Efficacy and safety of switching enfuvirtide to raltegravir in patients with viral suppression
In: Journal of the International AIDS Society, Band 11, Heft Suppl 1, S. P58
ISSN: 1758-2652
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In: Journal of the International AIDS Society, Band 11, Heft Suppl 1, S. P58
ISSN: 1758-2652
In: Journal of the International AIDS Society, Band 11, Heft Suppl 1, S. P272
ISSN: 1758-2652
In: Journal of the International AIDS Society, Band 11, Heft Suppl 1, S. P150
ISSN: 1758-2652
In: Journal of the International AIDS Society, Band 15, Heft S4, S. 1-2
ISSN: 1758-2652
ObjectivesPrimary ‐ evaluate the improvement in psychiatric symptoms attributable to changing the antiretroviral drug responsible for such symptoms to nevirapine (NVP). The tools used were a sleep test (the Pittsburgh Sleep Quality Index [PSQI]) and the Hospital Anxiety and Depression Scale (HADS). Secondary ‐ determine the neuropsychiatric disorders and evaluate adherence to treatment and quality of life.MethodsProspective, observational post‐authorisation study that included HIV‐1 patients from 36 Spanish hospitals who satisfied the following criteria: age over 18 years; change of antiretroviral treatment to NVP due to CNS side‐effects; a PSQI score >5 (significant sleep disturbance); a HADS score ≥10 on the day of starting NVP treatment; and no psychoactive drug treatment initiated during the 6 weeks prior to starting treatment with NVP. Other data gathered from the patients included clinical and demographic details and administration of the Epworth somnolence scale, the Medical Outcomes Study‐short form 30 items (MOS‐SF‐30) quality of life scale and the Simplified Medication Adherence Questionnaire (SMAQ). Evaluations were performed at baseline, 1 and 3 months after the change.Results129 patients were included (73.6% men; mean age, 43.2 ± 9.8 years; 36.5% homosexual, 30.2% heterosexual; 28.7% drug users; 38% AIDS; 33.3% co‐infection). The drug changed was efavirenz in 89.9% of cases. The reason for the change was sleep disturbances in 75.2%, anxiety in 65.1%, other psychiatric disturbances in 38.7%, attention disturbances in 31%, and other reasons in 31%; a mean of 2.4 neuropsychiatric disturbances were detected in each patient. CD4 rose from 582 ± 261 to 619 ± 299 (non‐significant difference). Only three patients had developed an HIV viral load at the end of the study. The differences produced by the change are shown in Table 1. 29 patients withdrew from the study, for the following reasons: 9 for NVP‐related toxicity (7 cases of rash and 2 of hepatitis); 7 for loss to follow‐up; 4 for voluntary withdrawal; 9 for other reasons.
Baseline (n=129)
1 month (n=100)
3 months (n=100)
p value, baseline‐1 mo
p value, baseline‐3 mo
Percentage of patients with a PSQI score >5, suggestive of a significant alteration of sleep
96.9%
60.7%
44%
<0.001
<0.001
Percentage of patients with clinical problems of anxiety and depression, HADS
86.8%
46.4%
32%
<0.001
<0.001
Mean score and percentage of patients with normal somnolence, Epworth scale
8.3±4.7/(65.9%)
6±4 (89.3%)
5.5±3.6 (91%)
<0.001/0.001
<0.001/0.001
Percentage of compliant patients, SMAQ
65.9%
75.9%
81%
0.036
0.013
Percentage of patients with a good quality of life, MOS‐SF‐30
57.5±18.9%
69.8±19.7%
73.6±16.8%
<0.001
<0.001
DiscussionThe study shows that the change to NVP from a drug that is causing neuropsychiatric disturbances (principally, efavirenz) is effective in resolving those disturbances, with an improvement in all the parameters studied (quality of sleep, anxiety/depression and somnolence). This leads to better adherence and a better quality of life with no detriment to their immunological and virological control.
In: Journal of the International AIDS Society, Band 13, Heft S4
ISSN: 1758-2652
7‐11 November 2010, Tenth International Congress on Drug Therapy in HIV Infection, Glasgow, UK
In: Journal of the International AIDS Society, Band 11, Heft Suppl 1, S. P176
ISSN: 1758-2652
In: Journal of the International AIDS Society, Band 11, Heft Suppl 1, S. P171
ISSN: 1758-2652
In: Journal of the International AIDS Society, Band 11, Heft Suppl 1, S. P191
ISSN: 1758-2652
In: Journal of the International AIDS Society, Band 11, Heft Suppl 1, S. P23
ISSN: 1758-2652
In: Journal of the International AIDS Society, Band 11, Heft Suppl 1, S. P50
ISSN: 1758-2652
In: Journal of the International AIDS Society, Band 15, Heft S4, S. 1-1
ISSN: 1758-2652
Antiretroviral treatment simplification with darunavir/ritonavir or lopinavir/ritonavir monotherapy maintains sustained HIV viremia suppression in clinical trials. However, data about the efficacy of this strategy in routine clinical practice is still limited, and no direct comparison between darunavir/ritonavir and lopinavir/ritonavir has been performed to date. We retrospectively studied all HIV‐1‐infected subjects who initiated monotherapy with darunavir/ritonavir or lopinavir/ritonavir while having plasma VL<50 c/mL, and had at least 1 subsequent follow‐up visit in our clinic. When two consecutive PI‐monotherapy regimens were used, each regimen was considered separately. The primary endpoint was the percentage of patients who maintained virological suppression (HIV‐1 VL <50 c/mL) through follow‐up. Virological failure was defined as at least two consecutive HIV‐1 VL >50 c/mL. We also evaluated other reasons for treatment discontinuation. Analyses were performed considering all regimens (full dataset analysis) either as "on treatment" or as "treatment switch equals failure". Five hundred and seventy‐three PI‐monotherapy regimens corresponding to 520 subjects were included, 262 with darunavir/ritonavir and 311 with lopinavir/ritonavir. Medians (IQR) follow‐up were 50 (26.3–107.6) and 85.6 (36.9–179.1) weeks for subjects on darunavir/ritonavir and lopinavir/ritonavir, respectively (p<0.001). Overall, 67 (11.7%) subjects experienced virological failure, 23 (8.7%) were on darunavir/ritonavir and 42 (13.5%) were on lopinavir/ritonavir (p=0.796). Two hundred and three (77.5%) patients on darunavir/ritonavir and 154 (49.5%) on lopinavir/ritonavir maintained virological suppression in the "treatment switch equals failure" (p=0.002). Other reasons for treatment discontinuation were gastrointestinal toxicity and dyslipidemia in 7.2% and 5.9% of cases, respectively. Gastrointestinal toxicities and dyslipidemia leading to treatment discontinuation were more frequent in patients on lopinavir/ritonavir (10.6% and 10.3%, respectively) than in patients on darunavir/ritonavir (3.1% and 0.8%, respectively). Monotherapy with darunavir/ritonavir or lopinavir/ritonavir as simplification strategy appears to be effective and safe in subjects with virological suppression in clinical practice. Virological efficacy seems to be similar between regimens. However, rates of discontinuation due to toxicities were higher in subjects on lopinavir/ritonavir than darunavir/ritonavir.
In: Journal of the International AIDS Society, Band 15, Heft S4, S. 1-1
ISSN: 1758-2652
BackgroundThe significant decrease in mortality has resulted in a large number of individuals aged over 50 living with HIV infection. Additionally, the coexistence of certain pathologies suggests premature aging. In this scenario, the presence of aging‐associated symptoms in the physician‐patient dialogue is yet to be explored.MethodsCross‐sectional observational study to evaluate the presence of aging‐associated symptoms in the physician‐patient dialogue and to explore the possible differences between genders in a sample of 100 HIV‐1 infected subjects diagnosed at least 15 years ago. The survey assessed questions/comments made by the patient, questions/comments made by the physician and patients' interest in obtaining more information than was provided. Number of patients and percentages were given and compared using the w2 or Fisher exact test (as appropriate).ResultsParticipants were 60 men and 40 women, diagnosed with HIV infection a median (IQ) of 18 (15.7–21) years ago, who had a nadir CD4 and CD4 cell count at the study entry of 172 (95–272) and 543 (403–677), respectively. Eighty percent of the subjects had VL <25 copies and 42% were HCV/HIV co‐infected (31 subjects with low fibrosis stage). The infection route had been mainly intravenous drug use (37%) and MSM (32%). Men and women had similar demographic and clinical characteristics. Sixty‐two percent of the participants acknowledged asking their physicians about aging‐associated symptoms (58% men vs 66% women; p=0.50), 48% reported that their physicians had provided information without having been asked (48% men vs 55% women; p=0.51) and 75% confirmed that they would like to have more information about aging‐associated symptoms (22% men vs 80% women; p<0.001).ConclusionsAround half of the men and women interviewed had discussed aging‐associated symptoms with their physician. However, this seemed insufficient for four‐fifths of the women, who would have liked to have obtained more information about aging.
In: Journal of the International AIDS Society, Band 15, Heft S4
ISSN: 1758-2652
BackgroundHealth beliefs are an important factor in the maintenance of an adherent behaviour. However, specific interventions based on the modification of health beliefs to promote adherence have not been applied in naïve HIV‐infected subjects.MethodsProspective randomized 48‐week study to evaluate the efficacy of a psychoeducative intervention based on health beliefs to promote adherence in a sample of naïve HIV‐1‐infected men who started antiretroviral therapy. Participants were randomized to follow three intervention visits to promote adherence with the use of projective drawing techniques, Life‐steps and Motivational interview (Intervention Group; GI) or to continue with the routine care (Control Group; GC). Adherence was assessed through self‐report and drug plasma levels. Mann‐Whitney nonparametric test, w2 or Fisher exact test were used to compare variables.ResultsParticipants were 40 men with a median (IQ) age of 35.2 (30.2–44.8) years, CD4 cell count at the study entry of 316 (229–539) cells/mm3 and HIV‐RNA VL of 65.000 (22.500–250.000) copies. The infection route had been mainly MSM (90%). QD and BID ARV therapy was prescribed in 29 (72.5%) and 11 (27.5%) subjects. Seven patients (2 in GI; 5 in GC) were lost to follow‐up. At week 48, 100% of subjects in GI and 60% in GC had 100% adherence (p=0.01). In GC, 26% and 14% of subjects had ≥95% and <95% adherence, respectively. No differences were found in adherence regarding QD or BID therapy. All subjects except for 3 had VL <25 copies at week 48.ConclusionsHigh adherence was observed in the majority of this group of naïve HIV‐infected men who initiated their first antiretroviral therapy. However, all subjects following the intervention had 100% adherence after one year of follow‐up. A psychoeducative intervention based on the modification of health beliefs may be a useful strategy to promote adherence in naïve HIV‐infected patients.
In: Journal of the International AIDS Society, Band 11, Heft S1
ISSN: 1758-2652
In: Journal of the International AIDS Society, Band 11, Heft Suppl 1, S. P114
ISSN: 1758-2652