Comunicación breves550Background: Adverse Drug Reactions (ADR), lead not just to a high
percentage of therapy abandonment, but also to a poor adherence to
treatment instructions resulting in failure of therapy. The purpose of this
study was to show the relation between the use of drugs and ADRs,
their impact on treatment and the severity of reaction as defined by the
DAIDS scale

Cortés, Jorge A.

Gil, F.

Guerrero, P.

Támara, José Roberto

Vesga, Juan Fernando

Álvarez Moreno, Carlos Arturo

Undetermined

Repositorio Institucional - Pontificia Universidad Javeriana

S550 17th ECCMID / 25th ICC, Postersor atazanavir/ritonavir [ATZ/r] as the second option for IND/r-intolerantpatients). Analysis was by intention-to-treat (ITT) and per protocol (OT),allowing changes of NNRTI or boosted PI within the same class ofantiretrovirals.Results: Sixty-six patients were randomised: 34 received an NNRTI-based regimen and 32 received a boosted PI-based regimen. 50% hadhad C events. Median (range) CD4+ and PVL at baseline were 40(1−99) cells/mm3 and 5.5 (4.0−>6) log10/mL, respectively. All patientscompleted 3 years of follow-up. Five patients died (NNRTI, 4; PI, 1) and12 developed a C event (NNRTI, 6; boosted PI, 6), most of them withinthe first six months. Seventeen patients changed EFV (NVP, 3; LPV/r1) or IDV/r (LPV/r 9, ATZ/r 3, EFV 3, NVP 1) because of adverseevents and eight patients stopped HAART or were lost for follow-up(NNRTI, 1; PI, 7). There were 12 virological failures (NNRTI, 5; PI,7). PVL< 200 copies/mL for NNRTI/PI arms at 1, 2 and 3 years was71%/65%, 68%/49% and 65%/29% (p = 0.05 at the last time point) byITT (M=F) and 73%/77%, 73%/69% and 73%/49% (p=NS at all timepoints) by OT analysis, respectively. Median CD4+ cell increase after 1,2 and 3 years by OT analysis was +186/+136, +226/+162 and +303/+220cells/mm3 (p=NS for all time points) for NNRTI/PI groups, respectively.At 1 and 2 years, immune activation (CD8+CD38+) was significantlylower in the NNRTI group (p = 0.004). There were no differences inT-cell subsets, proliferative responses to mitogens and recall antigensbetween both study arms.Conclusions: At 3 years, the virological response and the magnitude ofthe immune reconstitution induced by an NNRTI-based regimen was atleast as potent as that induced by a boosted PI-based regimen.P1916 The evolution of the avidity of HIV-1-specific antibodies isprevented by early treatment started during primary HIV-1infectionM. Selleri, M. Zaniratti, N. Orchi, A. Corpolongo, P. Zaccaro,G. Ippolito, M. Capobianchi, E. Girardi (Rome, IT)Objectives: Avidity of anti-HIV antibodies progressively increases afterprimary HIV-1 infection (PHI). It has been reported that an AvidityIndex (AI) <0.80 identifies recent (<6 months) infections, whereas anti-HIV antibodies with an AI  0.90 indicates long-standing infections.We evaluated if the administration of highly active antiretroviral therapy(HAART) during PHI may affect AI evolution.Methods: The AI and Western blot (WB) evolution patterns wereretrospectively analysed on serial serum/plasma samples from 13individuals with symptomatic PHI, defined as detectable viral load andnegative or indeterminate HIV-1 antibody tests. Five patients have neverbeen treated, eight individuals had initiated HAART at the time ofdiagnosis (range 0−46 days after presentation), of whom, 4 discontinuedHAART after a variable time lapse from PHI ( 1 year).Results: At diagnosis, the range of HIV viraemia was 0.003−38×106copies/mL. In untreated patients viraemia reached the set-point in 4−6months, while in all patients receiving HAART complete suppressionof viraemia (<50 RNA copies/mL) was achieved early, lasting for theentire observation period (12 months). At presentation, the median AIwas 0.42 (range 0.33–0.43) in untreated patients, and 0.44 (range 0.40–0.72) in subsequently treated patients. At 3, 6 and 12 months the medianAI was 0.75, 0.89, 0.97 in untreated patients, and 0.42, 0.49, 0.54 intreated patients. In the 4 patients who stopped HAART, AI increasedafter interruption, reaching the value of 0.80 in 6 months. WB patterntransiently/partially reversed during HAART in 2 patients.Conclusions: During PHI, early HAART, accompanied by rapidvirologic suppression, prevents the gradual increase of AI, whileresumption of viral replication is paralleled by a prompt increase of AI.This altered pattern of maturation of the antibody response in patientsachieving rapid control of viral replication may suggest a complexmechanism of immune response to HIV not yet fully investigated.P1917 Antiretrovirals adverse reactions from a prospectiveHIV/AIDS cohort study in Bogotá, ColombiaJ.F. Vesga, C. Alvarez, J.R. Tamara, J.A. Cortes, P. Guerrero, F. Gil(Bogota, CO)Background: Adverse Drug Reactions (ADR), lead not just to a highpercentage of therapy abandonment, but also to a poor adherence totreatment instructions resulting in failure of therapy. The purpose of thisstudy was to show the relation between the use of drugs and ADRs,their impact on treatment and the severity of reaction as defined by theDAIDS scale.Methods: Making use of a database designed in Access (ver 11.5 2003,Microsoft, USA), information from ADR to Antiretrovirals from 384HIV positive patients between June 2005 and June 2006 was analysed.Patients were seen routinely every 4 weeks, and data was collected fromsuch consults. Patient was asked about the presence of ADRs, lot anddrug manufacturer, the active commencement of the antiretroviral, theeffect of the reaction on the overall treatment scheme, and laboratoriesrelated to the negative reaction. For abnormal laboratory results a DAIDSgrade was established. Data was then analysed using programme Stata(Ver 9.0).Results: In the consequent year (4608 month/patient), 672 ADRs werereported to have occurred with the following frequency: metabolicreactions 28.1%, haematologic 28%, gastrointestinal 26.5%, neurologicand psychological 13.5%, dermatological 3.28%, hepatic 2.39%, renaland urological 0.9%.Regarding intensity of ADRs, 85.2% were mild, 14.4% moderate and1.7% severe. The most frequent ADRs were macrocytosis, nausea,hypertrygliceridaemia, combined dyslipidaemia and diarrhoea. Amongall ADRs 89.5% were classified as DAIDS grade I, 8.8% grade II,1% grade III and 0.4% grade IV. The 89.9% of ADRs mean no change inthe scheme of treatment, 6.3% required a change of the drug, 1.3% quitthe treatment, and 2.4% of treatments were transitorily suspended.Conclusions: ADRs were frequent in our study, however the mostof it were reported as mild reactions and didnt necessitate changeor suspension of the treatment. As expected, metabolic reactions likedyslipidaemia where most frequently found among protease inhibitorsand NNRTs than in NRTs.P1918 Pharmacokinetic parameters of 400/100 mgindinavir/ritonavir in HIV-infected Thai patientsS. Jaruratanasirikul (Songkhla, TH)Introduction: The dosage recommendations of 800/100mg indi-navir/ritonavir in the Thai population may lead to more severe sideeffects. This may be due to higher drug levels.Objective: The aim of this study was to assess the steady statepharmacokinetics of reduced doses of indinavir boosted with ritonavirin HIV infected Thai patients.Methods: Our study was conducted in ten HIV infected patients.All patients received 400/100mg indinavir/ritonavir combined withlamivudine and stavudine or zidovudine every 12 h. After 4 weeks ofstarting antiretroviral therapy, indinavir pharmacokinetics studies werecarried out and HIV-1 RNA viral load was determined at 24 weeks.Results: The pharmacokinetic parameters are shown as below and allpatients had a HIV-1 viral load less than 400 copies/mL after 24 weeksfollow up.Parameter Mean (SD) UnitsCmax 7.51 (3.57) mg/LCmin 0.86 (0.59) mg/LAUC0−12 38.14 (15.17) mg·h/LT1/2 2.94 (0.90) hTmax 2.10 (1.31) h

P1917 Antiretrovirals adverse reactions from a prospective HIV AIDS cohort study in Bogotá, Colombia

http://repository.javeriana.edu.co/bitstream/10554/51221/1/P1917.pdf

P1917 Antiretrovirals adverse reactions from a prospective HIV AIDS cohort study in Bogotá, Colombia

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