The Botswana government has recently introduced Dolutegravir to be used as the first line “backbone” anti-retroviral drug in the treatment of HIV infection in a national HIV treatment programme. Dolutegravir is a new second generation Integrase Strand Transfer Inhibitor that has been shown to be superior to all previously used HAART regimens.
Seatla’s project aims to assess the virological, immunological and clinical responses to a Dolutegravir based combination anti-retroviral therapy in ARV naïve HIV-1C infected patients in Botswana. A cohort of ART naïve adults will be followed in a “real life” government clinic setting for about 12 months after being initiated on DTG-TDF-FTC or DTG-ABC-3TC as per guidelines.
The primary end point to be assessed will be the proportion of patients with HIV-1 RNA levels below 50 copies/ml after 48 weeks of Dolutegravir based HAART and the time taken to achieve this virological suppression. Some of the secondary end points to be assessed will include the proportion of participants who develop drug resistant mutations, rates of primary drug resistance and safety profile of a DTG based HAART in HIV-1C infected patients in Botswana.
Very few clinical studies on Dolutegravir have been conducted in HIV-1C infected patients or in an African setting. Seatla hopes the data-set collected will bridge this knowledge gap and perhaps identify unique virological, immunological and safety issues that might occur with Dolutegravir based HAART use in a national “Test and Treat all” programme.