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Objective The 6 month assessment of the response to antiretroviral therapy (ART) is a critical step. In sub-Saharan Africa, few people have access to plasma viral-load measurement. We assessed the gain or loss in body mass index (BMI), alone or in combination with the gain or loss in CD4+ T-cell count (CD4), as a tool for predicting the response to ART. Methods In a cohort of 622 adults in Abidjan, Cote d&apos;Ivoire, we calculated the sensitivity, specificity and predictive values of BMI and CD4 for treatment success defined as viral-load undetectability (< 300 copies/ml) as gold standard. Findings After 6 months of ART, the median change in BMI was an increase of 1.0 kg/[m.sup.2] (interquartile range, IQR: 0.0-2.1), the median change in CD4 an increase of 148/[micro]l (IQR: 54-230) and 84% of patients reached viral-load undetectability. The distribution of change in BMI was similar among patients who reached undetectability and those who dial not (increases of 1.06 kg/[m.sup.2] versus 0.99 kg/[m.sup.2], P = 0.51). With larger changes in BMI, the specificity for treatment success increased but its sensitivity decreased and its positive predictive value was stable around 85%. AII results remained similar when combining changes in BMI with those in CD4 and when stratifying by groups of baseline BMI or CD4. Conclusion In settings where viral-load measurement is not available, a high BMI gain does not reflect virological success, even when combined with a high CD4 gain. In our population, most patients with detectable viral-load had probably adhered to the drug regimen sufficiently to reach significant gains in body mass and CD4 count but had adhered insufficiently to reach viral suppression. Resume Objectif L&apos;evaluation sur 6 mois de la reponse au traitement antiretroviral (ART) est une etape critique. En Afrique subsaharienne, peu de personnes ont acces a la mesure de la charge virale plasmatique. Nous avons evalue le gain ou la perte d&apos;indice de masse corporelle (IMC), isolement ou en association avec le gain ou la perte de cellules T CD4+ (CD4), en tant qu&apos;outils pour predire la reponse au traitement ART. Methodes Parmi une cohorte de 622 adultes d&apos;Abidjan, en Cote d&apos;lvoire, nous avons calcule la sensibilite, la specificite et les valeurs predictives de I&apos;IMC et des CD4 pour le succes du traitement, defini comme l&apos;impossibilite de detecter une charge virale (< 300 copies/ml), a titre normatif. Resultats Apres 6 mois de traitement ART, on obtenait comme valeur mediane de la variation de I&apos;IMC une augmentation de 1,0 kg/[m.sup.2] (intervalle interquartile, IIQ : 0,0-2,1) et comme mediane de la variation des CD4 une augmentation de 148/pl (IIQ : 54-230), ainsi qu&apos;une indetectabilite de la charge virale chez 84 % des patients. La distribution de la variation de I&apos;IMC etait similaire chez les patients ayant atteint I&apos;indetectabilite et chez ceux ne I&apos;ayant pas atteint (augmentation de 1,06 kg/[m.sup.2] au lieu de 0,99 kg/[m.sup.2], p < 0,51). Lorsque la variation de I&apos;IMC augmente, sa specificite a I&apos;egard du succes therapeutique diminue et sa valeur predictive positive reste stable autour de 85 %. Les resultats ne varient guere Iorsqu&apos;on combine les variations de I&apos;IMC, dans leur ensemble, et celles des CD4 et qu&apos;on opere une stratification par groupes d&apos;IMC ou de CD4 de depart. Conclusion Dans les situations ou I&apos;on ne dispose pas de mesure de la charge virale, un fort gain d&apos;IMC n&apos;implique pas un succes virologique, meme s&apos;il s&apos;accompagne d&apos;une importante elevation des CD4. Dans la population etudiee, la plupart des patients presentant une charge virale detectable avaient probablement respecte assez longtemps le schema therapeutique pour beneficier d&apos;augmentations notables de la masse corporelle et de la numeration des CD4, mais pas suffisamment pour atteindre la suppression virale. Resumen Objetivo La evaluacion a los 6 meses de la respuesta a la terapia antirretroviral (TAR) es una medida esencial, pero en el Africa subsahariana son muy pocas las personas con acceso a analisis de la carga viral en plasma. Evaluamos el aumento o disminucion del indice de masa corporal (IMC), aisladamente o en combinacion con el aumento o disminucion del recuento de linfocitos T CD4+ (CD4), como estrategia para predecir la respuesta a la TAR. Metodos En una cohorte de 622 adultos de Abidjan, Cote d&apos;lvoire, calculamos la sensibilidad, la especificidad y los valores predictivos del IMC y los niveles de CD4 como indicadores de la eficacia terapeutica, definida como una carga viral indetectable (< 300 copias/ml). Resultados A los 6 meses de iniciada la TAR, el IMC mediano habia aumentado en 1,0 kg/[m.sup.2] (intervalo intercuartilico, IIC: 0,0-2,1) y el nivel mediano de CD4, en 148/[micro]l (IIC: 54-230), y la carga viral habia pasado a ser indetectable en un 84% de los pacientes. La distribucion de la variacion del IMC fue similar en los pacientes que alcanzaron niveles indetectables y en los demas (aumento de 1,06 kg/[m.sup.2] frente a 0,99 kg/[m.sup.2], p = 0,51). Conforme aumentaba la variacion del IMC, la especificidad respecto de la eficacia terapeutica aumentaba, pero su sensibilidad disminuia, y su valor predictivo positivo se mantenia estable, en torno al 85%. Se obtenian siempre resultados similares al combinar distintos cambios del IMC y del recuento de CD4, asi como al estratificar los grupos en funcion de los valores basales de IMC o CD4. Conclusion En los entornos donde no es posible medir la carga viral, un gran aumento del IMC no refleja la eficacia virologica, aun cuando se combine con un incremento importante de los niveles de CD4. En la poblacion aqui estudiada, la mayoria de los pacientes con carga viral detectable probablemente habian seguido el tratamiento en la medida suficiente para conseguir aumentos importantes de la masa corporal y del recuento de CD4, pero no en la medida necesaria para lograr la supresion viral. [TEXT NOT REPRODUCIBLE IN ASCII.], Introduction International guidelines recommend that plasma viral load undetectability should be reached within the first 6 months of antiretroviral therapy (ART). (1) In patients with plasma viral load still detectable [...]

A cohort of 592 HIV-infected adults during 1292 person-years in Abidjan before the highly active antiretroviral therapy (HAART) era is followed. On the basis of the exhaustive monitoring of nonantiretroviral drugs actually delivered to the patients and of the real cost of drugs at the cohort center's pharmacy during the period, the mean cost of drugs per person per year overall, is estimated, by the drug characteristics, and by patients' baseline CD4 cell count.

Background. In Western Europe, North America, and Australia, large cohort collaborations have been able to estimate the short-term CD4 cell count-specific risk of AIDS or death in untreated human immunodeficiency virus (HIV)- infected adults with high CD4 cell counts. In sub-Saharan Africa, these CD4 cell count-specific estimates are scarce. Methods. From 1996 through 2006, we followed up 2 research cohorts of HIV-infected adults in Cote d'Ivoire. This included follow-up off antiretroviral therapy (ART) across the entire spectrum of CD4 cell counts before the ART era, and only in patients with CD4 cell counts >200 cells/lL once ART became available. Data were censored at ART initiation. We modeled the CD4 cell count decrease using an adjusted linear mixed model. CD4 cell count- specific rates of events were obtained by dividing the number of first events occurring in a given CD4 cell count stratum by the time spent in that stratum. Results. Eight hundred sixty patients were followed off ART over 2789 person-years (PY). In the ≥650, 500-649, 350-499, 200-349, 100-199, 50-99, and 0-49 cells/lL CD4 cell count strata, the rates of AIDS or death were 0.9, 1.7, 3.7, 10.4, 30.9, 60.8, and 99.9 events per 100 PY, respectively. In patients with CD4 cell counts ≥200 CD4 cells/lL, the most frequent AIDS-defining disease was tuberculosis (decreasing from 4.0 to 0.6 events per 100 PY for 200-349 and ≥650 cells/lL, respectively), and the most frequent HIV non-AIDS severe diseases were visceral bacterial diseases (decreasing from 9.1 to 3.6 events per 100 PY). Conclusions. Rates of AIDS or death, tuberculosis, and invasive bacterial diseases are substantial in patients with CD4 cell counts ≥200 cells/lL. Tuberculosis and bacterial diseases should be the most important outcomes in future trials of early ART in sub-Saharan Africa. [ABSTRACT FROM AUTHOR]

Aim: To determine the prevalence of hepatitis B virus (HBV) in adult human immunodeficiency virus (HIV) patients with CD4+ T-cell count less than 500/mm(3) and without antiretroviral therapy; to describe different HBV-HIV coinfection virological profiles; and to search for factors associated with HBs antigen (HBsAg) presence in these HIV positive patients., Methods: During four months (June through September 2006), 491 patients were received in four HIV positive monitoring clinical centers in Abidjan., Inclusion Criteria: HIV-1 or HIV-1 and 2 positive patients, age ≥ 18 years, CD4+ T-cell count < 500/mL and formal and signed consent of the patient. Realized blood tests included HIV serology, CD4+ T-cell count, quantitative HIV RNA load and HBV serological markers, such as HBsAg and HBc antibody (anti-HBcAb). We performed HBeAg, anti-HBe antibody (anti-HBeAb), anti-HBc IgM and quantitative HBV DNA load in HBsAg positive patients. Anti-HBsAb had been tested in HIV patients with HBsAg negative and anti-HBcAb-positive. HBV DNA was also tested in 188 anti-HBcAb positive patients with HBsAg negative status and without anti-HBsAb. Univariate analysis (Pearson χ(2) test or Fischer exact test) and multivariate analysis (backward step-wise selection logistic regression) were performed as statistical analysis., Results: Mean age of 491 patients was 36 ± 8.68 years and 73.3% were female. Type-1 HIV was found in 97% and dual-type HIV (type 1 plus type 2) in 3%. World Health Organization (WHO) clinical stage was 1, 2, 3 and 4 respectively in 61 (12.4%), 233 (47.5%), 172 (35%) and 25 patients (5.1%). Median CD4+ T-cell count was 341/mm(3) (interquartile range: 221-470). One hundred and twelve patients had less than 200 CD4+ T-cell/mm(3). Plasma HIV-1 RNA load was elevated (≥ 5 log(10) copies/mL) in 221 patients (45%). HBsAg and anti-HBcAb prevalence was respectively 13.4% and 72.9%. Of the 66 HBsAg positive patients, 22 were inactive HBV carriers (33.3%), 21 had HBeAg positive hepatitis (31.8%) and 20 had HBeAg negative hepatitis (30.3%). HBeAg and anti-HBeAb were indeterminate in 3 of them. Occult B infection prevalence (HBsAg negative, anti-HBcAb positive, anti-HBsAb negative and detectable HBV DNA) was 21.3%. Three parameters were significantly associated with the presence of HBsAg: male [odds ratio (OR): 2.2; P = 0.005; 95% confidence interval (CI): 1.3-3.8]; WHO stage 4 (OR: 3.2; P = 0.01; 95% CI: 1.3-7.9); and aspartate aminotransferase (AST) level higher than the standard (OR: 1.9; P = 0.04; 95% CI: 1.02-3.8)., Conclusion: HBV infection prevalence is high in HIV-positive patients. HBeAg positive chronic hepatitis and occult HBV infection are more frequent in HIV-positive patients than in HIV negative ones. Parameters associated with HBsAg positivity were male gender, AIDS status and increased AST level.

Objective: To assess the rates and determinants of mortality, loss to follow-up and immunological failure in a nongovernmental organization-implemented program of access to antiretroviral treatment in Côte d'Ivoire., Methods: In each new treatment center, professionals were trained in HIV care, and a computerized data system was implemented. Individual patient and program level determinants of survival, loss to follow-up and immunological failure were assessed by multivariate analysis., Results: Between May 2004 and February 2007, 10,211 patients started antiretroviral treatment in 19 clinics (median preantiretroviral treatment CD4 cell count, 123 cells/microl; initial regimen zidovudine-lamivudine-efavirenz, 20%; stavudine-lamivudine-efavirenz, 22%; stavudine-lamivudine-nevirapine, 52%). At 18 months on antiretroviral treatment, the median gain in CD4 cell count was +202 cells/microl, the probability of death was 0.15 and the probability of being loss to follow-up was 0.21. In addition to the commonly reported determinants of impaired outcomes (low CD4 cell count, low BMI, low hemoglobin, advanced clinical stage, old age and poor adherence), two factors were also shown to independently jeopardize prognosis: male sex (men vs. women: hazard ratio = 1.52 for death, 1.27 for loss to follow-up, 1.31 for immunological failure); and attending a recently opened clinic (inexperienced vs. experienced centers: hazard ratio = 1.40 for death, 1.58 for loss to follow-up). None of the three outcomes was associated with the drug regimen., Discussion: In this rapidly scaling-up program, survival and immune reconstitution were good; women and patients followed up in centers with longer experience had better outcomes; outcomes were similar in zidovudine/stavudine-based regimens and in efavirenz/nevirapine-based regimens. Decreasing the rate of loss to follow-up should now be the top priority in antiretroviral treatment rollout.

The incidence and determinants of severe morbidity recurrence in sub-Saharan African HIV-infected adults on antiretroviral therapy (ART) have never been reported. In a prospective cohort study of HIV-infected adults in Abidjan the association of severe morbidity occurrence and recurrence with follow-up CD4 counts and ART on/off status was analyzed by means of multivariate failure analysis for recurrent events (Prentice, Williams, and Peterson model). A total of 608 patients (median CD4 290/mm3 ) was followed off ART for 1824 person-years (PY). Of these 187 started HAART (median CD4 174/mm3 ) and were followed for 328 PY. The incidence of first, second, and third severe morbidity events was 40.6/100 PY, 68.4/100 PY, and 93.9/100 PY during the off-ART period, and 28.4/100 PY, 39.4/100 PY, and 37.6/100 PY during the on-ART period, respectively. The rates of recurrences were higher than the rates of first episodes for almost all diseases, even after stratifying by CD4 count and by ART on/off status. In multivariate analysis, the time-updated CD4 count was independently associated with increasing rates of morbidity first events and recurrences, after adjustment on other covariates (p > 10(4) ). By contrast, there was no association between the ART on/off status and the morbidity rates after adjustment for CD4 count (p = 0.37). Introducing ART led to a clear reduction in morbidity, mainly related to the ART-induced increase in CD4 count. In HIV-infected patients on ART, the incidence of severe morbidity varied with the past history of morbidity. The past history of morbidity should be taken into account when comparing HIV morbidity rates before and after ART initiation.

Background: Highly active antiretroviral therapy (HAART) is being scaled up in developing countries. We compared baseline characteristics and outcomes during the first year of HAART between HIV-1-infected patients in low-income and high-income settings., Methods: 18 HAART programmes in Africa, Asia, and South America (low-income settings) and 12 HIV cohort studies from Europe and North America (high-income settings) provided data for 4810 and 22,217, respectively, treatment-naïve adult patients starting HAART. All patients from high-income settings and 2725 (57%) patients from low-income settings were actively followed-up and included in survival analyses., Findings: Compared with high-income countries, patients starting HAART in low-income settings had lower CD4 cell counts (median 108 cells per muL vs 234 cells per muL), were more likely to be female (51%vs 25%), and more likely to start treatment with a non-nucleoside reverse transcriptase inhibitor (NNRTI) (70%vs 23%). At 6 months, the median number of CD4 cells gained (106 cells per muL vs 103 cells per muL) and the percentage of patients reaching HIV-1 RNA levels lower than 500 copies/mL (76%vs 77%) were similar. Mortality was higher in low-income settings (124 deaths during 2236 person-years of follow-up) than in high-income settings (414 deaths during 20,532 person-years). The adjusted hazard ratio (HR) of mortality comparing low-income with high-income settings fell from 4.3 (95% CI 1.6-11.8) during the first month to 1.5 (0.7-3.0) during months 7-12. The provision of treatment free of charge in low-income settings was associated with lower mortality (adjusted HR 0.23; 95% CI 0.08-0.61)., Interpretation: Patients starting HAART in resource-poor settings have increased mortality rates in the first months on therapy, compared with those in developed countries. Timely diagnosis and assessment of treatment eligibility, coupled with free provision of HAART, might reduce this excess mortality.