Positively Aware's HIV Drug Guide is a "Must Have"

viaSan Diego Gay and Lesbian News.com

The Positively Aware 16th Annual HIV Drug Guide, widely recognized throughout the country as the “must-have” reference tool for HIV service providers and consumers alike, is now available.

There are now 30 FDA-approved HIV therapies to choose from, and finding the most effective and appropriate medication regimen is vital to success in treating HIV. The guide provides important information to individuals living with HIV as well as their caregivers on how best to manage their treatment.

This 80-page issue of Positively Aware devotes a full page to each approved HIV medication, plus four experimental medications, three of which are slated for approval later this year: the integrase inhibitors elvitegravir and dolutegravir (the latter now available through expanded access), the new upcoming single-tablet regimen known as the “Quad,” and the pharmaco-enhancer boosting agent cobicistat.

The pullout drug chart, sponsored by Walgreens, includes dosing information, as well as food and liquid requirements for the drugs, along with a photo to help easily identify each medication. Readers will also find detailed information on side effects, drug interactions, and current trends in HIV care and treatment.
This year’s guide also has an updated and expanded article on HIV drug co-pay and patient assistance programs being offered by pharmaceutical companies, including an easy to read chart, plus information on AIDS Drug Assistance Programs, Medicare, and Medicaid.

“It’s so critical that people know that there is help available when accessing and paying for treatment,” Positively Aware Editor Jeff Berry said. “There is no reason why anyone should be denied access to lifesaving medication based solely on an inability to pay for their drugs or co-pays, or because they cannot afford health insurance.”

One of the most popular features of the guide is the viewpoint given on each medication from a well-respected physician and an activist. Contributors to this year’s Drug Guide include Dr. Joel Gallant, professor of medicine and epidemiology at the Johns Hopkins University School of Medicine’s Division of Infectious Diseases, and associate director of the Johns Hopkins AIDS Service; activist Joey Wynn, director of public policy at Broward House in Fort Lauderdale, Florida; Renata Smith, PharmD, clinical assistant professor in HIV/infectious diseases at the University of Illinois at Chicago; and Associate Editor Enid Vázquez.

“Positively Aware’s Annual HIV Drug Guide is a great source for cutting edge treatment information, not only for those of us who prescribe these drugs, but for our HIV-positive patients as well,” Gallant said. “I was happy to be asked again to contribute to this year's edition — it’s always an enjoyable project.”

Positively Aware is an internationally known and respected magazine devoted to HIV treatment and health. It has a circulation of over 100,000, and is published bi-monthly by Test Positive Aware Network (TPAN). Founded in 1987, TPAN is Chicago’s oldest peer-led AIDS service organization and specializes in treatment information, support services, and prevention.

To order copies of the magazine, call (773) 989-9400 or distribution@tpan.com. For more information about TPAN and Positively Aware magazine visit tpan.com and positivelyaware.com.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

British HIV Association: Revised Guidelines for Antiretroviral Therapy

viaHivandHepatitis.com, by Liz Highleyman 

The British HIV Association (BHIVA) has issued revised guidelines for antiretroviral therapy (ART) for adults and for pregnant women and prevention of mother-to-child HIV prevention. Comments are currently being accepted.

ART for Adults

 

The draft for adults includes guidance on starting ART in treatment-naive patients, supporting people on treatment, and managing people who experience virological failure. The guidelines also cover special considerations for specific patient populations.

The guidelines are available on the BHIVA website, which features an online form for comments, and published in the January 2012 issue of HIV Medicine. The deadline for feedback is March 5, 2012.

As described in an overview by Aidsmap, the revised guidelines recommend that clinicians should discuss with all HIV positive patients the growing evidence that effective ART reduces the likelihood of HIV transmission to sexual partners. However, evidence to date -- for example, recent findings from study HPTN 052 showing a 96% risk reduction -- mainly concerns heterosexual couples having vaginal sex.

Patients should be informed of the prevention benefits of ART even if they do not yet need treatment for their own health because their CD4 T-cell count has not fallen below 350 cells/mm^3.

Unlike the latest U.S. guidelines -- which raised the treatment initiation level to 500 cells/mm^3 -- BHIVA kept the 350 cells/mm3 threshold for most patients, though people with certain coinfections and other risk factors (e.g., hepatitis B or C, HIV-related kidney disease or neurocognitive impairment) may benefit from starting sooner.

BHIVA came down in favor of tenofovir/emtricitabine (the drugs in the Truvada combination pill) as the favored dual nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) component of ART. U.S. guidelines also deem tenofovir/emtricitabine as the "preferred" NRTI combo, although the new European AIDS Clinical Society (EACS) guidelines rank tenofovir/emtricitabine and abacavir/lamivudine (the drugs in Epzicom) as equals.

BHIVA and the U.S. panel both demoted abacavir due to concerns about lower effectiveness for people with high viral load and elevated cardiovascular risk; tenofovir, however, has been linked to kidney impairment. All guidelines authorities agree that individual risk factors should be taken into account when selecting antiretroviral drugs.

BHIVA lists drugs in 3 classes as preferred third agents: the NNRTI efavirenz (Sustiva), the boosted protease inhibitors atazanavir (Reyataz) or darunavir (Prezista), and the integrase inhibitor raltegravir (Isentress).

Read the Rest.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Poor adherence usually cause of second-line treatment failure in resource-poor settings

via Aidsmap, by Carole Leach-Lemens

Poor adherence rather than drug resistance appears more likely to be the cause of virological failure among patients on second-line ART in resource-poor settings, according to a systematic review and meta-analysis published in the advance online edition of AIDS.

The cumulative pooled proportion of the 2035 adults comprising the 19 studies from eight countries in sub-Saharan Africa and Asia failing virologically was 21.8%, 23.1%, 26.7% and 38.0% at six, 12, 24 and 36 months, respectively.

The authors note caution should be taken when reviewing these estimates as there were considerable differences between the studies as well as substantial statistical differences.

While most of the studies did not provide enough information to be able to distinguish conclusively between poor adherence and drug resistance as reasons for virological failure, in those that did poor adherence was the primary cause.

Nonetheless these findings highlight the limited options available after second line in resource-poor settings, notably where drug resistance is the cause of virological failure.

The researchers also stress the importance of improved access to greater virological monitoring as well as more intensive adherence counselling before resistance mutations develop.

The scale-up of ART in resource-poor settings has had a considerable effect on reducing death and disease. Standardised regimens notably simple, affordable fixed-dose combination therapies have facilitated adherence with rates comparable to those in resource-rich settings.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Fenway Health Report: The Implementation of PrEP in the Fight Against HIV

viaFenway Health

Pre-exposure chemoprophylaxis (PrEP)—taking antiretroviral medications to prevent HIV transmission—could be a “game changer” for HIV prevention. PrEP has demonstrated partial efficacy with men who have sex with men (MSM), transgender women, and heterosexuals in several recent studies. Recent modeling of PrEP implementation coupled with scaled up treatment predicts that PrEP could significantly reduce HIV incidence and prevalence. And if PrEP is accompanied by sustained care, behavioral interventions, and safety monitoring, PrEP need not lead to increased sexual risk behavior or drug resistance.

The latest Policy Focus from The Fenway Insitute summarizes the state of PrEP and microbicides research as of January 2012, looks at willingness to use PrEP among various populations, addresses concerns about PrEP that could present obstacles to implementation, offers strategies for effective implementation, and examines policy issues related to cost and how to make PrEP accessible to those most vulnerable to HIV.

The Fenway Institute’s analysis found that the most effective prevention interventions will be those that combine behavioral interventions, structural interventions, and emerging biomedical technologies, such as PrEP and microbicides. The analysis concludes with recommendations for implementation of PrEP, including:

■If the U.S. Food and Drug Administration (FDA), which is considering approving FTC-TDF for use as PrEP, feels that research on PrEP’s efficacy among heterosexuals is inconclusive, it should consider approving PrEP for MSM now separately and consider heterosexuals, IDUs and other populations in the near future as the science advances;

■The World Health Organization (WHO) should issue guidance on PrEP that takes into account the promising results of the iPrEx study, Partners PrEP, and the Botswana CDC study;

■Following the release of the Bangkok injection drug user (IDU) trial results, if appropriate the U.S. Centers for Disease Control and Prevention, the U.S. Public Health Service, and the WHO should issue guidance for PrEP with IDUs.;

■States should provide access to PrEP as a critical prevention service and prescription medication under the Essential Health Benefits provision of the Affordable Care Act;

■State Medicaid programs should also cover PrEP as a cost-saving measure that will improve public health and ultimately save money in health care costs;

■Provision of PrEP to MSM and transgender women should occur in a broader context of ensuring clinically competent health care to gay, lesbian, bisexual and transgender people.

Read the Full Report.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

UNAIDS Prevention Advocate Michel Sidibé's Approach to the Fight Against AIDS

viaNew York Times, by Donald G. McNeil Jr.

Shortly after Michel Sidibé became executive director of the United Nations’ AIDS prevention agency, a court in Senegal sentenced nine gay men, all AIDS educators, to eight years in prison for “unnatural acts.” In one of his first moves as the new chief of U.N.AIDS, Mr. Sidibe flew to Senegal to ask its aging president, Abdoulaye Wade, to pardon the men.
Mr. Sidibé, the son of a Muslim politician from Mali and a white French Catholic, asked the president — who is married to a white Frenchwoman — if he had ever suffered discrimination.
“Oh, Sidibé, you have no idea,” came the reply. “And for not marrying a Muslim.”

“Then, Uncle,” Mr. Sidibé said, using the African way to politely address an older man, “why do you accept that men here are put in jail for eight years just for being gay?”

Mr. Wade thought about it and promised to call his justice minister. Shortly afterward, the charges were dropped.

Asked if his predecessor — Dr. Peter Piot, a Belgian and one of the discoverers of the Ebola virus — could have gotten the same results, Mr. Sidibé said, “Without doubt, it would have been more difficult. It would be very automatically perceived as ‘the white people moralizing to us again.’ Since I’m African, I can raise it in a way that is less confrontational.”

Asked about that, Dr. Piot laughed and agreed, saying he sometimes thought his African missions, like those of the U2 singer Bono, “felt like a junior Tanzanian economist and Hugh Masekela coming to Washington to scold Congress for its budget deficit” — with Congress having to grin and bear it because it needed Tanzania’s cash.
Mr. Sidibé, 59, is a former relief worker, rather than a physician, and, along with English and French, he speaks West African Mandingo, the Tamashek of the Tuaregs and other languages.

With a combination of bonhomie and persistence, he has delivered difficult messages to African presidents very persuasively in his three years in office: Convince your men to get circumcised. Tell your teenage girls not to sleep with older men for money. Shelve your squeamishness and talk about condoms. Help prostitutes instead of jailing them. Ask your preachers to stop railing against homosexuals and order your police forces to stop beating them. Let Western scientists test new drugs and vaccines, despite the inevitable rumors that Africans are being used as guinea pigs.

“You can’t say ‘no’ to Michel,” said Dr. Piot, who hired him away from Unicef. “I was at a conference in Ethiopia in December, and for the first time, I felt I was hearing ‘ownership’ of AIDS by African countries. They weren’t talking so much about the donors, but about it as their own problem. I think he had a lot to do with that.”

Thanks, in part, to Mr. Sidibé’s intensive lobbying, South Africa and China are rapidly revising their approaches to the epidemic, and he hopes Russia and India soon will too. And the notoriously conservative African Union has created a committee to help populations it previously ignored: homosexuals, prostitutes and drug abusers.

Mr. Sidibé is from so deep in Africa that his professional career actually began in Timbuktu, helping Tuareg nomads. (His grandfather, he said, was a Fulani nomad in the same desert.)
He has the African shtick down. He calls anyone younger than him “my brother” or “my sister.” He seems to remember, and hug, everyone he has met before, from drivers to senators to journalists. He regales guests at cocktail parties with long parables about chameleons that he learned as a teenager in circumcision school (a bonding ritual that many African men remember with a mix of fondness and terror — a cross between boot camp and a bar mitzvah, but ending with a collective bris, sometimes done with a spear blade.)

Read the Rest.

 

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

World Health Organization Latest Statement on the Link Between Hormonal Contraceptives and HIV

via Plus News

Four months after a study suggested women on hormonal contraception may be at an increased HIV risk, the World Health Organization (WHO) has reaffirmed the birth control method's safety, but strongly recommends that women on progesterone-only injections, like Depo-Provera, also use condoms to prevent HIV infection.

In October 2011 the British medical journal, The Lancet, published the findings of a study showing that women who relied on hormonal shots to prevent pregnancy doubled their HIV risk. They also found that women on this type of birth control and living with HIV doubled the chances that they could transmit HIV to their partners.

Although the women in the study did not identify their birth control methods, most were probably using the progesterone-only, depot medroxprogeterone acetate shot. More commonly known by the brand name, Depo-Provera, this drug is the backbone of most African family-planning programmes.

The study prompted WHO meetings in late January and February 2012, during which experts and civil society representatives reviewed research on hormonal contraception and HIV risk. However, because no clinical trial has ever looked specifically at this potential link, including the October 2011 study, evidence remains largely inconclusive.

In the absence of a proven link between hormonal contraception and HIV infection, the WHO issued a statement on 16 February standing by current guidelines that allow women living with or at high risk of HIV to use hormonal contraception. However, the body has recommended that current guidelines be amended to advise women using progesterone-only injections be strongly advised to use condoms concurrently to prevent HIV infection. 

The need for future research into the matter was discussed at side meetings, said Dr Jared Baeten of the US University of Washington, one of the authors of the 2011 study. Although no decision was taken, he added that conducting such a trial would pose serious challenges. About 12 million women in sub-Saharan Africa are estimated to be on injectable contraception.

Read the Rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

HIV Treatment's Effect on Fractures

viaAidsmap, by Michael Carter

Treatment with antiretroviral drugs reduces the risk of low-impact fractures, according to a case-controlled study published in the on-line edition of AIDS. Investigators compared fracture incidence between patients taking HIV therapy and non-treated individuals.

Despite the overall beneficial effect of treatment, the investigators found a complex relationship between drug class and duration of therapy and fracture risk.

Although there are concerns that tenofovir (Viread, also in the combination pills Truvada and Atripla) causes reductions in bone mineral density, the investigators found no robust evidence that the drug was associated with an increased risk of fracture.

“Our study identified an overall reduced risk for fracture in persons treated versus not treated with antiretroviral drugs for HIV infection,” write the authors.

With the right treatment and care, the prognosis of many HIV-positive patients is excellent. However, there is an increased prevalence of low bone mineral density in patients with HIV. The exact causes are uncertain, but may include HIV infection itself, the ageing of the HIV-infected population, and the side-effects of antiretroviral therapy. Nor are the clinical consequences clear. Some studies have shown that patients taking HIV treatment have an increased risk of fragility fractures, but such findings have been contradicted by other research.

Because of this continuing uncertainty, investigators in the US designed a case-controlled study involving patients who received HIV care between 1997 and 2008. The incidence of  low impact fragility fractures was compared between patients who received HIV therapy lasting at least twelve months and individuals with no history of antiretroviral treatment. The relationship between specific classes of antiretrovirals, individual drugs and duration of therapy and fracture risk was also examined. Finally, because of tenofovir’s association with low bone mineral density, the investigators compared fracture incidence between patients taking this drug and that seen among individuals taking abacavir (Ziagen, also in the combination pills Kivexa and Trizivir).

Read the Rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Tenofovir linked with risk of kidney damage

via UCSF, by Steve Tokar

Tenofovir, one of the most effective and commonly prescribed antiretroviral medications for HIV/AIDS, is associated with a significant risk of kidney damage and chronic kidney disease that increases over time, according to a study of more than 10,000 patients led by researchers at the San Francisco VA Medical Center (SFVAMC) and the University of California, San Francisco (UCSF).

The researchers call for increased screening for kidney damage in patients taking the drug, especially those with other risk factors for kidney disease.

In their analysis of comprehensive VA electronic health records, the study authors found that for each year of exposure to tenofovir, risk of protein in urine – a marker of kidney damage – rose 34 percent, risk of rapid decline in kidney function rose 11 percent and risk of developing chronic kidney disease (CKD) rose 33 percent. The risks remained after the researchers controlled for other kidney disease risk factors such as age, race, diabetes, hypertension, smoking and HIV-related factors.

For individual patients, the differences in risk between users and non-users of tenofovir for each year of use were 13 percent vs. 8 percent for protein in urine, 9 percent vs. 5 percent for rapidly declining kidney function and 2 percent vs. 1 percent for CKD. “However, these numbers are based on the average risks in our study population, and patients with more risk factors for kidney disease would be put at proportionately higher risk,” said principal investigator Michael G. Shlipak, MD, MPH, chief of general internal medicine at SFVAMC and professor of medicine and epidemiology and biostatistics at UCSF.

Patients were tracked for an average of 1.2 years after they stopped taking tenofovir. They remained at elevated risk for at least six months to one year compared with those who never took the drug, suggesting that the damage is not quickly reversible, said Shlipak. “We do not know the long-term prognosis for these patients who stop tenofovir after developing kidney disease,” he cautioned.

The implications for patients already on or starting antiretroviral therapy are “mixed,” said Shlipak. “The best strategy right now is to work with your health care provider to continually monitor for kidney damage. Early detection is the best way to determine when the risks of tenofovir begin to outweigh the benefits.”

Shlipak noted that HIV, itself, increases the risk of kidney damage, while modern antiretroviral treatments clearly reduce that overall risk. “Patients need to be aware of their kidney disease risks before they start therapy, and this should influence the medications that they choose in consultation with their doctor,” he said. “For an otherwise healthy patient, the benefits of tenofovir are likely to exceed the risks, but for a patient with a combination of risk factors for kidney disease, tenofovir may not be the right medication.”

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

FDA Priority Review of HIV-fighting drug by Gilead

viaSan Francisco Business Times, by Ron Leuty

A plan to use an approved HIV-fighting drug from Gilead Sciences Inc. as prevention to the AIDS virus will get priority review by the Food and Drug Administration, the agency said Monday.

The move means that the use of Truvada as a way to reduce HIV risk could be approved by June 15, rather than face a standard 10-month agency review.

If approved, Truvada would be the first drug for uninfected people to reduce the risk of acquiring HIV.

But Foster City-based Gilead faces a rough road on its way to winning approval of Truvada as a preventative treatment.

At least one AIDS patient advocacy group has opposed the plan. The Los Angeles-based AIDS Healthcare Foundation has argued that a study of 2,499 gay men showed that Truvada was effective as a preventative 44 percent of the time — not enough to warrant approval by the FDA, it claims — and that men might believe taking the drug is a fail-safe measure and will stop using condoms.

The group has set up a web page, called nomagicpills.org, created mailers and taken out ad space in newspapers to spread its message.

What's more, the FDA news closely follows a finding by researchers at the University of California, San Francisco, and the San Francisco Veterans Administration Medical Center that found that one of Truvada's ingredients, tenofovir, is associated with a significant risk of kidney damage and chronic kidney disease that increases over time.

The study of 10,000 patients used VA electronic health records to find that for each year of exposure to tenofovir, the risk of protein in urine rose 34 percent and the risk of developing chronic kidney disease increased 33 percent.

Protein in urine is a marker of kidney damage.

The study's principal investigator was Dr. Michael Shlipak, chief of general internal medicine at the VA Medical Center and a professor of medicine and epidemiology and biostatistics at UCSF.

Truvada faces a May meeting in front of the FDA’s antiviral drugs advisory committee, Gilead said in a press release. That panel will give a non-binding recommendation to the agency.

A once-a-day pill that combines two AIDS-fighting drugs, Truvada originally was approved by the FDA in 2004 for patients who already have HIV.

The drug, which costs $12,000 a year, registered sales of $1.4 billion in 2011.

Read the Rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

In Conversation with Nomita Chandhiok: Exploring the ‘tool box’ of HIV prevention strategies

Original content from the Mapping Pathways blog team

“If a woman, for whatever reason, is unable to negotiate the use of a condom during sex, at least she can have something else to protect herself with – something that can help put her in control.”

Doctor Nomita Chandhiok is one smart lady. A gynaecologist by training, she is a scientist and researcher in the Division of Reproductive Health at the Indian Council of Medical Research (ICMR), the premiere research body of the government of India. Her job is to identify issues related to women’s health, sexual reproductive health, women’s infection, and HIV prevention that are relevant to India, and then conduct and coordinate studies that push forward research on these issues.

“HIV is a high priority for the Council,” says Dr. Chandhiok. “ARVs as prevention have really evolved.” She explains that all HIV prevention and treatment policies fall under the Indian government’s NACO programme. “As part of this programme, we would promote HIV prevention strategies such as PrEP or microbicides. Our focus so far has been on promoting condom use and safe sex practices, but now there could possibly be these new tools as well.”

Creating the toolbox
In particular, the ICMR is currently running a number of pre-clinical trials for product development and screening for microbicides. The organisation recently finished a Phase 1 trial that looked at an indigenously produced microbicide called Basant (the product is curcumin/turmeric based). The product was tested on 30 women and was found to be safe, says Dr. Chandhiok. Further studies would explore the post-coital efficacy of Basant and its male tolerability in 30-40 men. A study is also ongoing to identify and prepare six sites in the country for phase III microbicide trials. Dr. Chandhiok explains that these sites are located in three high-prevalence Indian states – Maharashtra, Andhra Pradesh, and Karnataka. The ICMR is seeking to determine the HIV incidence and prevalence rate amongst 9000 commercial sex workers in six districts in these areas. “Once we know the incidence rate, and if it is high enough (say 3-4% or more), we will then develop these sites for future HIV prevention trials.”

An empowerment tool for Indian women
Dr. Chandhiok has been working in this area for almost a decade. In 2003, she received a Fogarty Fellowship at Brown University, where she was exposed to research on microbicides as an HIV prevention tool.  “In early 2000, people thought HIV was going to spread like wildfire in India,” explains Dr. Chandhiok. As a result, the ICMR was looking ahead to find new prevention tools that they could possibly add to the government’s existing arsenal of HIV prevention strategies. As it turns out, the epidemic did not spread as imagined. “HIV is still a big issue in our country, but our numbers are better now… We don’t have a general epidemic. So, given the nature of the epidemic in India, any tools we develop will be for specific populations.”

Dr. Chandhiok explains further, “We talk in terms of a prevention toolbox. We don’t talk about one general tool. The aim is to provide several options that a person could  use through their entire sexual life. So, for example, you have a choice – if you can use a condom, great; if not, then you have the option of using a microbicide also.”

Dr. Chandhiok feels that prevention tools such as microbicides, once their efficacy has been proven and effective products created, could serve to empower Indian women. “As an empowerment tool for women these prevention tools need to be developed.” She explains, “These are very important for us to look at because if a woman, for whatever reason, is unable to negotiate the use of a condom during sex, at least she can have something else to protect herself with—something that can help put her in control.”

Concerns and challenges
Dr. Chandhiok is quick to point out that a lot of this discussion, though, is still theoretical. “At this point, we don’t have enough data to roll out tomorrow. There are still questions to be answered. We’re not at the point of saying we are ready to roll.”

For instance, she explains that oral PrEP, even were its efficacy to be proven, would still run into a huge implementation challenge in India. “In India, we don’t have strong regulation. You could be able to buy an ARV without prescription. So for something like PrEP, which is pill based, you don’t want people using it just like that without a proper prescription or a trained professional administering it and providing proper information and counselling.”

Dr. Chandhiok also feels that because HIV isn’t seen as such a priority issue amongst the majority of the population, adherence issues are another challenge, “Prevention is different from treatment. Only if I perceive myself at risk, only then will I think of preventing it.” And, as Dr. Chandhiok explains, in India most people do not perceive themselves as being at risk – HIV is perceived as a problem relegated to those at the margins of society, commercial sex workers or men who have sex with men. “Basically, for us to be able to roll out something like PrEP, we need government commitment, we need the funds to procure it, and we need a system to reach all the people who require it.” And, as it stands now, all three of these factors remain unclear.

The first and most important hurdle, however, is to prove the efficacy of these new prevention tools, says Dr. Chandhiok. “Only once efficacy is proven, can we even begin to think of all the implementation issues. And as it stands now, the trial results are contradictory; so we are still not too certain about how to proceed.” (Learn more about the various HIV prevention trials here).

Particularly disappointing was the closure of the VOICE trial’s study arm testing tenofovir gel last November, says Dr. Chandhiok. “I’m a little confused because of all the conflicting results. There is no one direction as yet, so we don’t know the clear path ahead. We can’t move forward until we have clear-cut evidence that these tools work.”

Note: The VOICE trial announced on November 25, 2011 the closure of its study arm testing tenofovir gel. The decision was made due to futility – while tenofovir gel was found to be safe, the trial was not able to prove the gel worked to prevent HIV. See the statement from the Microbicide Trials Network  for more information. Previously, the trial had to drop its tenofovir tablet arm due to futility as well. The Truvada tablet arm in the trial is continuing.

Nomita Chandhiok is the Deputy Director General in the Division of Reproductive Health at the Indian Council of Medical Research, the premiere research body of the government of India.



[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

WHO experts fail to agree on recommendations surrounding injectable contraceptives

via AllAfrica.com, by John Muchangi

Health experts have failed to agree on the use of injectable contraceptives, which were linked to increased HIV infections in Kenya. World Health Organisation said the decision will now be made when another team meets on February 15.

WHO had initially formed a team of 53 experts from 20 countries to review the research which revealed that injectable contraceptives like Depo Provera double the risk of contracting HIV.

Recommendations made by that team will now be assessed by the WHO Guidelines Review Committee - the body that oversees the production of WHO public health guidelines for countries. "The Committee will meet on 15 February and announce its recommendations the following day," said the organisation's spokeswoman Fadéla Chaib.

She insisted hormonal contraceptives and intrauterine devices known as IUDs do not offer any protection against HIV or other sexually transmitted infections. "Condoms are the mainstay of dual protection against both unwanted pregnancy and STIs including HIV," she said in a statement.

WHO's last guidance in 2009, based on the best evidence available at that time, said women at high risk of HIV infection and those living with HIV could safely use hormonal methods.

However, last year's study by the University of Washington, Kenyatta National Hospital, University of Nairobi and Moi University offered a different opinion. The study, published in The Lancet medical journal, revealed that injectables double the risk of women contracting HIV and also increase the risk of HIV-positive users infecting their male partners. It involved 3,800 couples from Kenya,Uganda, Tanzania, Botswana, Rwanda, South Africa and Zambia.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Mapping Pathways U.S.: What we’ve heard

Original content from the Mapping Pathways blog team

An important part of the Mapping Pathways project is to learn what people think and feel about ARV-based prevention strategies, not just through academic streams and studies but also through everyday experience and wisdom. What do the people who work daily with treatment and prevention and/or have first-hand experience of living with HIV think? What are their concerns? What information do they need about pre-exposure prophylaxis (PrEP), TLC+ (testing, linkage to care, plus treatment), post-exposure prophylaxis (PEP) and microbicides? Do they think these prevention tools can be useful for their community or country? Would they use them or prescribe them? Do they feel these questions are even important to explore?

The Mapping Pathways online survey and in-depth stakeholder interviews from 2011 – both conducted with individuals in India, South Africa and the United States – are important ways for us to gain knowledge on these questions. The team has been busy unpacking a number of interesting observations and ideas now that the interviews have finished and the survey is closed. Of course, this data is still preliminary but we thought we’d share some snapshots of what we’re hearing from US doctors, policymakers, and activists on the ground.

Big picture thoughts from U.S. respondents
Participants from the stakeholder interviews were generally supportive of the Mapping Pathways initiative and the four prevention interventions discussed in the interview. They believe having planning tools that assesses the relative benefits of each intervention is potentially important and could be empowering. One participant said, “This is very important and critical in terms of timing. We are at a crossroads in the US right now. We are more than a year after the release of the National HIV/AIDS Strategy, at the beginning of implementation of the Affordable Care Act, and are still in the midst the most difficult financial situation in modern times. We need to make decisions and choices that will result in a better response to strategize and improve access to health in general.”

Another participant felt very positively about ARV-based prevention strategies, “I think TLC+, microbicides and PrEP have a strong potential for ending HIV as we know it. I think if we can get past fears, fighting, and the positioning and come together locally, nationally, internationally and put our best thinking around how to make these interventions work for people living with and at risk of HIV, we can make a significant difference in incidence.” The empowering aspect of ARV-based prevention strategies was also a focus for some participants. One remarked, “I think the most important thing is microbicides – It gives people who are in a vulnerable position the power of control.”

Big picture concerns
Despite general enthusiasm, there were also reservations about the U.S.’s ability to expand the availability of these interventions, particularly TLC+, and oral PrEP, as microbicides are not yet available. Having adequate resources was the main concern across all four interventions. As one individual remarked, “I feel very strongly about treating people living with HIV… I think in theory, PrEP is great, but in practice? Where will the money come from? I don’t disagree with the concept (of PrEP), but think we should prioritize people living with HIV to get meds instead of people who are HIV negative. I am also concerned that only wealthy people will get PrEP.” Another individual echoed this sentiment, “We are totally under-resourced in this area… Private insurance and Medicaid have no interest in picking up that expense.”

Interest levels
In terms of greater or lesser enthusiasm about each particular intervention, a very preliminary assessment of the hierarchy (greater enthusiasm to lesser enthusiasm) would be:

• Microbicides: This type of intervention was seen as less costly and less controversial. It is important to emphasize that microbicides are still in the research and development phase.
• PEP, particularly occupational PEP: There were some concerns about resources, information, and availability of sexual PEP.
• TLC+: It was felt that this intervention favors starting ARVs regardless of CD4 count. There were mixed views and some discussion on whether the HPTN results support TLC+ with particular at-risk populations, e.g., IV drug users.
• PrEP: This generated several concerns and questions. These included worries about it being too costly and how would risk be defined; adherence concerns; and concerns about the long-term effects of ARVs on someone who is HIV-negative, which might offset the benefits of prevention.

Mapping Pathways will be disseminating our findings from the 2011 survey, stakeholder interviews, literature review and ExpertLens throughout the year at various conferences and through a number of publications, including scholarly journals, a RAND book, and other platforms. An oral presentation is scheduled to take place at Microbicides 2012.

The Mapping Pathways blog will be an important platform for these findings. Also coming soon, a lively Q&A with our U.S. colleague Jessica Terlikowski about her thoughts on the U.S. HIV prevention landscape in 2012. Stay tuned!

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Cotrimoxazole cost-effective and lifesaving for people starting ART in Sub-Saharan Africa

via Aidsmap, by Carole Leach-Lemens

Achieving full coverage of cotrimoxazole prophylaxis during the first six months of antiretroviral therapy would be a highly cost-effective way of reducing early death among those with advanced HIV infection in sub-Saharan Africa, researchers report in the advance online edition of the Journal of Acquired Immune Deficiency Syndromes.

The researchers developed a decision-analytic model from a health care perspective to compare costs and outcomes. Full cotrimoxazole prophylaxis coverage at an estimated additional cost of $3.29 for each person on ART prevented an additional 22 deaths compared to the base-case scenario (from 94 to 72 deaths per 1000 patients) at a cost of $146.91 for each death prevented over the first six months.

Potential cost savings for specific opportunistic infections (OIs) prevented by cotrimoxazole prophylaxis were also calculated.

Prevention of 45 new malaria episodes per 1000 persons treated would save between $69.95 and $203.32 per case averted, while prevention of 22 severe bacterial infections per 1000 persons would save between $68.62 and $126.71 per case averted. Prevention of four new cases of pneumocystis pneumonia would save between $75.69 and $88.41per case averted.

An intervention is considered very cost-effective by the World Health Organization if the incremental cost per life-year saved is no greater than the GDP per capita; in the case of the poorest countries in Africa this was calculated at $1695 in 2005. This analysis is not strictly comparable because it calculates cost savings in deaths averted.

Over the past decade the increasing availability and access to ART in resource-poor settings has resulted in reductions in AIDS-related deaths.

Yet, in sub-Saharan Africa people continue to present for care at an advanced stage of illness resulting in high rates (8-20%) of early death after starting ART compared to North America and Europe. Common causes of death include tuberculosis, pneumonia and diarrhoeal illnesses.

In North America and Europe it is common practice to give cotrimoxazole prophylaxis to those who present for care with advanced HIV, primarily to prevent PCP. Its use in African settings, however, appears to protect against a wider range of infections and is not restricted to those with advanced HIV.

Recent studies in sub-Saharan Africa, while not randomised, have shown a consistent reduction in death where people on ART got cotrimoxazole compared to no cotrimoxazole, note the authors. In particular cotrimoxazole has been shown to reduce the risk of tuberculosis and of malaria in people taking antiretroviral therapy. A meta-analysis of seven studies shows that cotrimoxazole prophylaxis reduced the death rate in people taking antiretroviral therapy by almost 60%.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Ethical Concerns Raised: Human Experimention Without Subject's Consent

viaNature.com by Matthew Walter

The injections came without warning or explanation. As a low-ranking soldier in the Guatemalan army in 1948, Federico Ramos was preparing for weekend leave one Friday when he was ordered to report to a clinic run by US doctors.

Ramos walked to the medical station, where he was given an injection in his right arm and told to return for another after his leave. As compensation, Ramos's commanding officer gave him a few coins to spend on prostitutes. The same thing happened several times during the early months of Ramos's two years of military service. He believes that the doctors were deliberately infecting him with venereal disease.

Now 87 years old, Ramos says that he has suffered for most of his life from the effects of those injections. After leaving the army, he returned to his family's remote village, on a steep mountain slope northeast of Guatemala City. Even today, Las Escaleras has no electricity or easy access to medical attention. It wasn't until he was 40, nearly two decades after the injections, that Ramos saw a doctor and was diagnosed with syphilis and gonorrhoea. He couldn't pay for medication.

“For a lack of resources, I was here, trying to cure myself,” says Ramos. “Thanks to God, I would feel some relief one year, but it would come back.” Over the decades, he has endured bouts of pain and bleeding while urinating, and he passed the infection onto his wife and his children, he told Nature last month in an interview at his home.

Ramos's son, Benjamin, says that he has endured lifelong symptoms, such as irritation in his genitals, and that his sister was born with cankers on her head, which led to hair loss. Ramos and his children blame the United States for their decades of suffering from venereal disease. “This was an American experiment to see if it caused harm to human beings,” says Benjamin.

Ramos is one of a handful of survivors from US experiments on ways to control sexually transmitted diseases (STDs) that ran in semi-secrecy in Guatemala from July 1946 to December 1948. US government researchers and their Guatemalan colleagues experimented without consent on more than 5,000 Guatemalan soldiers, prisoners, people with psychiatric disorders, orphans and prostitutes. The investigators exposed 1,308 adults to syphilis, gonorrhoea or chancroid, in some cases using prostitutes to infect prisoners and soldiers. After the experiments were uncovered in 2010, Ramos and others sued the US government, and US President Barack Obama issued a formal apology. Obama also asked a panel of bioethics advisers to investigate, and to determine whether current standards adequately protect participants in clinical research supported by the US government.

When details of the Guatemalan experiments came to light, US health officials condemned them as 'repugnant' and 'abhorrent'. Last September, the Presidential Commission for the Study of Bioethical Issues went further, concluding in its report1, that “the Guatemala experiments involved unconscionable violations of ethics, even as judged against the researchers' own understanding of the practices and requirements of medical ethics of the day”

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

New Approach to Phase 3 Clinical Drug Trials

viaThe Sacremento Bee, by the Forum for Collaborative HIV Research

As the war on HIV/AIDS begins its fourth decade, medical researchers, pharmaceutical manufacturers, patient advocates and government regulators face a new and unexpected scientific challenge: how to demonstrate the safety and efficacy of promising new antiretroviral drugs when the two traditional study designs – the superiority trial and the non-inferiority trial – are no longer useful in showing improvements in both "treatment experienced" patients and those who have never received drug therapy (treatment-naive patients).

Because this challenge could have a dampening effect on what is now a robust drug development pipeline for HIV, the Forum for Collaborative HIV Research has just released a new scientific paper that lays out a substantially different approach for conducting Phase 3 HIV clinical trials. 

Published in the journal AIDS, the paper summarizes the insights of specialists from the Food and Drug Administration, European Medicines Agency, academia, the patient advocacy community and industry that overcoming the current difficulties in conducting new HIV drug trials requires moving from the large-scale study model to a new approach where clinical improvements are demonstrated through a sequence of short, step-wise efficacy and safety studies.

"Despite the many valuable antiretroviral drugs now available to treat HIV, new antiretrovirals can bring important benefits, such as fewer side effects, less frequent dosing and a lower risk of drug resistance. That is why overcoming the barriers to innovation in HIV drug development is so critical," said Veronica Miller, Ph.D., Director of the Forum and one of the authors of the paper. "Our paper offers a new pathway for regulatory approval of promising new HIV drugs and reflects the best thinking of the top experts in the field."
The new pathway described in the paper calls for a multi-phased study design, which includes:

•A short study (10-14 days) comparing the investigational compound versus placebo, with the patient's current failing regimen as background, to evaluate short-term efficacy in viral load reduction
•A follow-on study where all participants receive the investigational drug (at a single or different doses) and are assessed at 24 weeks to evaluate dose response, safety, durability of initial response and development of resistance
•The possibility of a second comparative safety trial in patients with a minimum of two active drugs available where participants are randomized to the investigational agent plus a new optimized background regimen of antiretroviral drugs versus patients on a new optimized background regimen plus placebo

Read the Rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

In Conversation with Kate Morrow: Of Microbicides, Sensations, and Adherence (Part 2)

Original content from the Mapping Pathways blog team

Kathleen (Kate) Morrow is a staff psychologist at the Miriam Hospital and an associate professor (research) of Psychiatry and Human Behavior at the Alpert Medical School of Brown University. She is driving two innovative microbicide projects – Project LINK and Project MIST. Kate is also a member of the IRMA Steering Committee.

(In Part 1 of this interview, Kate talked about Project LINK and how she got started down this career path.)

MP: Could you describe your work with Project MIST? How does it broaden the scope of your earlier work with Project LINK?

KM: Like Project LINK, Project MIST is also part of the Microbicides Innovation Program. I’m doing the acceptability piece on that project, whose Principal Investigator is Robert Buckheit at ImQuest BioSciences. Out of Project LINK, we understood that women could feel the differences among various gels well enough to discern, with their ratings, one product from another. The women finally had a choice to make at the end of the study. Their experiences impacted the product they chose – different women chose different experiences.

We’re in the process of completing LINK analyses now, and one of the things we feel like we don’t have a handle on is how gel volume would play into, and impact, a woman’s perception and experience with a product. So, if we had the exact same gel, but in different volumes, would she experience different things? That’s a question in the field as well – how much gel do we need to apply? That depends on the dosage, the amount of drugs in each measure of gel. That’s still an open question – and we decided we needed to answer that question from the perspective of the user, so that, if we could, we could optimize the volume for drug delivery, as well as the user experience.

And for me, the big question hanging out there was – what do the guys think? From LINK, we now know what women feel and what they think about those feelings and sensations, but we don’t have any understanding of what their male partners feel and how that will drive their preferences for gels.

Last but not least, MIST also gave us the opportunity to try a quick-dissolving film developed by Lisa Rohan at the University of Pittsburgh. So, we’re looking at those three issues in Project MIST: volume and the difference between a gel and a film with respect to user experiences, and exploring male sexual partners’ sensory perceptions and experiences. Like LINK, it’s a mix method study: this time we’re incorporating the male partners into the qualitative data mix to understand their experiences.  We’ll continue to use the validated scales from LINK.

MP: What inspires you?

KM: Well, to begin with, there’s the work itself. I mean, I do this work because I think it’s really important – I think it’s a piece that’s missing otherwise from the field. There are some of us who focus on things like sexual pleasure (Anne Philpott among them), but we have to understand the mechanisms of sexual pleasure – how do we help with that process? These projects, LINK and MIST, uniquely do that. We’re very unique in the fact that what we are trying to understand is which sensory perceptions and experiences impact willingness to use a product and hopefully, down the line, adherence to product use. That way, we can better create a formula that will not only deliver the drug well, but also will make the sexual experience one that people will want to have – so they’ll continue to use the product. What gets me excited every day is trying to figure out that puzzle, and hoping that in the long run this work will have a beneficial impact on the field and our ability to end the HIV epidemic.

But, you know, research can get drab, it can drag along…you meet your small goals often but the big end points don’t come, I think, as often as we’d like them to! So it’s the little things every day that keep us going. I think the thing that inspires me the most in that sense is my participants. Personally, they’re not getting any benefit out of doing these studies with my team – they know it’s a placebo study. But they come in, they try the products, they give us their opinions… To me, they’re the experts, they’re the ones that are the key to my success and my ability to get the data in this field.

Since we started LINK, we’ve seen more than 400 women walk through our doors saying, “I want to help you do this.” They tried all the different products – and I know they weren’t all pleasant! Yet, our retention rate in the studies is well over 90% – it’s a group of women who really want this to happen. They’re dedicated, they try to be as honest as they can…you know, frankly, we ask them some difficult questions. In the qualitative interviews, they’re sitting across from us telling us the story of their experience – and that can’t be easy to do. At some level it’s got to be a little uncomfortable to talk about your sexual experiences in such detail. And now their male partners are also on board. They all understand the medical necessity of the study. They understand that a pleasurable sexual experience is important to microbicides and their ultimate use. I am constantly amazed by our participants.

MP: As a behavioral scientist, what is your role in this process?

KM: Well, it’s possible (in fact, it’s probable) that we will not be able to make one, single ideal microbicide for women. Everybody likes different things in sex, and people like different characteristics. What we’d like to do is raise the floor – get rid of the absolute bad characteristics and make the properties and performances of these gels good enough for people to use them.

Once we end up with a tolerable gel and begin to move into uptake and access and use, what we can then do as behavioral scientists is educate women and their partners about the not-so-great characteristics that might remain but that have to be there in order for the drug to be efficacious. It’s a balancing act between the experience of the user and the efficacy of the product. At some point, we’re likely to run into “we need it to be like this for the efficacy, we can’t change that”. So then, as a behavioral scientist, I have to say, “Okay, if you can’t change that, what impact is it going to have on the user and how can I help the user to cope with that?”

So, there are two things going on for me: on one hand, let’s make the best one possible to begin with. Then, if there are things we can’t change due to efficacy, how do I help people deal with those remaining issues? Even though it’s not going to be perfect, there are still things we can do as behavioral and social scientists to help deal with those imperfections.

MP: What’s the hardest part about your job?

KM: Not having enough time in the day! There’s just so much to do. I’d like it to move a whole lot faster than it can – but that’s just what it is. Obviously, I wish that we were there already. But day in and day out, I love my work. I love the science. I’m very appreciative of my participants and the efforts that they put in. My team is amazing and I think we’re doing good work and that we’ll be able to contribute, ultimately, to a better microbicide.

MP: What are you most excited about for 2012?

KM: Finishing up the LINK data and figuring out which of our scales are most useful to us in the process of evaluating candidate gels. And, of course, continuing with and finishing MIST and incorporating the male partner experience into the mix. Down the road, I’m hoping that we start a project to do similar kinds of science around rectal microbicides both with men who have sex with men (MSM) and women. I’m keeping my fingers crossed that it will get funded and take off this year. I’m just really excited about moving forward and trying to keep all of us moving forward.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Empowering Women to Fight HIV: An Interview with South African Dr. Sengeziwe Sibeko

via AllAfrica.com, interview with Dr. Sengeziwe Sibeko

What makes a young African doctor decide to devote her career to helping women fight HIV? Dr. Sengeziwe Sibeko is a 37-year-old medical researcher with a degree in obstetrics and gynecology from the University of KwaZulu Natal (UKZN) in South Africa, an MSc in epidemiology from Columbia University in the United States, and is about to take up a fellowship to study for her PhD at Oxford University in the United Kingdom. AllAfrica's Julie Frederikse interviewed Dr. Sibeko at the community women's reproductive health clinic run by the Centre for the Aids Program of Research in South Africa (Caprisa) in Durban.

When I did my internship back in 1998, I went to the rural northern part of KwaZulu Natal (the South African province where she lives and works) and I was really looking forward to saving lives - yet that was not what was happening at the time. People were dying. You came in each morning to see people die rather than to be able to save lives. But when I went on to do my community service (a two-year requirement for all South African medical students), I really enjoyed obstetrics and gynecology, so when I had the opportunity to specialise I knew that was what I wanted to do.

But over the five years of my specialisation, that changed too. It was no longer just about babies being born - women were coming in because they were sick and babies were dying. I found it to be a depressing situation, and this was further compounded by staff shortages due to people leaving the health system.

Given the depressing effects of Aids that you witnessed, how did you develop your passion around protecting African women from HIV?

My actual turning point came when I went overseas. I got a fellowship in 2006 (from the Fogarty International Clinical Research Scholars and Fellows). That meant that for the first time - I remember this so clearly - I was removed from the everyday numbing situation that I had been in back in South Africa.

So it was only when the National Institutes of Health (NIH) in Washington DC brought all the global health experts together, and their presentations showed me that this is how Asia is doing with the HIV and Aids situation, this is how the United States is doing, and this is you in sub-Saharan Africa - I almost collapsed! I never realised that this is the situation in the region where I'm from. It made me decide that I'm going to go home and be part of the solution.

So what did you do next?

I thought, we can't be waiting for women to come to the clinic, to be sick and to die - there's got to be a way to prevent women getting HIV in the first place. I wanted to do something major, and I saw that it must be through the public health route. So I went into Caprisa and met Dr. Quarraisha Abdool Karim. The time that I joined coincided with a conference on the potential of microbicides to fight HIV. So I thought, wow, I'm in the right place, this could save women's lives. I became the overall gynecologist of the study, so I like to think of it as my baby.

When I joined the field there hadn't been any success stories with microbicides. There were lots of negative trials and the field was almost dying. I remember talking to Dr. Henry Gabelnick (head of Caprisa's research partner, the U.S. reproductive health group, CONRAD) who is the greatest proponent of microbicides, and I told him, if you give up on this concept you give up on women. Because I see this as a woman-empowering strategy. It gives women the opportunity to be in control when they can't negotiate other safe sex practices.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Keep up the fight for microbicides

via AllAfrica.com, by Julie Frederikse

Africans tracking the worldwide HIV epidemic have not found much to celebrate since Aids began ravaging the continent 30 years ago, but researchers are optimistic that they are learning as much from their failures as their successes.

Sub-Saharan Africa still carries the biggest burden of HIV worldwide, and while there has been a significant improvement in access to antiretroviral treatment in recent years, scientists searching for a gel or vaccine that can prevent HIV infection ride a rollercoaster of hope and disappointment.

Take the case of a husband and wife team from the University of KwaZulu-Natal in South Africa. Professors Salim Karim and Quarraisha Abdool Karim head up a research unit that has been at the forefront of clinical trials to find a safe and effective microbicide to protect women from HIV.

In July 2010, delegates at the last World Aids conference gave the couple a standing ovation when they announced the results of one of the most promising studies on HIV prevention to date. Their team at the Centre for the Aids Program of Research in South Africa (Caprisa), showed that a vaginal gel called tenofovir was able to reduce sexual transmission of the virus by 39 percent overall and 54 percent in women who used it consistently.

But the euphoria over this breakthrough has dissolved into disappointment, with the unexpected finding of a wider sub-Saharan African study that the microbicidal gel, when prescribed daily, does not prevent HIV infections. This has led to the suspension of tenofovir in the Vaginal and Oral Interventions to Control the Epidemic (Voice) trial.

Tenofovir is an antiretroviral drug that is taken successfully by many people living with Aids to suppress the virus. The hope had been that tenofovir could also be used to prevent HIV infection. Women are twice as likely as their male partners to acquire HIV during sex and account for 60 percent of adult HIV infections in sub-Saharan Africa. An effective microbicide would give women the option of applying the vaginal gel themselves before sex, without necessarily informing their partners.

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Current State of Microbicide Research

via Cold Spring Harbor Perspectives in Medicine, by Robin J. Shattock and Zeda Rosenberg

Microbicides represent a potential intervention strategy for preventing HIV transmission. Vaginal microbicides would meet the need for a discreet method that women could use to protect themselves against HIV. Although early-generation microbicides failed to demonstrate efficacy, newer candidates are based on more potent antiretroviral (ARV) products. Positive data from the CAPRISA 004 trial of tenofovir gel support use in women and represent a turning point for the field. This article reviews current progress in development of ARV-based microbicides. We discuss the consensus on selection criteria, the potential for drug resistance, rationale for drug combinations, and the use of pharmacokinetic (PK)/pharmacodynamic (PD) assessment in product development. The urgent need for continued progress in development of formulations for sustained delivery is emphasized. Finally, as the boundaries between different prevention technologies become increasingly blurred, consideration is given to the potential synergy of diverse approaches across the prevention landscape.

An effective microbicide may be one of the best ways to address a central gap in current HIV prevention strategies: lack of a discreet method that women can use to protect themselves from infection. Recently, the World Health Organization reported that AIDS is the leading cause of death among women of reproductive age globally, and particularly in sub-Saharan Africa (World Health Organization 2009). Methods available to prevent HIV include condoms, male circumcision, and behavioral interventions, but data indicate that they are insufficient to protect women. Among women in sub-Saharan Africa, one of the highest-risk factors for acquiring HIV is being in a stable long-term relationship where condom use is low (Shattock and Solomon 2004).

Condoms are impractical for women who want to conceive children or who cannot persuade their partners to use them. Next to an effective vaccine, microbicides (topical preexposure prophylaxis [PrEP]) and oral PrEP have the greatest potential to provide women with protection they can control. Both could be configured to protect men and women from transmission of HIV during unprotected anal intercourse.
Microbicides are topical PrEP products, such as gels, capsules, tablets, films, and intravaginal rings (IVR). They are designed to be applied either around the time of coitus, used on a daily basis (gels and films), or to deliver product over a prolonged period

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

South Africa's Health Services: An Interview with CAPRISA's Dr. Quarraisha Abdool Karim

via AllAfrica.com, interview with Dr.Quarraisha Abdool Karim

Dr. Quarraisha Abdool Karim is an infectious diseases epidemiologist and associate scientific director of the Centre for the Aids Programme of Research in South Africa (Caprisa). AllAfrica's Julie Frederikse spoke to the 51-year-old and asked her about the challenges facing her team as they search for effective ways to prevent HIV and other sexually transmitted infections.

We appreciate that there are many challenges. To simply walk in and say, doctors and nurses, you must now provide this or that - it won't work. We are aware that services are very strained in the public health sector. Morale is low, staff feel overwhelmed, and nurses often don't get sufficient support in the implementation of policy decisions.

So we have been working with the family planning nurses, using a Quality Improvement Strategy model that's been used extensively to improve the quality of health care delivery and access to important health interventions. It's similar to Paolo Freire's work in education, in that we aim to work with health care staff using empowering and enabling approaches.

How would you assess the government's sexual and reproductive health services in South Africa?

This country has one of most enviable lists of contraceptive methods available at no cost, yet the main method used is Depo Provera (which a recent study has shown to double the risk of transmission of HIV to women). There are IUDs and implants, which may be much better, safer options. So why are they not being promoted? Even with the injectables, there is NET-EN (norethisterone enanthate), which has a lower dose of progesterone and has a favourable safety profile for use by young people.

The point is that we have as policy on our essential drug list an extensive group of fertility control methods, so why is this not translated into access at point of delivery? The answer relates to the fact that the normal interaction time between a health professional and a client is very short, sometimes as short as 30 to 40 seconds. This doesn't leave time to consider other contraceptive options. We know you can't change people overnight, especially when their prescribing patterns are limited to just giving an injection, and perhaps asking a question like, 'do you know your HIV status?' But we know that we've got to change health care provision - to include HIV testing, screening for STIs and cervical cancer, just to mention a few. It's got to be part of a comprehensive model for prevention and treatment - but the challenges are in how to integrate this in over-stretched clinics.

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Measuring condom usage and ART coverage in South Africa

via Journal of the Royal Society, by Leigh F. Johnson, Timothy B. Hallett, Thomas M. Rehle, and Rob E. Dorrington

This study aims to assess trends in human immunodeficiency virus (HIV) incidence in South Africa, and to assess the extent to which prevention and treatment programmes have reduced HIV incidence. Two models of the South African HIV epidemic, the STI (sexually transmitted infection)–HIV Interaction model and the ASSA2003 AIDS and Demographic model, were adapted. Both models were fitted to age-specific HIV prevalence data from antenatal clinic surveys and household surveys, using a Bayesian approach. Both models suggest that HIV incidence in 15–49 year olds declined significantly between the start of 2000 and the start of 2008: by 27 per cent (95% CI: 21–32%) in the STI–HIV model and by 31 per cent (95% CI: 23–39%) in the ASSA2003 model, when expressed as a percentage of incidence rates in 2000. By 2008, the percentage reduction in incidence owing to increased condom use was 37 per cent (95% CI: 34–41%) in the STI–HIV model and 23 per cent (95% CI: 14–34%) in the ASSA2003 model. Both models also estimated a small reduction in incidence owing to antiretroviral treatment by 2008. Increased condom use therefore appears to be the most significant factor explaining the recent South African HIV incidence decline.

Read the full article here.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]