Among patients with HIV infection who experienced treatment failure, including those with either a history of antiretroviral (ART) failure, multi-drug resistant HIV strains, or multiple comorbidities, a dolutegravir-based treatment regimen was found to be associated with a sustained treatment response. These findings were published in Infectious Diseases Now.
In this multicenter, longitudinal, observational study conducted between February 2017 and January 2018, researchers retrospectively enrolled patients with HIV infection who were started on dolutegravir treatment for the first time between February 2014 and September 2016. The follow-up period was 24 months after treatment initiation. Treatment failure was defined as an HIV viral load of greater than or equal to 50 copies/mL on analysis of 2 consecutive blood sample specimens, or failure due to clinical or biologic safety issues. The primary outcomes were treatment response and time to treatment response.
Among a total of 459 patients included in the study, 329 completed 24 months of treatment with dolutegravir. Of patients included in the final analysis, the mean age was 50 years, 64.1% were men, and patients had been living with HIV infection for a mean of 16 (range, ˂1 to 32) years. At baseline, the mean duration of antiretroviral treatment was 13 years and patients had previously been exposed to a mean of 7 treatment regimens prior to initiating treatment with dolutegravir.
In regard to comorbidities, 22.2% of patients had dyslipidemia, 21.8% had hypertension, and 9.8% had chronic kidney failure.
Among patients included in the study, 78.6% achieved viral suppression following 24 months of treatment with dolutegravir. Of note, dolutegravir treatment was discontinued in 86 patients, of whom 17 failed to achieve or main viral suppression and 38 stopped treatment due to tolerability issues. The researchers found evidence of mutations resistant to dolutegravir in 5 patients. In addition, the most frequently reported adverse events among patients treated with dolutegravir were diarrhea (n=9) and arthralgia (n=7).
Overall, a total of 7 patients died during the study; however, none of these deaths were found to be related to dolutegravir treatment. In addition, 5 pregnancies were reported in patients treated with dolutegravir, for which the outcome was normal in all cases.
This study was limited by its observational design and the proportion of patients lost to follow-up. Other limitations included potential inclusion bias, heterogeneity among the ARTs that were used in combination with dolutegravir, and the inability to accurately determine the time course of treatment responses as follow-up visits and blood sampling did not occur at regular intervals.
According to the researchers, “this large observational study indicates that a sustained treatment response can be obtained following initiation of a dolutegravir-based treatment regimen in [patients with HIV infection] experiencing treatment failure, even in vulnerable patients with [either] a long history of previous ART failure, multi-drug resistant HIV strains, or multiple comorbidities.”
Disclosure: Some authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Landman R, Marcelin AG, Bennani M, et al. COPEDOL: a two-year observational study in pretreated HIV-1-infected patients switching to a dolutegravir-based regimen. Infect Dis Now. Published online December 15, 2021. doi: 10.1016/j.idnow.2021.12.005