HIV+ individuals having problems adhering to drug regimens -- Patients' AIDS battle fatigue shown 20 years after the start of the epidemic

Research Triangle Park, NC (March 14, 2001) � Twenty years after the start of the epidemic, patients� "AIDS Battle Fatigue" is visible, with HIV+ individuals finding it difficult to comply with their drug regimens and looking to take fewer and better drugs, according to data from a survey conducted by Savitz Research and underwritten by GlaxoSmithKline. Results of the survey were released today. A total of 371 HIV+ individuals responded to surveys distributed by questionnaire to 2,500 households that had reported having an HIV+ member, and via the Internet to another 2,602 individuals. All respondents were ensured confidentiality. The data are not representative of all HIV+ individuals and participants did not necessarily respond to each question, but the survey offers insights into current perspectives on HIV treatment.

A total of 62 percent of the 292 HIV+ respondents who are taking medication said it is somewhat or very difficult to adhere to their prescribed anti-HIV/AIDS drug plan. The major obstacle to complying with treatment every day is "too many pills," cited by 67 percent of those responding, followed by side effects (61 percent), food restrictions (55 percent), frequency of having to take the pills (49 percent) and timetable for having to take pills (48 percent). One percent noted cost as an obstacle. Many reported the drug regimen interferes with their daily life (43 percent) or lifestyle (30 percent) as well as their job (11 percent).

"There are many challenges to being adherent to the drug regimens. Almost every HIV+ patient gets what I call �battle fatigue� or AIDS fatigue. You just really get so tired of taking the drugs, taking them with or without food, watching what you eat, and knowing that you�re going to be doing this the rest of your life," said David Morris, who was diagnosed with HIV in 1983 and is the administrator of the wellness program at Beth Israel Deaconess Medical Center, Boston. Morris has taken anti-AIDS medications for 15 years and counsels HIV+ and other individuals as part of his job. Morris takes 14 pills a day and has had multiple treatment failures and new regimens over the years.

According to Charles Farthing, M.D., of the AIDS Healthcare Foundation in Los Angeles, the adherence problems for HIV+ people are not wholly unlike those of people with other chronic illnesses, but unlike with some chronic illnesses, the repercussions for those with AIDS can be deadly. "People with hypertension or high cholesterol can have a difficult time complying with their treatment plan on a daily basis so we are certainly not surprised about adherence issues with HIV+ people, who can have far more complicated regimens," said Dr. Farthing.

"Adherence is of particular concern with HIV/AIDS because strict adherence is essential to suppress the virus and prevent it from developing mutations, causing resistance to drugs and leading to treatment failure. That means, without a very high level of adherence � most believe in excess of 95 percent � drug treatments will ultimately fail and patients will progress in their disease."

Many HIV/AIDS treatment plans, particularly those for people with more advanced disease, include 20 or more pills per day, consisting of anti-HIV drugs and medications to manage related infections, nutritional deficiencies, pain, fatigue, depression, insomnia and side effects such as nausea and diarrhea. Each of these drugs has its own schedule and dosage requirements, and many drugs have food and water restrictions. However, HIV drug therapy is by no means always complicated � with some patients on regimens of 1-3 pills twice a day.

Other research shows that 80 percent of patients admit missing some doses at certain times. In one study, approximately 40 percent had missed a dose in the previous 3 days, explaining that they forgot, they were feeling sick, didn�t have the drugs with them at the right time, or they were too busy.

The Survey on Treatment Adherence by HIV+ People was managed and tabulated by Savitz Research, Chicago, and fielded through a written questionnaire by National Family Opinion (NFO), which has a databank of self-identified HIV+ individuals, and via the Internet to a Greenfield Online databank of survey volunteers.

The survey asked the 292 respondents who were currently taking HIV drugs to identify what would be the three most important changes to make it easier to take anti-HIV drugs. Administration issues (how drugs must be taken) were indicated at least once among the three responses by 93 percent of the 266 people responding, including "reducing the number of times you need to take pills" (45 percent), "fewer pills to take" (41 percent) and "have a single pill rather than multiple pills" (18 percent). Respondents were able to cite multiple answers.

Similarly, when asked to name the most important characteristic of a "better" HIV drug, 67 percent of the 259 HIV+ individuals responding wanted to improve administration aspects, which included a reduction in the number of times to take the pills (25 percent), fewer pills (25 percent), a single pill rather than multiple pills (19 percent), and 15 percent who said "make the drugs easier to take." At the same time, 64 percent noted side effects among their three responses to the question, including 58 percent who said "lower the amount of side effects." Another 28 percent said improve efficacy and 8 percent cited cost. "Reducing side effects" was the leading concern of 39 percent of the respondents. "It may be difficult for people without HIV infection to understand why someone wouldn�t be absolutely perfect about taking drugs that can prevent the development of AIDS or slow its progression. But we must realize that taking drugs is a reminder that people are �sick� and the drugs often come with annoying or sometimes debilitating side effects," said Dr. Farthing. "Many people have trouble finishing a simple antibiotic regimen that requires a person to take two or three pills a day for only 10 days. Some HIV/AIDS patients might begin taking their pills at 6 a.m. and take up to 20 or 30 pills in the course of the day." However, he said that studies show people are more adherent if they only have to take medication twice a day with fewer pills on each occasion, than if they are required to take medication three or more times a day.

The survey asked those who are on medication to indicate how difficult it is to follow their drug plan. Of the 99 people who said it was more difficult than they thought it would be (34 percent of 293 responding), 43 percent said it became difficult to take their drug regimen after the first year, 21 percent said after the first day, 7 percent said after the first week, and 15 percent after the first month. Reasons for it becoming difficult at that point were (in descending order of mentions) "side effects," "too many pills," "food restrictions," "interferes with daily life," "frequency of having to take the pills," "timetable for taking the pills," "pills are a reminder that I�m sick," "pills are too large," "interferes with lifestyle," "taking pills in public," "complexity of the routine," "interferes with job," "keeping the pills cold," "water restrictions" and "mixing the drugs according to directions."

"As a drug manufacturer we obviously are greatly concerned about making effective medication that people can and will take," said Amy Keller, International Product Development Team leader for GlaxoSmithKline. "This survey reinforces our belief that a key goal should be fewer pills that are simple to take." A series of questions assessed how their physician or health provider prepared the HIV+ respondents for taking anti-HIV/AIDS drugs. One out of every four of the 278 respondents said there was no preparation given by their physician prior to starting their drug regimen. Another 36 percent of 291 respondents said they were not mentally prepared to start their drug plan.

The survey indicates a high level of understanding by respondents of the importance of strictly complying with an anti-HIV drug regimen. When asked "How important is it for an individual to stay with the prescribed anti-HIV/AIDS drug plan," 85 percent of 370 responding rated it 8-10, with 10 being "very important." Only 3 percent rated it 0-2. In response to "How closely does a person have to follow doctor�s orders for anti-HIV/AIDS drugs to work at the highest level," 90 percent of 368 responding rated it 8-10, and no one rated it below a 5. A full 41 percent of 362 respondents believed incorrectly that no doses of an anti-HIV/AIDS drug could be skipped or else the treatment becomes ineffective. Though an ideal goal, it is equally important for patients not to give up trying to adhere to a drug regimen because an occasional dose is missed.

The average time survey respondents had been on anti-HIV/AIDS drugs was 6 years, 7 months, with 9 percent on therapy under 2 years and 28 percent on therapy 10 years or more. Thirty-four percent of the 292 respondents said they were taking 5 drugs or more; 16 percent were taking 4; 40 percent, 3; and 9 percent, 2 drugs. No one indicated taking only 1 drug.

The respondent group (371 individuals) was 73 percent male and 27 percent female; 59 percent were under age 35, and 41 percent age 35 and over. Some 23 percent had a four-year college degree or more, with another 53 percent having some college or a two-year degree. Fourteen percent reported earning more than $100,000 with 17 percent earning between $50,000 and $99,999; 33 percent earned less than $20,000. A total of 88 percent identified as Caucasian, 5 percent as African-American and 5 percent as Hispanic.

The survey was conducted in September 2000 to assess the attitudes and HIV/AIDS treatment adherence practices of HIV+ individuals. Savitz Research managed and tabulated the data, which were collected through a written questionnaire and an Internet survey. The questionnaire went to a National Family Opinion (NFO) databank of 2,500 households that had previously indicated having a member who is HIV+. Completed questionnaires were received from 1,491 (60 percent). Of those, 341 respondents identified themselves as HIV+, which NFO attributes to the sensitive and very private nature of this disease. The Internet survey was fielded by Greenfield Online to a databank of 2,602 individuals who had volunteered to be surveyed on the Web. Thirty individuals identified themselves as HIV+ and their responses were added to the NFO survey totals. All respondents were ensured confidentiality.

The Centers for Disease Control and Prevention (CDC) HIV Prevention Strategic Plan Through 2005 estimates that 800,000 to 900,000 individuals in the United States have HIV, about a third of whom are not aware they are infected. Another 40,000 become newly infected each year. Approximately 350,000 patients are currently on anti-HIV drug regimens.

GlaxoSmithKline is a pharmaceutical industry leader in HIV research and therapies. The company is engaged in basic research programs designed to investigate new targets to treat HIV.

Note to Editors: A b-roll package and print graphics are available upon request to Bob Szafranski at 312-558-1770. Graphics are also available in PDF format at www.pcipr.com.

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Survey Overview

The Survey on Treatment Adherence by HIV+ People was conducted in September 2000 to assess the attitudes and HIV/AIDS treatment practices of individuals with HIV. Questions were asked relating to medical treatments and general attitudes toward HIV/AIDS. The survey was underwritten by GlaxoSmithKline.

Savitz Research, Chicago, managed and tabulated the data, which were collected through a written questionnaire and an Internet survey. All respondents were ensured confidentiality. The questionnaire went to a National Family Opinion (NFO) databank of 2,500 households that had previously indicated having a member who is HIV+. Completed questionnaires were received from 1,391 (60 percent). Of those, 341 identified themselves as HIV+, which NFO attributes to the sensitive and very private nature of this disease.

The Internet survey was fielded by Greenfield Online to a databank of 2,602 volunteers. Thirty individuals identified themselves as HIV+ and their responses were added to the NFO survey totals, for a total of 371 HIV+ respondents.

The data are not representative of all HIV+ individuals and participants did not necessarily respond to each question, but the survey offers insights into current perspectives on HIV treatment.

The Centers for Disease Control and Prevention publish the HIV/AIDS Surveillance Report including the age distribution by gender of those who are infected with the HIV virus. Responses to this survey among 371 people came from a somewhat older group of individuals than the CDC reports, and accordingly, the data are sample balance weighted to data published in Vol. 11, No. 2 providing the age distribution of all males and females at their age of diagnosis.