Pfizer And GSK's ViiV Healthcare's Two-Drug HIV Treatment Matches Gilead's Three-Drug Combo In Major Trial

Tuesday, GSK Plc GSK / Pfizer Inc PFE-owned ViiV Healthcare said its two-drug HIV regimen Dovato was as effective as Gilead Science Inc‘s GILD three-drug combo Biktarvy in a head-to-head trial.

Japanese pharmaceutical company Shionogi & Company is also a stakeholder in ViiV healthcare.

ViiV Healthcare released 48-week findings from PASO DOBLE (GeSIDA 11720 study), the largest head-to-head, phase IV randomized clinical trial (RCT) investigating the 2-drug regimen Dovato (dolutegravir/lamivudine [DTG/3TC]) compared to the 3-drug regime Biktarvy (bictegravir/ emtricitabine/tenofovir alafenamide fumarate [BIC/FTC/TAF]) for virologically suppressed HIV-1 patients.

Also Read: Pfizer/GSK-Backed ViiV Healthcare’s HIV Drug Associated With Increased Resistance, WHO Report Says.

Findings showed that switching to DTG/3TC demonstrated non-inferior efficacy in maintaining viral suppression compared with switching to BIC/FTC/TAF.

In the PASO DOBLE clinical trial, 553 patients switched treatment to either Dovato (n=277) or Biktarvy (n=276).

The study found in a key secondary endpoint that weight increased significantly more in participants who switched to BIC/FTC/TAF than in those who switched to DTG/3TC through week 48.

The proportion of participants with weight gain greater than 5% was significantly higher for Biktarvy, at 29.9%, compared to 20% for Dovato.

Weight change with Dovato was consistent across genders and prior regimens. However, participants switching from abacavir-based regimens experienced a 45% higher rate of over 5% weight gain with Biktarvy compared to Dovato (30.6% vs. 21.1%). When switching from TDF-based regimens, the weight gain rate with Biktarvy was about twice as high as with Dovato (40.7% vs. 19.5%).

In 2023, Dovato generated sales of 1.82 billion pounds, while Biktarvy brought in $11.8 billion.

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Image created using artificial intelligence via Midjourney.