A Phase IV Study on Safety, Tolerability and Efficacy of Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate in Treatment Naïve Adult Indian Patients Living with HIV-1

Abstract

Purpose WHO recommends dolutegravir (DTG) based regimens as first-line treatment for HIV-1 infection. However, few studies have been conducted in Indian population. Hence, our study evaluated the safety, tolerability, and efficacy of DTG 50 mg with Tenofovir and Lamivudine (300/300mg) fixed dose combination in treatment naïve adult Indian patients. Methods This was an open label, multicenter, prospective, interventional, phase IV study conducted across 14 sites between February 2019 and July 2020. 24 weeks was the treatment duration for each subject. The primary end point was to assess the incidence of adverse events (AEs) and secondary end points were to assess the proportion of patients achieving plasma HIV-1 RNA levels <50 copies/mL at week 24 and change in CD4+ cell count from the baseline. Safety analysis was conducted using Safety Analysis Set and efficacy analysis was carried out using Full Analysis Set and Per protocol set. Results A total of 288 patients were screened; 250 were enrolled; and 229 completed the study. 389 AEs were reported from 58% of patients. Of these, 61 were related to study treatment. One event of decreased creatinine clearance led to study discontinuation. One serious event of pyrexia was reported, which was unrelated to the study drug. The most common AEs were headache (18%), pyrexia (14%), vomiting (6.4%) and upper respiratory tract infections (6%). No deaths were reported. At week 24, 86.8% of the patients achieved plasma HIV-1 RNA levels <50 copies/mL and the mean CD4 cell count increased from 350.2 (SD, 239.73) at baseline to 494.6 (SD, 261.40) with an average increase of 143.2 (SD, 226.14) cells. Conclusion This study demonstrated the safety and efficacy of DTG based regimen in treatment naïve HIV-1 patients in Indian population and support use of DTG as first-line treatment regimen.

Brief Report: Lower Self-Reported Antiretroviral Therapy Adherence Among Adolescents in Boarding Schools Compared to Day Schools

“…We observed that ALH were more likely to need to attend a clinic during school time, likely as clinics do not consider aligning day school ALH clinic visits with school schedules. With once-daily DTG-based regimens, 31,32 adjusting medication timing to fit the school schedules is feasible. We recently identified that schools in Kenya lack medication use policies making it challenging to ensure access when needed.…”

Đánh Giá Hiệu Quả Của Phác Đồ Acriptega Trong Năm Đầu Tiên Trên Người Nhiễm Hiv Chưa Từng Điều Trị Arv

“…Với các nghiên cứu về tác dụng của DTG cho người nhiễm HIV lần đầu điều trị, kết quả tháng thứ 6 về lượng virus HIV giảm dưới ngưỡng phát hiện chiếm tỉ lệ 86,8%, cao hơn so với kết quả của chúng tôi (78,2%), nhưng lượng virus HIV ban đầu của bệnh nhân nghiên cứu chúng tôi cao hơn, và ngưỡng phát hiện là 20 bản sao/mL và CD4 tăng thêm 143 tế bào 5 cũng tương đương như của nghiên cứu chúng tôi là tháng thứ 6 tế bào CD4 tăng thêm 162 tế bào/mm 3 .…”

The Cost-Effectiveness of Dolutegravir in Combination with Tenofovir and Lamivudine for HIV Therapy: A Systematic Review

“… 5 , 6 DTG with two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) has shown significant efficacy in HIV suppression in individuals. 7 , 8 DTG-based regimens may be more effective for CD4 recovery and virologic suppression than EFV-based regimens, making them a preferred treatment option for initial HIV treatment. 9 DTG also has fewer drug interactions than EFV, a better genetic barrier to developing drug resistance, and is particularly effective against HIV-2 infection, which is inherently resistant to EFV.…”