Hurdles to Treating HIV With Generic Drugs

Advances in the development of combination antiretroviral therapy (ART) for the treatment of HIV have completely changed the natural course of the infection in the US and worldwide.

ART extends the lives of patients infected with HIV and successfully suppresses the virus to prevent transmission. Most recently, ART demonstrated efficacy in preventing HIV infection in high-risk populations, such as men who have sex with men, when used as preexposure prophylaxis (PrEP).

Although both doctors and patients coping with a multitude of other disease states often look forward to the availability of generic medications to offset the costs associated with treatment, this has not been the case with HIV therapy. With an ever-changing health insurance landscape, identifying and overcoming resistance to the use of generic HIV medications could be more important than it has been in the past.

Dr. Erika Martin, PhD, an Associate Professor of Health Policy at the University at Albany, and Dr. Bruce Schackman, an Associate Professor of Public Health at Weill Cornell Medical College, recently examined some of the barriers to Treating and Preventing HIV with Generic Drugs in a perspective published last week in the New England Journal of Medicine.

At the current time, most patients living with HIV infection are covered by some combination of federal (Medicare), state (Medicaid) and private insurance. In many cases, the patient may not see the end result of the savings that can be associated with switching to 1 or more generics as part of their regimen, while at the same time they are faced with the challenges of a greater pill burden or increased dosing frequency that goes along with HIV regimens that include generic drugs.

Doctors are also wary of the impact that pill burden and dosage frequency may have on patient compliance, and, as a consequence, on medication efficacy. Martin and Schackman point out, “there is a perception — but no strong evidence — that increasing the number of pills in a once-daily regimen will adversely affect adherence and viral suppression.”

Surmounting this barrier will likely require better dissemination of information and education among healthcare providers, but to date, there are no studies available that point to the best methods of sharing this information among practitioners.

Drug manufacturers create other obstacles to the adoption of generic HIV medications in the US. Martin and Schackman write, “a key barrier to the uptake of generics is modification of brand-name products coupled with aggressive marketing of modified products.”

Manufacturers of HIV medications employ a number of methods to delay the availability of generic formulations. Coformulation of numerous active ingredients into a single dosage form makes for easier administration but also results in extended patent lives.

Altered inactive ingredients or other changes in formulation may result in fewer side effects or improved efficacy, leading prescribers and patients to turn away from older generics in favor of newer (and apparently safer) options.

Lastly, drug companies may file for approval for additional indications or pediatric formulations “that introduce new patent claims and extend market exclusivity,” according to Martin and Schackman.

Only time will tell what role generic medications could play in the future of HIV treatment.

This article was originally published by MD Magazine.