Cheaper, Simpler Protocol Prevents HBV Recurrence After Liver Transplant

Jim Kling

May 10, 2010

May 10, 2010 (San Diego, California) — An interim analysis shows that a combination of the nucleoside reverse-transcriptase inhibitor emtricitabine with the protease inhibitor tenofovir disoproxil fumarate (FTC/TDF) plus hepatitis B immune globulin (HBIG) effectively and safely prevents the recurrence of chronic hepatitis B after liver transplantation. The study was presented here at the American Transplant Congress (ATC) 2010.

At baseline, patients had a median age of 59 years; 80% were men; and 37.5% were Asian, 25% were black, and 32.5% were white. All patients had undetectable levels of hepatitis B virus (HBV) DNA (<169 copies/mL [29 IU/mL]). Median time since transplant was 3.4 years (range, 0.3 to 17.7 years).

Liver transplant patients were at least 12 weeks postoperative, had a creatinine clearance of greater than 40 mL/min, had had no chronic hepatitis B recurrence after transplantation, and had received less than 12 months of treatment with TDF prior to transplant.

Patients were treated with FTC/TDF plus HBIG for 24 weeks, and then randomized into equal groups. One group continued FTC/TDF plus HBIG, and the other discontinued HBIG and remained on FTC/TDF. Both groups were treated for an additional 72 weeks.

The researchers grouped patients into 3 categories on the basis of baseline creatinine clearance/renal function: 7 patients had normal renal function (>80 mL/min); 24 had mild renal impairment (50–80 mL/min); and 9 had moderate renal impairment (30-49 mL/min). At week 72, the 3 groups had median serum creatinine values of 1.1, 1.2, and 1.4 mg/dL, respectively, with a median change from baseline of –0.10, 0.0, and –0.20.

Of the 40 patients enrolled, 3 dropped out before week 24, and 33 had entered the randomized stage at 72 weeks. To date, 29 patients have completed 48 weeks of treatment, and 24 patients have remained on treatment until week 72.

Four patients who showed mild renal impairment at baseline had a creatinine clearance of less than 50 mL/min; they remained stable on treatment. None of the patients had a serum creatinine increase of more than 0.5 mg/dL or a phosphorus level of less than 2 mg/dL.

"Notably, no patient has experienced HBV recurrence, including the treatment group that discontinued HBIG and remained on FTC/TDF alone," the researchers reported.

"Long-term prophylaxis with HBIG is inconvenient and expensive. We decided to combine it with new antivirals and to drop HBIG [for part of the treatment period]," Lewis Teperman, MD, director of transplantation at the New York University Medical Center in New York City, said during his presentation. "I believe [the approach] will become a mainstay of therapy. It's cheaper and more convenient, and is available as a pill. If you can get patients off expensive, invasive therapies, you're better off," Dr. Teperman told Medscape Transplantation.

"It's a pretty good study. I can't wait to see the rest of it," Mark Johnson, MD, director of the transplant program at Piedmont Hospital in Atlanta, Georgia, who moderated the session, told Medscape Transplantation. "It's less costly and more convenient for the patients. I think that's great."

Dr. Teperman's study was sponsored by Gilead. Dr. Johnson has disclosed no relevant financial relationships.

American Transplant Congress (ATC) 2010: Abstract 126. Presented May 2, 2010.