New Regimen of Rilpivirine and Dolutegravir Holds Promise for Simpler, Safer HIV Treatment

HIV treatment has come a long way from the multidrug cocktails of years ago. Now, Janssen Sciences Ireland UC and partner ViiV Healthcare have announced positive results from two Phase 3 studies that evaluated HIV patients as they switched from a three- or four-drug regimen to a two-drug regimen—the first of its kind—that promises to simplify treatment even further and help patients avoid dangerous drug side effects.

Presented at the recent Conference on Retroviruses and Opportunistic Infections in Seattle, the new regimen consists of rilpivirine, marketed by Janssen as EDURANT, and dolutegravir, marketed by Viiv as TIVICAY, taken together. In the trials, patients on the two-drug regimen were able to achieve viral suppression after 48 weeks, making the regimen just as effective as the currently prescribed three- or four-drug regimen in terms of maintenance.

Scientists are eager to reduce the number of drugs an HIV patient must take. “Every antiretroviral that is taken as part of an HIV regimen adds to the potential side effects for the patient, [and] so by reducing the amount of antiretrovirals in the treatment there is less potential for side effects in the long term,” Brian Woodfall, MD, Global Head, Late Development, Infectious Diseases and Vaccines at Janssen told Contagion^®.

One particular area of concern is with nucleotide reverse transcriptase inhibitors (NRTIs), a class of drug currently prescribed to treat HIV. “While newer NRTIs have improved upon the toxicity issues seen with the earliest therapies, there are still some safety concerns associated with contemporary NRTIs,” stated Dr. Woodfall. “NRTIs have been associated with bone density, renal, and cardiovascular (CV) side effects. HIV is increasingly treated as a lifelong condition, [and] so it is important to identify new treatment options that reduce side effects over the long term, particularly as HIV patients can be more susceptible to renal or CV complications as they age.”

The scientists are hopeful that the rilpivirine/dolutegravir regimen will be approved for HIV patients who have been able to keep their viral levels suppressed for a year, as that is the group that was studied in the trials. The two-drug regimen will be a next-step treatment once patients are able to get their viral levels under control using a different form of therapy.

Rilpivirine/dolutegravir is not without side effects. Some of the study participants reported stuffy nose and general upper-respiratory infection, headache, and diarrhea. These side effects are similar to those reported by subjects taking three- or four-drug cocktails. Overall, however, serious side effects were no more common among those taking the two-drug therapy.

If the two-drug regimen is approved, patients will need to discuss with their doctors whether the regimen is appropriate for them based on their personal risk factors. At this time, no information is available about the potential cost of rilpivirine/dolutegravir.

According to the Centers for Disease Control and Prevention, 1,242,000 people in the United States are living with HIV. Roughly the same number have gone on to be diagnosed with AIDS. Although overall HIV cases have fallen in recent years, young gay and bisexual men, particularly African-Americans and Latinos, are disproportionately affected by the disease and have not seen declines in new cases.