Josep M. Llibre MD, PhD, physician and researcher of the Fight AIDS Foundation, has presented the results of the SWORD 1 and 2 studies in the Conference on Retroviruses and Opportunistic Infections (CROI), the world's largest HIV/AIDS conference which is being held this week in Seattle, WA, USA. These are twin studies that have been carried out in parallel at different centers around the world to evaluate a strategy to simplify antiretroviral treatment.
In addition to making an oral presentation on the subject, Dr. Llibre has been invited to one of the press conferences of the CROI as a spokesman for the numerous group of scientists who have collaborated in the development of the studies, being the Hospital Germans Trias i Pujol one of the centers that have participated more actively. The press conference took place yesterday at 3pm in Seattle, WA, (local time).
The studies: from their goal to their results
Antiretrovirals are classified into several categories or families depending on how they fight HIV. Each class of drugs has been designed to combat a specific stage in the life cycle of the virus, and HIV therapy generally consists of a combination of at least three drugs that must belong to more than one class to ensure its effectiveness and to avoid the appearance of resistances.
Being able to reduce the number of antiretroviral drugs used in therapy is a goal that can be very beneficial to the patient: if the person is exposed to two drugs instead of three or four, the possibility of side effects and associated toxicities is reduced. Taking into account that HIV therapy should be taken for life to control infection, interest in simplification studies is more than justified.
In this context SWORD 1 and SWORD 2 studies have been carried out globally to evaluate the efficacy and safety of a change in therapy from the current one (based on a combination of three or four drugs) to a combination with only two drugs: Dolutegravir (DTG) and Rilpivirine (RPV). The power, safety and ability to not create resistances of Dolutegravir made it the optimum basic agent; and Rilpivirine (RPV) was an ideal partner because of its proven safety, tolerability and efficacy in treatment changes. DTG + RPV "combo" should be taken once a day and applied to patients who had maintained undetectable viral load (below 50 copies/ml) at least in the last 12 months and who had never had a virological failure.
1,024 patients participated in the two studies, which lasted 48 weeks. 511 people continued therapy with 3-4 drugs (control group), and 513 switched to the DTG + RPV combination.
SWORD studies conclude that the simplified treatment with DTG+RPV demonstrates a high efficiency, not inferior to that of the therapy with three or four drugs, offering the potential advantages of the reduction in the accumulated exposure to more drugs of the strictly necessary. Therefore, as long as the patient meets the criteria indicated (being virologically suppressed and having had no virologic failure in his history), he could benefit from the change into simplified treatment with this combination of two drugs. The pharmaceutical product composed of Dolutegravir and Rilpivirine co-formulated in a single tablet is expected to be available to physicians and patients in a generalized manner in a short period of time. ViiV Healthcare and Janssen, owners of DTG and RPV patents respectively, expect to apply to regulatory agencies in the first half of 2017.