Lone Larsen

Saquinavir hard gel suppresses viral load insufficiently in HIV-infected patients naive to anti-retroviral therapy: a retrospective cohort study.

Protease inhibitors are important components in anti-retroviral regimens. In this retrospective study 29 HIV-infected patients treated with a regimen of zidovudine, lamivudine and saquinavir hard gel in 1 centre in Denmark were compared with 58 patients treated with zidovudine, lamivudine and ritonavir or indinavir followed at 5 other centres in Scandinavia. All patients were naive to anti-retroviral therapy prior to institution of the actual anti-retroviral regimen and were followed for a median of 1.3 and 1.4 y respectively. The 2 groups did not differ significantly with respect to age, gender, route of infection, ethnic background, viral load, CD4 count, AIDS at baseline or frequency of clinical controls. Six and 12 months after initiating anti-retroviral therapy, 31% and 34% of the patients on the saquinavir regimen obtained HIV-RNA < or = 500 compared with 76% and 73% in the control group (p < 0.001). In contrast to viral load, the increase in CD4 count did not differ significantly between the 2 groups. In conclusion, we found that with respect to suppression of viral load a regimen of saquinavir, zidovudine and lamivudine seemed to be inferior to a regimen of zidovudine, lamivudine and ritonavir or indinavir.

The effect of nevirapine in combination with nelfinavir in heavily pretreated HIV-1-infected patients: a prospective, open-label, controlled, randomized study.

Summary: The purpose of the current study was to determine the efficacy and safety of nevirapine combined with nelfinavir and two nucleoside reverse transcriptase inhibitors (NRTIs) in patients previously exposed to highly active antiretroviral therapy (HAART). In a prospective, open‐label, randomized study, 56 HIV‐infected adults who had received HAART, including saquinavir hard gel capsule, ritonavir, or indinavir, were randomly assigned to receive nevirapine in addition to nelfinavir and two NRTIs. The proportion of patients who achieved an undetectable viral load (plasma HIV‐RNA <200 copies/ml) at weeks 24 and 36 was significantly higher in the nevirapine group than in the control group (55% and 52% vs. 22% and 22%; p = .015 and p = .047). No differences in CD4 cell count or clinical outcome were observed. In the nevirapine group, 17% of patients discontinued treatment because of rashes. We conclude that the addition of nevirapine, when switching from one protease inhibitorcontaining regimen to one containing nelfinavir, has a substantial effect on viral suppression.

Touch screens as a tool in patient care in the IBD outpatient clinic

Abstract Objective: We have introduced online touch screens in the waiting room for patients with ulcerative colitis (UC) or Crohns disease (CD) for recording of symptoms before their consultation. This has made disease activity scores readily available to the physician in our newly established database, ‘Gastrobio’. We wanted to validate the use of touch screens compared to paper questionnaires. Material and methods: A total of 54 patients with UC and 74 patients with CD were included in the study. The UC patients filled out the Short Health Scale (SHS) and Simple Clinical Colitis Activity Index (SSCAI). The CD patients filled out the SHS and Harvey–Bradshaw Index (HBI). Paper questionnaires and touch screen versions were used in random order and comparison between the two modalities was made by Spearman correlation test, Bland–Altman plots, and Kappa-statistics. Results: Among the 128 patients, the two SHS scores (SHS touch versus SHS paper) were found to be highly correlated (Spearman correlation; 0.92 for UC and 0.92 for CD). Also, on average, Bland–Altman plots demonstrated a difference close to zero between the two modalities. Agreement between paper version and touch screen version of SCCAI and HBI scores was also high (Kappa-statistics; 78% raw and 98% weighted for SCCAI; 65% raw and 97% weighted for HBI). Conclusions: It is feasible to introduce touch screens in the outpatient clinic and to have patients record their symptoms before the consultation. However, the study may not be representative for elderly patients.

The Danish National Registry for Biological Therapy in Inflammatory Bowel Disease

Aim The aims of The Danish National Registry for Biological Therapy in Inflammatory Bowel Disease are to ensure that biological therapy and the clinical management of patients with inflammatory bowel disease (IBD) receiving biological treatment are in accordance with the national clinical guidelines and, second, the database allows register-based clinical epidemiological research. Study population The study population comprises all Danish patients with IBD (both children and adults) with ulcerative colitis, Crohn’s disease, and IBD unclassified who receive biological therapy. Patients will be enrolled consecutively when biological treatment is initiated. Main variables The variables in the database are: diagnosis, time of diagnosis, disease manifestation, indication for biological therapy, previous biological and nonbiological therapy, date of visit, clinical indices, physician’s global assessment, pregnancy and breastfeeding (women), height (children), weight, dosage (current biological agent), adverse events, surgery, endoscopic procedures, and radiology. Descriptive data Eleven clinical indicators have been selected to monitor the quality of biological treatment. For each indicator, a standard has been defined based on the available evidence. National results will be published in an annual report and local results on a quarterly basis. The indicators will be reported as department-specific proportions with 95% confidence intervals, and the national average will be provided for comparison. An estimated 1,200–1,300 new biological therapies are initiated each year in Danish patients with IBD. Conclusion The database will be available for research during 2016. Data will be made available by The Danish Clinical Registries (www.rkkp.dk).

Changing Infliximab Prescription Patterns in Inflammatory Bowel Disease: A Population-Based Cohort Study, 1999–2014

BackgroundnLong-term data on real life use of infliximab (IFX) for inflammatory bowel disease (IBD) are lacking. We studied prescription patterns during the first 16 years following marketing authorization.nnnMethodsnIn a population-based cohort from the North Denmark Region, all IBD patients exposed to IFX during 1999 to 2014 were identified.nnnResultsnA total of 623 patients (210 with ulcerative colitis [UC] and 413 with Crohns disease [CD]) were exposed to IFX. In patients with UC, age at first exposure decreased by 10 months per calendar year (P < 0.05) during the study period. In patients with CD, disease duration at time of first IFX exposure decreased by 7 months per calendar year (P < 0.001). From 2005-2009 to 2010-2014, the proportion of IFX-exposed patients with pancolitis (40% vs 24%, P = 0.04) and the proportion of patients with extensive CD (P = 0.002) decreased. The mean time to discontinuation of IFX remained stable in patients with CD during the study period (2.5-3.0 years) and increased from 0.34 years (2005-2009) to 1.11 years (2010-2015) in patients with UC (P = 0.04).nnnConclusionnDuring the first 16 years postmarketing, age at first exposure to IFX decreased in patients with UC, whereas disease duration at time of first exposure decreased in patients with CD. Also, a significant change toward less extensive disease in both UC and CD patients exposed to IFX was observed. Treatment duration in patients with UC increased during the study period, but did not reach the more constant and longer duration of treatment observed in patients with CD.