NEW YORK (Reuters Health) – Rates of death or progression to AIDS at four years are low and similar with antiretroviral regimens containing raltegravir or efavirenz, according to a new observational study.
“Based on the short-term randomized evidence for virologic control that we cite, we hypothesized that the raltegravir group might have better long-term clinical outcomes than the comparator group,” Dr. Stephen R. Cole from the University of North Carolina, Chapel Hill, told Reuters Health by email. “We did not see this.”
Integrase inhibitor-containing regimens provide favorable short-term virologic control in HIV-infected individuals, but less is known about longer-term comparative effectiveness, especially in terms of clinical endpoints like HIV disease progression or mortality.
Dr. Cole and colleagues used data from the Center for AIDS Research Network Integrated Clinical Systems and the Centers for Disease Control and Prevention to estimate the four-year risk of AIDS-defining illness or mortality for HIV-infected adults initiating a regimen of raltegravir or efavirenz on a backbone of emtricitabine and tenofovir disoproxil fumarate.
During follow-up, 6% of the 415 patients on raltegravir received a diagnosis of an AIDS-defining illness and 3% died, compared to 5% and 2%, respectively, of 2,646 patients receiving efavirenz, the team reports in Clinical Infectious Diseases, online May 12.
The combined four-year risk of incident AIDS or death from any cause was 9.9% among those who started the raltegravir regimen and 8.1% among those who started the efavirenz regimen.
After accounting for dropout, treatment changes, and other confounders, the per-protocol four-year risk of incident AIDS or death from any cause did not differ significantly between those who started the raltegravir regimen (7.2%) and those who started the efavirenz regimen (7.7%).
“The present work attempts to learn about the comparative effectiveness of two treatment plans in a nonrandom sample of patients who were not randomized to their treatment plan,” Dr. Cole said. “This is inherently difficult work, yet together we must attempt to learn.”
“Our study is no exception to the rule that rarely should a single scientific study alter treatment guidelines,” he concluded. “Such guidelines are better produced through a thoughtful synthesis of the full evidence base. Patients are better served by thoughtful discussion about the limitations of our knowledge.”
The study did not have commercial funding; one co-author reported financial ties to Merck, which makes raltegravir.
SOURCE: http://bit.ly/2qmA0jq
Clin Infect Dis 2017.
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