What's Hot in HIV Clinical Science

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A lot has changed in the world of HIV clinical science since last year's IDWeek meeting. In the past year, groundbreaking clinical data have dramatically reshaped the way the medical community thinks about HIV treatment.

Some new revelations have been frustrating setbacks. For example, the relapse of the "Mississippi baby" made it clear that there is still more work to be done to disrupt latent reservoirs of HIV.

Yet other research has led to dramatic changes in treatment guidelines, such as the new World Health Organization (WHO) guidelines that now recommend antiretroviral treatment (ART) for all newly diagnosed patients, regardless of their CD4+ count.

During a keynote symposium at IDWeek 2015 in San Diego, California, Adaora Adimora, M.D., M.P.H., a professor of medicine and epidemiology at the University of North Carolina, offered a comprehensive look back at the last year of clinical science in HIV.


Treating HIV

The biggest news in the last 12 months regarding HIV treatment has been the Strategic Timing of Anti-Retroviral Therapy (START) study, a randomized controlled trial that proved that patients who start on ART right after diagnosis are better off than patients who wait until their CD4+ count reaches 500. The START study was the first of its kind, and it overhauled treatment guidelines and codified medical consensus around when to start treatment.

The last 12 months also saw a paradigm shift in regard to which regimen to start patients on first. Now, integrase inhibitors are generally the U.S. Department of Health and Human Services (DHHS)'s recommended first choice for treatment-naive patients. Efavirenz (Sustiva, Stocrin) and atazanavir (Reyataz) have been relegated to "alternative" treatments due to their inferior side effect profiles.

Finally, 2015 brought data to support a new formulation of tenofovir (TDF), called tenofovir alafenamide (TAF). This new and improved drug shows immense promise in reducing the bone and renal toxicity associated with TDF. Soon, TAF will likely replace almost all TDF-based regimens, Adimora said.


Comorbidities

Not only has the medical community learned how to better treat HIV patients in the past year, but it has also gained understanding in how to treat patients who have HIV alongside other common comorbidities.

Of note is hepatitis C (HCV) and HIV coinfection. In years past, patients infected with both viruses were treated as a special group: Excess caution was used when considering these patients as candidates for the new HCV direct-acting antivirals, such as sofosbuvir (Sovaldi). Today, however, this group of patients no longer needs to be treated as a distinct group, Adimora asserted. When it comes to cure rates for regimens containing sofosbuvir and other hepatitis C drugs, patients with HIV do just as well as those who were HIV uninfected.

Another hot-topic issue in HIV treatment revolves around statins. Studies have demonstrated that HIV patients have an increased risk of myocardial infarction compared to the average population. This brings up an important question: should HIV patients be prescribed statins, even if they don't qualify for statin use under current cholesterol guidelines? Launched this year, the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) study is a randomized controlled trial that will examine this important issue.


Cure Remains Elusive

Although the world marveled at the supposed cure of the Mississippi baby, her relapse in the summer of 2014 demonstrated that progress toward a cure for HIV will continue to move forward by incremental steps, rather than by leaps and bounds. The child's rebounding viral load was a stark reminder that the latent reservoir for HIV needs to be better understood.

The latent reservoir refers to CD4+ cells that are infected with HIV, but are not actively producing virus. To overcome this stubborn, innate defense mechanism of the virus, latency needs to be disrupted. Recently, two different drugs, romidepsin and panobinostat, were able to "awaken" latent T-cells infected with HIV. If used in combination with current antiretroviral therapies, these drugs might be the future of an HIV cure, Adimora said.


Prevention and Care

Despite all the advances in clinical science, the fact remains that far too many patients have not achieved viral suppression, Adimora said. In fact, viral suppression is less common in younger patients than in older patients, and this discrepancy is likely caused by lapses in the HIV treatment cascade. Not enough patients are screened and subsequently linked to services.

One terrifying example seen in 2015 was the epidemic in Indiana, where a rural community without adequate resources was suddenly struck by hundreds of new HIV cases closely associated with the rise in injection drug use in the region. Delivering care to these patients was a significant challenge for clinicians on the ground. Many of the newly infected patients were living below the poverty line and had little understanding of HIV transmission because of an abstinence-only public school education. In addition, the state of Indiana had no needle exchange program.

The Indiana outbreak is a clear example that significant gaps in the treatment cascade still exist. Without addressing those, HIV epidemics will continue to plague communities, Adimora warned.