The good news keeps getting better for the HIV Prevention Trials Network (HPTN) 052 study, which found last year that HIV-infected persons on antiretroviral therapy (ART) were 96 percent less likely to transmit the virus to an uninfected partner through vaginal sex. At the International AIDS Conference (IAC) in Washington this week, two late-breaker sessions focused on additional data from the landmark trial – showing that not only is starting HIV-infected patients on treatment earlier have additional health benefits, it also makes a lot of financial sense.
Patients who receive early versus delayed ART initiation showed a trend toward delaying the time to both AIDS and non-AIDS primary events and significantly delayed the time to AIDS events, death and tuberculosis, said investigator Rochelle Walensky, MD, MPH, Associate Director of the Program in Epidemiology and Outcomes Research at the Harvard Center for AIDS Research. Participants treated in the early therapy arm had significantly lower overall incidence of clinical events, likely due to reversal of immune suppression.
Using an HIV microsimulation model (CEPAC-International) the investigators also were able to project clinical impact, costs and cost-effectiveness of early ART initiation utilizing the HPTN 052 study data. The researchers found that not only does this strategy increase survival, it also prevents costly opportunistic infections, averts early transmissions and is very cost-effective.
“The clinical, behavioral and economic data are converging to clearly support early treatment for discordant couples [where one person is HIV-infected and the other is not] and others given the benefit to the individual, the impact on transmission and that it is very cost effective,” said Kenneth Freedburg, MD, of Harvard Medical School, who presented the cost-effectiveness data at IAC Friday.
“The policy response should be as convincing as the data.”
Investigators looked at care and drug costs, costs of opportunistic infection care and treatment, and cost benefits related to averted infections. No indicators that were non-medical were included in the analysis for cost-effectiveness. The study looked at five-year and lifetime cost-effectiveness in South Africa and India. At five years, the intervention was deemed “very cost-effective” in India, and “cost-saving” in South Africa, because of the much higher cost of care in that country, including labs. “Very cost-effective” was defined as less than one times the per capita gross domestic product, which in South Africa is $8,100 and in India is $1400. The cost of early ART was $530 per year of life.
Presumably if they had looked at productivity and orphans averted, the results would have been even better, Freedberg said.
“Early ART is a triple winner: HIV-infected patients do better, their partners are protected and it is very cost-effective,” Walensky said in a press release. “Regardless of the country setting, over the long term treatment as prevention offers excellent return on investment across a wide range of assumptions about transmission and treatment effects.”
The HPTN 052 study of 1,763 serodiscordant couples, 97 percent of which are heterosexual, at 13 trial sites in Africa, Asia, and North and South America is ongoing. Since the preliminary results were released in May of 2011, the World Health Organization and the United States both revised their treatment guidelines.
“This expanded analysis of the HPTN 052 study results provides more evidence that treatment as prevention is a strategy we can’t afford to ignore,” said Myron Cohen, MD, Co-Principal Investigator of HPTN, and the HPTN 052 Protocol Chair in a press release.
“Clearly the results of the model indicate there is a great return on this important health investment.”