June 21, 2010 (Boca Raton, Florida) — Adding an abbreviated version of Tai Chi to antidepressant therapy with escitalopram improved resilience, quality of life, and cognitive function in adults with major depression 60 years and older, according to new research presented here at the New Clinical Drug Evaluation Unit (NCDEU) 50th Anniversary Meeting.

“Fewer than half of elderly depressed patients respond to first-line antidepressant pharmacotherapy,” Helen Lavretsky, MD, from the David Geffen School of Medicine at the University of California, Los Angeles, said in her poster presentation here. “There is some information in the literature about the benefits of tai chi in older adults, but this relates to their balance and their physical functioning. We wanted to see whether tai chi would be helpful in improving depression.”

The study recruited 112 adults with major depression and treated them with 10 mg of escitalopram daily for 6 weeks. The 70 subjects who partially responded to escitalopram continued to receive 10 mg of escitalopram per day. In addition, they were randomly assigned to receive either 10 weeks of tai chi chih for 2 hours a week or to a lecture on health education for 2 hours a week.

“Tai chi chih is a shortened form of tai chi that has only 20 movements and is easier to remember over the course of 10 weeks,” Dr. Lavretsky explained.

Most of the patients (62%) were women, and their mean age was 70 years.

The patients were evaluated for depression, anxiety, resilience, health-related quality of life, psychomotor speed, and cognition.

Both tai chi and health education patients showed similar improvement in the severity of depression, with mean Hamilton Rating Scale for Depression scores of 6.0 in both groups, Dr. Lavretsky reported. However, subjects in the tai chi group showed significantly greater improvement in resilience than did subjects in the health education group (70.2% vs 65.0%; P < .05).

The tai chi group also had better health-related quality of life, with mean well-being scale scores of 80 on the 36-Item Short Form Health Survey vs 66 for the health education group (P < .05), and measures of executive cognitive function, as shown by Stroop mean error scores of 0.03 vs 0.4 errors in the health education group (P < .05).

“Patients who were in the Tai Chi arm had a greater resilience to stress, and I thought the improvement in cognitive measures, such as memory and executive function measures, with tai chi was particularly impressive,” Dr. Lavretsky said in an interview.

“I’m in Los Angeles, so people tend to like alternative medicine interventions,” she added. “The limiting measure was the degree of arthritis that patients had. The patients who were in the education group liked that intervention, too, but it was very interesting to me to see that this gentle form of exercise had these superior results. Even C-reactive protein levels in the tai chi group were improved.”

Commenting on this poster for Medscape Medical News, Craig Nelson, MD, division chief of the Department of Geriatric Medicine at University of California, San Francisco, noted, “The interesting thing about this study was that it showed that the effect of tai chi was greater than that of the education program. That is impressive, because older depressed patients tend to have more of a benefit from a group effect, which an educational program would provide.”

He suggested that tai chi may be different in its effects than other exercise. “Looking at such a comparison might be the subject of another study,” he said.

by Emma Hitt, PhD

Nurse-managed care of patients receiving antiretroviral therapy (ART) for HIV may result in comparable outcomes to physician-managed care and enable expanded access to care in resource-poor settings.

Ian Sanne, MD, from the University of the Witwatersrand, in Johannesburg, South Africa, and colleagues with the Comprehensive International Program for Research in AIDS in South Africa conducted a randomized noninferiority trial at 2 South African primary-care clinics. They published their findings online June 16 in The Lancet.

According to Dr. Sanne and colleagues, a shortage of 4.3 million health workers (ie, physicians, midwives, nurses, and support workers) exists worldwide, and only 17.4 medical practitioners, most located in urban areas, are available to treat 100,000 people in South Africa.

To compare outcomes of nurse vs physician management of physician-initiated ART care for HIV-infected patients, researchers randomly assigned HIV-positive individuals with a CD4 cell count of fewer than 350 cells per microliter or World Health Organization (WHO) stage 3 or 4 disease to ART care monitored by either nurses (n = 404) or physicians (n = 408).

Treatment failure was defined as a composite of the following endpoints: traditional virological failure, occurrence of dose-limiting toxic effects, death, and all clinic losses that translated to failure of the treatment strategy to maintain patients on ART.

Of the patients, 46% demonstrated treatment failure — 48% in the nurse group and 44% in the physician group (hazard ratio, 1.09; 95% confidence interval, 0.89 – 1.33), which was within the limits for noninferiority.

Other outcomes at a median follow-up of 120 weeks were also comparable between the nurse- and physician-monitored patients, including deaths (10 vs 11), virological failures (44 vs 39), toxicity failures (68 vs 66), and program losses (70 vs 63).

According to the researchers, approximately 16% to 17% of patients were considered treatment failures because of the dose-limiting toxic effects of stavudine, which included a high frequency of lipomorphological changes and lactate increases.

“WHO and South African guidelines have moved away from reliance on stavudine; however, this drug remains widely used in resource-poor HIV therapy programmes,” they write. “The dose reduction of stavudine to 30 mg after the first year of the study, which was in line with WHO recommendations, might have reduced drug-limiting toxic effects,” they add.

“The results of this study lend support to the expanded access to treatment with use of models of task shifting in primary health care,” the authors conclude.

Independent commentators Mark Boyd, MD, from National Centre in HIV Epidemiology and Clinical Research and St Vincent’s Hospital, , Sydney, Australia, and Chidi Nwizu, MBBS, from the University of Maryland School of Medicine, in Baltimore, point out that “it is marvellous to see the results of a practical and innovative study which helps propel the field forward and improves our collective confidence that despite all the obstacles we can succeed.”

However, they add that many HIV-infected patients reside and access care in rural areas. “The study sites in [the Comprehensive International Program for Research in AIDS in South Africa] were not rural and had reasonable access to laboratories and ancillary services,” they write. “These are potential challenges in decentralisation models that include task-shifting.”

The study was supported by the National Institutes of Health, the US Agency for International Development, and the National Institute of Allergy and Infectious Diseases. The authors and Dr. Nwizu have disclosed no relevant financial relationships. Dr. Boyd serves on an HIV advisory board for MSD Australia and for Bristol-Myers Squibb Australia; has received funding and/or has partnered with Merck, Abbott, and the American Foundation for AIDS Research; and has spoken at events for Abbott and Merck, received honoraria from MSD Australia and Janssen-Cilaq Australia, and serves as vice president of the Australasian Society for HIV Medicine.

We, the UNITAID board members representing non-governmental organisations (NGOs) and communities affected by HIV/AIDS, tuberculosis, and malaria, are writing to you to express our deep concern that Bristol-Myers Squibb (BMS) is to close a factory in France that manufactures a second-line antiretroviral medicine for children with HIV/AIDS who weigh less than 10 kg: buffered didanosine in the 25 mg formulation.
Closing this factory means that 4000—7000 babies currently enrolled in treatment plans in developing countries through UNITAID could be left without the medicines they need. Didanosine is the last therapeutic option for these babies and without it they could die. We understand that closure of the plant will take place in June of this year, with no plans for resumption of production before April, 2011, at the earliest, when a new plant is due to open. Therefore there is likely to be a shortage of about 15 000 packs of didanosine 25 mg across all UNITAID beneficiary countries between now and when production is expected to resume in April, 2011.
Currently, there is no alternative generic product that has been assessed by WHO and prequalified for use by UN agencies. We urge you, as the Chief Executive Officer of BMS, a company that prides itself on its high standards of corporate responsibility, to respond urgently to our concerns, outlining the steps you will take to avoid any treatment interruption. We would also like your confirmation that a BMS plant will resume production of this vital medicine in 2011.

Many developed countries – including the UK – have a lifetime ban on blood donations from men who have ever had sex with other men, even if the encounter took place many years earlier.

The policy was introduced in the early 1980s as the threat of HIV/Aids emerged.

But writing in the Canadian Medical Association Journal, Mark Wainberg and Norbert Gilmore note that the highly sensitive procedures now routinely used for testing mean it would be very hard for infected blood to slip through.

It was time, they said, to consider scrapping the old policy of “indefinite deferral” and look at asking men to wait between one and five years after having sex with another man before giving blood.

“The current policy is counterproductive in terms of loss of donors, loss of good will, student protests, donor boycotts, among other negative effects,” they write.

“We believe that any potentially negative consequences of a change in deferral would be offset by the benefits.”

Transmission time

Opponents of the lifetime ban point to new testing techniques which are able to detect the HIV virus in the blood after as little as 12 days – down from three to six months previously.

Thus a “window” where infected blood might unknowingly enter the supply system remains, but it is a very short one. And opponents of the lifetime ban also point to the moral issue of double standards.

http://news.bbc.co.uk/1/hi/health/10163222.stm

Interestingly a paper from BMJ (http://www.bmj.com/cgi/content/full/338/feb26_1/b318) holds a very different opinion.

It’s quite a prompt way to share front-line informaiton or so. I like the idea but haven’t found their daily updates are really useful yet.

A clinical trial of a vaccine against a major cause of pneumonia and meningitis has shown that it can prevent three out of four cases of reinfection in HIV-infected adults in Africa.

http://www.aidsmap.com/en/news/BEF8C8CE-BC45-4DD4-B859-00E42D5F9459.asp

TB Trials

Circumcision is thought to protect men from HIV infection because foreskin tissue appears particularly susceptible to the virus, and may serve as an entry point for it. However, circumcision would not affect HIV risk from receptive anal sex — and that, again, could outweigh any protective effect of circumcision during insertive sex.

A review in journal of Urol on three randomized, controlled trials concluded that “circumcising adult males reduces the incidence of HIV by 50% to 60%. Adult male circumcision does not seem to have an adverse impact on sexual function. Epidemiological and economic modeling suggests that adult male circumcision can potentially be a highly cost-effective strategy for HIV prevention. ” (The impact of male circumcision on HIV transmission, Doyle,S.M.; Kahn,J.G.; Hosang,N.; Carroll,P.R.)

A report from CDC consultation published in this year Public Health Rep.
suggested that (1) sufficient evidence exists to propose that heterosexually active males be informed about the significant but partial efficacy of MC in reducing risk for HIV acquisition and be provided with affordable access to voluntary, high-quality surgical and risk-reduction counseling services; (2) information about the potential health benefits and risks of MC should be presented to parents considering infant circumcision, and financial barriers to accessing MC should be removed; and (3) insufficient data exist about the impact (if any) of MC on HIV acquisition by MSM, and additional research is warranted.

A little bit history here from AIDSInfo: Lopinavir/ritonavir in capsule and oral solution form was approved by the FDA on September 15, 2000, for use with other antiretrovirals in the treatment of HIV infection in adults and children 6 months of age or older. Lopinavir/ritonavir in tablet form was approved by the FDA on October 28, 2005. In March 2006, the capsule form of the medicine was phased out in the U.S. in favor of the new tablet.

once-daily dosing of lopinavir/ritonavir tablets and oral solution means lopinavir/ritonavir can be used noce or twice a day (as recommended before) combining with other therapies. This will be an easiler way of treatment and may reduce further poor adherence among HIV-diagnosed patients, which is critical for immunosupression and virological suppression.

1. The few HIV prevention campaigns that do exist do not target the elderly.
2. Older people may not consider themselves at risk of HIV infection.
3. Health care providers may not consider the diagnosis in older patients and therefore may not undertake HIV testing or may attribute symptoms of HIV to ‘normal ageing’.
4. Despite the stereotypes, many older people lead sexually active lives. Studies of sexual activity in people aged over 50 showed that 81.5% were involved in one or more sexual relationships including sex with prostitutes,and a national US survey suggested that only a small minority of people over 70 consistently used condoms. Older women may be especially at risk because age-related vaginal thinning and dryness can cause tears in the vaginal wall.
5. The increase in foreign travel makes access to countries with thriving sex industries easier.
6. The introduction and usage of potency drugs has extended the sex lives of many elderly males.
7. Injection drug usage, despite our misconceptions, is a contributor to HIV transmission in older people. In the USA, injection drug use accounts for more than 16% of AIDS cases in those aged 50 or over.
8. The stigma of HIV may be perceived to be greater in the elderly population leading them to hide their diagnosis or avoid testing.

The paper is a very good review in Age and Aging. My colleague – Ruth Smith present some important findings at the joint conference of the British HIV Association (BHIVA) and the British Association for Sexual Health and HIV (BASHH) last week. In the United Kingdom, one in twelve HIV diagnoses are of a person over the age of 50. Whilst rates of late diagnosis are high in older adults, just under half of these diagnoses are thought to be of an infection that was acquired when the person was over the age of 50.

The article will be available at http://www.aidsmap.com/cms1061207.asp after a few weeks.