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September 30, 2009

Need for Perfect Adherence Might Drop After a Year on Treatment

"The need to maintain near-perfect adherence to antiretroviral (ARV) therapy might decrease the longer a person is able to keep virus suppressed, according to a study published September 29 in the online journal PLoS One.

"Though seriously potent, ARV treatment has a major Achilles’ heel—the virus can easily develop resistant to the drugs if they aren’t taken on time as prescribed every day. Previous estimates of the older drugs found that people shouldn’t miss more than one dose per month if they were on a once-daily regimen. Though some researchers have said they think the newest drugs might be a tad more forgiving than that, they still argue that high levels of adherence are key to long-term treatment success.

"Some researchers, however, including Michael Rosenblum, PhD, from the University of California at San Francisco, and his colleagues have suspected that the need for near-perfect adherence might decrease the longer a person successfully maintained very low levels of HIV. ..."

Read more in POZ, September 30, 2009.

Overview of ARV studies at IAS [July 19-22, 2009, in Cape Town, South Africa]

"The conference included a broad range of important studies that could inform use of currently approved drugs, and first results of a new integrase inhibitor.

"First results of new integrase compound: GSK1349572


"Raltegravir in treatment-naive patients


"Nevirapine vs atazanavir/ritonavir in treatment-naive patients: ARTEN study


"Darunavir/r monotherapy studies


Maraviroc results similar to efavirenz when analysed using more sensitive tropism test"

Read more in i-base, September/October 2009.

Peer support and text reminders lead to only transient improvements in HIV treatment adherence

"These findings suggest that receiving informational, emotional, and affirmational support from peers might promote adherence, but that effect did not persist when the support was discontinued. Ongoing social support, perhaps from individuals more integrated into participants’ lives, may hold greater promise in promoting and sustaining long-term adherence”, write the investigators."

Read more in Aidsmap, September 30, 2009.

Abacavir impairs endothelial function, possibly explaining increased heart attack risk

"Treatment with abacavir impairs endothelial function, providing a possible explanation for the drug’s association with an increased risk of heart attack, US investigators report in the September 24th edition of AIDS.

"They found that patients currently receiving abacavir (as well as those who had taken the drug in the past) had impaired flow-mediated dilation in the brachial artery compared to individuals with no history of treatment with the drug."

Read more in Aidsmap, September 30, 2009.

September 29, 2009

Genital Ulcer Disease Flare-ups in Women Starting HIV Treatment

"HIV-positive women have a heightened risk of genital ulcer disease flare-ups in the first month after starting antiretroviral (ARV) treatment, according to a study published online September 23 in the Journal of Acquired Immune Deficiency Syndromes.

"When HIV-positive people with suppressed immune systems start potent ARV therapy, they might experience symptoms of diseases that have been silent, or latent, sometimes for years. This is called immune reconstitution inflammatory syndrome, or IRIS, and the symptoms that can crop up are actually caused by the rekindled immune system overreacting to the presence of infectious organisms rather than the underlying disease itself. There have been reports that this can occur with infectious diseases that cause genital ulcers, such as herpes simplex virus, but the exact timing of the sometimes painful flare-ups hasn’t been well documented."

Read more in POZ, September 29, 2009.

September 28, 2009

Etravirine (Intelence) label change in the US due to severe hypersensitivity reactions

"Severe, potentially life-threatening, and fatal skin reactions have been reported. These include cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme. Hypersensitivity reactions have also been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure. In Phase 3 clinical trials, Grade 3 and 4 rashes were reported in 1.3% of subjects receiving etravirine compared to 0.2% of placebo subjects. A total of 2% of HIV-1-infected subjects receiving etravirine discontinued from Phase 3 trials due to rash [see Adverse Reactions (6)]. Rash occurred most commonly during the first 6 weeks of therapy.

"Discontinue etravirine immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia). Clinical status including liver transaminases should be monitored and appropriate therapy initiated. Delay in stopping etravirine treatment after the onset of severe rash may result in a life-threatening reaction."

Read more in i-base, September/October 2009.

Reduced efavirenz dose safe and effective in patients with high blood levels of drug

"Doses of efavirenz can be safely reduced in patients who have high blood concentrations of the drug, Dutch investigators report in the October 1st edition of the Journal of Acquired Immune Deficiency Syndromes. Reducing the dose of the drug meant that patients were less likely to discontinue treatment with efavirenz due to side-effects, and reducing the dose of the drug did not increase the risk of viral load becoming detectable.

"Efavirenz (Sustiva, also in the combination pill Atripla) is one of the drugs recommended for first-line antiretroviral treatment. The drug has a potent anti-HIV effect, is easy to take and has a mild side-effect profile.

"However, a proportion of individuals who start treatment with efavirenz report central nervous system side-effects. These can include problems sleeping, vivid dreams, and depression. Although such side-effects are often mild and transient, a small number of patients discontinue treatment with efavirenz because of them. "

Read more in Aidsmap, September 28, 2009.

Infections and smoking increase risk of non-AIDS cancers for people with HIV

"A meta-analysis has found that, compared to the general population, HIV-positive individuals have an increased risk of several non-AIDS-defining cancers. The research, which is published in the online edition of the Journal of Acquired Immune Deficiency Syndromes, showed that HIV-positive individuals had an increased risk of several infection-related cancers, as well as malignancies that are related to smoking."

Read more in Aidsmap, September 28, 2009.

September 26, 2009

Deportation of migrants with HIV often contravenes human rights treaties

"National governments should reconsider deportation policies for people living with HIV, Human Rights Watch said in a report released yesterday. The organisation called on governments, international agencies and donors to ensure that HIV-positive migrants have access to antiretroviral therapy when detained and to ensure that, if deported, migrants are able to maintain access to treatment and care.

"The report was co-authored with the African HIV Policy Network, Deutsche AIDS-Hilfe and the European AIDS Treatment Group, and describes cases from a wide range of countries around the world."

Read more in Aidsmap, September 25, 2009.

U.S. closer to lifting HIV travel ban

"The Obama administration has taken a new step toward lifting the ban on HIV-positive foreign nationals entering the United States in a possible indication that a full repeal is coming soon.

"A memo issued Tuesday by U.S. Citizenship & Immigration Services instructs officers to place on hold any green card applications for foreign nationals that would otherwise be denied simply because of HIV status.

"These holds will continue until the release of the final rule change, which is expected later this year from the Department of Health & Human Services."

Read more in Washington Blade, September23 , 2009.

September 24, 2009

HIV Vaccine Regimen Demonstrates Modest Preventive Effect in Thailand Clinical Study

"In an encouraging development, an investigational vaccine regimen has been shown to be well-tolerated and to have a modest effect in preventing HIV infection in a clinical trial involving more than 16,000 adult participants in Thailand. Following a final analysis of the trial data, the Surgeon General of the U.S. Army, the trial sponsor, announced today that the prime-boost investigational vaccine regimen was safe and 31 percent effective in preventing HIV infection."

Read more in, September 24, 2009.

Note: See 3 articles on this study today in AIDSMAP (dated 24.09.09).

Efficacy of Trichloroacetic Acid in the Treatment of Anal Intraepithelial Neoplasia in HIV-Positive and HIV-Negative Men Who Have Sex With Men

"On a per lesion basis, 73% of AIN 1 and 71% AIN 2/3 cleared to no lesion or AIN 1 or less, respectively. Conclusions: Topical 85% TCA was safe and well tolerated. It was more effective in younger patients and among HIV-positive patients, those with 2 or fewer lesions. A high proportion of AIN 2/3 lesions responded to TCA treatment."

Read more in JAIDS, September 24, 2009.

Detectable HIV Viral Load Is Associated With Metabolic Syndrome

"Conclusions: Persistent viremia is a significant predictor for the development of MS [metabolic syndrome]. Viral control through effective antiretroviral therapy is paramount not only for the control of HIV disease progression but also for the prevention of MS and associated cardiovascular disease."

Read more in JAIDS, September 24, 2009.

September 23, 2009

Drexel Nursing Students Trade Books for iPods

"'Instead of carrying 47-pounds of books in a backpack, students can now take a four-ounce device out of their pocket and look up information they are unsure about right in front of the patient,' said Donnelly. ...

"All students that received their new iPods downloaded five books -- three of which interact with each other -- through an application called Skyscape. Medical updates are downloaded four times a year -- a luxury books cannot offer."

Read more in NBC Philadelphia, September 21, 2009.

AIDS protesters demand G-20 fund disease treatment

"PITTSBURGH (AP) - About 100 AIDS activists dressed in black are marching behind coffins in Pittsburgh, demanding the world's most powerful leaders help thousands worldwide who will die of the disease.

"Protesters say the Group of 20 is using the global financial crisis as an excuse to cut promised funding.

"They say some African nations are already running out of key drugs, and some clinics are taking people off HIV treatment."

Read more in WFMJ, September 22, 2009.

September 22, 2009

HCV: Wait for Something New or Treat Now?

"Some people coinfected with both HIV and hepatitis C virus (HCV) are holding out for new treatments that will improve their chances of permanently clearing HCV. David Evans talks with HCV/HIV coinfection activist Tracy Swan to find out whether the current crop of experimental agents will be worth the wait."

Read more in POZ, September 22, 2009.

Comment, by JSJ: It should be more widely known that hepatitis C treatment research was delayed, possibly for years, by a fight over intellectual property. Several companies stopped their search for a hepatitis C protease inhibitor after disputes with Chiron, which had basically patented the virus so that other companies could not make a competing blood test for it. Later, a compromise allowed the treatment research to resume, resulting in the hepatitis C protease inhibitors now in clinical trials.

Personal note: Years ago we saw an X-ray crystallography setup during a tour of Gilead Sciences; the project's purpose was to determine the chemical structure of the hepatitis C protease, in order to design an inhibitor. Apparently that research was stopped due to the legal disputes, and Gilead's hepatitis C research was restarted later.

For more information:

* 2004, AP story:

* 2006, Council on Foreign Relations: "Reforming U.S. Patent Policy: Getting the Incentives Right" (pages 19-20): (free PDF download on that page)

* The most important media work was by reporter Mike McGraw in the Kansas City Star, February 15, 2004. His story seems to have been removed from the newspaper's Web site. The Google and Bing search engines failed to find an accessible copy anywhere; but Yahoo search found one at It might be the only full text online; and this article has key information not in the other reports. Could the consistent misspelling of the company name have helped protect it? If you have any interest in the history of hepatitis C treatments and patents, save a copy immediately.

A problem in researching this history is that many of the companies affected have reached a settlement with Chiron (sometimes after being sued), and will not talk.

Importance today: In hepatitis C most of the damage has already been done. But the history is critical because major decisions continue to be made on patent reform, pharmaceutical patents, and the patenting of pathogens (such as the hepatitis C virus) and human genes.

If you have information, you can send it to John S. James,, or to AIDS Treatment News, 1233 Locust St., 5th floor, Philadelphia PA 19107.

National Gay Men's HIV/AIDS Awareness Day and the Internet

"Understanding how gay and bisexual men are using the Internet and its impact on HIV transmission, testing, and care is critical. Sunday, September 27, is National Gay Men's HIV/AIDS Awareness Day (NGMHAAD), which National Association of People with AIDS (NAPWA) and its partners originated and sponsor. NAPWA is using the Internet to support this day which was launched in 2008 in response to the increasing rates of HIV among gay and bisexual men. Here are some comments from Tom Kujawski, NAPWA’s Vice President of Development about the day:"

Read more in, September 22, 2009.

September 21, 2009

Tobacco, marijuana and alcohol may lower levels of some anti-HIV drugs

"Tobacco and marijuana may reduce levels of atazanavir (Reyataz) in the body, whilst tobacco and alcohol may lower efavirenz (Sustiva or Stocrin) levels in individuals who carry specific genetic variations, according to two posters presented last week at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco. ...

A limitation of these studies is that the investigators did not specifically look at adherence, which may be influenced by substance use. They also did not report the amount of substances used. The first report did not distinguish between boosted and unboosted atazanavir, which has a major impact on drug concentrations. The second did not explore whether liver damage due to heavy drinking might play a role in altered drug processing."

Read more in Aidsmap, September 21, 2009.

GS-9350 boosts atazanavir just as well as ritonavir

"GS-9350, a new pharmacoenhancer being developed by Gilead Sciences, equals ritonavir (Norvir) as a booster of blood levels of atazanavir (Reyataz), researchers reported last week at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) l in San Francisco. ...

"Atazanavir levels were 'bioequivalent', or functionally similar, in people taking 150 mg GS-9350 and those taking 100 mg ritonavir. The atazanavir concentration across the dosing interval (known as area under the curve) was equal with both boosting agents, and the maximum atazanavir concentration (known as Cmax) was also similar. Half-life, or how long the drug remains in the body, was comparable. Using the 100 mg dose of GS-9350, however, produced lower atazanavir levels.

"Nine participants discontinued the study early, five of them due to adverse events. Most side-effects were mild and no serious problems were reported, including liver toxicity or clinically relevant heart rhythm changes. However, three people taking GS-9350 stopped early due to skin rash, which resolved after the drug was discontinued."

Read more in Aidsmap, September 21, 2009.

September 20, 2009

Your guide to getting through this flu season unscathed

"The only thing experts can say for sure about this flu season is that it will be unlike any other, with multiple flu viruses circulating, one of which most people are defenseless against. "This year we are in uncharted territory," says Centers for Disease Control and Prevention director Thomas Frieden. "What will happen in the coming weeks and months will only become clear in the weeks and months ahead." Here is a handy guide to prepare for flu season by USA TODAY's Steve Sternberg, compiled from information provided by the CDC and other sources."

Read more in USA Today, September 20, 2009.

White House National HIV/AIDS Community Discussion to be Held in Washington D.C.

"On Monday, September 21st, the next National HIV/AIDS Community Discussion will be held in Washington, D.C. These Discussions, hosted by the White House Office of National AIDS Policy (ONAP), offer the public a chance to provide input as the White House works to fulfill the President’s pledge to develop a National HIV/AIDS Strategy (NHAS)."

RSVP at Office of National AIDS Policy, September 18, 2009.

September 18, 2009

Health care reform: News links in Kaiser Daily Health Report today:











Read more in Kaiser Daily Health Report, September 18, 2009.

Boosted protease inhibitor regimens with 3TC work despite M184V resistance

"People with HIV who have developed resistance to 3TC (lamivudine) can still achieve viral load suppression using boosted protease inhibitor regimens that include 3TC as part of the nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) "backbone", researchers reported this week at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco. ...

"Drug resistance generally increases the risk of treatment failure and disease progression, but the presence of the M184V mutation appears to decrease viral fitness by reducing its ability to replicate and increasing susceptibility to other NRTIs. This is demonstrated by the fact that viral load may increase by a small amount when people with this mutation stop taking 3TC, indicating that the drug had an antiviral effect despite resistance."

Read more in Aidsmap, September 18, 2009.

Maturation inhibitor bevirimat is well tolerated and effective in predicted responders

"The HIV maturation inhibitor bevirimat was well tolerated in a 32-person study presented this week at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco. While antiviral activity was not particularly impressive overall, a genotypic test can predict which patients are likely to respond well."

Read more in Aidsmap, September 18, 2009.

Countries pay widely varying prices for ARVs

"Many countries struggle to pay for antiretroviral (ARV) drugs for all those who need them, but a new study has found that some nations are paying up to three times more for the life-prolonging medicines than others with similar HIV prevalence and income levels.

"In 2007 Nigeria paid US$334 per patient per year for a combination of first-line ARVs that cost Congo only US$95. Both are low-income countries, but Nigeria has a higher HIV prevalence of 3.1 percent, compared to Congo's 1.2 percent.

"A working paper released last week by the AIDS2031 project, which draws on expertise from around the world to consider the most effective long-term responses to the HIV/AIDS epidemic, looks at why the prices of ARVs vary so widely from one country to another, and what can be done to improve affordability."

Read more in IRIN, September 9, 2009.

September 17, 2009

Possible Link to Alleged Heart Disease Risk With Abacavir

"People taking abacavir (found in Ziagen, Epzicom and Trizivir) had a higher risk for endothelial dysfunction—when the cells lining the blood vessels are less able to carry out their functions for processing blood flow, which can lead to heart disease—according to a study published in the September 24 issue of AIDS. Scientists have been looking for the cause of heart attack and heart disease risk associated with abacavir ever since studies first suggested a link."

Read more in POZ, September 17, 2009.

Nutritional formula linked to reduced CD4 cell loss in untreated people

"A complex nutritional formula may help slow CD4 cell decline and reduce immune activation in people with HIV who have not yet started antiretroviral therapy, according to an international study presented this week at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco. ...

"The NR100157 formula contains multiple ingredients individually shown to have beneficial effects on immune function: ...

"The study was stopped early with only 340 enrollees after a planned interim analysis showed a significant benefit in the NR100157 group and no safety concerns."

Read more in Aidsmap, September 17, 2009.

IL-7 may boost CD4 and CD8 T-cells, study shows

"Injections of the cytokine interleukin-7 (IL-7) led to "brisk" increases in naive and central memory T-cells and appeared to stimulate multiplication of precursor cells in the thymus, investigators with the small INSPIRE study reported this week at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco."

Read more in Aidsmap, September 17, 2009.

GSK's second integrase inhibitor looks potent and well-tolerated in early study

"The experimental integrase inhibitor S/GSK1265744, which is being developed as a backup to S/GSK1349572 (GSK-572), also demonstrated high potency and good tolerability in early studies, researchers reported this week at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco."

Read more in Aidsmap, September 17, 2009.

A Retrospective Analysis of AIDS-Associated Kaposi’s Sarcoma in Patients With Undetectable HIV Viral Loads and CD4 Counts Greater Than 300 cells/mm3

"Conclusions: In the highly active antiretroviral (HAART) era, a substantial proportion of patients with KS had undetectable HIV VLs and CD4 counts greater than the level typically associated with opportunistic diseases. They required systemic therapy to control their KS but were significantly less likely to die and demonstrated a trend toward better 15-year survival than patients having KS with lesser CD4 counts and detectable HIV VLs."

Read more in Journal of the International Association of Physicians in AIDS Care (JIAPAC), September 1, 2009.

September 16, 2009

The Role of HIV-Related Immune Depletion in Cancers

"Having a CD4 count less than 500 was a significant additive factor in the risk of developing a non-AIDS-related cancer, according to a study published in the October 1 issue of Clinical Infectious Disease. Both low CD4 counts and high viral loads were implicated in an increased risk for AIDS-related cancers."

Read more in POZ, September 16, 2009.

FDA Approves H1N1 Vaccine

"The U.S. Food and Drug Administration (FDA) has approved vaccines from four pharmaceutical companies for the H1N1 virus (swine flu), Reuters reports."

Read more in POZ, September 16, 2009.

September 15, 2009

Single-Dose PRO 140 Reduces HIV Levels for at least 10 Days

"A single intravenous (IV) dose of the HIV entry inhibitor PRO 140reduced virus by nearly 100-fold for up to 10 days in a small phase IIa study, according to a study presented at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco and reported by the National AIDS Treatment Advocacy Project (NATAP).

"PRO 140 is a monoclonal antibody. Monoclonal antibodies are artificially created antibodies that can attach to viruses, bacteria or even human cells. Pro 140 attaches to a CD4 cell receptor called CCR5, which HIV uses to enter and infect CD4 cells.

Read more in POZ, September 15, 2009.

Once-Daily Replacement Raltegravir as Good as Twice-Daily in Pilot Trial

"People who replaced a protease inhibitor (PI) with raltegravir did as well if they took standard twice-daily raltegravir or if they later switched to once-daily raltegravir in a 125-person study [1]. Clinicians at Carlos III Hospital in Madrid saw a trend toward improved quality of life in the once-daily group."

Read more in NATAP, September 15, 2009.

Note: This was not a randomized trial.

Virologic Response Differences Between African Americans and European Americans Initiating Highly Active Antiretroviral Therapy With Equal Access to..

"Conclusions: Despite similar durations of HIV infection and equal access to health care, AAs [African Americans] were significantly less likely to achieve viral suppression compared with EA [European Americans]."

Read more in JAIDS, September 11, 2009.

September 14, 2009

Herpes Zoster ... Don't Forget HIV

"HIV infection should always be considered in patients under 65 with herpes zoster. Awareness of herpes zoster in HIV may help to reduce the incidence of people presenting late with HIV infection..."

Read more in British Medical Journal, September 14, 2009.

Once-daily pill effective as multiple dosings for oral yeast infection in HIV/AIDS patients

"It's a tablet that you just stick on the gum and it releases an anti-fungal agent over the course of six to eight hours. Because the anti-fungal agent stays in the mouth, it provides the same relief as the oral medication but with few or no side effects." ...

The study compared the effectiveness and safety of taking 50 milligrams of a miconazole mucoadhesive buccal tablet once-daily to 10 milligrams of clotrimazole, a common anti-fungal pill five times a day. Of the 578 patients enrolled in the randomized study, 291 received the tablet and 287 received the clotrimazole pill."

Read more in EurekAlert!, September 14, 2009.

Tobacco and Alcohol Could Lower Efavirenz Blood Levels

"The study’s authors found that people who smoked tobacco and who were rapid metabolizers had significantly lower blood levels of efavirenz than rapid metabolizers who did not smoke, as well as slower metabolizers. The same was true for rapid metabolizers who drank alcohol. There was also a trend for such individuals to have lower CD4 counts and higher viral loads than nonsmokers and people who did not drink alcohol."

Read more in POZ, September 14, 2009.

Master gene that switches on disease-fighting cells identified by scientists

"The master gene that causes blood stem cells to turn into disease-fighting 'Natural Killer' (NK) immune cells has been identified by scientists, in a study published in Nature Immunology today. The discovery could one day help scientists boost the body's production of these frontline tumour-killing cells, creating new ways to treat cancer.

"The researchers have 'knocked out' the gene in question, known as E4bp4, in a mouse model, creating the world's first animal model entirely lacking NK cells, but with all other blood cells and immune cells intact. This breakthrough model should help solve the mystery of the role that Natural Killer cells play in autoimmune diseases, such as diabetes and multiple sclerosis. Some scientists think that these diseases are caused by malfunctioning NK cells that turn on the body and attack healthy cells, causing disease instead of fighting it. Clarifying NK cells' role could lead to new ways of treating these conditions."

Read more in EurekAlert!, September 13, 2009.

September 11, 2009

Plasma Cytokine Levels in Tanzanian HIV-1-Infected Adults and the Effect of Antiretroviral Treatment

"Conclusions: Our findings support the role of HIV viral replication as the most important promoter of immune activation and prove the importance of ART in reducing immune activation and viral replication even in sub-Saharan Africa where patients are exposed to an abundance of other infectious agents."

Read more in JAIDS, September 10, 2009.

Ghostwriting Is Called Rife in Medical Journals

"Six of the top medical journals published a significant number of articles in 2008 that were written by ghostwriters financed by drug companies, according to a study released Thursday by editors of The Journal of the American Medical Association. ...

In the scientific literature, ghostwriting usually refers to medical writers, often sponsored by a drug or medical device company, who make major research or writing contributions to articles published under the names of academic authors.

The concern, the researchers said, is that the work of industry-sponsored writers has the potential to introduce bias, affecting treatment decisions by doctors and, ultimately, patient care.

According to the study, responding authors reported a 10.9 percent rate of ghostwriting in The New England Journal of Medicine, the highest rate among the journals.

Editors of the Boston-based journal said Thursday that they were “puzzled” and “skeptical” of the findings.

The study also reported a ghostwriting rate of 7.9 percent in JAMA, 7.6 percent in The Lancet, 7.6 percent in PLoS Medicine, 4.9 percent in The Annals of Internal Medicine, and 2 percent in Nature Medicine. ...

“It was very compelling, and I find it quite shocking, to be honest,” Ginny Barbour, chief editor of PLoS Medicine, the journal of the Public Library of Science, said after the meeting. “We are a journal that has very tough policies, very explicit policies on ghostwriting and contributorship, and I feel that we’ve basically been lied to by authors."

Read more in New York Times, September10 , 2009.

Comment: It would be a mistake to go to far in reacting to this, and banning any help to researchers from writers. Many doctors and scientists are not also writers, and they have other things to do. Struggling with the writing or with finding time to do it will often delay publication of their results, sometimes by years. This process will cumulatively delay the whole multi-billion-dollar research enterprise, and reduce the quality of patients' care. Yet this serious mistake could easily be made, since people do not see what could have been, and therefore do not see the damage.

Our first thoughts about standards:

1. The process, including any role by pharmaceutical or device companies, must be properly disclosed;

2. The authors listed on the paper must know what's going on and be in control of the writing -- or exceptions must be disclosed (for example, if a leader of the study who has died should be listed among the authors);

3. Ideally, the original research budget should include a small percentage for publication (both for help from medical writers, and also to subsidize the publication process, so the paper will be available to all, not only to subscribers to some journal). Then industry money will not be needed for the writing or publication.

September 10, 2009

AIDS advocates: Health care reform matters

"AIDS Foundation of Chicago (AFC) has been working hard to educate its members and supporters about the importance of health care reform in relation to an epidemic that impacts over 1 million people in the U.S. The organization believes that health care reform could accelerate efforts in the fight against AIDS and get people--namely low-income individuals, those living with chronic medical condition and people with co-occurring medical conditions--the care that the current health care system is failing to provide them."

Read more in; Chicago Free Press, September 10, 2009.

HIV Screening Tests Proposed to Be Added to Medicare’s List of Covered Preventive Services

"The Department of Health and Human Services (HHS) today announced a new proposal that would cover Human Immunodeficiency Virus (HIV) infection screening for Medicare beneficiaries who are at increased risk for the infection, including women who are pregnant and Medicare beneficiaries of any age who voluntarily request the service."

Read more in, September 9 , 2009.

Effect of Antiretroviral Therapy on Risk of Sexual Transmission of HIV Infection and Superinfection

"CDC Guidance on ART and its Effect on Sexual Transmission of HIV

"* Use of ART may be a promising tool for slowing the transmission of HIV within populations if prevention benefits are not offset by increases in risk behavior. Success of such a program will depend critically upon 1) widespread testing and early identification of infected persons, 2) ongoing counseling to support maintenance of safer sexual behaviors, 3) adequate clinical follow-up to monitor for adverse effects of ART, and 4) geographic and financial accessibility of treatment for affected persons.

* In accordance with U.S. Department of Health and Human Services guidelines, clinicians may consider the potential benefit of decreased risk of HIV transmission to others in deciding whether to initiate ART in infected patients (even at CD4 counts of >350 cells/μL).

* The risk of sexual HIV transmission is substantially reduced for individual couples in which the infected partner is on effective ART and has achieved undetectable plasma HIV viral load, but is not completely eliminated. Sexual transmission of HIV may still occur when the infected partner is on effective ART. In February 2008, CDC issued a statement reiterating its previous recommendations that people living with HIV who are sexually active use condoms consistently and correctly with all sexual partners.

* For couples in which both partners are infected, the potential implications of superinfection are unclear. Use of condoms is recommended in this setting as well."

Read more in U.S. Centers for Disease Control and Prevention, August 2009.

AIDS Treatment Activist Coalition: Pharmaceutical Report Card

"With people in the U.S. with AIDS expected to live close to a normal life span, the majority of pharmaceutical companies are not developing innovative new long-term treatment options that offer improved efficacy, safety and tolerability.

"The ATAC Pharmaceutical Company HIV/AIDS Report Card evaluates the nine largest HIV/AIDS drug-producing pharmaceutical companies in five categories: drug development portfolio and plans, access to drugs, pricing, community relations and marketing practices. The average final grade was a C-. See below for how ATAC ranked each of the companies on the five categories, and view the additional resources for more information."

Read more in, September 10, 2009.

September 9, 2009

Potent inhibition of HIV-1 by TRIM5-cyclophilin fusion proteins engineered from human components

"Extensive attempts to elicit HIV-1 resistance to hT5Cyp were unsuccessful. ...

"Upon challenge with HIV-1, these mice showed decreased viremia and productive infection in lymphoid organs and preserved numbers of human CD4+ T cells. We conclude that hT5Cyp is an extraordinarily robust inhibitor of HIV-1 replication and a promising anti–HIV-1 gene therapy candidate."

Read more in Journal of Clinical Investigation, September 8, 2009.

Special Notice Regarding The Kaiser Daily U.S. HIV/AIDS Report

"As our regular readers know, we have recently made changes to our daily reports on health policy and HIV/AIDS. Our health policy report has found a new home on Kaiser Health News where it has been expanded and improved upon and is now being regularly updated with multiple editions and news alerts published throughout the day. Our new Global Health Policy Report anchors our recently launched Global Health Gateway on, where it provides daily updates on global health issues, including HIV/AIDS. As of today, we will no longer be producing a separate domestic HIV/AIDS report. Instead, we will provide coverage of domestic HIV/AIDS policy issues through our Daily Health Policy Report on Kaiser Health News. To subscribe to Kaiser Health News' Daily Health Policy Report and/or the Kaiser Daily Global Health Policy Report, please login to your profile – If you'd like to contact us, please email"

Read more in Kaiser Daily HIV/AIDS Report, September 3, 2009.

CARE fears health care reform could harm Houston’s HIV/ AIDS community

"The Ryan White CARE Act, enacted in 1990 as the largest federally funded program for people living with HIV and AIDS, ends on September 30. If Congress doesn’t reauthorize it, patients in cities across the country may go without access to their medications, doctors and case management. ...

"The Ryan White CARE Act has enough money to continue most operations through March. Still, doctors and patients are concerned. Most said they weren’t sure where they’d turn for care if the money runs out."

Read more in, August 31 , 2009.

Alert: USPTO-Pfizer pushing for TRIPS Plus measures in India

"The United States Patent and Trademark Office, in collaboration with the Pfizer Limited, is organizing a meeting in India for NGO's and the media titled “Intellectual Property and Innovation in the Pharmaceutical Industry” from 2:30-5:30 p.m. at the Taj President Hotel in Mumbai on September 9, 2009. The meeting is being organized with the assistance of the US Embassy in India.

On the agenda are controversial TRIPS Plus measures such as Data Exclusivity and Patent Linkage which are designed to delay the registration of generic medicines by several years, besides seriously interfering with the implementation of public health safeguards such as compulsory licensing. ...

It is important to note that the most recent report of the UN Special Rapportuer on the RIght to Health has highlighted concerns with the adverse impact of such TRIPS-plus measures on access to treatment and has recommended that developing countries not adopt these. See [note: link to Oxfam in the original].

The WHO has also cautioned developing and least developed countries against such provisions. See ...

The fact is that for incremental innovation by Indian companies the market and not patents is the driving force. This is borne out by the development of the three –in- one AIDS pill – one of the most revolutionary innovations in AIDS treatment for the developing world. That the individual compounds were not patented in India made combining them possible."

Read more in Commons-Law, September 9, 2009.

September 8, 2009

H1N1 Flu and HIV Webinar Highlights

Nearly 850 participants joined online and/or via conference call last week to hear from leading experts and local grantees about H1N1 Preparedness and HIV. ...

The webinar shared information about the basic facts about H1N1 ["swine flu"], how it relates to HIV, and what we can do to support H1N1 preparedness in our communities. We’ve provided this information in multiple formats, so you can listen to the audio recording, read the transcript, and visit the many resources and websites mentioned on the call.


Read more in, September 8, 2009.

Mouth Full of Problems: A Crisis in HIV Dental Care

"People with HIV are simultaneously more likely than their HIV-negative counterparts to have more frequent and more serious oral health issues, while being less likely to have the funds and insurance to cover necessary procedures. The public support that is available for providing clinical oral health care to people with HIV, Reznick says, is drying up as various states confront catastrophic budget crises. “We’re just not seeing enough [funding] increases to take care of the people we already serve,” Reznick laments, 'So it’s an overwhelming need and no resources to pay for it.'"

Read more in POZ, September 8, 2009.

Association of HIV Infection, Demographic and Cardiovascular Risk Factors With All-Cause Mortality in the Recent HAART Era

"Conclusions: HIV infection was associated with a 3-fold mortality risk compared with controls after adjustment for demographic and CVD risk factors. In addition to low baseline CD4 count, older age and current smoking were strong and independent predictors of mortality in a US cohort of HIV-infected participants in clinical care."

Read more in JAIDS, September 8, 2009.

Delays in switching treatment: NRTI resistance can be slower to emerge than expected

"Resistance mutations associated with AZT or d4T treatment accumulate at a relatively slow rate in people who remain on failing antiretroviral treatment for long periods, an analysis of the EuroSIDA cohort has shown.

"The study, published in the September 1st edition of the Journal of Infectious Diseases, show that once initial resistance to AZT or d4T develops (thymidine analogue resistance), the acquisition of further resistance mutations tends to be a slow process, with an average of one thymidine analogue mutation developing during 4.3 years of follow-up."

Read more in Aidsmap, September 8, 2009.

Safeguarding the future of HIV/AIDS initiatives

"Despite all the progress and the messages of success and hope, the past 9 years are also marked by missed opportunities, unfulfilled promises, and worries for the future. By the end of 2005, 1·3 million people were receiving antiretrovirals, a far cry from the 3 million aim of WHO's 3 by 5 programme. And as 2010, the deadline for Universal Access, approaches, this effort looks set to fall short with an estimated 3 million receiving treatment but 7 million still wanting. ...

"The achievements so far have been dependent on unprecedented growth in donations for health. Spending on HIV/AIDS programmes has increased nearly 40 times in the past decade, with US$10 billion being spent worldwide in 2007. Annual requests submitted to the Global Fund leapt from between $500 million and $1 billion up to 2007 to $2·75 billion in 2008, and even larger requests are expected in 2009 for 2010. But in the face of the global economic downturn, the donations to the Global Fund might be left wanting to the tune of $3 billion. To continue to expand prevention and treatment for HIV/AIDS, as we must, the global community will need to find innovative solutions that do more with less, are more efficient, build on past advances and experience, and marshall the grass-roots resources of the communities most affected."

Read more in The Lancet Infectious Diseases, September 2009 (free Lancet registration required).

Tool to Offer Fast Help for H.I.V. Exposure

"Time is of the essence in treating someone who may have been exposed to the AIDS virus. Starting Wednesday, emergency room doctors throughout New York State will be just a computer click away from concise guidelines for starting prompt drug treatment that can reduce the risk of becoming infected.

"The guidelines come in the form of a computer application, or widget, developed by a team of doctors from St. Vincent’s Hospital in Manhattan with financing from the state’s AIDS Institute. They are to be given to more than 200 emergency departments this week and distributed more widely over time."

Read more in New York Times, September 8, 2009.

Comment: We don't know of any online access to the tool at this time, although the basic information is available.

Antibodies found that prevent HIV from causing severe AIDS

"Scientists were able to isolate two antibodies responsible for resistance to the disease in an African patient. The discovery could be key to the development of a vaccine. ...

"This is opening up a whole new area of science," said Dr. Seth F. Berkley, president and chief executive of the International AIDS Vaccine Initiative, which funded and coordinated the research."

Read more in Los Angeles Times, September 4, 2009.

September 5, 2009

Awareness: Clinical Trial Rule Is Widely Ignored

"Many researchers are ignoring a 2005 requirement that they register proposed clinical trials in a government database as a condition for publishing their results in medical journals. And the journals are publishing the papers anyway, a new study reveals."

Read more in New York Times, September 4, 2009.

September 4, 2009

HPV Vaccine for Boys: Public Comments Welcome

"Should the federal government pay for the Gardasil HPV vaccine for boys and young men covered by government-funded health programs? The Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC) is holding a public hearing October 21 and 22 in Atlanta to discuss this important question and would like to hear from concerned community members, both in person and in writing. ...

FDA approval is more scientific than political. The same is not true, however, when it comes to government decisions to pay for certain components of medical care. When ACIP recommended that government funds be used to vaccinate girls and young women, conservative activists objected strongly, claiming that the vaccine promoted promiscuity. ...

The mobilization of HIV and gay health activists is due, in part, to the fact that men who have sex with men have the highest rates of HPV infection and are likely to need the vaccine the most. Conservative groups are also expected to advocate against the government recommending payment for the vaccine, suggesting that it will promote both promiscuity and homosexuality.

Information about the ACIP hearing, which is open to the public, can be found on the CDC website. Written comments can also be submitted to the ACIP by e-mail at"

Read more in POZ, September 4, 2009.

Also note two articles published online today in JAIDS:

* Anal Sexually Transmitted Infections and Risk of HIV Infection in Homosexual Men; and

* Sexual Violence and HIV Risk Behaviors Among a Nationally Representative Sample of Heterosexual American Women: The Importance of Sexual Coercion.

Comment: Women usually get HPV from men, so vaccinating boys should stop some of these transmissions as well.

Early treatment and interruption makes no difference to disease progression, study finds

"The largest study yet done on the whether immediate antiretroviral therapy (ART) may benefit people with recent HIV infection has found that immediate treatment followed by treatment interruption produced no reduction in the subsequent viral load ‘set point’ of people starting ART in early infection, and no reduction in the expected set point of patients starting treatment in acute infection, before seroconversion.

"The ACTG 371 study did find that in subjects who interrupted their treatment after a year of treatment, a large minority (40%) of patients, and nearly half (48%) of those with a baseline viral load of under 100,000 copies/ml, still had a viral load less than 5,000 six months after ceasing to take their initial treatment regimen.

"However the researchers were unable to say if their strategy produced improved immune control and clinical benefit compared to similar patients who do not start ART. They conclude: “Early ART followed by treatment interruption does not produce the profound alterations in disease course that were originally suggested by uncontrolled studies."

Read more in Aidsmap, September 4, 2009.

Comment: It had been hoped that very early treatment could permanently reduce the viral-load setpoint. That did not happen in this study.

A New Simpler Gene Therapy for HIV

"Anderson’s group has developed a hybrid gene delivery device that doesn’t require taking cells out of the body. Instead, they have taken a naturally occurring genetic splicing molecule, called interfering RNA, packaged it inside a hollowed-out Sindbis virus and attached a monoclonal antibody to the surface so that these viral delivery devices (called a vector) interact only with the immune cells the team wants them to genetically alter.

"Thus far, the team members have conducted two successful sets of experiments. In the first, they proved that their gene therapy can deliver the genetic payload to CD4 cells and cause them to stop making CCR5. They then tried injecting the gene therapy into specially bred mice that have human immune cells. Two weeks after the injections, the human immune cells in the mice no longer had CCR5 receptors, and the cells were highly resistant to HIV infection."

Read more in POZ, September 3, 2009.

Life Expectancy After HIV Diagnosis Based on National HIV Surveillance Data From 25 States, United States

"Introduction: We estimate life expectancy and average years of life lost (AYLL) after an HIV diagnosis using population-based surveillance data from 25 states that have had name-based HIV surveillance since 1996. ...

"Results: Average life expectancy after HIV diagnosis increased from 10.5 to 22.5 years from 1996 to 2005. Life expectancy (years) was better for females than for males but improved less for females (females: 12.6-23.6 and males: 9.9-22.0). In 2005, life expectancy for black males was shortest, followed by Hispanic males and then white males. AYLL for cases diagnosed in 2005 was 21.1 years (males: 19.1 and females: 22.7) compared with 32.9 years in 1996.

"Conclusions: Disparity in life expectancy for females and both black and Hispanic males, compared with males and white males, respectively, persists and should be addressed."

Read a little more in JAIDS, September 2, 2009.

d4T dose reduction does not result in poorer treatment outcomes in South African patients

"The use of a reduced dose of d4T (stavudine), as recommended by the World Health Organization, did not reduce the likelihood of viral load suppression after six months in a large cohort of South African patients, researchers from the Aurum Institute of Health Research report in the August 24th edition of AIDS.

"The use of d4T in first-line treatment has been phased out in the developed world due to toxicity, but in developing countries fixed-dose combinations containing d4T are still widely used due to the drug’s low cost compared to tenofovir or abacavir. In South Africa d4T remains a staple component of first-line treatment in the public health system, despite widespread calls for its use to be phased out."

Read more in Aidsmap, September 4, 2009.

September 3, 2009

Frequency of Long-Term Nonprogressors in HIV-1 Seroconverters From Rakai Uganda

"Objective: Studies on long-term nonprogressors (LTNP) have been conducted in the USA and Europe. This study examined the frequency of LTNPs and HIV controllers among 637 HIV-1 seroconverters in rural Uganda. ...

Conclusions: The frequency of LTNPs appears to be relatively high in Uganda and it may be important to take this into account when designing studies of viral pathogenesis and performing HIV vaccine trials in sub-Saharan Africa. (C) 2009 Lippincott Williams & Wilkins, Inc."

Read more in JAIDS, September 2, 2009.

September 2, 2009

Cheap viral load test is as reliable as standard: Botswana places large order

"A new viral load test designed for resource-poor settings is as reliable as a standard assay, according to a report in the Journal of Acquired Immunodeficiency Syndromes. The test, the ExaVir Load assay designed by the Swedish firm Cavidi, produces reliable results with samples as small as 0.25 millilitres, implying that it could be used for paediatric use. However it only produced consistent results for people with viral loads over 1000, the researchers note.

"Cavidi has been producing low-cost viral load assays since 2002, and the researchers tested versions 2 and 3 of the ExaVir Load assay. The researchers found that the average cost of the assay including all equipment was one-fifth of the test they compared it with, the Roche COBAS Amplicor assay. ...

ExaVir is a purely quantitative assay that measures the amount of reverse transcription and therefore cannot detect what kind of viral RNA is being produced. Because of this it cannot detect resistance mutations or HIV subtype – but should be able to detect novel subtypes which may be missed by RNA assays."

Read more in Aidsmap, September 1, 2009.

India rejects patents on two HIV drugs

"India’s patent office yesterday rejected patent applications for tenofovir and darunavir, leaving the way open for any Indian company to manufacture the drugs, and to export tenofovir to Brazil, where the government has also rejected the patent."

Read more in Aidsmap, September 2, 2009.

Researchers identify promising agents for HIV cure research

"Researchers from the University of North Carolina and Merck are identifying promising new leads in the search for agents that may be able to purge HIV from resting CD4 cells, a key requirement for any prospect of a cure for HIV infection.

"The findings, reported by David Margolis and Nancie Archin in the September 15th edition of AIDS, show that a group of compounds called class 1 HDAC inhibitors show the most promise in activating previously latent HIV within resting CD4 cells. The findings may also explain why previous studies using another HDAC inhibitor, the antiepileptic valproic acid, showed only weak effect."

Read more in Aidsmap, September 2, 2009.