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December 1, 2011

NYC Recommends Early HIV Treatment, Regardless of CD4s

by Tim Horn

New York City health officials now recommend offering antiretroviral (ARV) treatment to all city residents living with HIV, regardless of their CD4 cell counts, making it the second major city in the United States—after San Francisco—to bypass the more conservative federal HIV treatment guidelines.

According to a December 1 letter from the New York City Department of Health and Mental Hygiene, authored by commissioner Thomas Farley, MD, MPH, the recommendation is based on evidence that ARV treatment can improve the health of people living with HIV and that ARV therapy can prevent ongoing transmission of the virus.

“I am more optimistic than ever that we can really drive down rates of infection, and that we may ultimately see the end of this epidemic,” Farley said, according to a November 30 article in The New York Times.

New York City has long been the epicenter of HIV/AIDS in the United States. About 110,000 New Yorkers are living with HIV—almost three times the national average—and diseases associated with the virus are the third leading cause of death for New York City residents between ages 35 and 54.

In San Francisco, where more than 18,000 people are believed to be living with HIV, health officials made headlines in April 2010 when they began recommending ARV treatment immediately following diagnosis, regardless of whether or not patients’ CD4 counts met U.S. Department of Health and Human Services (DHHS) criteria for initiating therapy.

According the DHHS’s Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents, most recently updated in October 2011, ARV therapy is generally recommended once a person’s CD4 cell count falls below 500. Panelists were split on whether to recommend treatment even earlier, on account of strengths and weaknesses of the scientific data available.

Charles King, president of the NYC-based advocacy group Housing Works, told the Times that while he personally opted for ARV therapy right away, he believed that the science did not yet support a policy as aggressive as the one the NYC health department is espousing.

Indeed, King's skepticism echoes controversy that followed the San Francisco recommendation in 2010.

Farley’s letter, along with a draft document further explaining the health department’s recommendation, however, suggests there is enough evidence to support treatment for both individual and public health gains.

“Evidence indicates that [ARV therapy] benefits the health of persons with early HIV infection,” Farley writes. “One large, observational study demonstrated that patients who initiate [ARV therapy] when CD4 counts are higher than 500 cells/mm3 live longer than those who do not, and that untreated HIV infection may lead to a number of non-AIDS-defining illnesses.”

Farley points to the San Francisco Department of Public Health recommendations as supportive and also suggests that the DHHS’s split pertaining to an early treatment recommendation is indicative of growing evidence in favor of this approach.

As for the public health benefits of immediate treatment initiation, Farley noted the results of HIV Prevention Trials Network study 052 (HPTN 052), which found that treating HIV-positive people with ARV drugs reduced the risk of transmitting the virus to HIV-negative partners by 96 percent, at least among heterosexual couples. “This study confirms the large body of evidence from observational studies, statistical models and mother-to-child transmission trials showing that [ARV therapy] can prevent new HIV infections from occurring.”

One particular concern surrounding recommendations for early/immediate treatment involves the possibility of increased drug resistance, particularly if people living with HIV are put onto therapy before they’re ready or prepared to adhere to strict dosing requirements. The supporting documentation for the NYC health department, however, suggests this shouldn’t be an overarching worry.

“Although there is concern about resistance,” the document states, “the incidence and prevalence of HIV drug resistance is stable or decreasing in countries, such as the United States and Canada, where optimal treatment is readily available, [ARV therapy] use is tailored to the results of resistance testing, and treatment is closely monitored with frequent viral load measurements.

“Expanding [ARV therapy] in this context,” the health department concludes, “is not expected to substantially change [the prevalence of drug resistance].”

As for cost, the health department anticipates that immediate treatment will be supporting by private health insurance and, for uninsured or underinsured individuals, by the New York AIDS Drug Assistance Program (ADAP). “It is also expected that expanded [ARV therapy] will be a cost-effective intervention for people living with HIV/AIDS in New York. Although this expansion will result in the increased cost of more people receiving [ARV therapy], these medication costs should be offset by fewer hospitalizations and less HIV transmission.”

Health department officials note, however, that its recommendations may not necessarily be for all people living with HIV, nor are they a requirement. According to another accompanying document intended specifically for HIV-positive residents of New York, the agency notes: “If you are not ready to make the commitment to take [ARV therapy], including taking the correct dose at the correct time exactly as prescribed,” treatment should be delayed. “Discuss any concerns you may have with your health care provider. The final decision of when to start treatment is up to you.”

Search: new york city, nyc, department of health, thomas farley, treatment, arv, early, immediate, cd4s, san franscisco

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