Harare, Zimbabwe - Men and women infected with HIV reduced the risk of transmitting the virus to their sexual partners through initiation of oral antiretroviral therapy (ART), according to findings from a large multinational clinical study conducted by the HIV Prevention Trials Network (HPTN), a global partnership dedicated to reducing the transmission of HIV through cutting-edge biomedical, behavioral, and structural interventions.
The study, known as HPTN 052, was designed to evaluate whether immediate versus delayed use of ART by HIV-infected individuals would reduce transmission of HIV to their HIV-uninfected partners and potentially benefit the HIV-infected individual as well. Findings from the study were reviewed by an independent Data and Safety Monitoring Board (DSMB). HPTN 052 is the first randomized clinical trial to show that treating an HIV-infected individual with ART can reduce the risk of sexual transmission of HIV to an uninfected partner.
“The study was designed to evaluate the benefit to the sexual partner as well as the benefit to the HIV-infected person. This is the first randomized clinical trial to definitively indicate that an HIV-infected individual can reduce sexual transmission of HIV to an uninfected partner by beginning antiretroviral therapy sooner. HPTN recognizes the significant contribution that this study’s participants have made to furthering the progress in HIV treatment and prevention. We are very grateful for their participation.”
HPTN 052 began in April 2005 and enrolled 1,763 HIV-serodiscordant couples (couples that have one member who is HIV-infected and the other who is HIV-uninfected), the vast majority of which (97 percent) were heterosexual. The study was conducted at 13 sites across Africa including Zimbabwe, Asia and the Americas. The HIV-infected person was required to have a CD4 cell count between 350-550 per cubic millimeter (cells/mm3) at enrollment, and therefore did not require HIV treatment for his or her own health. Couples were randomized to one of two groups. In one group, the HIV-infected person immediately began taking ART (immediate ART group). In the other group, the HIV-infected person began ART when his or her CD4 cell count fell below 250 cells/mm³ or if he/she developed an AIDS-related illness (the delayed ART group).
Throughout the study, both groups received HIV-related care that included counseling on safe sex practices, free condoms, treatment for sexually transmitted infections, regular HIV testing, and frequent evaluation and treatment for any complications related to HIV infection. Each group received the same amount of care and counseling. Any HIV-uninfected person who became HIV-infected during the course of the study was referred to local services for appropriate medical care and treatment.
Earlier therapy is a superior option that benefits both an infected individual and his or her uninfected partner and we support global efforts to offer ART to everyone who needs it. Among the 877 couples in the delayed ART group, 27 HIV transmissions occurred. This was in contrast to only one (1) transmission that occurred in the immediate ART group. This difference was highly statistically significant. The viruses transmitted in these 28 cases were confirmed to be linked by genetic analysis, confirming that the source of the new infection was the previously HIV-infected partner.
In the originally HIV-infected individuals themselves, 17 cases of extrapulmonary tuberculosis occurred in the delayed ART group, compared with three (3) cases in the immediate ART group, also a statistically significant finding. There were also 23 deaths during the study. Thirteen (13) occurred in the delayed ART group and 10 in the immediate ART group. Study participants and investigators are being informed of the results, and HIV-infected participants in the delayed ART group will be offered ART. All study participants will continue to be followed for at least one more year.
Recently released data from another study, HPTN 043, demonstrated that community mobilization boosts HIV testing in developing countries and is one option for effectively increasing coverage of HIV testing services. The HPTN is evaluating a test, link to care, plus treat approach for prevention of HIV transmission in HPTN 065, a study currently underway in the USA. This study will demonstrate the population-level impact of increased knowledge of HIV status and linkage to care on HIV transmission.
The HIV Prevention Trials Network (HPTN) is a partnership between scientists and communities around the world to develop, evaluate, and implement cutting-edge biomedical, behavioral, and structural interventions to reduce the transmission of HIV. HPTN uses randomized controlled clinical trials, designed and conducted according to the highest scientific and ethical standards, to identify the best combinations of interventions for the populations at highest risk of HIV infection worldwide. HPTN is largely funded by National Institute for Allergy and Infectious Diseases with additional funding from National Institute on Drug Abuse and National Institute for Mental Health, at the US National Institutes of Health.
Tuesday, June 21, 2011
New Hope for HIV?
Johannesburg, South Africa – Researchers, advocates, funders and pharmaceutical companies’ representatives gathered in Johannesburg, South Africa to prepare and plan for the implementation of 1% Tenofovir Gel. The meeting that ran on 13 and 14 June 2011 is a follow up to a similar meeting, “next steps 1% Tenofovir Gel,” meeting held in South Africa last year. The August 2010 meeting came subsequent to the historic results of the CAPRISA 004 trial released early in July 2010 at the International AIDS Conference at Vienna, Austria. The study results showed that 1% tenofovir gel reduced the risk of HIV infection in women by 39% compared with placebo (control arm), and by 54% in the women who reported more consistent gel use.
The purpose of this high-level indaba was to indentify priority actions to ensure rapid expansion and availability of 1% tenofovir gel following licensure and to inform normative guidance on use of the gel in high HIV incidence countries and settings. The meeting seeks also to identify key contextual issues related to product introduction and implementation that will guide product roll out strategies.
Players in the HIV prevention field are concerned about outlining current plans for market authorization, manufacturing and supply; synthesise and build on existing knowledge on microbicides and other health innovations particularly related to sexual and reproductive health, including family planning.
Follow up studies currently ongoing will provide parallel comparisons of oral and topically applied antiretroviral strategies for prevention of HIV infection in women. One such study, the MTN 003 (Microbicides Trials Network), VOICE (Vaginal & Oral Interventions to Control the Epidemic) is a phase IIb safety and effectiveness study of 1% tenofovir gel, tenofovir tablet, Truvada tablet for prevention of HIV infection in women. This study is being rolled out at sites in South Africa, Uganda and Zimbabwe with a target sample size approximately 5000 women.
The Zimbabwe arm of the study has enrolled 600 women at sites in Chitungwiza's Zengeza Clinic, Seke South and Harare at the Spilhaus Clinic, Harare Central Hospital. The sites under the auspices of the UZ-UCSF are part of the larger effort to bring much needed HIV prevention empowerment hope for many women who make up the majority of people living with HIV.
The WHO/UNAIDS meeting was being attended by close to 60 delegates form USAID, WHO, UNAIDS, and various research institutions,advocacy groups and government representatives. Conspicuous with their absence were Ministry of Health officials from Zimbabwe, where a reasonably sized population is part of the trials. The meeting was fully sponsored by UNAIDS, WHO and USAID.
The purpose of this high-level indaba was to indentify priority actions to ensure rapid expansion and availability of 1% tenofovir gel following licensure and to inform normative guidance on use of the gel in high HIV incidence countries and settings. The meeting seeks also to identify key contextual issues related to product introduction and implementation that will guide product roll out strategies.
Players in the HIV prevention field are concerned about outlining current plans for market authorization, manufacturing and supply; synthesise and build on existing knowledge on microbicides and other health innovations particularly related to sexual and reproductive health, including family planning.
Follow up studies currently ongoing will provide parallel comparisons of oral and topically applied antiretroviral strategies for prevention of HIV infection in women. One such study, the MTN 003 (Microbicides Trials Network), VOICE (Vaginal & Oral Interventions to Control the Epidemic) is a phase IIb safety and effectiveness study of 1% tenofovir gel, tenofovir tablet, Truvada tablet for prevention of HIV infection in women. This study is being rolled out at sites in South Africa, Uganda and Zimbabwe with a target sample size approximately 5000 women.
The Zimbabwe arm of the study has enrolled 600 women at sites in Chitungwiza's Zengeza Clinic, Seke South and Harare at the Spilhaus Clinic, Harare Central Hospital. The sites under the auspices of the UZ-UCSF are part of the larger effort to bring much needed HIV prevention empowerment hope for many women who make up the majority of people living with HIV.
The WHO/UNAIDS meeting was being attended by close to 60 delegates form USAID, WHO, UNAIDS, and various research institutions,advocacy groups and government representatives. Conspicuous with their absence were Ministry of Health officials from Zimbabwe, where a reasonably sized population is part of the trials. The meeting was fully sponsored by UNAIDS, WHO and USAID.
Tuesday, October 26, 2010
SAT Engages Communities in NPTs
Kadoma, Zimbabwe - More than 50 representatives of Community Based Organisations (CBOs) and media representatives met at Kadoma to strategise on ways to engage local communuties in New Prevention Technologies (NPTs).
In her opening remarks, Deputy Executive Director & Company Secretary of the Southern African AIDS Trust (SAT) Flanny Chiganze spoke about the yawning gaps existing between communities and research. The workshop sought to help SAT assess suitability of NPT modules, strengthen the capacity of media representatives to report on NPT trials with accuracy and sensitivity, raise skills amongst community-based organisations (CBOs) to critically analyse media discourse about HIV prevention trials as well as increase the capacity of community representatives to understand and communicate NPT trial results effectively.
Main on the agenda were discusions around the following:
1. Understanding the Research process
2. Understanding Prevention Trials
3. Understanding Trial Results
4. Interpreting Trial Results (Post)
5. Critical Analysis of Trial Reporting
SAT will be rolling out similar workshops in Zambia and Malawi. Zimbabwe is home to microbicide and PrEP research studies being conducted by the University of Zimbabwe -University of California, San Francisco (UZ-UCSF) Collaborative Research Programme.
In her opening remarks, Deputy Executive Director & Company Secretary of the Southern African AIDS Trust (SAT) Flanny Chiganze spoke about the yawning gaps existing between communities and research. The workshop sought to help SAT assess suitability of NPT modules, strengthen the capacity of media representatives to report on NPT trials with accuracy and sensitivity, raise skills amongst community-based organisations (CBOs) to critically analyse media discourse about HIV prevention trials as well as increase the capacity of community representatives to understand and communicate NPT trial results effectively.
Main on the agenda were discusions around the following:
1. Understanding the Research process
2. Understanding Prevention Trials
3. Understanding Trial Results
4. Interpreting Trial Results (Post)
5. Critical Analysis of Trial Reporting
SAT will be rolling out similar workshops in Zambia and Malawi. Zimbabwe is home to microbicide and PrEP research studies being conducted by the University of Zimbabwe -University of California, San Francisco (UZ-UCSF) Collaborative Research Programme.
FDA and CONRAD Chart U.S. Regulatory Path for 1% Tenofovir Gel for HIV Prevention
Arlington, VA - - The U.S. Food and Drug Administration (FDA) held an end-of-Phase II meeting to determine the next steps required for U.S. licensure of 1% tenofovir gel, a microbicide product recently found to be effective at reducing the rate of HIV and herpes infection in women when used before and after sex.
The meeting, held on October 20, 2010, was requested by CONRAD, a division of the Eastern Virginia Medical School in Norfolk, VA. CONRAD was one of the partners in the Phase II study, “CAPRISA 004,” which evaluated 1% tenofovir gel in prevention of male-to-female HIV transmission in 889 women in South Africa. USAID provided funding for the trial, conducted by the Centre for Programme Research for AIDS in South Africa and U.S. based FHI, which was the first study to show that a vaginal gel can reduce the risk of HIV and herpes infection in women. CONRAD manufactured and provided the tenofovir gel for the study.
Tenofovir gel was found to be 39% effective in reducing a woman’s risk of becoming infected with HIV during sex and 51% effective in preventing genital herpes infections in the women participating in the trial. Results of the CAPRISA 004 clinical trial were reported in July 2010 and represent the first “proof of concept” for a vaginal microbicide.
A number of key stakeholders contributed to the collaborative meeting with the FDA, including representatives from the U.S. National Institutes of Health, the U.S. Agency for International Development, Gilead Sciences, Microbicides Trial Network (MTN), South African clinical investigators, the International Partnership for Microbicides (IPM) and FHI.
During the meeting, the FDA stated their preference for two well-controlled studies to verify the safety and efficacy of 1% tenofovir gel prior to submission of a New Drug Application (NDA). The FDA furthermore stated that the NIH-sponsored Phase IIB study, MTN-003, known as VOICE (Vaginal and Oral Interventions to Control the Epidemic), represents a second adequate and well-controlled study that would, if successful, serve as the second pivotal trial together with CAPRISA 004 to support the submission of an NDA for 1% tenofovir gel.
In addition, the FDA has granted Fast Track approval designation for 1% tenofovir gel, which facilitates the development and expedites the review of drugs that are intended for treating serious diseases and fill an unmet medical need. With Fast Track designation, an NDA can be submitted as a “rolling review”, which allows a clinical trial sponsor to submit completed sections of its NDA for review by the FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed.
The agency agreed that the current preclinical program for 1% tenofovir gel is sufficient to support a future NDA. However, they stated that additional safety data on adolescents would be needed and that information on in vivo drug interaction studies with commonly used vaginal products should be obtained. Also, the FDA will ultimately need data on post menopausal women. It was also agreed that a future meeting with the FDA would be held to address any outstanding discussions associated with product quality, including chemistry, manufacturing and controls (CMC). Since much of the clinical work on 1% tenofovir gel has been and will be conducted in South Africa, FDA officials indicated that they can work through the FDA’s
“Office of International Programs” with the goal of coordinating the data and review processes with the South African Medicines Control Council.
CONRAD and its partners appreciate the contributions and detailed recommendations put forth by the FDA, which have helped clarify the next steps required for testing and licensure of 1% tenofovir gel.
In 2006, CONRAD and IPM obtained a co-exclusive, royalty-free license from Gilead Sciences to develop 1% tenofovir gel as a topical microbicide for use by women in developing countries to prevent HIV.
The meeting, held on October 20, 2010, was requested by CONRAD, a division of the Eastern Virginia Medical School in Norfolk, VA. CONRAD was one of the partners in the Phase II study, “CAPRISA 004,” which evaluated 1% tenofovir gel in prevention of male-to-female HIV transmission in 889 women in South Africa. USAID provided funding for the trial, conducted by the Centre for Programme Research for AIDS in South Africa and U.S. based FHI, which was the first study to show that a vaginal gel can reduce the risk of HIV and herpes infection in women. CONRAD manufactured and provided the tenofovir gel for the study.
Tenofovir gel was found to be 39% effective in reducing a woman’s risk of becoming infected with HIV during sex and 51% effective in preventing genital herpes infections in the women participating in the trial. Results of the CAPRISA 004 clinical trial were reported in July 2010 and represent the first “proof of concept” for a vaginal microbicide.
A number of key stakeholders contributed to the collaborative meeting with the FDA, including representatives from the U.S. National Institutes of Health, the U.S. Agency for International Development, Gilead Sciences, Microbicides Trial Network (MTN), South African clinical investigators, the International Partnership for Microbicides (IPM) and FHI.
During the meeting, the FDA stated their preference for two well-controlled studies to verify the safety and efficacy of 1% tenofovir gel prior to submission of a New Drug Application (NDA). The FDA furthermore stated that the NIH-sponsored Phase IIB study, MTN-003, known as VOICE (Vaginal and Oral Interventions to Control the Epidemic), represents a second adequate and well-controlled study that would, if successful, serve as the second pivotal trial together with CAPRISA 004 to support the submission of an NDA for 1% tenofovir gel.
In addition, the FDA has granted Fast Track approval designation for 1% tenofovir gel, which facilitates the development and expedites the review of drugs that are intended for treating serious diseases and fill an unmet medical need. With Fast Track designation, an NDA can be submitted as a “rolling review”, which allows a clinical trial sponsor to submit completed sections of its NDA for review by the FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed.
The agency agreed that the current preclinical program for 1% tenofovir gel is sufficient to support a future NDA. However, they stated that additional safety data on adolescents would be needed and that information on in vivo drug interaction studies with commonly used vaginal products should be obtained. Also, the FDA will ultimately need data on post menopausal women. It was also agreed that a future meeting with the FDA would be held to address any outstanding discussions associated with product quality, including chemistry, manufacturing and controls (CMC). Since much of the clinical work on 1% tenofovir gel has been and will be conducted in South Africa, FDA officials indicated that they can work through the FDA’s
“Office of International Programs” with the goal of coordinating the data and review processes with the South African Medicines Control Council.
CONRAD and its partners appreciate the contributions and detailed recommendations put forth by the FDA, which have helped clarify the next steps required for testing and licensure of 1% tenofovir gel.
In 2006, CONRAD and IPM obtained a co-exclusive, royalty-free license from Gilead Sciences to develop 1% tenofovir gel as a topical microbicide for use by women in developing countries to prevent HIV.
Thursday, September 23, 2010
Donors hold key to HIV-free generation
NEW YORK — Top UN health officials are confident that an HIV-free generation is possible by 2015, but have warned of the need to fully fund HIV/AIDS prevention and treatment programmes to ensure that steady progress in recent years does not fall by the wayside.
“This is an unprecedented moment [of] unprecedented momentum. I urge development partners to support the Global Fund [to Fight AIDS, Tuberculosis and Malaria] in their replenishment,” said World Health Organization Director-General Margaret Chan, speaking on 21 September at an event on the sidelines of the three-day Millennium Development Goals summit at the UN headquarters in New York.
Chan added that without adequate funding all the good will, positive interventions and commitments from countries would amount to little.
The importance of preventing mother-to-child transmission of HIV (PMTCT) to achieve three of the Millennium Development Goals (MDGs) - reducing child and maternal deaths, as well as halting and beginning to reverse the spread of HIV/AIDS - “cuts out the fights and competition”, for funding and programming, Chan noted.
Efforts to achieve the three goals could benefit from various women’s health funding and policy commitments rolled out this week during the summit to mark 10 years since countries committed to the MDGs. But HIV, the leading cause of death among reproductive-age women worldwide, could also serve as a weak link causing women’s health targets to veer off track.
About 45 percent of HIV-positive pregnant women received antiretroviral (ARV) treatment to prevent HIV transmission to their children in 2008, an increase from the 35 percent that were treated in 2007.
Scaling up treatment to the 1.4 million pregnant women living with HIV who needed ARV treatment in 2009 to prevent mother-to-child transmission “can be done,” Jimmy Kolker, UN Children’s Fund (UNICEF) chief of HIV/AIDS, told IRIN/PlusNews before the high-level meeting. “It doesn’t require any specific breakthrough or work that isn’t already there.”
Global Fund seeking pledges
But efforts remain partially dependent on donor countries’ contributions to the Global Fund, a major contributor to PMTCT programmes. The international aid agency is seeking replenishment of US$13-20 billion for a three-year period in a “hugely challenging economic environment”, according to Global Fund Executive Director Michel Kazatchkine.
France pledged $1.4 billion to the Global Fund, which provides a fifth of all financing for AIDS globally, this week; Canada later followed with its own pledge of $540 million, while Germany will provide $25 million to Côte d’Ivoire in a debt swap agreement and Norway announced that it will increase its contribution to the Global Fund by 20 percent for the next three years, making a total contribution of $225 million.
Attention is now shifting to the USA, which is being lobbied by advocacy organizations like ONE to donate $6 billion. Kazatchkine said he was expecting an announcement this week from US President Barack Obama, but although Obama spoke of strengthening the US’s commitment to the Global Fund in his speech at the summit on 22 September, he did not reveal any funding pledges.
The US contributed a record-setting $1.05 billion to the Global Fund for the 2010 fiscal year, but has been criticized for not merging AIDS programming and funding laid out in the US President's Emergency Plan for AIDS Relief (PEPFAR), and in its new $63 billion Global Health Initiative with international strategies.
The Global Fund fell short by $3 billion in its last replenishment in 2007. It reached a partial goal of $10 billion to be distributed over 2008, 2009 and 2010.
“Each single dollar counts and when you cut the money short you jeopardize a few more lives,” said Sophio Moyo, Africa director for ONE. “We need to continue to invest in this. Donors have to put their money where their mouth is.”
Scaling up PMTCT services
High-burden countries, specifically in sub-Saharan Africa, have continued to do their part in tackling mother-to-child transmission of HIV, according to Kazatchkine, switching from sub-optimal single-dose nevirapine to “the most appropriate antiretroviral regimens”.
This gradual shift has resulted in an overall increase of 65 percent in PMTCT budgets in high-burden countries.
Seventy out of 123 reporting countries revealed plans to further scale up PMTCT services in 2008, a jump from the 34 countries that presented such plans in 2005.
Namibia, which has a 15 percent rate of HIV prevalence among adults, was singled out for its success in broadening its PMTCT services since 2005. Now more than 60 percent of HIV-positive pregnant women receive ARV treatment and HIV prevalence among children under one dropped from 13.5 percent in 2006 to 7 percent in 2009, according to Namibian President Hifikepunye Lucas Pohamba.
Stigma challenges
Chan praised Pohamba for his commitment to eradicating mother-to-child transmission, maintaining the upbeat tone that characterized much of the event.
“Even just a few years ago it would have been inconceivable that a panel discussion about women living with HIV could be called a time for hope,” said UNICEF’s Executive Director Anthony Lake. “A few years ago, for far too many women a diagnosis of HIV meant, in effect, a double death sentence for the mother and the baby.”
Yet it will take more than confidence, agreement on a common strategy to eliminate PMTCT, and adequate funding, to help HIV-positive pregnant women receive testing and treatment on a universal scale, said UNICEF’s Kolker.
PMTCT could be key to cutting child mortality “In every context there are challenges of stigma so mothers are not tested, or don’t come back for the results,” Kolker explained. “Or they take the medicines home but they don’t take them as instructed. Many things must change in attitude and behaviour to make services readily available.”
In 2008, only 5 percent of pregnant women in low- and middle-income countries reported that their male partners were tested for HIV. Kolker said engaging fathers is “absolutely crucial” in making services more widespread and dispelling notions about women having “low moral character” and bringing the infection into their relationships.
“This is an unprecedented moment [of] unprecedented momentum. I urge development partners to support the Global Fund [to Fight AIDS, Tuberculosis and Malaria] in their replenishment,” said World Health Organization Director-General Margaret Chan, speaking on 21 September at an event on the sidelines of the three-day Millennium Development Goals summit at the UN headquarters in New York.
Chan added that without adequate funding all the good will, positive interventions and commitments from countries would amount to little.
The importance of preventing mother-to-child transmission of HIV (PMTCT) to achieve three of the Millennium Development Goals (MDGs) - reducing child and maternal deaths, as well as halting and beginning to reverse the spread of HIV/AIDS - “cuts out the fights and competition”, for funding and programming, Chan noted.
Efforts to achieve the three goals could benefit from various women’s health funding and policy commitments rolled out this week during the summit to mark 10 years since countries committed to the MDGs. But HIV, the leading cause of death among reproductive-age women worldwide, could also serve as a weak link causing women’s health targets to veer off track.
About 45 percent of HIV-positive pregnant women received antiretroviral (ARV) treatment to prevent HIV transmission to their children in 2008, an increase from the 35 percent that were treated in 2007.
Scaling up treatment to the 1.4 million pregnant women living with HIV who needed ARV treatment in 2009 to prevent mother-to-child transmission “can be done,” Jimmy Kolker, UN Children’s Fund (UNICEF) chief of HIV/AIDS, told IRIN/PlusNews before the high-level meeting. “It doesn’t require any specific breakthrough or work that isn’t already there.”
Global Fund seeking pledges
But efforts remain partially dependent on donor countries’ contributions to the Global Fund, a major contributor to PMTCT programmes. The international aid agency is seeking replenishment of US$13-20 billion for a three-year period in a “hugely challenging economic environment”, according to Global Fund Executive Director Michel Kazatchkine.
France pledged $1.4 billion to the Global Fund, which provides a fifth of all financing for AIDS globally, this week; Canada later followed with its own pledge of $540 million, while Germany will provide $25 million to Côte d’Ivoire in a debt swap agreement and Norway announced that it will increase its contribution to the Global Fund by 20 percent for the next three years, making a total contribution of $225 million.
Attention is now shifting to the USA, which is being lobbied by advocacy organizations like ONE to donate $6 billion. Kazatchkine said he was expecting an announcement this week from US President Barack Obama, but although Obama spoke of strengthening the US’s commitment to the Global Fund in his speech at the summit on 22 September, he did not reveal any funding pledges.
The US contributed a record-setting $1.05 billion to the Global Fund for the 2010 fiscal year, but has been criticized for not merging AIDS programming and funding laid out in the US President's Emergency Plan for AIDS Relief (PEPFAR), and in its new $63 billion Global Health Initiative with international strategies.
The Global Fund fell short by $3 billion in its last replenishment in 2007. It reached a partial goal of $10 billion to be distributed over 2008, 2009 and 2010.
“Each single dollar counts and when you cut the money short you jeopardize a few more lives,” said Sophio Moyo, Africa director for ONE. “We need to continue to invest in this. Donors have to put their money where their mouth is.”
Scaling up PMTCT services
High-burden countries, specifically in sub-Saharan Africa, have continued to do their part in tackling mother-to-child transmission of HIV, according to Kazatchkine, switching from sub-optimal single-dose nevirapine to “the most appropriate antiretroviral regimens”.
This gradual shift has resulted in an overall increase of 65 percent in PMTCT budgets in high-burden countries.
Seventy out of 123 reporting countries revealed plans to further scale up PMTCT services in 2008, a jump from the 34 countries that presented such plans in 2005.
Namibia, which has a 15 percent rate of HIV prevalence among adults, was singled out for its success in broadening its PMTCT services since 2005. Now more than 60 percent of HIV-positive pregnant women receive ARV treatment and HIV prevalence among children under one dropped from 13.5 percent in 2006 to 7 percent in 2009, according to Namibian President Hifikepunye Lucas Pohamba.
Stigma challenges
Chan praised Pohamba for his commitment to eradicating mother-to-child transmission, maintaining the upbeat tone that characterized much of the event.
“Even just a few years ago it would have been inconceivable that a panel discussion about women living with HIV could be called a time for hope,” said UNICEF’s Executive Director Anthony Lake. “A few years ago, for far too many women a diagnosis of HIV meant, in effect, a double death sentence for the mother and the baby.”
Yet it will take more than confidence, agreement on a common strategy to eliminate PMTCT, and adequate funding, to help HIV-positive pregnant women receive testing and treatment on a universal scale, said UNICEF’s Kolker.
PMTCT could be key to cutting child mortality “In every context there are challenges of stigma so mothers are not tested, or don’t come back for the results,” Kolker explained. “Or they take the medicines home but they don’t take them as instructed. Many things must change in attitude and behaviour to make services readily available.”
In 2008, only 5 percent of pregnant women in low- and middle-income countries reported that their male partners were tested for HIV. Kolker said engaging fathers is “absolutely crucial” in making services more widespread and dispelling notions about women having “low moral character” and bringing the infection into their relationships.
Thursday, July 22, 2010
Making Microbicides, Making History
The CAPRISA 004 Study results are out. The results showed a 1% tenofovir gel in 39% in preventing HIV infection and 51% effectiveness in preventing HSV-2 infection, was the highlight of the 18th World AIDS conference in Vienna, Austria.
The study, conducted by the Centre for the Aids Programme of Research in South Africa (Caprisa 004), tested the safety and effectiveness of using 1 percent tenofovir gel tested in 889 women for up to two-and-a-half years in two South African communities, one rural and one urban. Half of the women were randomly assigned to use a gel containing an antiretroviral drug, the other half were given a placebo gel. All were instructed to apply the gel within 12 hours before and 12 hours after intercourse.
The result is outstanding with evidence of high scientific and ethical integrity. No matter how the data is analysed, the analysis consistently showed statistically significant results.
The study showed two things:
1. ARVs can indeed be used as a prophylaxis
2. Microbicides (topical application of a substance in the vagina) is indeed a possible modality for HIV prevention and that women like it.
Futher results show that the observed result was due to high concentration of the tenofovir gel in the vagina and cervical tissues of study participants who remained HIV negative throughout the study. Of significance also is evidence that the higher the level of the tenofovir in the cervico-vaginal fluid, the less the HIV infection and HSV-2 infection observed. Plasma concentration (blood level of tenofovir that could result from systemic absorption of the gel from the vagina) of tenofovir and its metabolite was negligible thereby possibly explaining the absence of resistance in the study.
The result is indeed a proof of concept and exciting for the following reasons:
(i). shows that not only does topical application of 1% tenofovir prevents HIV infection, but that the gel can also prevent HSV infection (thus providing two possible synergistic mechanisms for HIV prevention)
(ii). this is demonstrated consistently across all types of analysis
(iii). consistent with prior results from ARV based prevention studies like the PMTCT study
(iv). has animal studies to support the finding.
Co-chair of the Voice Study, Zimbabwe's CAPRISA equivalent, Prof Mike Chirenje siad, "It is gratifying that we are a step closer to identifying a safe and effective HIV prevention method for women. But to know for certain that tenofovir gel is effective, additional studies must be performed, because we can’t be sure that what worked for the women in Caprisa 004 will be the same for women elsewhere."
However, this finding - as exciting as it may be - is not enough to roll out the product, other studies also need to be conducted - including studying the efficacy of intermittent ARV gel dosing for HIV prevention, rectal safety and efffectiveness and how long an interval between HIV testing will be unacceptable risk for resistance.
The study, conducted by the Centre for the Aids Programme of Research in South Africa (Caprisa 004), tested the safety and effectiveness of using 1 percent tenofovir gel tested in 889 women for up to two-and-a-half years in two South African communities, one rural and one urban. Half of the women were randomly assigned to use a gel containing an antiretroviral drug, the other half were given a placebo gel. All were instructed to apply the gel within 12 hours before and 12 hours after intercourse.
The result is outstanding with evidence of high scientific and ethical integrity. No matter how the data is analysed, the analysis consistently showed statistically significant results.
The study showed two things:
1. ARVs can indeed be used as a prophylaxis
2. Microbicides (topical application of a substance in the vagina) is indeed a possible modality for HIV prevention and that women like it.
Futher results show that the observed result was due to high concentration of the tenofovir gel in the vagina and cervical tissues of study participants who remained HIV negative throughout the study. Of significance also is evidence that the higher the level of the tenofovir in the cervico-vaginal fluid, the less the HIV infection and HSV-2 infection observed. Plasma concentration (blood level of tenofovir that could result from systemic absorption of the gel from the vagina) of tenofovir and its metabolite was negligible thereby possibly explaining the absence of resistance in the study.
The result is indeed a proof of concept and exciting for the following reasons:
(i). shows that not only does topical application of 1% tenofovir prevents HIV infection, but that the gel can also prevent HSV infection (thus providing two possible synergistic mechanisms for HIV prevention)
(ii). this is demonstrated consistently across all types of analysis
(iii). consistent with prior results from ARV based prevention studies like the PMTCT study
(iv). has animal studies to support the finding.
Co-chair of the Voice Study, Zimbabwe's CAPRISA equivalent, Prof Mike Chirenje siad, "It is gratifying that we are a step closer to identifying a safe and effective HIV prevention method for women. But to know for certain that tenofovir gel is effective, additional studies must be performed, because we can’t be sure that what worked for the women in Caprisa 004 will be the same for women elsewhere."
However, this finding - as exciting as it may be - is not enough to roll out the product, other studies also need to be conducted - including studying the efficacy of intermittent ARV gel dosing for HIV prevention, rectal safety and efffectiveness and how long an interval between HIV testing will be unacceptable risk for resistance.
Tuesday, June 1, 2010
Communications Handbook Launched
The Microbicides Media & Communications Initiative (MMCI) on Monday 24 May 2010, on the sidelines of the International Microbicides Conference (M2010), launched a Communications Handbook for Clinical Trials.
The handbook offers strategies, tips and tools to manage controversy, convey messages and disseminate results. The handbook is co-published by the Microbicides Media & Communications Initiative (MMCI), a multi-partner collaboration housed at the global Campaign for Microbicides (GCM) at PATH in Washington, DC, and the Family Health International (FHI) in Research Triangle Park, NC, USA. The project was made possible by the generous support of the American people through the US Agency for International Development (USAID) through dual grants to MMCI and FHI.
The handbook is designed to serve the needs of those who conduct, plan, or implement clinical trials with the objectives of providing practical guidance on how to anticipate and respond to the special communications challenges posed by the conduct of clinical trials in relation to the involvement of the media.
The handbook includes:
1. Sample communication plans for clinical trials
2. Communications and crisis-planning templates and checklists
3. Scenario-planning tools to facilitate planning for the release of trial results
4. Ideas on delegating communications tasks to reduce demands on key site personnel
5. Tips and techniques on how to communicate effectively in interviews, in meetings, and with the media
Chapters of the handbook were shared with over 80 individuals in 13 countries and involved many others who authored case studies, shared materials, and reviewed earlier drafts of the publication.
The preface of the handbook was done by Archbishop Desmond M. Tutu who remarked, "One of the greatest joys and responsibilities of democracy is the freedom of speech. We have the luxury and the burden to communicate our struggles, our hopes, our work, and our passion. In the fight against HIV and the long journey to finding new ways for the most vulnerable to protect themselves, a key challenge is to communicate the logic and the promise of this important work."
The handbook is available on request to: handbook@mmci-communications.org
The handbook offers strategies, tips and tools to manage controversy, convey messages and disseminate results. The handbook is co-published by the Microbicides Media & Communications Initiative (MMCI), a multi-partner collaboration housed at the global Campaign for Microbicides (GCM) at PATH in Washington, DC, and the Family Health International (FHI) in Research Triangle Park, NC, USA. The project was made possible by the generous support of the American people through the US Agency for International Development (USAID) through dual grants to MMCI and FHI.
The handbook is designed to serve the needs of those who conduct, plan, or implement clinical trials with the objectives of providing practical guidance on how to anticipate and respond to the special communications challenges posed by the conduct of clinical trials in relation to the involvement of the media.
The handbook includes:
1. Sample communication plans for clinical trials
2. Communications and crisis-planning templates and checklists
3. Scenario-planning tools to facilitate planning for the release of trial results
4. Ideas on delegating communications tasks to reduce demands on key site personnel
5. Tips and techniques on how to communicate effectively in interviews, in meetings, and with the media
Chapters of the handbook were shared with over 80 individuals in 13 countries and involved many others who authored case studies, shared materials, and reviewed earlier drafts of the publication.
The preface of the handbook was done by Archbishop Desmond M. Tutu who remarked, "One of the greatest joys and responsibilities of democracy is the freedom of speech. We have the luxury and the burden to communicate our struggles, our hopes, our work, and our passion. In the fight against HIV and the long journey to finding new ways for the most vulnerable to protect themselves, a key challenge is to communicate the logic and the promise of this important work."
The handbook is available on request to: handbook@mmci-communications.org
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