Navigation Links
Study of tenofovir vaginal gel shows daily dosing ineffective due to lack of adherence
Date:3/4/2013

ARLINGTON, VIRGINIA (12:15 EST MARCH 4, 2013) Researchers with the Microbicide Trials Network (MTN) today announced results of the Vaginal and Oral Interventions to Control the Epidemic (VOICE) study at the Conference for Retroviruses and Opportunistic Infections (CROI) in Atlanta, Georgia. The VOICE study tested oral and vaginal antiretroviral-based approaches as HIV prevention methods in 5,029 women in South Africa, Uganda, and Zimbabwe. Funded by the U.S. National Institutes of Health and managed by the MTN, the VOICE study was a major undertaking, which has provided important data regarding drug safety, effectiveness, acceptability and adherence.

"The principal investigators of the study, Drs. Jeanne Marazzo and Zvavahera Mike Chirenje, and the entire VOICE team have done an outstanding job," said CONRAD Executive Director Gustavo Doncel, M.D., Ph.D.

VOICE launched in September 2009 as a Phase IIB safety and effectiveness study to compare 3 different once-daily HIV prevention strategies: 1) a pill of combination emtricitabine and tenofovir (Truvada), 2) a pill containing only tenofovir (Viread), and 3) tenofovir 1% vaginal gel. Study participants received ongoing HIV risk-reduction counseling, condoms, and diagnosis and treatment of sexually transmitted infections throughout the trial. They were tested monthly for HIV and quarterly for drug levels.

In an evaluation of plasma samples in a subset of the women, drug was detected on average in 28% of participants taking oral tenofovir, 29% of participants taking oral Truvada, and 23% of participants in the vaginal gel study arm. Unfortunately, due to the low adherence, none of the products were deemed effective in reducing HIV acquisition in this particular trial. The estimates of effectiveness for both oral tenofovir and Truvada were less than zero. The study showed a 14.7% reduction of HIV infection in the tenofovir gel arm, when compared to placebo gel. This level of protection, however, was not statistically significant.

Some of the previous studies using the same antiretrovirals in tablet or gel form for HIV prevention showed effectiveness. In particular, CAPRISA 004, a study completed in 2010 using the same tenofovir vaginal gel used in the VOICE trial, showed an average of a 39% reduction in HIV infections and a 54% reduction in women who used it at least 80% of the time. Additionally, tenofovir gel reduced the risk of herpes genital infections by 51%. The dosing regimen was different than the daily dosing used in the VOICE study women in CAPRISA 004 were required to insert 1 dose before sex and 1 dose after sex, not to exceed 2 doses in 24 hours (a regimen dubbed BAT24). CAPRISA 004 was the first trial to show that a topical product containing tenofovir could reduce HIV infection and suggests that a dosing method that requires women to use the product around the time of sex, versus daily dosing, may be preferable to women.

To that end, FACTS 001, a study sponsored by CONRAD, funded by USAID, the Bill & Melinda Gates Foundation and the South African government, and co-chaired by the South African scientists, Drs. Helen Rees and Glenda Gray, is currently being conducted at 9 sites in South Africa. The trial replicates the dosing regimen used in CAPRISA 004 (i.e., BAT 24). FACTS 001 is using a variety of methods to collect information about gel use, condom use, and sexual behavior in order to measure adherence. The study has enrolled close to 1,900 participants and is expected to be complete at the end of 2014. FACTS 001 is an important study as it is designed to confirm the results obtained in CAPRISA 004 and contribute to the approval of tenofovir gel as a pericoital method for prevention of HIV infection in women.

The VOICE study also found that single women under 25 were the least likely to use the product and the most likely to acquire HIV. "The VOICE results highlight the gravity of the epidemic, especially in young, unmarried women, and the importance of developing products that appeal to them. At CONRAD, we remain committed to designing HIV prevention products based on innovation and sound product development strategies," said Dr. Doncel.

"The results of the CAPRISA 004 and VOICE trials illustrate that there are some women who may only want to use a product when they know they are having sex and the FACTS 001 study plays a very important role in testing that hypothesis. We need more information on the type of products that women who are at the highest risk level want and will use," said Dr. Jill Schwartz, CONRAD's Medical Director.


'/>"/>

Contact: Annette Larkin
alarkin@conrad.org
703-772-6427
CONRAD
Source:Eurekalert

Related medicine news :

1. Study Suggests Vaccine May Help Kids With Brain Cancer
2. Study reveals how cancer drug causes diabetic-like state
3. Coffee Drinking in Pregnancy Wont Lead to Sleepless Baby: Study
4. Lower GI problems plague many with rheumatoid arthritis, Mayo Clinic study finds
5. Veggies Like Broccoli, Cabbage May Help Fight Breast Cancer: Study
6. No Added Cancer Risk From Hip Replacement Materials: Study
7. Reported Decline in U.S. Pneumonia Deaths May Be False: Study
8. Early Study Finds Some Promise for Lung Cancer Vaccine
9. Narcissists Often Ace Job Interviews, Study Finds
10. Sexual objectification of female artists in music videos exists regardless of race, MU study finds
11. Soy may alleviate hot flashes in menopause, large-scale study finds
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/29/2016)... ... April 29, 2016 , ... Reltok Nasal Products proudly announces that ... head and neck/ear, nose and throat specialty, has added the KOTLER NASAL AIRWAY™ to ... AIRWAY™ is a newly patented safety device secured by nasal surgeons onto the ...
(Date:4/29/2016)... ... April 29, 2016 , ... Jvion, the ... of funding led by Eastside Partners, with participation from existing investor Martin Ventures. ... base and accelerate its technology and product roadmap. , “Jvion is ...
(Date:4/29/2016)... ... April 29, 2016 , ... Regenerative Medicine Solutions ... to Work employee satisfaction survey, earning them second place for Tampa’s Best Places to ... employees. , “This is a great accomplishment for our team,” says RMS Human ...
(Date:4/29/2016)... ... April 29, 2016 , ... The infertility specialists at ... Sanaz Ghazal, and Dr. Daniel A. Potter -- are proud of the recent release ... Technology (SART). In April, SART published the latest verified data for 375 ...
(Date:4/29/2016)... ... April 29, 2016 , ... ... their animal line of probiotics, Petbiotics ™, as they fondly call them. ... animal rescue groups networking for their non-profit organizations. Animal rescues across the nation ...
Breaking Medicine News(10 mins):
(Date:4/27/2016)... New York , April 27, 2016 ... market report titled, "Skincare Devices Market - Global Industry ... 2023." According to the report, the global skincare devices ... and is anticipated to expand at a CAGR of ... Mn in 2023. Browse the full Skincare Devices ...
(Date:4/27/2016)... 27, 2016 Research ... "Global Anesthesia Disposables Market 2016-2020"  report to ... ) ,The global anesthesia disposables market is ... 4.03% during the period 2016-2020.  ... to patients, safety. Organizations like the CDC ...
(Date:4/26/2016)... 2016 Diplomat Pharmacy, Inc. (NYSE: DPLO) is ... , Pharm D., to Vice President of Education and ... Hagerman will continue to lead and oversee Diplomat University, ... education and training to Diplomat employees and external professionals ... University also houses the quality assurance department, which focuses ...
Breaking Medicine Technology: