A Johns Hopkins expert in drug treatments for HIV and AIDS has taken the lead in an international effort to drastically change the manufacturing and prescribing of widely used combination therapies during the last 10-years to ensure that 8 of the 34 million infected people worldwide can keep their disease under control.

The report is published in the journal The Lancet Infectious Diseases. Charles Flexner, M.D., a clinical pharmacologist and infectious disease expert and professor at the Johns Hopkins University School of Medicine and the university’s Bloomberg School of Public Health, said:

“We can do more with less of the active pharmaceutical agent in many anti-HIV drug compounds and we can adopt more efficient techniques to make the drugs more quickly and for less money than before.”

According to Flexner and other researchers from Johns Hopkins and the Clinton Health Access Initiative, better drug formulations, more efficient and cheaper manufacturing methods, shorter treatment periods, and lower-dose prescription are all possible, safe and potentially effective.

The majority of people with HIV live in poor sub-Saharan Africa and either don’t have access to treatment on their own or cant afford treatment. Flexner notes that implementing these efforts would make the drugs more accessible to these people.

Flexner explained:

“Our biggest challenge in treating those already infected with HIV in the developing world is figuring out how we are going to stretch our existing drugs further to treat two or even three times as many people. Fortunately, the scientific and chemical engineering evidence is on our side.”

According to the researchers the cost of manufacturing existing drugs should be reduced. They highlight that the majority of anti-HIV drugs prescribed in developing countries are generic and are already priced as low as possible. Annual drug costs for treating individuals with HIV is between $130 to $1,500 per patient.

The researchers note that pharmaceutical companies usually avoid reducing the cost of antiretroviral therapies because there is no financial incentive for them. Flexner explains: “There’s simply no financial incentive for them to make any changes under our current drug pricing structure. So it is up to the scientific community to step up and fill in the gap.”

The new report serves as an action plan for stretching the use of anti-HIV drugs. In June 2010, more than 140 scientists, pharmaceutical industry representatives, policy experts and philanthropists gathered in Alexandria, Va., as part of the first consensus conference on antiretroviral drug optimization.

According to the experts, using cheaper suppliers of raw materials or formulation changes to optimize how efficiently drugs are absorbed by the body are at the top of the list for reducing the cost of anti-HIV drugs.

Flexner highlights that in 2007, a new, competing manufacturer for a raw ingredient used to synthesize tenofovir, the world’s most widely prescribed antiretroviral drug and a key component of the widely used combination therapy, Atripla. According to flexner, within four years, the novel product reduced the price of tenofovir by 60% and saved aid programs millions.

Flexner explained: “Many drugs, such as tenofovir, have a body absorption rate – a measure of how much of the key active chemical ingredient actually gets into the bloodstream – of less than 30 percent.”

If this percent was doubled, the number of pill patients require could be significantly reduced.

In addition, if the average dose needed to effectively treat the disease was reduced from 300 milligrams daily to 150 milligrams, 50% more people could have access to tenofovir.

The majority of drugs prescribed contain higher doses than are actually required. Although overdosing does not harm people taking the drugs, Flexner says, “it shows how drug manufacturers are erring on the side of caution, in prescribing more of a drug rather than less, which may be particularly true of antiretroviral medications, whose development was sped along in the past two decades in a rush to fight HIV disease.”

According to Flexner: “Lowering the dose of prescription drugs used in treating people in the developing world is perhaps the most controversial of the group’s proposals, as we do not want there to be any possibility of providing substandard care.”

In order to confirm that reducing doses of antiretroviral drugs will not result in substandard treatment, studies are currently being conduced using slightly lower doses of efavirenz and stavudine, especially for slimmer or shorter people in developing countries whose average body mass may not warrant the larger doses.

Flexner said: “Even if two-thirds the daily dose, or maybe even half, works just as well as the initial prescription, millions more people infected with the disease stand a good chance of gaining access to our existing supply of anti-HIV drugs.”

In addition, researcher are also evaluating the use of add-on pharmacological “boosting” drugs to improve the effects of active ingredients in other drugs, while pharmacologists are looking to extend the shelf life of anti-HIV drugs in order to make them more accessible for HIV-positive people in poor countries.

Flexner concluded: “All these seemingly small innovations and improvements can add up.”

In May, the team met with the United Nation’s World Health Organization in Geneva in order to work on update treatment guidelines for HIV disease to incorporate their optimal drug use strategies.

Written by Grace Rattue