エイズと臨床研究のジャーナル

Acquired immunodeficiency syndrome (AIDS) is a disease of the human immune system caused by the human immunodeficiency virus (HIV). It spreads from person to person mainly by sexual route (most common), parenteral (blood transfusion, needle sharing in drug use, needle stick injury etc).1 According to India HIV Estimation 2017 report, 2.1 million people were living with HIV. National adult (15–49 years) HIV prevalence in India is estimated to be 0.22% (0.16% – 0.30%) in 2017. 0.25% (0.18-0.34) among males and at 0.19% (0.14-0.25) among females. The adult HIV prevalence at national level has continued its steady decline from an estimated peak of 0.38% in 2001-03 through 0.34% in 2007 0.28% in 2012 and 0.26% in 2015 to 0.22% in 2017. AIDS related deaths has declined by almost 71%. 2 India is the third largest country with HIV/AIDS patients.

Acquired immunodeficiency syndrome (AIDS) is a disease of the human immune system caused by the human immunodeficiency virus (HIV). It spreads from person to person mainly by sexual route (most common), parenteral (blood transfusion, needle sharing in drug use, needle stick injury etc).1 According to India HIV Estimation 2017 report, 2.1 million people were living with HIV. National adult (15–49 years) HIV prevalence in India is estimated to be 0.22% (0.16% – 0.30%) in 2017. 0.25% (0.18-0.34) among males and at 0.19% (0.14-0.25) among females. The adult HIV prevalence at national level has continued its steady decline from an estimated peak of 0.38% in 2001-03 through 0.34% in 2007 0.28% in 2012 and 0.26% in 2015 to 0.22% in 2017. AIDS related deaths has declined by almost 71%. 2 India is the third largest country with HIV/AIDS patients.

Background: HIV-1 DNA drug resistance testing is increasingly used to guide antiretroviral (ARV) regimen switches in the setting of viral suppression. In this single-arm study, HIV-1 DNA resistance testing was used to assess eligibility for the fixed-dose combination of abacavir/ dolutegravir/lamivudine in the context of a switch study evaluating changes in bone mineral density in HIV-1 positive adults ages 50 years and older. Methods: Study subjects had viral loads which were <50 copies/mL at study screening. Susceptibility to each component of the switch regimen was assessed using an HIV-1 DNA genotypic resistance assay. A regimen switch was made only when the subject’s virus was sensitive to each component of the switch regimen. Viral load measurements were obtained per study protocol through weeks 24 and 48. Results: At week 24, the HIV-1 RNA viral load was <50 copies/mL for 44 of 44 study participants with available follow-up data, (95% CI [0.920, 1]). At week 48, 41 of 42 participants were virologically suppressed to <50 copies/mL, (95% CI [0.874, 0.999]); 1 participant had a viral load of 62 copies/mL. Conclusion: In this pre-selected population of virologically suppressed patients, HIV-1 DNA resistance testing successfully identified candidates for ARV treatment modification to an available single tablet regimen. These results support the utility of HIV-1 DNA drug resistance testing in the clinical setting.

Background: HIV-1 DNA drug resistance testing is increasingly used to guide antiretroviral (ARV) regimen switches in the setting of viral suppression. In this single-arm study, HIV-1 DNA resistance testing was used to assess eligibility for the fixed-dose combination of abacavir/ dolutegravir/lamivudine in the context of a switch study evaluating changes in bone mineral density in HIV-1 positive adults ages 50 years and older. Methods: Study subjects had viral loads which were <50 copies/mL at study screening. Susceptibility to each component of the switch regimen was assessed using an HIV-1 DNA genotypic resistance assay. A regimen switch was made only when the subject’s virus was sensitive to each component of the switch regimen. Viral load measurements were obtained per study protocol through weeks 24 and 48. Results: At week 24, the HIV-1 RNA viral load was <50 copies/mL for 44 of 44 study participants with available follow-up data, (95% CI [0.920, 1]). At week 48, 41 of 42 participants were virologically suppressed to <50 copies/mL, (95% CI [0.874, 0.999]); 1 participant had a viral load of 62 copies/mL. Conclusion: In this pre-selected population of virologically suppressed patients, HIV-1 DNA resistance testing successfully identified candidates for ARV treatment modification to an available single tablet regimen. These results support the utility of HIV-1 DNA drug resistance testing in the clinical setting.

Objectives: The aim of the study was to evaluate the effect of lamivudine on the erythrocyte mean corpuscular volume.

Methods: We conducted a retrospective evaluation of the mean corpuscular volume in patients prescribed lamivudine, and a comparison group of patients not taking lamivudine or other NRTIs known to affect the MCV, using electronic patient records from a single UK centre.

Results: A total of 456 patients whilst on lamivudine were compared to 483 patients not having taken lamivudine. The mean MCV in the lamivudine group was 94.1 (83-100 fl)., which was statistically significantly higher than that in patients not taking lamivudine, 91.6 fl, including those taking emtricitabine (p-value<0.0001). Of patients prescribed lamivudine, 49 (10%) developed a clinically significant macrocytosis, with an odds ratio for macrocytosis of 3.3 compared to patients not taking lamivudine. The effect of lamivudine on MCV was independent of patient age, sex, ethnicity, and weight, dose of lamivudine or duration of therapy with lamivudine. A similar, but lesser, effect was seen with emtricitabine.

Conclusion: This study suggests that lamivudine causes an increase in the mean corpuscular volume of erythrocytes, and that this is sufficient to cause a clinical macrocytosis in 10% of patients. This is of clinical relevance for practitioners managing patients prescribed lamivudine, in guiding the need for investigating macrocytosis.