Published: Jul 7, 2013
By Michael Smith, North American Correspondent, MedPage Today
Reviewed by F. Perry Wilson, MD, MSCE; Instructor of Medicine, Perelman School of Medicine at the University of Pennsylvania
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
- These preliminary results from a randomized trial demonstrated that early HIV therapy in patients with symptoms of primary infection or CD4 counts < 500/mm3 led to marked reduction in viral DNA.
- Be aware that the primary purpose of the trial -- to evaluate the feasibility of stopping therapy in select patients -- has yet to be reported.
KUALA LUMPUR -- Preliminary data from a French randomized trial suggest that early HIV treatment might be a step toward so-called post-treatment control, a researcher said here.
Post-treatment control is what investigators are calling the ability to stop HIV therapy -- after some time on treatment -- without having the virus resume replication within the body.
Some 14 patients -- known as the Visconti cohort and all treated within weeks of their infection -- have been shown to have such control, some for several years, according to Antoine Cheret, MD, of Sorbonne-Paris-Cite University in Paris.
At the 7th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention here, Cheret presented early data from the first randomized trial aimed at duplicating the Visconti cohort.
The Optiprim study has enrolled 90 patients with early HIV infection and randomly assigned them to 24 months of a standard triple-drug regimen -- boosted darunavir (Prezista) plus tenofovir/emtricitabine (Truvada) -- or the same regimen plus raltegravir (Isentress) and maraviroc (Selzentry).
The primary endpoint of the study is what happens to the levels of HIV DNA -- regarded as the indicator of the reservoir if HIV needed to resume replication -- after the treatment period.
But at that time, Cheret reported, investigators plan to stop treatment for 6 months to see if either regimen leads to post-treatment control.
The "only problem with the presentation is they didn't have the results," commented Robert Murphy, MD, of Northwestern University Feinberg School of Medicine in Chicago.
Nonetheless, Murphy, who's involved in studies aimed at eradicating HIV reservoirs as a potential step to remission, said the data Cheret presented -- overall information about control of HIV and decline in HIV DNA -- is important.
"This will help in designing future trials," he said, even though it's preliminary.
At baseline, Cheret reported, the 90 patients were within a few weeks of infection, had a median plasma viral load of 5.4 log10 copies of HIV RNAS per milliliter, and a median of 472 CD4-positive T cells per microliter of blood.
They also had a median of 3.65 log10 copies of HIV DNA per million peripheral blood mononuclear cells (PBMCs).
As expected, viral loads declined during treatment with 92% of patients having undetectable levels after a year and CD4 cell counts rose by a median of 235 cells.
And HIV DNA fell by a median of 1.43 log10 copies per million PBMCs, while one in four patients had a drop of at least 2.0 log10 copies, Cheret reported.
While it would have been nice to see the data broken down by treatment group, "these are very important numbers," Murphy commented.
The study had support from Merck, Janssen, ViiV Healthcare, and Gilead.
Cheret made no disclosures.
Murphy reported financial links with Gilead.
Primary source: International AIDS Society
Cheret A, et al "Impact of 12 months HAART on cell-associated HIV-DNA in acute primary HIV-1 infection in the OPTIPRIM-ANRS 147 trial" IAS 2013; Abstract WEAB0101.