By Ethan Covey
Dolutegravir-lamivudine (DTG/3TC; Dovato, ViiV Healthcare) demonstrates high rates of virologic suppression among people living with HIV and who have reactive anti–hepatitis B core antibody (anti-HBc) and no evidence of active hepatitis B virus (HBV) infection, according to data presented at AIDS 2024, held in Munich (abstract OAB0106LB).
The high virologic suppression is comparable to that found with three- or four-drug comparator regimens.
“DTG/3TC has demonstrated robust and durable efficacy, a high barrier of resistance, and is recommended by international guidelines for people living with HIV who are initiating ART [antiretroviral therapy] and those who are virologically suppressed,” said presenting author Danielle Fox, PharmD, the global scientific advisor for ViiV Healthcare.
“As two-drug regimens have emerged, they may contain regimens that are lacking hepatitis B activity,” Dr. Fox continued.
“The clinical management of people living with HIV with a past exposure to hepatitis B, who have not yet demonstrated immunity to hepatitis B, is important to prevent clinical progression of liver disease, potential for hepatitis B reactivation and/or liver-associated complications,” she added.
In a study of people living with HIV who switched to DTG/3TC, investigators concluded that those who had isolated reactive anti-HBc had lower rates of HIV suppression after switching to DTG/3TC than those with nonreactive anti-HBc (Malagnino, et al. European AIDS Conference 2023; Warsaw, Poland. Oral presentation RA2.07).
“This real-world evidence prompted us to conduct a systematic analysis of the randomized clinical data available to help to examine how DTG/3TC impacts the treatment of HIV viral suppression in those who have been exposed to hepatitis B but do not have immunity,” Dr. Fox said.
Dr. Fox and her colleagues analyzed data from a total of 76 people living with HIV with a past exposure to an HBV infection and no immunity to hepatitis B who were participants in four phase 3/3b studies: GEMINI-1/-2 (n=46), STAT (n=5), TANGO (n=13) and SALSA (n=12).
“While the numbers of participants were small, participant demographics were generally comparable between treatment groups across all studies,” Dr. Fox said.
Of note, the studies did not proactively collect HBV vaccination data from participants.
Among participants in the studies who met the criteria for the analysis, high rates of virologic suppression were seen, including when using a more stringent measure of HIV viral load of HIV-1 RNA less than 40 copies/mL.
When looking at safety, liver function test toxicities were reported in 10 of 23 (43%) participants receiving DTG/3TC in GEMINI-1/-2 and three of 16 (19%) receiving DTG/3TC in TANGO/SALSA; most were identified as being grade 1 or 2. No instances of HBV reactivation were reported in any of the studies.
“Overall, these results support the safety and efficacy of DTG/3TC in people living with HIV who have isolated reactive anti-HBc,” Dr. Fox said.
Dr. Fox is an employee of ViiV Healthcare and owns stock in GSK.
