Top 10 Clinical Review


Runners-Up: Top HIV Clinical Developments of 2014

December 15, 2014

More Long-Acting Injectable Antiretroviral Therapy

There were no new data of note regarding long-acting injectable antiretroviral therapy this year, but this important advance in treatment continues to move closer to reality. The results of the LATTE trial demonstrated that oral rilpivirine and a dolutegravir-like integrase inhibitor in development could maintain viral suppression as well as continued therapy with tenofovir/emtricitabine/efavirenz. A follow-up study of this approach, using the injectable versions of these two medications administered every two months, is now underway. Assuming this study also demonstrates safety and efficacy, the buzz regarding this approach will grow into a roar.

At first glance, long-acting injectable antiretroviral therapy, given every two to three months, would seem ideal for the nonadherent. Then again, do you want to be chasing down a patient who has missed his last two scheduled shots and has slowly falling levels of HIV drugs with relatively modest barriers to drug resistance? Will injections be administered in only clinical settings or local pharmacies? Can health departments get in on the act? What about using these drugs for PrEP?

These and other questions will need answering, hopefully before the drugs come to market. Word is slowly getting out. Long-acting antiretroviral therapy is coming. Be prepared. Be very prepared.

Midterm Elections

Cynical types scoff that it matters little who wins elections and turns the wheels of power. For them, the events that make up daily existence are hardly affected by whether those who make policy tip red or blue. The headlines and sound bites they are fed shout out points scored in a game played far from them and their concerns. But when decisions made by those who govern do affect them in ways they do not like, then comes the indignation, the demands for action, the whining -- often too late.

The domination by the Republican Party of the midterm elections for Congress will be felt by all of us. Why Americans voted the way they did is being analyzed and explained by innumerable commentators. Here, I look only to the potential impact of this outcome on people living with HIV infection.

The Republican opposition to the Affordable Care Act (a.k.a. Obamacare) will be one of the most obvious and direct effects of the election on HIV-infected persons. While complete rollback of the program, which has expanded health care coverage to millions and contains elements that have become popular, is highly unlikely, the GOP win will lead to efforts to weaken provisions of the act, reducing benefits. For example, as I write this, House Republicans are mounting a legal challenge to a component of the law that provides financial assistance to low and moderate-income people. If that component is altered, it would lead to increases in the size of deductibles and copays for those with insurance.

The drubbing of the President's party will also embolden his opponents at the state level who have refused to expand Medicaid. Hardly any states in the U.S. South, where the majority of people living with HIV live, have expanded Medicaid. This continued resistance to expansion of this program for Americans living in poverty will deprive many with HIV from affordable care and medication not covered by the Ryan White Care Act. In 23 states, Republicans control the legislature and the governor's office. It is likely people living with HIV will see threats to state-run programs that benefit them.

Another anticipated outcome of this election is the continued shrinkage of the budget for the National Institutes of Health (NIH). During the 2013 Republican-orchestrated sequestration, a friend of a friend posted on Facebook that she was burning with anger that her child, suffering from brain cancer, could not get into an NIH clinical trial because Democrats would not agree to exemptions to the sequester agreement. That the NIH's budget had been shrinking since the GOP gained control of the House in 2011 did not incite her indignation, despite the greater harm done by these cuts.

Less funding for the NIH means continued threats to the research -- research that can lead to a vaccine or even a cure for HIV infection, or to advance interventions that prevent acquisition of the virus.

NIH funding as a share of GDP, FY 1950-2019

Patients often complain to me about their copays and deductibles, shifty insurance plans and exorbitant hospital bills. I listen. I also ask them if they vote -- and I remind them that it does indeed make a difference who wins and who loses.

What are some other top clinical developments of 2014? Read more of Dr. Wohl's picks.

David Alain Wohl, M.D., is an associate professor of medicine in the Division of Infectious Diseases at the University of North Carolina and site leader of the University of North Carolina AIDS Clinical Trials Unit at Chapel Hill.

Copyright © 2014 Remedy Health Media, LLC. All rights reserved.

This article was provided by TheBodyPRO.

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