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July/August 2003


Many HIV-Positive People May Not Take Meds: Study

An analysis of HIV-infected patients who died at one Texas hospital in 1999-2000 found that more than half of them were not taking highly active antiretroviral therapy. "I was really startled to see that so many patients were not on HIV therapy in an era when it's supposed to be widespread, and access is there," said the study's lead author, Dr. Mamta K. Jain of the University of Texas Southwestern Medical Center-Dallas. The full report, "Changes in Mortality Related to Human Immunodeficiency Virus Infection: Comparative Analysis of Inpatient Deaths in 1995 and in 1999-2000," was published in the journal Clinical Infectious Diseases (2003;36(8):1030-1038).

The researchers compared HIV-positive patients who died in 1995 (before HAART availability) to those who died in 1999-2000. They also assessed whether or not patients in the later group were taking HAART. Jain's team evaluated 200 HIV/AIDS patients -- 112 who died in 1995 and 88 who died in 1999-2000.

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Despite "widespread availability" of HAART, only 48 percent of patients who died in 1999-2000 were taking HAART at the time of death, the authors reported. The main reasons the patients were not taking the drugs were an inability to adhere to the treatment regimen and an HIV diagnosis less than six months prior to death. Other reasons included an inability to tolerate the drugs due to underlying liver disease, the study indicates.

Another finding of the study is that many HIV-infected individuals not receiving HAART were minorities. Nine out of 12 patients who were diagnosed with HIV shortly before death, and 12 of 18 patients who did not take HAART as prescribed, were black or Hispanic, the authors wrote.

The team did see a decline in the number of people dying due to HIV. However, AIDS-defining illnesses, such as Pneumocystis carinii pneumonia, were still an important cause of death in patients not taking HAART, according to the report.

"I don't want to paint a gloomy picture," Jain said. "Definitely, the number of cases of patients dying with AIDS has decreased radically. But we were expecting to see a change in the types of diseases people were dying from, and we didn't see that. I think this study is important because, if you look at the HIV/AIDS literature, you see these dramatic changes, and people are living longer ... but I think we kind of lose sight of the fact that there are still areas in the country that still are seeing a lot of the same problems that we did prior to HAART being available." Last year, CDC estimated that up to one-third of the nation's 850,000-950,000 HIV-positive people do not appear to be receiving treatment (Reuters Health, 04.17.03).


Hepatitis B a Deadly Threat to U.S. Asians

Hepatitis B, relatively rare in the United States, is a "silent killer" of people of Asian descent, who are 20 to 30 times more likely to be infected than other ethnic groups. While comprising just 3.6 percent of the U.S. population, Asians account for half the nation's patients with hepatitis B, which can lead to cirrhosis of the liver, liver cancer and death. From 5 percent to 15 percent of people in U.S. Asian communities are infected, depending on the locale. A recent University of California-Irvine study of 828 Vietnamese people in Orange County age 18 and older found that 13 percent had hepatitis B and 69 percent had been exposed to it.

Laws in 31 states now require that children be vaccinated for the disease when they enter middle school, but some people are asking why federal and local authorities are not spending more money to warn older children and young adults -- particularly in Asian communities -- about the need for testing and vaccination.

Doctors and activists in Orange County's Little Saigon -- the world's largest community of expatriate Vietnamese -- say they hear the subject discussed on Vietnamese-language TV and radio. But community activist Diep Tran said she knows of no government outreach program. "The community is aware of hepatitis B and liver cancer, but they don't know the extent of how the disease spreads, how you contract it or what the treatment is," she said. Vietnamese men have the highest rate of liver cancer in the world, much of it caused by hepatitis B, said Steven McPhee, a UC-San Francisco professor of medicine and principal investigator at the Vietnamese Health Promotion Project.

Hepatitis B is spread by oral or sexual contact and is endemic in much of Asia. Many are exposed during birth. It is also passed from child to child because of childhood scrapes, skin diseases or kids sharing toothbrushes. Hepatitis B is 100 times more easily transmitted than HIV, said Dr. Gary Euler, an epidemiologist for the National Immunization Project at CDC. Euler said the latest estimates are that two-thirds of children of Asian origin ages 2-18 have been vaccinated (Los Angeles Times, 04.28.03, Jeff Gottlieb; Daniel Yi).


Attitude Is Key Part of Treatment Adherence

A small Chicago study suggests that attitudes about HIV/AIDS among HIV-infected people can be broken down into types that are predictive of how well the patients will adhere to their medication regimes. "The people who do well over the long haul are different from those who don't do well, principally on the basis of being able to take their medications," said Dr. John Flaherty, associate professor of medicine at Northwestern University. "I think we spend most of our time in the clinic on that issue with patients." Seventy-two HIV patients were given 34 statements to rank according to how much they agreed or disagreed with them. The first part of the questionnaire dealt with demographics, the patient's drugs, and illnesses. The second part involved ranking various attitude statements. HAART adherence was determined by a self-report questionnaire, plus results from viral load and genotypic assay. Analysis revealed the following five different patient attitudes:

  • Empowered: Patients who clearly knew about HIV/AIDS and why it is important to take antiretroviral medication. The patients who fit into this group had the greatest amount of adherence, said Farheen Ali, MD, study coauthor and fellow of infectious disease at the University of Chicago.

  • Dependent: Patients who could be described as depressed. They identified with statements that showed they were very dependent on physicians and family support, Ali said. "They didn't understand why they were supposed to take medications, but they did so because they were told to do so."

  • Ashamed: "This group predominantly expressed feelings of shame and guilt about the disease," Ali said. "They felt they were responsible for contracting HIV in the first place." This group tended to be more adherent than not adherent.

  • Optimistic: HIV patients who could be described as blind optimists, who believed they were OK and who planned to continue taking their medications, Ali said. While they tended not to know or understand much about their disease, they did appear to be adherent, he said.

  • Denial: HIV patients who predominantly said they strongly agreed that they would live their natural life spans, Ali noted. These patients require a lot of work because of their unrealistic expectations and beliefs, he said. The patients "all had excuses for missing their medication doses, such as they fell asleep or [were] out of the house. So it seemed they felt they'd be OK, but didn't want to deal with the medication." The denial group also reported that they had not received all the information they needed from their physicians, and they appeared to have some distrust of the medical community, he added.

Because of the small cohort, the differences were not statistically significant, and further studies will need to be conducted to confirm the findings, said Flaherty. It is crucial that clinicians are able to refer patients to social workers, psychiatrists, advanced practice nurses, and others who may help them with their psychological issues that impact adherence, Flaherty said. The study, "Subjective Attitudes and Adherence to HAART in HIV-Infected Adults," was presented in October at the 40th Annual Meeting of the Infectious Diseases Society of America in Chicago (AIDS Alert, 03.01.03).


Severe Hepatotoxicity During Combination ARV Treatment

Issues concerning severe adverse events from combination antiretroviral therapy (ART) are becoming increasingly evident, limiting therapeutic benefits in a significant proportion of patients. Typical hepatic drug toxicity is exhibited by all classes of antiretrovirals; it is shown by a rise in transaminase levels and occasionally by signs of drug hypersensitivity or steatohepatitis. In the current study, all patients who initiated any combination of ART during an 18-month period were assessed to define prospectively the incidence and factors associated with the occurrence of severe hepatotoxicity (SH), as well as the histology and outcomes from SH during ART.

Seven hundred fifty-five HIV-positive patients consecutively prescribed new ART were selected. Liver function tests were assessed at baseline, after one month, and every four months thereafter. Liver biopsy was recommended in case of SH (i.e., increase in liver enzymes greater than or equal to 10 times the upper limit of normal or five times baseline if markedly abnormal).

Twenty-six cases of SH were observed with an incidence of 4.2 per 100 person-years. SH incidence was not significantly different by treatment regimen (four per 100 person-years in patients treated with two nucleoside reverse transcriptase inhibitors (NRTI) plus one protease inhibitor (PI), six per 100 person-years in those treated with two NRTIs, and none in those treated with two NRTIs plus one non-nucleoside reverse transcriptase inhibitors (NNRTI). Patients developing SH during combination ART differed from those who did not by the following factors: they were more often male; had intravenous drug use as a risk factor for HIV acquisition; were younger; were more often coinfected with HCV, HBV, and HDV; and had higher baseline alanine aminotransferase and bilirubin values and longer prothrombin time. Anti-HCV and HCV RNA reactivity were detected in all but one of 26 patients with SH. HBsAg was detected in five patients, as was anti-HDV IgM. The patient without HCV-RNA reactivity showed HBsAg and HDV-Ab IgM reactivities.

Liver failure was rarely seen (1.1 per 100 person-years). Liver damage was invariably observed in patients with chronic viral hepatitis. Liver histology showed exacerbation of viral hepatitis in all 16 patients for whom a liver biopsy was available at the time of SH. A direct correlation was found between ALT increase and increase in CD4+ T-cell count in patients with SH. Death occurred during follow-up in seven of 26 patients (27 percent), all of whom showed LF and baseline CD4+ count less than 200 cells/mm3 (7/7 patients = 100 percent vs. 8/19 patients without LF). Relapse of SH was observed after ART was recommenced in seven of 17 patients (41 percent). Five of these seven patients did not show further SH relapse after treatment with interferon.

Severe hepatotoxicity was related to preexisting chronic viral hepatitis followed by irreversible LF in a few patients, all with severe CD4+ T-cell depletion before starting ART. "Besides the fact that all patients with chronic viral hepatitis should be strictly monitored for liver damage after starting ART, this observation strengthens the importance of careful follow-up in patients with chronic hepatitis and a low CD4+ T-cell count. When the CD4+ T-cell count is 200 to 350 cells/mm3, the risk of SH resulting in LF may be low according to our data; thus ART could be started quite safely," researchers concluded. "Antihepatitis pre- or co-medication could be an effective preventive or curative measure" (Journal of Acquired Immune Deficiency Syndromes, 03.01.03, Vol. 32; No. 3: P. 259-267, Massimo Puoti et al.).


Syphilis Outbreak Unabated in New York City

New York City's health department is predicting that the current syphilis outbreak among gay and bisexual men will continue through 2003 and might even grow larger by the end of the year. As of the week of April 7, 105 cases of primary or secondary syphilis have been reported to the health department, and just six of those cases were among women. There were 102 cases reported during the same period in 2002, with five cases among women. That trend of men dominating the male-to-female ratio of cases began in 1998 and has increased since then.

The health department is also reporting an increase in the number of early latent cases of syphilis for the first quarter of 2003. There were 242 such cases, with 32 among women, in 2003 compared to 165 cases, with 31 among women, during the same quarter in 2002. An early latent case is someone who no longer exhibits the obvious physical symptoms of primary and secondary syphilis such as lesions on the penis, vagina, or anus or in the mouth and later a rash anywhere on the body. Early latent cases of syphilis, like primary and secondary cases, must be treated in order to prevent the potentially life-threatening final stage syphilis.

The 2003 data are preliminary, but they suggest that the syphilis outbreak will continue unabated. They also indicate that some gay and bisexual men have given up safe sex practices. A syphilis infection, like some other STDs, increases the likelihood of getting or acquiring HIV.

The health department is recommending that sexually active gay and bisexual men get tested for syphilis every year, whether or not they have symptoms. It is also telling physicians to treat patients they suspect have syphilis even before the result is confirmed with a test (Gay City News [New York City], 04.25.03, Duncan Osbourne).


Class-Action Lawsuit by Inmates for Hep C Treatment

Oregon inmates allege in a pending class-action lawsuit that treatment for hepatitis C is so woefully inadequate in the state's 12-prison, 11,800-inmate system that it violates the constitutional ban on cruel and unusual punishment. Prisoners say health care managers systematically deny treatment to hold down costs.

The federal lawsuit seeks $17.5 million for inmate medical expenses, including drug therapy, chemotherapy and potential liver transplants. "It's just unconscionable what's going on," said Phyllis Beck, director of the Hepatitis C Awareness Project in Eugene, Ore. "They're letting prisoners die of hepatitis C." Beck said, "The main reason a lot of these prisoners aren't getting treatment is because of the cost."

Portland lawyer Michelle Burrows filed the suit on behalf of 11 current and former inmates. District Court Judge Anna Brown recently granted Burrows' motion to expand the suit into a class action. All Oregon inmates with hepatitis C now are considered plaintiffs. Corrections Department spokesperson Perrin Damon said, "Treatment protocol is both medically appropriate and conforms with the state's legal obligation to provide medical care to state prison inmates. We look forward to responding to the plaintiffs' claims in court."

Corrections officials estimate that about 30 percent of all Oregon inmates -- roughly 3,500 -- are infected with hepatitis C. Corrections Department Medical Director Dr. Steve Shelton, who oversees the prison system's management of hepatitis C, declined to provide complete data on the number of prisoners given medication for the infection. In 2001, the only data made available by the department, a dozen inmates received the drug therapy. At a low-end cost of $18,000 per inmate, providing treatment for 10 percent of the infected inmates in Oregon would cost taxpayers at least $6.3 million. At a high-end cost of $30,000 per inmate, the total bill would rise to $10.5 million (Associated Press, 05.05.03, Alan Gustafson).


The Impact of Apathy and Depression on Quality of Life

Although highly active antiretroviral therapy (HAART) for HIV has significantly improved disease prognosis, challenges remain for patients living with a chronic medical condition. As a result, the importance of quality of life (QOL) among HIV patients continues to be a critical component of patient care. Recent studies have identified a range of factors that influence QOL, including increased viral load; decreased CD4 count; physical disability; and elevated fatigue. Psychosocial factors such as limited social support, restricted financial resources and poor access to health care are associated with lower QOL.

Neuropsychiatric aspects of HIV are also strongly associated with overall QOL, with depression being the most common. Apathy -- a reduction in goal-directed behavior that is manifested by decreased behavioral, cognitive, or psychological activity -- has recently been identified as a potentially important neuropsychiatric symptom associated with HIV. In the current study, the authors examine the contribution of apathy and depression on QOL among individuals infected with HIV.

A total of 45 HIV-positive patients (16 males, 29 females) were recruited from an academic HIV care program, with the majority being infected with HIV through IV drug use. Those excluded from the study include patients with a history of bipolar disease or schizophrenia, neurologic disorder, learning disability, or developmental disability. Average age for the patient was 42.7 (5.7) and 95.5 (63.7) months since diagnosis. All patients were taking HAART and all but two were asymptomatic. The median CD4 cell count was 310. The study included 22 control subjects who were recruited from the community and met the same exclusion criteria. The control group averaged 38.6 (10.7) years of age.

Study results revealed that while apathy is more prevalent in HIV-infected subjects compared to the noninfected control subjects, the impact of apathy on QOL is relatively minimal when compared to depression. The clinical implications of the study are twofold. First, the frequency of apathy is far less than the frequency of clinically significant depression. The current study, as well as previous investigations, suggests that approximately 20 percent to 30 percent of HIV-positive patients report apathy ratings that exceed the threshold for clinical significance, compared to 80 percent reporting depression ratings that exceed the threshold for clinical significance. This study clearly indicates that depression is more common than apathy in this population.

The second major clinical implication is that the impact of apathy on health-related QOL is far less than the impact of depression. Despite the higher rates of both apathy and depression in this sample, only depression is strongly associated with ratings of health-related QOL and should remain the primary mental health concern for practitioners who provide treatment for HIV-infected individuals.

Demographic factors associated with an increased risk of depression include comorbid substance abuse, an increased number of severe life events, greater physical disease, and low social support. In addition, women, homosexual men, and those with a history of psychiatric illness prior to seroconversion are more likely to experience significant depression following seroconversion.

Depression increases with greater HIV disease severity and increased sense of hopelessness regarding one's physical health. In addition to the effectiveness of pharmacotherapy and psychotherapeutic interventions for HIV-positive individuals, there is preliminary evidence that successful treatment of HIV with HAART is associated with reductions in depression severity. Depression is associated with reduced QOL and poor adherence to HIV treatment regimes. Furthermore, there is some evidence that depression compromises the immune system, and in turn hastens progression of the disease. The authors concluded that "effective treatment of depression has the potential to significantly influence the mental and physical health of a population living with a chronic condition that continuously presents physical, social, and psychological challenges" (AIDS Patient Care and STDs, 03.03, Vol. 17; No. 3: P. 115-120, David Tate et al.).


Viral Protein Explains Why Some HIV-Positive People Stay Healthy

Canadian and U.S. scientists reported Thursday that people who stay healthy years after HIV infection are more likely than other HIV patients to be infected with virus that has a particular protein alteration. The finding offers another possible explanation why a small number of people with HIV never develop AIDS, and points toward new therapies that might prevent the progression of HIV in other patients, as well.

Experiments with an HIV protein -- viral protein R (Vpr) -- revealed that altering or deleting the protein greatly decreased the number of immune cells destroyed by HIV, the process that enables HIV to progress to AIDS. Treatments that block Vpr may help infected people to stay healthy, said study author Dr. Andrew Badley of the Mayo Clinic in Rochester, Minnesota. "Since mutations in Vpr can alter the outcome of HIV disease, it is possible, if not likely, that we can develop inhibitors of Vpr that may also modify disease outcome," Badley said.

In the small number of HIV patients known as nonprogressors, levels of the virus remain low, even without treatment, and AIDS does not develop. Badley and colleagues examined the makeup of HIV extracted from the blood of people with HIV, some of whom were nonprogressors. Once researchers identified that a particular HIV mutation was present more often in nonprogressors, they designed HIV samples that contain normal or mutated forms of Vpr, and some samples lacking the protein. Badley and his team then mixed those different forms of HIV with human blood cells, and discovered that each type of virus had a different effect on immune cells.

"The amount of cell death was minimal in the virus that did not have Vpr, was quite high in the virus that contained normal Vpr, and was kind of halfway in between in the virus that contained the mutant Vpr," Badley said.

Badley explained that HIV in nonprogressors likely succeeds in killing immune cells, but at such a slow rate, people are able to make new immune cells fast enough that their immune system does not become compromised. He noted that he and his colleagues are currently looking at developing Vpr inhibitors. "Certainly, we're talking a number of years, as opposed to a number of months" before a new treatment would be available for people, he said (Reuters Health, 05.15.03, Alison McCook).


Study Links Alcohol Intake to HIV Progression

HIV-infected patients who are drinkers tend to have higher levels of the virus in their blood and lower CD4 counts than similar patients who do not drink, according to a preliminary study. However, this was seen only in patients taking antiretroviral drugs, which suggests that drinkers may be less likely than nondrinkers to take their medication consistently, according to lead author Dr. Jeffrey H. Samet.

"Alcohol is a factor associated with poor adherence," Samet said. However, he stressed that the findings only offered "suggestive evidence that alcohol plays a role in outcomes of people with HIV." "Attention to the alcohol consumption in HIV patients is important for both physicians and patients," said Samet, who is at Boston University.

In the current study, researchers looked at 349 HIV-infected patients with a history of alcohol problems. They found that patients taking antiretroviral drugs who were moderate or problem drinkers had higher levels of HIV in their blood and lower CD4 counts, a sign of immune function.

"Although our results suggest that alcohol use in conjunction with highly active antiretroviral therapy may result in more rapid HIV disease progression... the underlying nature of this association remains unclear," write Samet and colleagues. One major limitation of the study is that it only looked at patients' viral load and CD4 count on a single day. Such a snapshot is not nearly as good as following patients over time while monitoring adherence to medication and alcohol consumption, explained Samet. Future studies will need to follow patients over time to see whether or not alcohol is associated with adverse HIV outcomes, he noted (Reuters Health, 05.14.03, Keith Mulvihill).


Bush Signs $15 Billion AIDS Bill

President Bush signed into law a $15 billion program to prevent and treat AIDS in poor countries in Africa and the Caribbean that have been devastated by the epidemic.

The program, first introduced by the White House four months ago, is designed to triple U.S. investment in international AIDS assistance during the next five years. It requires that a substantial portion of the prevention money be spent to encourage sexual abstinence outside marriage -- an approach favored by conservatives but viewed as largely ineffective by public health specialists. The administration had leaned hard on Congress to enact the legislation this month, hoping it would give the president leverage in urging the leaders of seven other major industrialized nations to increase their international AIDS funding when he meets with them in France next week.

But Congressional Democrats portray the White House's commitment to the program, and to international public health in general, as hollow. They have begun to make the case that, even as Bush gave the AIDS initiative a prominent spot in his State of the Union address, he proposed cutting other international public health and relief programs.

While they were delighted by the new law, several AIDS activists suggested that the administration's commitment to easing the epidemic within this country is shaky. They said the White House has recommended funding cuts for the Ryan White CARE Act, and that federal aid to state programs that subsidize HIV therapies has not kept pace with demand.

The law envisions $3 billion a year in subsidies through 2008, but it remains uncertain how much will actually be spent. The congressional appropriations process for next year is in the early stages, and members of both parties have cautioned that it may be difficult to fit that sum within the tight limits on foreign aid that Republicans have approved.

In his remarks at the signing, Bush sought to link the AIDS initiative to several of the largest humanitarian steps taken in 20th century America. He called the initiative "the largest, single up-front commitment in history for an international public health initiative involving a single disease" (Washington Post, 05.28.03, Amy Goldstein, Dan Morgan).


Gay Men Not Heeding Warnings About Spermicide

A considerable percentage of men who have sex with men do not know that the spermicide nonoxynol-9 offers no protection against HIV infection and could even enhance transmission, according to a recently released study. In fall 2001, researchers from CDC's Division of HIV/AIDS Prevention interviewed 573 homosexual and bisexual men in the streets of the San Francisco Bay Area aiming to see if the men had absorbed warnings issued since 2000 by CDC and the World Health Organization that N-9 should not be used during anal intercourse. Studies have shown that N-9, a spermicide contained in some condoms and lubricants, offers no STD protection and destroys the protective lining of the rectum, which could allow HIV to be more easily transmitted.

Overall, 61 percent, or 349, of the 573 men interviewed had heard of the spermicide. Just more than half of the 349 had heard that it might not protect against HIV. Of the men who knew about N-9, 83 percent had used it, of which 67 percent had used it for anal intercourse in the previous year. Of those who used it during anal sex, 41 percent did so without using a condom because they thought it would protect them against HIV transmission, the study, "Rectal Use of Nonoxynol-9 Among Gay Men Who Have Sex with Men," reported in the April 11th issue of the journal AIDS (2003;17(6):905-909). "So even though they were hearing the message, it wasn't translating into behavioral change," said lead author Dr. Gordon Mansergh, a senior behavioral scientist at CDC.

The study aimed to evenly sample races, ages, education and income. Twenty-nine percent were Latino, 28 percent were African American, 28 percent were Caucasian, and 15 percent were other. The ages ranged from 18 to 67, and 50 percent were HIV-negative, 38 percent were HIV-positive, and 12 percent had an unknown status.

Of those interviewed, African Americans were more likely to say they would use N-9 during anal intercourse. Those with unknown HIV status and Latinos were less likely to have heard of N-9 and therefore more likely to have unknowingly used it, said Mansergh. Although gay mens' understanding may have changed since the study was conducted, the results demonstrate that public health 9fficials should be more targeted with their messages, particularly when the message changes, Mansergh said (Reuters Health, 05.21.03, Alicia Ault).





  
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