In Spain, HIV treatment guidelines are well known and generally followed. However, in some patients there are no plans to initiate ART despite having treatment indications. The current barriers to ...ART initiation are presented.
A cross-sectional survey including every HIV infected patient in care in 19 hospitals across Spain in 2012, with ≥1 indication to start ART according to 2011 national treatment guidelines, who had not been scheduled for ART initiation. Reasons for deferring treatment were categorized as follows (non-exclusive categories): a) The physician thinks the indication is not absolute and prefers to defer it; b) The patient does not want to start it; c) The physician thinks ART must be started, but there is some limitation to starting it, and d) The patient has undetectable viral load in absence of ART.
A total of 256 patients, out of 784 originally planned, were included. The large majority (84%) were male, median age 39 years, 57% MSM, 24% heterosexuals, and 16% IDUs. Median time since HIV diagnosis was 3 years, median CD4 count, 501 cells/mm3, median viral load 4.4 log copies/ml. Main ART indications were: CD4 count <500 cells/mm(3), 48%; having an uninfected sexual partner, 28%, and hepatitis C coinfection, 23%. Barriers due to, the physician, 55%; the patient, 28%; other limitations, 23%; and undetectable viral load, 6%.
The majority of subjects with ART indication were on it. The most frequent barriers among those who did not receive it were physician-related, suggesting that the relevance of the conditions that indicate ART may need reinforcing.
To evaluate the influence of nevirapine on atazanavir trough concentrations (Ctrough) in a group of HIV-infected patients, we performed an open-label pilot study enrolling patients receiving 300/100 ...mg atazanavir/ritonavir once daily for 2 weeks or longer. Nevirapine was added at a dose of 200 mg once daily from Days 0 to 14 and 200 mg twice daily from Days 14 to 28. Atazanavir and nevirapine plasma Ctroughs were determined at Days 0 and 28. Atazanavir Ctroughs were compared between Days 0 and 28. Atazanavir and nevirapine Ctroughs at Day 28 were compared with historical controls receiving either 400 mg atazanavir once daily or 200 mg nevirapine twice daily.
Fourteen patients were enrolled and 11 completed the study. The geometric mean (range) atazanavir Ctrough decreased from 0.631 mg/L (range, 0.235-1.87 mg/L) at Day 0 to 0.316 mg/L (range, 0.142-1.109 mg/L) at Day 28 to give a geometric mean ratio of 0.59 (95% confidence interval, 0.38-0.80; P = 0.026); nonetheless, the atazanavir Ctrough remained higher than the minimum effective concentration in 80% of the participants and higher than the median concentration in the control subjects receiving 400 mg atazanavir once daily without ritonavir (geometric mean ratio, 3.20; 95% confidence interval, 1.65-6.22; P = 0.001). The nevirapine Ctrough at Day 28 was slightly higher than in the historical controls on 200 mg nevirapine twice daily without atazanavir (geometric mean ratio, 1.46; 95% confidence interval, 1.04-2.06; P = 0.030).
We conclude that coadministration of 300/100 mg atazanavir/ritonavir once daily plus 200 mg nevirapine twice daily was safe and well tolerated but resulted in a decrease of atazanavir Ctrough by nearly half. Therefore, monitoring atazanavir Ctrough is recommended in patients treated with this drug combination, and increasing the atazanavir dose might be necessary.
Background. The combination of didanosine, lamivudine, and efavirenz (ddI/3TC/EFV) for the initial treatment of human immunodeficiency virus type 1 (HIV-1) infection has been insufficiently analyzed ...in clinical trials. Methods. We conducted an open-label, randomized study to compare the noninferiority of ddI/3TC/EFV with the lamivudine-zidovudine tablet and EFV (COM/EFV), both administered with food to improve tolerability and convenience. Patients were stratified by HIV-1 RNA level of <5.0 log10 or ⩾5.0 log10 copies/mL. The primary end point was the percentage of patients with an HIV-1 RNA level of <50 copies/mL at week 48, determined by intention-to-treat analysis. Results. Three hundred sixty-nine patients were randomized: 186 for ddI/3TC/EFV treatment and 183 for COM/EFV treatment. Both groups were well matched in terms of baseline characteristics; 19.3% of patients received a Centers for Disease Control and Prevention assessment of clinical category C, median HIV RNA level was 5.0 log10 copies/mL, and median CD4+ cell count was 208 cells/µL. At week 48, by intention-to-treat analysis, 70% of patients in the ddI/3TC/EFV group and 63% of patients in the COM/EFV group had an HIV-1 RNA level of <50 copies/mL (treatment difference, 7.1%; 95% confidence interval, −2.39% to 16.59%). Fourteen patients (8%) in the COM/EFV arm and 26 patients (14%) in the ddI/3TC/EFV arm discontinued the study medication because of adverse events (P=.046). One patient (1%) in the ddI/3TC/EFV arm and 11 patients (6%) in the COM/EFV arm discontinued medication because of hematological toxicity (P=.003). Conclusions. At week 48, ddI/3TC/EFV administered once per day with food did not have results inferior to those of COM/EFV treatment. A statistically significantly higher proportion of patients in the COM/EFV arm than in the ddI/3TC/EFV arm discontinued therapy because of adverse events, mainly because of hematological toxicity. Clinical trials registration. NCT00256828.
Patients on methadone maintenance therapy who are administered nelfinavir show a decrease in methadone plasma levels. However, the clinical relevance of this fact is seldom significant because it ...does not correlate with the appearance of opioid withdrawal symptoms (OWS). The objective of this study was to assess the clinical and pharmacokinetic interactions between methadone and nelfinavir.
A prospective multicenter study of human immunodeficiency virus (HIV) positive patients on stable methadone therapy who initiated nelfinavir was performed. To determine the presence of OWS, 2 questionnaires, objective and subjective, were administered at weeks 1, 2, 3 and 4. A pharmacokinetic study measuring the minimal plasmatic concentration of methadone was done at baseline and at week 4.
29 patient were included. In 7 patients who underwent pharmacokinetic studies, the minimal plasmatic concentration of methadone decreased after 4 weeks of nelfinavir treatment from 6.889 ng/ml to 4.354 ng/ml (37%; p = 0.046). However the results of the questionnaires did not show the significant OWS, which precluded an increase in the dose of methadone.
In patients under stable methadone treatment, antiretroviral therapy including nelfinavir does not require any significant modification of methadone dose. The decrease in methadone plasmatic levels does not correlate with OWS.
We investigated atorvastatin effectiveness and tolerance in HIV patients with hypercholesterolemia related to antiretroviral treatment.
Prospective study that included HIV+ patients under ...antiretroviral treatment who displayed secondary dyslipemia and medical treatment criteria (according to NCEP-III). These patients were given 10 mg/day atorvastatin and hygienic-dietetic measures. If the therapeutic objectives were not achieved, the dose of atorvastatin was increased to 20 mg/day. Patients were followed up for 6 months.
32 patients were included. In 5 cases it was necessary to increase the dose from 10 mg atorvastatin to 20 mg. The therapeutic objective was obtained in 62% cases, with a good clinical tolerance. Only one adverse effect was noticed, which forced the removal of the drug.
In our study atorvastatin was effective for the treatment of dyslipemia in HIV patients, and it was safe and well tolerated.
Stavudine (d4T) has shown a favourable short and long-term tolerability profile. Nevertheless, its usage is currently decreasing due to some safety concerns. We aimed to evaluate the efficacy and ...safety of d4T low-dose-based regimens.
This was a multicenter and retrospective review chart of patients receiving standard doses of d4T for > or = 6 months (weight > 60 kg: 40 mg/12 h; weight < 60 kg: 30 mg/12 h) and having undetectable viral load for at least 3 months before the d4T dose reduction (weight > 60 kg: 30 mg/12 h; weight < 60 kg: 20 mg/12 h). Immunological and viral parametres, lipid profile and side effects were determined.
A total of 982 patients were included. The main reason for reducing the dose was prevention of toxicity (76%). After 6 months of follow-up, 97% and 84% patients had less than 400 and 50 cp/ml, respectively, and the CD4 cell count increased by 38 cel/ml. Lipids, lipodystrophy and peripheral polineuropathy improved but there was no statistical significance.
A d4T dose reduction in an immuno-virologically stable population does not affect treatment efficacy. Longer follow-ups are required to confirm improvements in the safety profile.
We intended to find out the effectiveness of lactic acidosis therapy for mitochondrial toxicity.
HIV-patients receiving nucleoside reverse transcriptase inhibitors (NRTIs), hospitalized with lactic ...acidosis or symptomatic hyperlactatemia. Venous hyperlactatemia was considered at > 2.2 mmol/l. Treatment consisted of a daily vitamin regime of L-carnitine, thiamine, vitamin B6, hydroxicobalamine, and vitamin C; any glucose intake was discontinued. NRTIs treatment was stopped immediately.
Nine patients on current therapy were identified who had symptomatic hyperlactatemia (n = 4) or lactic acidosis (n = 5) from 1/2001 to 9/2002. All were patients with AIDS, receiving NRTIs with a mean duration of 5 years: ddI (n = 7), d4T (n = 5), AZT(n = 3), 3TC (n = 2), abacavir (n = 1). Most common symptoms were tachypnea, slight fever, abdominal pain, nausea, vomiting and diarrhea. All patients had a favourable prognosis after administration of L-carnitine and vitamin complexes, with discontinuation of NRTIs and glucose intake. Clinical features lasted 7 days. After 15 (5) months of follow up, none had a recurrence of the syndrome.
The application of this therapy could play a role in the treatment of NRTI - related lactic acidosis.
To find out the type of emergency consultations made by users at a substance abuse treatment center (SATC).
Prospective study of emergency consultations made during six months by patients controlled ...at a SATC.
333 patients were followed up; 27 (8%) of them consulted and 9 (33%) were found to have an HIV infection. Heroin addicts consulted more times and repeated visits more commonly than cocaine addicts (p < 0.04 and 0.03). Patients enrolled in the methadone maintenance programme consulted less commonly than patients included in other programmes (p < 0.01). 35% of visited patients did not need treatment and 75% were discharged.
We have detected two different types of consultations: those owing to a psychiatric/drug disorder in patients followed-up for less than 1 year, which are resolved after just one visit, without need of hospitalization; and those consultations caused by medical disorders, frequently related to HIV, which are generated by patients submitted to longer follow-up periods; these patients use to repeat the consultations and are commonly admitted.
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