GSK Trial Data Shows Strong Support for Two-Drug Regimen Option For Treating HIV Patients

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GlaxoSmithKline continues to make headway in the development of two-drug regimens to benefit HIV patients – even those who have high levels of the virus.

During the 22nd International AIDS conference in Amsterdam, GSK’s ViiV Healthcare, the subsidiary focused on HIV treatments, released data from its late-stage GEMINI 1 and 2 studies that showed a combination of dolutegravir (DTG) and lamivudine (3TC) has a similar efficacy to the tri-drug combination dolutegravir and two nucleoside reverse transcriptase inhibitors, tenofovir disoproxil fumarate/emtricitabine. The two-drug regimen was being studied in treatment-naïve HIV patients. The GEMINI studies showed efficacy in patients with both high and low viral loads, the company said.

After tracking patients who were on the two-drug regimen for 48 weeks, ViiV said 91 percent of those patients had a high level of HIV-1 viral control versus 93 percent of patients who had been taking the triple-drug regimen. The difference between the two groups was not statistically significant, GSK said.

ViiV’s Chief Scientific Officer John Pottage said the company’s GEMINI data shows that the success of the two-drug regimen shows the benefits of that approach. He said researchers should rethink the traditional approach of using three or more drugs in combination to treat HIV. No patient should take more medicine than they need, Pottage said in a statement.

GSK said it will begin the process to seek regulatory approval for its two-drug regimen, which will put Gilead Sciences’ HIV pipeline squarely in the sights of the U.K.-based company. In February the U.S. Food and Drug Administration (FDA) gave its approval to Gilead Sciences' Biktarvy, a triple combination treatment of bictegravir and emtricitabine/tenofovir alafenamide for the treatment of HIV-1 in adults who haven’t been treated with antiretrovirals.

Pedro Cahn, the principal investigator for the GEMINI study, said the three-drug regimen has been a standard-of-care for HIV patients over the past 20 years. The development of more potent drugs has allowed the focus to shift to “tolerability and convenience,” Cahn said.

“The GEMINI studies show that we can get the efficacy of three drugs in a two-drug regimen with the tolerability and drug interaction profile of DTG and 3TC. These are important findings for people living with HIV who will spend their lifetime taking drugs to suppress their virus. The studies have the potential to expand the treatment paradigm for first-line therapy of people living with HIV,” Cahn said in a statement.

In addition to the GEMINI studies, ViiV also showed off 100-week data from its switching studies of Juluca, the first two-drug HIV regimen approved by the FDA. The ViiV data showed that switching patients from a three- or four-drug HIV regimen to Juluca (co-developed by Janssen) or another two-drug formula, maintained efficacy in treating the virus and was also tolerable to patients. Pottage said the data from the Phase III SWORD studies showed to the “growing evidence base” for Juluca and similar drugs.

Data from the trial showed 89 percent of patients on the two-drug regimen maintained viral suppression over 100 weeks. The company did note that three participants with NNRTI mutations failed to maintain suppression on the two-drug regimen.

“The results confirm the ability of Juluca to maintain efficacy over a 100-week period and importantly support that the long-term safety profile of this regimen is consistent with the respective labels of the component medicines. This 100-week data should provide physicians with further confidence that they may be able to reduce the number of antiretroviral drugs required to effectively maintain virologic suppression in their patient’s HIV,” Pottage said in a statement. 

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