A standard of care treatment in high-income settings, the benefits of dolutegravir-based treatments for HIV have been clear, with a built-in barrier to the development of drug-resistance, and a less frequent or severe side effects that interfere with staying on a medicine. But the benefits in low-income countries have been harder to assess, with costs, lack of testing on pregnant women as well as limited testing on women at all, and most recently, studies indicating a possible risk of birth defects among infants whose mothers became pregnant while taking the drug, slowing adoption of the medicine.
Now, findings from the first study to examine outcomes among patients starting to use the drug in a low income setting show use of the drug to be cost effective, as well as safe and extremely effective in suppressing viral loads quickly, and maintaining viral suppression below detectable levels.
The study, reported in Clinical Infectious Diseases, took place at the YRG Centre for AIDS Research and Education in Chennai, India, a nonprofit facility treating patients according to WHO guidelines that was founded by the ground-breaking physician Dr. Suniti Solomon.
At the center, etween April 2017 and May 2018, 564 patients, including ones new to treatment and ones among whom previous treatments had failed, started regimens that included dolutegravir. Of 239 patients visiting the clinic six months later, none had discontinued treatment, treatment had not failed in any, and each patient with a viral load test was virally suppressed. Tests showed patients kidneys and livers doing well. Rates of opportunistic infections among the group dropped from 7.4 percent to 3.3 percent. There were no reports of side effects that have complicated other treatments — no sleep disturbances, no psychiatric side effects, and no reported cases of an inflammatory response that can occur when a newly awakened immune system meets a newly acquired, or newly surfacing infection.
The authors, led by Dr. Nagalingeswaran Kumarasamy of YRG CARE, note that “further surveillance is needed” from programs using the drug among women of child-bearing age, and that guidelines have cautioned against using women who intend to become pregnant using the drug, following findings in Botswana potentially linking use of the drug at conception with infants neural tube defects. But, they conclude, dolutegravir is an “attractive replacement” for efavirenz, the presently more commonly used drug linked to greater rates and severity of side effects, and greater risks of drug resistance. They note that further research might determine if more widespread adoption of dolutegravir would slow HIV incidence, by more quickly suppressing viral loads to undetectable — and untransmissable levels.