A third of people with HIV on antiretroviral therapy (ART) do not have sustained viral suppression and many are not receiving regimens recommended by the latest US treatment guidelines, according to data from the Medical Monitoring Project presented at IDWeek 2015 in San Diego. However, this study included many people with long-term HIV infection who may not have been able to use preferred first-line regimens.
Yunfeng Tie from ICF International and colleagues with the Centres for Disease Control and Prevention analysed data from more than 18,000 participants in the Medical Monitoring Project – an ongoing national surveillance system for adults receiving HIV medical care in the US – from 2009 through 2012. Of the 18,095 total participants in the study, about three-quarters were men, 41% were black, 43% were over age 50, and the same proportion had been on ART for at least 10 years; only 5% had started ART during the past year. Although more than 70% had ever had an Aid diagnosis, nearly half had a CD4 T-cell count above 500 cells/mm3 in the past year. About half had a high school education or less and 46% had an income at or below the poverty level. Just over 40% were smokers, 4% reported injection drug use, and 25% reported non-injection drug use.
Most (92%) HIV-positive adults receiving medical care were prescribed ART. Of these, 52% were prescribed regimens recommended by the 2014 DHHS treatment guidelines for first-line therapy.
The most common regimen was efavirenz plus tenofovir/emtricitabine (the drugs in Atripla), taken by 27% – or about half of those prescribed a recommended first-line regimen. The next most common combos were ritonavir-boosted atazanavir (Reyataz), boosted darunavir (Prezista), and raltegravir (Isentress), all with tenofovir/emtricitabine, at 11%, 5%, and 4%, respectively; 80% of participants on ART achieved undetectable viral load (HIV RNA<200 copies/mL) after starting therapy. However, the proportion of participants who maintained durable viral suppression over the course of 1 year fell to 66%; 84% of participants reported good adherence during the past 3 days; 16% of participants reported experiencing side effects more than half the time during the prior month; efavirenz-based regimens were associated with the highest recent and durable viral suppression rates, as well as the best adherence.Participants prescribed recommended regimens were more likely to achieve viral suppression than those on non-recommended regimens; raltegravir was associated with the fewest side effects; and people prescribed non-recommended regimens were more likely to report side effects.
These response rates are lower than the rates generally seen in clinical trials of new antiretroviral agents – typically around 90% – however they are more in line with those observed in various “cascade of care” studies which look at real-world clinical outcomes.
The report says this study should be interpreted cautiously as many of the participants had extensive treatment experience and probably had drug-resistant HIV. Such people are more challenging to treat, and recommended first-line regimens may not be appropriate for these patients.
Just as some of the non-recommended regimens in 2014 were recommended in earlier versions of the guidelines, the top option in this study is no longer considered the best available. As of the April 2015 guidelines update, efavirenz has been take off the recommended list, largely due to its side effects, and replaced with well-tolerated integrase inhibitors.
Background: U.S. antiretroviral therapy (ART) guidelines issued by the Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents specify recommended initial and not-recommended ART regimens, but nationally representative data on ART prescribing practices and on the effectiveness of guideline-specified ART regimens are sparse.
Methods: We used data from 18,095 participants in the 2009 through 2012 cycles of the Medical Monitoring Project, a nationally representative sample of HIV-infected adults receiving medical care in the United States. We classified ART regimens according to guidelines. Using multivariable logistic regression, we computed adjusted prevalence ratios (APR) and 95% confidence intervals (CI) to assess the independent associations between ART regimen categories and outcomes: durable viral suppression (all viral load tests Results: Almost all (92%) HIV-infected adults receiving medical care were prescribed ART. Of those prescribed ART, 52% were prescribed recommended regimens, 6% alternative regimens, 29% not-recommended regimens, and 13% other regimens; 66% achieved durable viral suppression, 84% were dose-adherent, and 16% reported side effects. Compared to persons on recommended regimens, persons prescribed not-recommended regimens (APR 0.98, CI 0.96-0.99) and other regimens (APR 0.92, CI 0.88-0.96) were less likely to achieve durable viral suppression and be dose-adherent (APR 0.97, CI 0.95-0.98 for not-recommended regimens; APR 0.93, CI 0.91-0.95 for other regimens). Compared to those prescribed recommended regimens, persons prescribed alternative regimens (APR 1.29, CI 1.11-1.50), not-recommended regimens (APR 1.18, CI 1.07-1.31), and other regimens (APR 1.18, CI 1.05-1.33) were more likely to report side effects.
Conclusion: One-half of persons on ART were prescribed recommended ART regimens. Persons on not-recommended and other regimens were less likely to achieve viral suppression and more likely to report side effects. HIV providers should continue to be encouraged to prescribe ART according to established guidelines when clinically appropriate.