Triplex reduces cytomegalovirus complications by half and induces immunity in stem cell transplant

Below please find summaries of new articles that will be published in the next issue of

Annals of Internal Medicine

. The summaries are not intended to substitute for the full articles as a source of information. This information is under strict embargo and by taking it into possession, media representatives are committing to the terms of the embargo not only on their own behalf, but also on behalf of the organization they represent.

1. Triplex reduces cytomegalovirus complications by half and induces immunity in stem cell transplant recipients

Abstract:

http://annals.

org/

aim/

article/

doi/

10.

7326/

M19-2511

URL goes live when the embargo lifts

The novel Triplex vaccine reduced rates of cytomegalovirus (CMV) complications in patients undergoing allogeneic hematopoietic stem cell transplant (HCT) by half and induced immunity to the virus. No vaccine-associated safety concerns were identified. Findings from a phase 2 randomized clinical trial are published in

Annals of Internal Medicine

.

Undergoing HCT heightens risk for complications due to reactivation of latent CMV in recipients positive for the virus. Preemptive therapy can successfully treat CMV reactivation, although antiviral agents have significant side effects. Consequently, there is still an unmet need for a durable approach to suppress both early and late CMV reactivation and its consequences.

Researchers from City of Hope Comprehensive Cancer Center and two partner cancer centers (Dana-Farber and M.D. Anderson) studied 102 CMV-seropositive HCT recipients at high risk for CMV reactivation to determine the safety and efficacy of Triplex for reducing CMV complications. Participants were randomly assigned to either Triplex or placebo on days 28 and 56 after HCT. At 100 days, the researchers found that reactivation of CMV occurred in 5 Triplex recipients and 10 receiving placebo. In addition, despite having transplant-induced weakened immune systems, patients who received Triplex developed immunity against CMV that was 212 percent higher than those in the placebo group. The recipients reported no vaccine-associated adverse effects and transplant outcomes were similar in both groups. According to the authors, these findings suggest that Triplex is safe and effective for reducing CMV complications in HCT patients.

Media contacts: For an embargoed PDF please contact Lauren Evans at

[email protected]

. To speak with the lead author, Don J. Diamond, PhD, please contact Letisia Marquez at

[email protected]

.

2. Adding maraviroc to standard c-ART does not seem to improve clinical outcomes for patients with advanced HIV infection

Abstract:

http://annals.

org/

aim/

article/

doi/

10.

7326/

M19-2133

URLs go live when the embargo lifts

Adding maraviroc to standard combined antiretroviral therapy (c-ART) does not seem to improve clinical outcomes for patients initiating treatment for advanced HIV infection. Findings from a double-blind randomized controlled trial are published in

Annals of Internal Medicine

.

One-third of patients with HIV in resource-rich countries are diagnosed late in the disease. These patients with advanced HIV infection face increased risk for AIDs-defining events and mortality due to opportunistic infections, which may be related to weakened immunity. Maraviroc, an antiretroviral drug with immunologic effects, could benefit such patients.

Researchers from Henri Mondor Hospital, Créteil, France, randomly assigned 416 HIV-positive adults initiating treatment with c-ART for the first time to either C-ART plus placebo or maraviroc for 72 weeks to assess the benefit of adding maraviroc to standard c-ART. The researchers found that among persons diagnosed with advanced HIV infection in 3 European countries, the incidence of severe morbidity was 11.2 per 100 person-years, and adding maraviroc to standard c-ART for these patients had no effect on this. Maraviroc use was associated with higher risk for virologic failure at week 48 but not at week 72. The gain in CD4 T-cell count was similar in both groups throughout the study but increase in CD4-CD8 ratio was lower in the maraviroc group. The authors conclude that maraviroc seems to show no clinical benefit for patients diagnosed with advanced HIV.

Media contacts: For an embargoed PDF or speak with an author please contact Lauren Evans at

[email protected]

.

###