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Bridging the Gaps
The 12th World AIDS Conference Revealed Many Inequities in the Delivery of Optimal Care to People With HIV Disease

By Paul A. Volberding, M.D.

August 1998

The 12th World AIDS Conference -- which drew more than 9,000 clinicians, researchers, epidemiologists, public-health officials, advocates, and activists to Geneva, Switzerland, last month -- convened under the rubric "Bridging the Gap." That unifying theme was chosen by the organizers of this largest of all AIDS conferences to emphasize the disparity between the quality of care provided to people with HIV by developed nations, where combination antiretroviral therapy has become the standard of care, and by developing nations, where even palliative care is often unavailable.

What the organizers of the 12th World AIDS Conference termed a gap in healthcare delivery is, in fact, a chasm -- and one that will, in all likelihood, remain unbridgeable for decades to come. On one side of this great abyss is Canada -- where the national health service provides state-of-the-art testing and treatment to all seropositive individuals, regardless of socioeconomic circumstances. On the other side is Cambodia, where tracking, testing, and treatment of HIV are nonexistent. On one side, Australia; on the other, Angola. On one side, Switzerland; on the other, Swaziland. There are rare exceptions to this pattern -- Thailand, for example, has done a praiseworthy job of educating its citizens about the risks inherent in unprotected sexual relations -- but by and large the world divides into countries that can afford programs to prevent and treat HIV infection... and those that cannot.

Nowhere is the misery of the have-not nations more evident than in sub-Saharan Africa, where an estimated 20 million people have contracted HIV infection in the last two decades. In the worst-hit regions, one adult in every four is seropositive, and absent the development of a cheap, safe, and effective vaccine -- a prospect that looks no closer now than it did in Vancouver two years ago -- many of these countries will be dramatically depopulated in the coming decade.

The stark contrast between Canada and Cambodia, between Australia and Angola, between developed nations and developing ones, is the most obvious gap in the quality of healthcare provided to people with HIV, but it is by no means the only one. One does not have to leave the United States to find disturbing disparities in the way HIV infection is treated; these gaps exist right here. They are not as immediately apparent as the continental divide that separates healthcare in North America from that in South America, but they are real -- and consequential. Gender and geography, race and risk factor, education and economics -- all affect the quality of care that people with HIV infection receive in this country. And these are gaps that we should be able to bridge.

The gender gap in HIV treatment

The gender gap is a particularly puzzling phenomenon. As we were reminded again and again in Geneva, women with HIV disease are diagnosed later -- and treated less aggressively -- than their male counterparts. This disparity exists at all socioeconomic levels, and it persists despite efforts to establish parity in the treatment of seropositive individuals, irrespective of their sex. Gender inequality is hardly unique to the treatment of HIV infection, as data on differences in angioplasty and coronary bypass rates for men and women reveal, but this gap in the quality of care provided to HIV-infected females is particularly distressing given how vulnerable they are to HIV infection and its sequelae.

"One of the great ironies of the HIV epidemic is that women are more and more the target of HIV infection, yet women are much less likely to be the targets of prevention efforts. Females whose only risk factor for HIV infection is sexual contact with one or more seropositive males represent the fastest-growing subpopulation of seroconverters -- up 36% between 1994 and 1996, the last year for which the C.D.C. has accurate statistics -- yet care providers are less likely to recognize infection in women."

One of the great ironies of the HIV epidemic is that women are more and more the target of HIV infection, yet women are much less likely to be the targets of prevention efforts. Females whose only risk factor for HIV infection is sexual contact with one or more seropositive males represent the fastest-growing subpopulation of seroconverters -- up 36% between 1994 and 1996, the last year for which the C.D.C. has accurate statistics -- yet care providers are less likely to recognize infection in women.

To assist clinicians and other care providers in recognizing -- and treating -- the host of opportunistic infections that are unique to seropositive women, the editors of HIV Newsline have developed a special Pull Out and Save feature, "The Most Common Opportunistic Infections in Women with HIV," which you will find in this issue. It identifies the signs and symptoms of these OIs, describes how they are diagnosed and treated, offers alternative therapies, alerts providers to potential problems that can occur when these treatments are administered, and suggests ways that physicians and patients can work together to reduce the likelihood of recurrent infections. For further information on our continuing efforts to provide clinicians with readable, reliable, relevant, up-to-the-minute information on women with HIV, see "Notice to Readers" in this issue.

The gap between results in clinical studies and results in clinic patients

A number of the presentations made at the 12th World AIDS Conference in Geneva underscored the existence of another, less baffling but no less troubling gap, this one between the results achieved by patients who participate in clinical trials and by the patients we see in the clinic. We have long recognized that the results obtained in clinical trials are rarely matched in office practice -- because the subjects who enroll in such trials are, for the most part, a self-selected group of exceptionally well motivated patients. As a rule they are better educated than their non-participating counterparts, both in general terms and in the specifics of their disease, and they are almost always better monitored. As a result of all these factors they tend to be more compliant -- and in a disease like HIV infection, where absolute adherence to one's assigned regimen correlates so strongly with effective suppression of viral burden, compliance is all (see "The Problem of Protease Resistance" and "Compliance: How You Can Help" in Vol. 3, No. 3 of HIV Newsline).

"Clinical findings presented in Geneva suggest that tight adherence to an assigned regimen may be more predictive of long-term efficacy than which particular combination of antiretroviral agents a particular patient is assigned."

Indeed, the clinical findings presented in Geneva suggest that tight adherence to an assigned regimen may be more predictive of long-term efficacy than which particular combination of antiretroviral agents a particular patient is assigned. The guiding principle of current therapy is to choose the most potent combination of available agents, with the intention of reducing the patient's viral burden to the lowest possible level for the longest possible time with the fewest possible toxicities -- and to do so with a regimen that afford the greatest likelihood of long-term adherence (see "Optimal Antiretroviral Therapy for HIV Infection," the Pull Out and Save feature that appeared in Vol. 3, No. 6 of HIV Newsline).

On the face of it, this principle would seem to dictate a regimen that included at least two nucleoside analogs and at least one protease inhibitor. But as we have reported at intervals over the past two years, some of the subjects enrolled in the INCAS trial have maintained undetectably low viral loads (<20 copies/mL) for more than two years on a regimen that combines two nucleosides and a non-nucleoside reverse-transcriptase inhibitor (see "Nevirapine plus two nucleosides exerts durable effect," Vol. 4, No. 2). As Dr. Julio Montaner, one of the INCAS trial's principal investigators, noted in Geneva, more than three-quarters of his patients who have remained highly compliant with this novel triple-drug regimen have continued to derive clinically significant benefits, well into their third year of therapy.

The consensus of many of those attending the conference is that the non-nucleoside reverse-transcriptase inhibitors as a class offer an alternative to the protease inhibitors -- when these NNRTIs are used at effective doses and in combination with at least two nucleoside analogs. The accumulating data on the newest NNRTI, efavirenz (DMP-226, Sustrin®), strongly suggest that it has potent antiretroviral activity when used in combination with other agents (see "Efavirenz plus indinavir dramatically reduces viral load," Vol. 2, No. 2, page 39, and "The Next Generation of Antiretroviral Agents -- An Update," Vol. 3, No. 6). All of us recognize that the NNRTIs lack the potency of the protease inhibitors, but they permit us to achieve near-complete suppression of viral replication in many patients -- while holding the most powerful class of antiretroviral agents in reserve for use later.

Because high-level compliance plays such a paramount role in the benefits achieved on any combination therapy, there is a tendency to blame patients whenever an antiretroviral regimen begins to fail. This is especially cruel to patients who are conscientious about compliance, patients whose breakthroughs should properly be attributed to therapeutic decisions made before the advent of the protease inhibitors... and to deficiencies inherent in all of the available antiretroviral combinations.

But laying the blame on patients is cruel irrespective of how compliant those patients actually are. As Dr. Margaret A. Chesney notes in "Compliance: How You Can Help," the multidrug antiretroviral regimens that are now being prescribed, with their exceedingly strict dosing schedules and their detailed directives regarding such factors as timing of meals and intake of fluids, "are the most complicated that have ever been prescribed for continuous and open-ended treatment of such a large patient population." In this light the appropriate response to any mention of compliance problems in patients on combination antiretroviral therapy is not "Why can't these patients comply with their assigned dosing schedule?" but "How does anyone manage to stay fully compliant with such a demanding dosing regimen?"

For patients and care providers alike, the most heartening news to come out of the 12th World AIDS Conference is that real progress is being made in developing simpler dosing schedules -- with the ultimate aim being once-daily doses of all the components of a maximally suppressive multidrug regimen. Once-a-day formulations of the nucleoside analogs ddI and 3TC, the NNRTIs nevirapine and efavirenz, the nucleotide analog adefovir, and the protease inhibitors nelfinavir and ABT-378 are now in clinical trials, and we can look forward to a day when compliance with antiretroviral regimens will be considerably easier to achieve.

The information gap in HIV treatment

The 9,000-plus participants in the 12th World AIDS Conference included most of the roughly 3,000 clinicians who treat roughly 80% of the HIV-infected individuals in this country. These AIDS experts were the subject of the editorial that I contributed to the June issue of HIV Newsline. It carried the somewhat provocative title "Should the Treatment of HIV Infection Be Left to Specialists?" After answering that question affirmatively, I took considerable care to identify those experts -- a tricky task, given that there are, as yet, no national criteria for identifying, certifying, or credentialling experts on HIV infection. "In a sense," I concluded, "the real test of who is -- and who isn't -- an expert on HIV infection is probably not a question of particular training but of passionate commitment. The experts are those who see the patients, attend the meetings, read the literature, review the data, and fine-tune their approach to clinical care accordingly."

Careful as I was, I was not careful enough, apparently. I indicated that expertise in the diagnosis and treatment of HIV infection crosses many disciplinary lines. "In some places," I wrote, "care is provided mostly by specialists in infectious disease, while in other places hematologists, pulmonologists, oncologists, and even family practitioners have become self-taught AIDS experts." Several family practitioners took exception to my phrasing -- which, they felt, demeaned family practitioners.

It was not my intention to slight any group of providers; indeed, I was trying to make a case for how uniquely inclusive HIV expertise is. Elsewhere in my editorial I noted that the effective management of HIV disease, particularly in its advanced stages, requires a multidisciplinary approach -- and even the experts rely on other experts to help them provide optimal care to AIDS experts. There is nothing that says a family practitioner or general internist cannot provide expert care to HIV-infected individuals -- assuming, of course, that those providers attend the meetings, read the literature, review the data, and fine-tune their approach to clinical care accordingly. But as anyone who hefted the telephone-directory-sized abstract book at the 12th World AIDS Conference could not help but note, keeping abreast of new developments in the field is a weighty responsibility.

What statistics on prescribing patterns tell us is that the experts on HIV infection, whether they are specialists in infectious disease, hematologists, pulmonologists, oncologists, or family practitioners, do attend the meetings, read the literature, and review the data. And they do fine-tune their approach to clinical care accordingly. It is the non-experts whose diagnostic skills and prescribing habits are not up to date; it is the non-experts who are still prescribing dual-nucleoside therapy -- or occasionally even ZDV monotherapy -- more than two years after multidrug therapy became the standard of care in this country.

HIV Newsline is the only publication of its kind that is sent free of charge to every care provider in the country who treats people with HIV infection -- even if a provider's practice includes only one or two seropositive individuals. As such, our publication serves a unique purpose: it provides practitioners on the periphery of HIV treatment with clear, concise, up-to-the-minute information on the diagnosis and treatment of one of the most complex diseases ever confronted by healthcare providers. The information that we disseminate to all of our readers helps them make intelligent, informed decisions about the care of their HIV-infected patients -- including, on occasion, the decision to refer a patient to a clinician with greater experience, and therefore greater expertise, in treating HIV disease.

Notice to Readers
The special Pull Out and Save feature in this issue, "The Most Common Opportunistic Infections in Women with HIV," was developed for HIV Newsline by Dawn Averitt, an advocate for people living with HIV who is both a frequent contributor to, and a member of the editorial advisory board of, AIDS Care. Ms. Averitt and Dr. Catherine M. Wilfert, a charter member of the editorial advisory board of HIV Newsline and the Scientific Director of the Elizabeth Glaser Pediatric AIDS Foundation, have agreed to serve as guest editors of a special issue of AIDS Care, wholly focused on women with HIV infection, which will appear in October. In order to devote our full energies and resources to that special double issue, we will not be publishing an August issue of AIDS Care.

Paul A. Volberding, M.D., is Editor-in-Chief of HIV Newsline and AIDS Program Director at San Francisco General Hospital.

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