Research Linking Contraceptives to HIV Raises Policy Questions

via PBS Newshour, by Talea Miller

A study showing injected hormonal birth control could make women more vulnerable to HIV is raising big questions about medical guidance in regions with high HIV rates.

Research conducted by the University of Washington in seven African countries found use of injected hormonal contraceptives doubled women's risk of contracting HIV and the chances of passing HIV to a partner.

Policymakers are moving cautiously in response to the findings, which were first released this summer at an HIV conference and published again this week by the Lancet. The World Health Organization has scheduled a January 2012 review of the research, but for now the organization and the U.S. Agency for International Development are making no new contraceptive recommendations and the two groups have emphasized the study's limitations.

In a statement released in August when the study first surfaced, USAID noted flaws in the study's design and called for a randomized, controlled version to flesh out the results. The agency also noted that while a few previous studies show a connection between hormonal contraception and HIV transmission, the majority of previous research found no association.

"USAID does not believe that a change in contraceptive policy or programming is appropriate or necessary at this time," the statement said, and a USAID spokesperson said Tuesday that finding still stands.
The WHO also took issue with the study's reliance on data based off observations in a written response to the Lancet publication.

Read the rest.



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Extension of iPrEX HIV PrEP Study Begins at 11 Sites in 6 Countries

Via iPrEX News.

The iPrEx Open-Label Extension Study (iPrEx OLE), the next phase of the first human study to report efficacy results on pre-exposure prophylaxis (PrEP) to prevent HIV infection, has begun at clinical trial sites around the world. Approximately 2,000 men and transgender women who have sex with men are expected to participate in the 72-week iPrEx OLE study. Study sites in the United States and South Africa are enrolling participants now, as other study sites finalize the regulatory approval process.

In PrEP, antiretroviral medications that are usually used to treat HIV are taken by uninfected people to reduce their risk of infection. The iPrEx study found that men and transgender women who have sex with men (MSM) who took a single daily tablet containing the HIV medications emtricitabine and tenofovir (FTC/TDF), known commercially as Truvada®, experienced an average of 44% fewer HIV infections than those who received a placebo (blank pill). HIV infection rates in the iPrEx study dropped by 90% among those who used PrEP consistently enough to have detectable drug in the body. The HIV risk reduction benefits of PrEP were in addition to those provided by safer sex counseling, condoms, HIV testing and the detection and treatment of sexually transmitted infections. iPrEx study results were published in the New England Journal of Medicine in November, 2010.

The news of the start of iPrEx OLE follows the announcements by two other major PrEP studies, Partners PrEP and the CDC study in Botswana, known as TDF2, which demonstrated the safety and efficacy of PrEP in heterosexual women and men.

AdvertisementiPrEx OLE is a continuation of the iPrEx study that will collect additional data on PrEP efficacy, safety and adherence. All HIV-negative participants who took part in the original iPrEx study and who wish to participate will receive FTC/TDF for HIV prevention for 72 weeks through iPrEx OLE. No placebo will be used in the Open Label Extension.

"We are in a critical moment in HIV prevention research," said iPrEx Protocol Chair Robert Grant, MD, MPH of the Gladstone Institutes and the University of California at San Francisco. "iPrEx provided the first proof of an important new method of HIV prevention that can help slow the global toll of 2.6 million new HIV infections each year. Partners PrEP and the TDF2 study have now expanded that finding by demonstrating the effectiveness of PrEP in heterosexual women and men. Developing and deploying proven HIV prevention methods -- including PrEP, microbicides, vaginal gels, clean needles, medical male circumcision, early treatment, counseling, testing, condoms and suppressive therapy for pregnant women will all be key to slowing the global epidemic."

Read the rest here.

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

Two large studies show that ARVs can prevent HIV

Today, all of us in the HIV prevention field have woken up to heartening news: two large PrEP studies have shown that taking antiretrovirals (ARVs) can reduce the risk of HIV infection through sexual intercourse by 62-73% among heterosexual couples. This news comes close on the heels of the encouraging results from the IPrEX trial, which showed that ARVs could provide protection against HIV among gay men.

The Partners study, funded by the Bill & Melinda Gates Foundation, took place in Kenya and Uganda. It was stopped a year and a half early because of the highly significant results. Unlike the earlier FEM-PrEP trial, adherence in this case was extremely high: more than 97% of doses dispensed were taken, and 95% of participants stayed in the study. The TDF2 study, conducted in Botswana, concluded as planned.

The results of both these PrEP studies are being called “fundamentally important for HIV prevention” and provide added impetus to the ongoing discussion about ensuring the widespread availability of affordable ARV drugs in developing countries.

To know more, check out Reuters’ coverage of the studies here or The Washington Post’s story here. For more details, read the article on The University of Washington website as well as the CDC website.

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

The Great Paradox of the HIV Epidemic

Mark Chataway is co-chairman of Baird’s CMC, a Mapping Pathways partner organisation. Here, he discusses the HIV landscape in Botswana and Zimbabwe.

"Every now and then, it strikes me that despite all our progress in the field of HIV, there is still so much for us to find out. This seems most apparent when I consider the HIV situation in two African countries: Botswana and Zimbabwe.

In 2001, Botswana’s then-president, Festus Mogae, said, “We are threatened with extinction. People are dying in chillingly high numbers. It is a crisis of the first magnitude.” The government acknowledged that tackling the epidemic was a matter of national importance, and it acted accordingly – Botswana became the first African country to declare its objective of providing ARV drugs to all its needy citizens. As in so many other fields, Botswana was to become a model for the rest of the world. (Having worked for the Government of Botswana as a consultant, I often wish that we, in the UK, were governed with equivalent honesty, efficiency and vision.)

Botswana has two significant HIV/AIDS-related initiatives with international partners: ACHAP (African Comprehensive HIV/AIDS Partnerships) and BOTUSA. Its own funding for HIV programmes has increased steadily. Botswana has achieved universal treatment access (that means at least 80% of Batswana who need HIV treatment are receiving it). Almost every major political and religious leader has addressed AIDS openly and often. There are enormous, well-financed programmes focussed on behaviour change and risk reduction. Yet, HIV prevalence is not falling nearly as fast as many think it should have done (click here for prevalence details).

On the other hand, there is the puzzling case of Zimbabwe, where HIV prevalence has fallen dramatically over the last decade or so – it peaked at 26.5% in 1997 and, according to government figures, fell to 14.3% in 2010. While this is an excellent development, it is also rather inexplicable. Access to treatment is very limited. A long-serving health minister was accused of sexually molesting adolescents (although he vehemently denied it) and other political leaders have addressed AIDS only sporadically. Sustained persecution of men who have sex with men has driven the gay community underground. Many of the urban poor have been driven from their homes and forced to live as refugees in rural areas. According to everything we know, Zimbabwe’s political upheaval, economic distress, and the collapse of many primary healthcare services should have exacerbated the epidemic. While some researchers claim the declining prevalence is a result of successful public-awareness and behaviour-change programmes, there are many troubling doubts in the international public health community about whether those factors really constitute an adequate explanation. The real explanation is probably complicated and involves the rising mortality from other causes, the inability of people to travel and the disappearance of much of the middle class.

The difference between these two countries brings into sharp relief the great paradox of the HIV epidemic – we just do not know why the epidemic seems intractable in some places but declines rapidly in others (or fails ever to take hold). There is no model that explains Botswana and Zimbabwe. There are similar paradoxes all over the world: for example, in India, Tamil Nadu has more AIDS cases than any other state, but it has an excellent healthcare system, relatively good status for women and very high levels of literacy and health literacy. Bihar is almost the opposite on every count but has very low HIV prevalence.

For me, it highlights how, even after living with HIV/AIDS for nearly three decades, the world still has so much to learn about the dynamics of HIV and how it functions in various scenarios. The need of the hour is well controlled, randomised clinical trials and policy analysis. We can then create more effective programmes based on good science."

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

PrEP Forum: Listen Now for Free

Chicago, USA - On June 15, fellow AFC partner organization Lifelube hosted a forum with Feast of Fun podcast hosts Fausto Fernós and Marc Felion. The forum was a discussion on the iPrEx study, and PrEP as an HIV prevention method, and featured scientists, advocates, and real people taking Truvada prophylactically. Please take the time to listen to the podcast for free on Feast of Fun's website, and share your thoughts on the iPrEx study, PrEP, and the forum itself.

Keith Green, Marc Felion, Dr. Bob Grant and Fausto Fernós

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

CAPRISA Team Acknowledged for Outstanding Achievement in Global Health

Via EurekaAlert.

[June 20, 2011] the CAPRISA 004 study leadership team [was] awarded the inaugural Drug Information Association (DIA) President's Award for Outstanding Achievement in World Health. The award recognizes the team's significant contribution to the field of HIV prevention and is being presented during the opening plenary of the annual DIA conference. The CAPRISA 004 study demonstrated the effectiveness of tenofovir 1% gel in reducing the risk of HIV and herpes infection in women.

"The CAPRISA 004 trial provides new hope for women who bear the brunt of the HIV epidemic in Africa. When implemented, it could have a profound impact on the course of this epidemic," said Study Co-principal Investigator Dr. Salim S. Abdool Karim, Director of CAPRISA and Pro Vice-Chancellor (Research) of the University of KwaZulu-Natal, South Africa. "This breakthrough would not have been possible without the close collaboration between the three South African and the three U.S. partners who led this study; I am proud and honored to receive this award on behalf of this remarkable team."

The Center for the AIDS Program of Research in South Africa (CAPRISA) of the University of KwaZulu-Natal and Columbia University spearheaded the trial in partnership with FHI and CONRAD, with the support of USAID, and the South African government through the Technology Innovation Agency (TIA). Gilead Sciences donated the active ingredient for the manufacture of the gel.

"We are pleased that the DIA has recognized the CAPRISA team's outstanding achievement and significant contribution to the fields of microbicide research and HIV prevention," said Howard Jaffe, M.D., President and Chairman of the Board of the Gilead Foundation. "Gilead congratulates the principal investigators, study staff and partners, and commends the courageous women who participated in this historic trial."

The CAPRISA 004 study of tenofovir gel involved 889 women at two sites in KwaZulu-Natal, South Africa. Women in the study were advised to use the gel up to 12 hours before sex and again soon after having sex, for a maximum of two doses within 24 hours. Women using the gel with the active ingredient had an average of 39% fewer HIV infections and 51% fewer genital herpes infections compared to women who used a placebo gel. These results provided the first evidence that an antiretroviral drug can reduce the risk of HIV in women.

"USAID made the right decision in supporting the CAPRISA 004 trial. We were thrilled to collaborate with the South African government in funding the study and we continue to work closely with a wide range of partners in planning for all of the aspects of implementation as we await the results of confirmatory trials," said Dr. Jeff Spieler, Senior Technical Advisor in Science and Technology in Population and Reproductive Health (PRH) at USAID.

Read the rest here.

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

FACTS 001 trial announced in South Africa

Yesterday was a big day in the world of HIV prevention and treatment. The FACTS 001 study was announced - a follow-up study to confirm the effectiveness of tenofovir and to verify the CAPRISA 004 results in "larger, more diverse populations". The Phase III trial will be conducted by FACTS (Follow-on African Consortium for Tenofovir Studies) and led by Professor Helen Rees, the Executive Director of WHRI (Wits Reproductive Health and HIV Institute). Read on for excerpts from two articles on the study.

Times LIVE

The Big Read: South African scientists are launching an important HIV clinical trial to confirm the efficacy of a gel that reduces the risk of women getting HIV.

This is the first South African-led consortium to conduct HIV research at seven centres, said the executive director of the Wits Reproductive Health and HIV Institute, Professor Helen Rees.

Until now, multi-site trials were led by international scientists collaborating with local peers.

"The planning for the Facts study is well under way and we hope to be in the field by August," said Rees.

The past year has seen a revolution in HIV-prevention research sparked by three exciting results - one being the gel.

A Tenofovir vaginal gel proved 39% effective at protecting young women from HIV and halved the risk of Herpes HSV-2, according to the Caprisa 004 study in KwaZulu-Natal.

Facts aims to confirm these results.

To read on, click here.

allAfrica.com

Pretoria — After encouraging results on a vaginal gel containing the antiretroviral drug tenofovir, which reduces HIV infection and risk of contracting genital herpes, a follow-up study to test the safety of the gel has been launched.

The Phase III trial, to be known as FACTS 001, will be conducted by the Follow-on African Consortium for Tenofovir Studies (FACTS) led by Professor Helen Rees, who is the Director of the Wits Reproductive Health and HIV Institute (WRHI). It is expected to start by the end of July and run for 24 months.

The study prior to this, known as CAPRISA 004, was conducted last year by the Centre for the Aids Programme of Research in South Africa (CAPRISA) on nearly 900 women in KwaZulu-Natal.

It showed that the use of the gel reduced HIV infection by 39 percent and also reduces the risk of contracting genital herpes by 51 percent.

However, CAPRISA 004 was a relatively small trial (Phase IIb trial) and was not designed for licensure purposes.

On Tuesday, the Department of Science and Technology, in partnership with the United States, launched FACTS 001, which will test the safety and effectiveness of 1 percent tenofovir gel.

FACTS 001 will be a bigger study than CAPRISA 004, involving 2200 women aged 18 to 30 years at seven trial sites across South Africa.

Read the rest of the article here.

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