Drug Access

FDA Tentatively Approves Mylan's Generic Version of Antiretroviral Viread for Use in PEPFAR

Public Health & Education

Male Circumcision Does Not Offer Protection Against HIV Among U.S. Black, Hispanic MSM, Study Says

Global Challenges

MSF Calls on Roche To Reduce Cost of Oral Antibiotic To Prevent Blindness Among People With HIV/AIDS in Developing Countries

Businesses in Fiji Should Increase Efforts To Fight HIV/AIDS, Conference Delegates Say

Recent Releases

HIV Working Group Releases Report on Vaccine, Microbicide Research, Development

Drug Access

FDA Tentatively Approves Mylan's Generic Version of Antiretroviral Viread for Use in PEPFAR

[Dec 05, 2007]

Pharmaceutical company Mylan on Tuesday announced that it has received tentative FDA approval for its generic version of Gilead Sciences' antiretroviral drug Viread for use in the President's Emergency Plan for AIDS Relief, the AP/Yahoo! Finance reports. India-based Matrix Laboratories will produce the drug, called tenofovir disoproxil fumarate, in 300-mg tablets (AP/Yahoo! Finance, 12/4). The tentative approval for PEPFAR allows a company to immediately sell an antiretroviral in certain countries outside the U.S., Thomson Financial/Forbes reports. The approval also indicates that the product has achieved all safety, efficacy and manufacturing quality standards for marketing in the U.S. (Peer, Thomson Financial/Forbes, 12/4).

Mylan Vice Chair and CEO Robert Coury said that the approval is "another milestone for Mylan and Matrix and their commitment to the company's growing antiretroviral franchise." He added, "We applaud Matrix for its high quality science and manufacturing capabilities that resulted in earning this important tentative approval in such a short time frame" (Mylan release, 12/4). Mylan owns a 71.5% stake in Matrix. The company did not announce pricing information or international sale plans (AP/Yahoo! Finance, 12/4).

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Public Health & Education

Male Circumcision Does Not Offer Protection Against HIV Among U.S. Black, Hispanic MSM, Study Says

[Dec 05, 2007]

Male circumcision does not offer any level of protection against HIV among black and Hispanic men who have sex with men in the U.S., researchers said Monday at the National HIV Prevention Conference in Atlanta, Reuters reports.

For the study, Greg Millett of CDC and colleagues studied 1,079 black and 957 Hispanic MSM residing in Los Angeles, New York City and Philadelphia. The study participants filled out a computer survey and received an HIV test. According to the study, circumcised black and Hispanic MSM were as likely to become HIV-positive as those who were uncircumcised.

The study also found that circumcision did not offer a protective benefit for a subset of black MSM who recently had sex with female partners or among MSM "reporting recent unprotected sex with a male partner in which they were exclusively the insertive male partner," Millett said. He added, "Overall, we found no association between circumcision status and HIV infection status" among black or Hispanic MSM.

Black and Hispanic men are more likely than white men to be HIV-positive, which could offset any protection circumcision provides, Millett said. In addition, black and Hispanic MSM could be exposed to HIV more often than white MSM because they are more likely to have sex with other black and Hispanic MSM, Reuters reports (Fox, Reuters, 12/4).

Webcasts of the conference will be available online at kaisernetwork.org.

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Global Challenges

MSF Calls on Roche To Reduce Cost of Oral Antibiotic To Prevent Blindness Among People With HIV/AIDS in Developing Countries

[Dec 05, 2007]

Medecins Sans Frontieres on Saturday called on pharmaceutical company Roche to provide its oral antibiotic valganciclovir at a reduced cost in developing countries to help prevent a virus that can cause blindness among people living with HIV/AIDS, Reuters reports.

Cytomegalovirus retinitis -- which can cause blindness within three to six months in people living with HIV/AIDS -- occurs in about 25% of people with advanced AIDS in developing countries -- such as Cambodia, Myanmar and China -- MSF said. The group said that CMV retinitis easily is diagnosed and that valganciclovir -- sold under the brand name Valcyte -- is an effective treatment. However, the drug is too costly for agencies to supply it to people living with the disease in developing countries, according to MSF.

Roche said that compared with costs in developed countries, it offers Valcyte in developing countries at the lowest possible cost for long-term provision and on the same terms as its antiretroviral drugs, Reuters reports. Roche has offered to provide aid agencies with Valcyte at a reduced cost of $1,900 for a four-month course, but MSF said the price is too high and excludes many countries where the problem is most widespread. The cost of the drug has forced MSF into "tough compromises," Reuters reports. The group uses treatment options in Thailand that include intravenous treatment or injecting drugs directly into the eyes. MSF pays more than $10,000 for a four-month course of Valcyte per patient in China.

Valcyte primarily is used to prevent CMV retinitis in organ transplant patients in developed countries, Roche said. "For this reason, Roche has to ensure its long-term commitments for transplant patients globally whilst helping to increase access to Valcyte for AIDS patients in the poorest countries of the world," Roche spokesperson Martina Rupp said, adding, "Based upon the not insignificant patient need and the fact that treatment duration cannot necessarily be assumed to be consistently short," the company considers "drug donations of Valcyte to be neither feasible or sustainable" (Cage, Reuters, 12/3).

Tido von Schoen-Angerer, head of MSF's essential medicines campaign, in a statement said, "This is a classic case of the vicious circle." He added that because the "price of the drug is so high, HIV programs aren't screening and therefore are not reporting large numbers of CMV patients. But since on paper there are so few patients, bringing down the price of this treatment and ensuring its availability has never been a priority" (MSF release, 11/30). There is an "urgent need for Roche to both extend their discounted prices to all developing countries and to lower this price further," MSF said (Reuters, 12/3).

CMV Retinitis Screening Should Be Included in Routine HIV/AIDS Care, Study Says

In related news, screening for CMV retinitis should be incorporated into routine HIV/AIDS care in developing countries, according to a study published in the Dec. 1 issue of PLoS Medicine, SciDev.net reports. For the study, David Heiden, an ophthalmologist at the California Pacific Medical Center, and colleagues examined retinal screening of 325 people with AIDS who attended MSF clinics in Cambodia, Myanmar, South Africa, Thailand and Uganda. They found 20% of patients had CMV retinitis, and additional studies showed that 37% of individual eyes were blind because of the disease. Health care for HIV/AIDS in developing countries rarely includes routine screening for the disease, which can remain latent or be triggered by factors such as HIV.

The World Health Organization has not included CMV retinitis in its guidelines for management of HIV in developing countries or in its Vision 2020 blindness program, according to the authors. "CMV has been ignored in resource-poor settings, but must be in the list," Heiden said.

The initial step toward addressing CMV retinitis is to train health workers to use an indirect ophthalmoscope -- a fast, low-cost device that eliminates the need for special eye tests -- according to the study. The second step is treatment, the authors write, adding that although Valcyte is an "effective treatment" for CMV retinitis, it is a "single-source monopoly product priced at a level that is absurdly unrealistic. The medication needs to [be] made available and affordable" (Garcia/Pratchaya, SciDev.net, 12/3).

The study is available online.

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Businesses in Fiji Should Increase Efforts To Fight HIV/AIDS, Conference Delegates Say

[Dec 05, 2007]

Businesses in Fiji should respond to HIV/AIDS and increase their efforts to fight the disease, delegates attending the Fiji-Australia Business Council Forum said on Monday, the Fiji Times reports. Australia's AIDS ambassador Murray Proctor at the conference said HIV/AIDS demands a response from businesses because it affects absenteeism, staffing and training. According to Proctor, HIV/AIDS also "undermines the prosperity and coherence of the communities in which our businesses operate." If the HIV/AIDS situation worsens, there will be an economic snowballing effect "as fewer goods and services are purchased, markets weaken and AIDS takes the economy" into a "downward spiral," Proctor said (Marau, Fiji Times, 12/4).

Steven Vete of UNAIDS at the conference said the most effective way to prevent the spread of HIV is to protect the basic human rights of marginalized groups. "The challenge is to work in partnership to improve the quality of life of your staff and their families and help to develop a program for Pacific small and medium enterprises," Vete said. According to Vete, human rights include access to food; shelter; clean running water; health care; and dignity regardless of race, gender and sexual orientation. Vete said that ways employers can help fight the spread of HIV include inviting HIV-positive people to speak with their workers, encouraging testing and sponsoring community outreach programs. "Doing something about [HIV/AIDS] will save lives as well as money," Vete said (Fiji Times, 12/4).

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Recent Releases

HIV Working Group Releases Report on Vaccine, Microbicide Research, Development

[Dec 05, 2007]

"Building a Comprehensive Response: Funding for HIV Vaccines, Microbicides and Other New Preventive Options: 2000 to 2006," HIV Vaccine and Microbicides Resource Tracking Working Group: The report provides estimates of investment in HIV vaccine and microbicide research and development from 2000 to 2006. The report also includes estimates of investment in new prevention options -- including male circumcision, suppression of the genital herpes virus HSV-2, cervical barriers and pre-exposure prophylaxis.

The report found that over the seven year period, public and philanthropic funding for HIV vaccine and microbicide research and development almost tripled. In 2006, total global investment in preventive HIV vaccine research and development was about $933 million -- a 23% increase compared with 2005 funding levels. For microbicide research and development during the same year, worldwide investment was about $222 million -- a 35% increase compared with 2005. Between 2000 and 2006, five public-sector funders and two foundations provided $183.6 million for research and development in support of new prevention options, the report found. The report added that financial needs for research and development will "remain substantial in the coming years" ("Building a Comprehensive Response: Funding for HIV Vaccines, Microbicides and Other New Preventive Options: 2000 to 2006," November 2007).

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