; 95% CI: 1,26–2,43; p<0,01), with CD4 cell counts <200 cells/μl, Fig. B (68% vs 31%; OR: 2,92; 95% CI: 1,99–4,27; p<0,01), and in patients at CDC stage C (65% vs 35%; OR: 2,05; CI: 1,27–3,31; p<0,01). Conclusions: In Spain, HIV is still diagnosed late (as measured by CD4 count<350 cells/μl). Treatment based on NNRTIs are more frequently used in na ve patients, although PIs/r-based regimens play an important role being the preferred option in patients with high viral load (≥100.000 copies/ml) and low CD4 cell count (<200 cells/μl).
Immunological predictors of CD4+ T cell decline in antiretroviral treatment interruptions
Elena Seoane, Salvador Resino, Santiago Moreno, Juan de Quiros, Ana Moreno, Rafael Rubio, Juan Gonzalez-García, José Arribas, Federico Pulido, Ma ángeles Mu?oz-Fernández
BMC Infectious Diseases , 2008, DOI: 10.1186/1471-2334-8-20
Abstract: 27 HIV-infected patients participated in a prospective multicenter study in with a 24 month follow-up. Patients on stable highly active antiretroviral therapy (HAART), with CD4+ count > 600/μL, and HIV-RNA < 50 copies/ml for at least 6 months were offered the option to discontinue antiretroviral therapy. The main outcome was a decline in CD4+ cell count to < 350/μL.After 24 months of follow-up, 16 of 27 (59%) patients (who discontinued therapy) experienced declines in CD4+ cell count to < 350/μL. Patients with a CD4+ nadir of < 200 cells/μL had a greater risk of restarting therapy during the follow-up (RR (CI95%): 3.37 (1.07; 10.36)). Interestingly, lymphoproliferative responses to Mycobacterium tuberculosis purified protein derivative (PPD) below 10000 c.p.m. at baseline (4.77 (1.07; 21.12)), IL-4 production above 100 pg/mL at baseline (5.95 (1.76; 20.07)) in PBMC cultured with PPD, and increased IL-4 production of PBMC with p24 antigen at baseline (1.25 (1.01; 1.55)) were associated to declines in CD4+ cell count to < 350/μL.Both the number (CD4+ nadir) and the functional activity of CD4+ (lymphoproliferative response to PPD) predict the CD4+ decrease associated with discontinuation of ART in patients with controlled viremia.After more than ten years of use, combination antiretroviral therapy (ART) continues to have a significant impact on the morbidity and mortality of HIV infection [1,2]. Despite significant improvement in the toxicity profile and the convenience of administration of currently recommended therapies, the need for lifelong ART makes it desirable to find ways of decreasing the exposure to drugs [3]. Treatment interruption has been proposed as one such a possibility and it has been explored in several clinical studies in different contexts [4-6].Recently, large clinical trials have concluded that treatment interruptions can no longer be recommended due to the risk of clinical progression in some circumstances [4]. However, other studies, both retros
Comparison of Cryptococcal Antigenemia between Antiretroviral Na?ve and Antiretroviral Experienced HIV Positive Patients at Two Hospitals in Ethiopia  [PDF]
Tafese Beyene, Yimtubezinash Woldeamanuel, Daniel Asrat, Gonfa Ayana, David R. Boulware
PLOS ONE , 2013, DOI: 10.1371/journal.pone.0075585
Abstract: Background Cryptococcal meningitis is a major cause of HIV/AIDS-related deaths in Africa. Cryptococcosis is a neglected killer. However, meningitis can be prevented by early cryptococcal antigen (CrAg) screening and preemptive antifungal treatment during a prolonged period of detectable, subclinical infection. We determined the prevalence of cryptococcal antigenemia in comparison to CD4 count and clinical symptoms. Methods We surveyed 254 consenting HIV-infected participants to obtain demographic information and clinical history. Serum CrAg was measured by latex agglutination at two sites in the Oromia region of Ethiopia among all persons receiving a CD4 count. Results Of the 254 participants, 127(50.0%) were ART-na?ve, 121(47.6%) were ART-experienced, and 6(2.4%) were ART-defaulters. The prevalence of cryptococcal antigenemia was 10.2% overall being 14.2% among ART-naive, 4.1% among ART-experienced, and 50% (3/6) among ART-defaulters, irrespective of CD4 count. Cryptococcal antigenemia was more frequently detected from ART-na?ve patients (p = 0.012) and ART-defaulters (p = 0.001) compared with ART-experienced. Serum CrAg positivity was 20.9% in persons with CD4≤150 cells/μL, 12.2% in 151–200 cells/μL, 5.8% among 201–350 CD4/μL, and none above 350 cells/μL. Potential meningitis symptoms were common in the outpatient cohort irrespective of CrAg-status, with only fever and altered mental status statistically more common in CrAg-positive compared to CrAg-negative persons (P<0.05), yet no symptom had a positive predictive value >33%. Conclusion We report a 20.9% cryptococcal antigenemia prevalence among those with CD4+ T cells count ≤150 cells/μL, irrespective of ART status, with even higher CrAg prevalence in ART-na?ves and ART-defaulters. These groups are target populations for CrAg screening at entry into HIV care.
Haematological Profile of Human Immunodeficient (HIV) Seropositive Patients on Antiretroviral (ARV) Therapy: Implication of Nutrition
Ejike F. Chukwurah,Deborah Echeobi,Robert O. Nneli
Research Journal of Medical Sciences , 2012,
Abstract: This study investigated the haematological profile of HIV seropositive patients on antiretroviral therapy who were placed on diets enriched green leafy vegetables. Eighty patients/subjects-male and females who met our inclusion criteria were selected into into three study groups-Control (group 1), group 2 (HIV + positive patients not on ARVs) and group 3 (HIV + patients on ARVs). All the HIV infected subjects were attending the HIV/AIDS clinics at the University of Nigeria Teaching Hospital, Enugu while apparently healthy individuals who were HIV seronegative constituted the control. Five milititers of venous blood collected from each subject under asceptic conditions into EDTA bottles was used to determine platelet count, erythrocyte sedimentation rate and packed cell volume. The second line regimens of ARVs were administered to all subjects in group 3 after their HIV serostatus were confirmed while group 2 were not given ARVs. All subjected were advised to fortify their diets with green leafy vegetables. The mean platelet count in group 3 was 556±153.9(SD) 109 / L; ESR = 92.15±10.31(SD) per mm h; PCV = 29.10±3.10(SD) %. For the group 2, platelet count was 81.5±31.26(SD)109/L; ESR = 95.9±25.2(SD); PCV = 24.81±2.10(SD) %. Control had platelet count of 251.4±64.97(SD) 109/L; ESR = 14.29±6.37(SD) per mm h; PCV = 41.0±4.57(SD)%. Antiretroviral therapy and nutrition increased platelet counts than ESR and PCV in HIV+ patients on antiretroviral therapy.
Effectiveness and tolerability of abacavir-lamivudine-nevirapine (ABC/3TC/NVP) in a multicenter cohort of HIV-infected ARV-experienced patients
D Podzamczer,E Ferrer,J Llibre,M Leal
Journal of the International AIDS Society , 2012, DOI: 10.7448/ias.15.6.18269
Abstract: Purpose of the study: Very scarce information has been published to date with the combination of ABC/3TC/NVP but it is currently being used in clinical practice in many centers in Spain. Our aim was to present the clinical experience with this regimen in a cohort of adult HIV-infected pts. Methods: Retrospective, multicenter, cohort study. Consecutive adult HIV-infected ARV-experienced pts, HLA-B*5701-negative, who started ABC/3TC/NVP between 2005–2010, with at least one follow-up visit, were included. Demographic, clinical and laboratory variables were assessed at baseline, month 1, and every 3–4 months thereafter. The primary end point was HIV-1 viral load (VL) <40 c/mL at 48 weeks. Data were analyzed by intent-to-treat (ITT) (non-completer=failure) and on treatment (OT). Summary of results: 227 pts were included and followed up for a median of 30 (0.5–76) months. 75% male, 47 (24–83) years, 21% AIDS, 13% HCV+, baseline CD4 570 (32–1404) cells/μL and VL undetectable in 90% with a median of <1.59 (<1.59–5.1) log. Most pts were receiving NVP (63%), ABC (25%) or both (4%) in the previous regimen. ABC/3TC/NVP was initiated due to toxicity (42%), simplification (35%) or other reasons (22%) including to reduce drug cost. After 48 weeks, VL was <40 c/mL in 82% (ITT) and 94% (OT), and in 94% (OT) after 96 weeks. CD4 increased +63 (p<0.001) and +77 (p<0.001) cells/μL after 48 and 96 weeks, respectively. One or more drugs of the regimen were discontinued in 18% of pts during follow up: toxicity (7%), virologic failure (3%), lost to follow-up (3%), unrelated death (0.4%) or other reasons (4%). No significant differences were observed in ALT, AST, or triglyceride changes during follow up. A significant increase of 7%, 10% and 14% was observed in total cholesterol, LDLc and HDLc, and a significant decrease in TC/HDL ratio ( 5%, p=0.004) after 96 weeks, respectively. Conclusions: In this particular cohort of ARV-experienced pts previously receiving NVP or ABC, a combination of ABC/3TC/NVP was safe and mantained virologic suppression in the vast majority of pts, with rates similar to other switch strategies. A favourable lipid profile was observed after 96 weeks of follow up.
Retention in Care and Outpatient Costs for Children Receiving Antiretroviral Therapy in Zambia: A Retrospective Cohort Analysis  [PDF]
Callie A. Scott, Hari Iyer, Deophine Lembela Bwalya, Kelly McCoy, Gesine Meyer-Rath, Crispin Moyo, Carolyn Bolton-Moore, Bruce Larson, Sydney Rosen
PLOS ONE , 2013, DOI: 10.1371/journal.pone.0067910
Abstract: Background There are few published estimates of the cost of pediatric antiretroviral therapy (ART) in Africa. Our objective was to estimate the outpatient cost of providing ART to children remaining in care at six public sector clinics in Zambia during the first three years after ART initiation, stratified by service delivery site and time on treatment. Methods Data on resource utilization (drugs, diagnostics, outpatient visits, fixed costs) and treatment outcomes (in care, died, lost to follow up) were extracted from medical records for 1,334 children at six sites who initiated ART at <15 years of age between 2006 and 2011. Fixed and variable unit costs (reported in 2011 USD) were estimated from the provider’s perspective using site level data. Results Median age at ART initiation was 4.0 years; median CD4 percentage was 14%. One year after ART initiation, 73% of patients remained in care, ranging from 60% to 91% depending on site. The average annual outpatient cost per patient remaining in care was $209 (95% CI, $199–$219), ranging from $116 (95% CI, $107–$126) to $516 (95% CI, $499–$533) depending on site. Average annual costs decreased as time on treatment increased. Antiretroviral drugs were the largest component of all outpatient costs (>50%) at four sites. At the two remaining sites, outpatient visits and fixed costs together accounted for >50% of outpatient costs. The distribution of costs is slightly skewed, with median costs 3% to 13% lower than average costs during the first year after ART initiation depending on site. Conclusions Outpatient costs for children initiating ART in Zambia are low and comparable to reported outpatient costs for adults. Outpatient costs and retention in care vary widely by site, suggesting opportunities for efficiency gains. Taking advantage of such opportunities will help ensure that targets for pediatric treatment coverage can be met.
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