"Acyclovir and Transmission of HIV-1 from Persons Infected with HIV-1 and HSV-2"
New England Journal of Medicine Vol. 362; No. 5: P. 427-439, (02.04.2010) C. Celum and others for the Partners in Prevention HSV/HIV Transmission Study Team   CDC NPIN Summary
Among those infected with both HIV-1 and herpes simplex virus type 2 (HSV-2), daily acyclovir treatment provides a dramatic reduction in occurrence of genital ulcers from HSV-2, but does not reduce transmission of HIV-1 itself, authors of the current study report.

Investigators followed 3,360 couples in 14 sites in Africa. Only one member of each couple was HIV-positive - 68 percent of whom were women - and that partner was also infected with HSV-2. Infected partners were evenly assigned at random to take either acyclovir 400 mg twice daily or placebo.

During the 24-month study period, 132 HIV seroconversions were reported among the previously uninfected partner. Of these, 84 infections were determined to be from the study partner; 38 were not genetically linked as determined by viral sequencing, and 10 other transmissions were lost to follow up for other reasons.

Of the 84 transmissions, 41 were in the group treated with acyclovir (hazard ratio 0.92; 95 percent CI 0.60 to 1.41; P=0.69). Consistent with previous findings, partners who were uninfected with HIV-1 but positive for HSV-2 at the start of the study were at increased risk for becoming HIV-1 positive compared to those without HSV-2 (hazard ratio 2.02; 95 percent CI 1.15 to 3.57).

The authors suggest that the lack of efficacy of acyclovir in suppressing HIV-1 transmission is not due to poor activity of the treatment against HSV-2, as treatment reduced the occurrence of genital ulcers by 73 percent. In addition, they discounted the likelihood of noncompliance, as acyclovir reduced mean plasma concentration of HIV-1 by 0.25 log10 copies/mL (95 percent CI 0.22 to 0.29; P less than 0.001).

The results suggest that a greater reduction in HIV-1 levels is needed to reduce the risk of transmission, the authors said. “This indication that a greater reduction in the plasma viral load may have to be achieved provides information that can be useful in the development of other biomedical strategies for the prevention of HIV-1 such as the treatment of coexisting infections (e.g., malaria or helminthic infection), and in the development of HIV-1 vaccines directed at reducing the HIV-1 viral load.”



"HIV-Positive Patients' Discussion of Oral Health with Their HIV Primary Care Providers in Miami, Florida"
AIDS Care Vol. 21; No. 12: P. 1578-1584, (12..2009) Margaret Pereyra; Lisa R. Metsch; Lauren Gooden  CDC NPIN Summary
During the course of their infection, more than 90 percent of persons living with HIV will have at least one oral manifestation of HIV disease. Given this prevalence, and the fact that clinically significant manifestations of oral disease may affect treatment regimens, clinical guidelines suggest that oral cavity examination should be included in initial as well as interim physical examinations of HIV patients.

In the current study, the researchers sought to describe HIV patients' discussion of oral and dental health with their HIV primary care providers and to identify the correlates of that discussion. Cross-sectional baseline data from a random trial testing the efficacy of a risk-reduction intervention were examined by the researchers.

The study's subjects were HIV-positive men and women accessing care at five HIV primary care clinics in Miami-Dade County, Fla. Of participants, 37 percent had no discussion of oral health with their provider. After controlling for age, gender, education, and clinic, the odds of discussion of oral health for respondents with five or more primary care visits in the past year were half the odds of those with fewer visits. For men reporting illicit drug use, odds of discussion were 35 percent of that for non-drug-using men. Odds of discussion were 1.4 times greater for each additional health topic (e.g., nutrition, smoking) that was discussed.

“Given that more than one-third of patients reported no discussion of oral health with their HIV primary care providers in the past year, there is a need to increase the focus on oral health in the HIV primary care setting,” the authors concluded.

 

February 10, 2010 - FDA approved Norvir (ritonavir) 100 mg Tablets - These tablets do not require refrigeration.
Summarized below are highlights from the new Norvir Tablet package insert. Unlike the capsule formulation, Norvir tablets must be taken with meals. As a result, Section 2 DOSAGE AND ADMINISTRATION contains the following information specific to the tablet formulation.
NORVIR is administered orally. NORVIR tablets should be swallowed whole, and not chewed, broken or crushed.
General Dosing Guidelines - Patients who take the 600 mg twice daily soft gel capsule NORVIR dose may experience more gastrointestinal side effects such as nausea, vomiting, abdominal pain or diarrhea when switching from the soft gel capsule to the tablet formulation because of greater maximum plasma concentration (Cmax) achieved with the tablet formulation relative to the soft gel capsule [see Clinical Pharmacology (12.3)]. Patients should also be aware that these adverse events (gastrointestinal or paresthesias) may diminish as therapy is continued.
Dose Modification for NORVIR - Dose reduction of NORVIR is necessary when used with other protease inhibitors: amprenavir, atazanavir, darunavir, fosamprenavir, saquinavir, and tipranavir. Prescribers should consult the full prescribing information and clinical study information of these protease inhibitors if they are co-administered with a reduced dose of ritonavir.

Complete label information will be made available soon at DailyMed or Drugs@FDA

 

Study Suggests Brief, Intense Raltegravir Treatment Does Not Reduce Persistent Viremia in People on a Suppressive HAART Regimen
AIDSinfo At-A-Glance Volume 6 Issue 7 (2.19.10)
“We investigated whether intensification with the integrase inhibitor raltegravir decreases plasma HIV-1 RNA levels in patients receiving suppressive antiretroviral therapy. … Subjects … with long-term HIV-1 suppression receiving combination antiretroviral regimens had their regimens intensified for 4 weeks with raltegravir. Plasma HIV-1 RNA level was determined before, during, and after the 4-week intensification period, using a sensitive assay (limit of detection, 0.2 copies of HIV-1 RNA/mL of plasma). … There was no evidence in any subject of a decline in HIV-1 RNA level during the period of raltegravir intensification or of rebound after discontinuation. Median levels of HIV-1 RNA before (0.17 log(10) copies/mL), during (0.04 log(10) copies/mL), and after (0.04 log(10) copies/mL) raltegravir intensification were not significantly different … . Intensification of antiretroviral therapy with a potent HIV-1 integrase inhibitor did not decrease persistent viremia in subjects receiving suppressive regimens, indicating that rapidly cycling cells infected with HIV-1 were not present. Eradication of HIV-1 from infected persons will require new therapeutic approaches.”

More information is available:

• PubMed: Study abstract
• ClinicalTrials.gov: Study summary
• AIDSinfo: Raltegravir (Isentress) fact sheet
  
   

NAM Covers 17th Conference on Retroviruses and Opportunistic Infections, San Francisco, USA
16-19 February 2010
The annual Conference on Retroviruses and Opportunistic Infections (CROI) is one of the major conferences of the year for the HIV world. The conference aims to give scientists and doctors an opportunity to share their HIV research, so that the work they do in clinical practice and in laboratories can be turned into progress around the world.
Highlights from this year's conference may include new information on:
• Treatment as prevention
• Hepatitis and HIV co-infection in the developing world
• Heart disease and bone problems in people on long-term treatment
• HIV and the brain: should we worry about long-term effects?
• Cancers in people with HIV
• TB prevention and treatment

NAM is an award-winning, community-based organisation, which works from the UK. We deliver reliable and accurate HIV information across the world to HIV-positive people and to the professionals who treat, support and care for them.

Live Coverage Blog for CROI Launches
The International Foundation for Alternative Research in AIDS (IFARA) launched it blog to provide Live coverage of CROI Press Conferences, on-demand Interviews, Summary Panel discussions in multiple languages and programming for special populations.

CROI - Conference on Retroviruses and Opportunistic Infections – is the pre-eminent conference on the science of AIDS, covering current HIV/AIDS and Hepatitis research peer reviewed by thousands of attendees in poster sessions and convened sessions from February 17-19th 2010 at the Moscone West Convention Center, San Francisco, CA

PRESS CONFERENCES: will be webcast on www.IFARABLOG.org 1pm PT each day at CROI

ON DEMAND INTERVIEWS: Community educators and scholarship recipients of the CROI will interview leading scientists and clinicians presenting data and discussion about the use of anti-HIV and Hepatitis medications being presented and reviewed at the CROI. These interviews should provide a deeper look at the work of the researchers and answer some of the questions one might have about the individuals work.

MAIN PROGRAM: “A LONG LIFE WITH AIDS / UPDATE 2010”. IFARA produces its ninth annual webcast from the Conference on Retroviruses and Opportunistic Infections, “CROI” on February 20th, 2010 (3-5pm ET, 2-4pm CT, 1-3pm MT, noon-2pm PT, 11am-1pm AKT, 10am-Noon HT). The webcast direct from San Francisco will be a two-hour summary of the CROI conference, highlighting new information related to HIV and Hepatitis treatment issues. This multi-panel program is appropriate for medical and non-medical HIV/AIDS providers and informed community, supportive friends and family. To become a host in your city or view the program see above contacts.

PROGRAMMING FOR SPECIAL POPULATIONS: Panel programs hosted by individuals who are best able to present useful information requested by special populations will be presented on Saturday the 20th before and after the MAIN PROGRAM. Focuses: African American, Native American, Women, Aging, Youth, (special language programs) Spanish, French, German, Italian, Russian, Chinese, Japanese.

IFARA is a not for profit organization dedicated to delivering important new HIV/AIDS and Hepatitis information to as many interested people as possible, focusing on diverse populations and multiple levels of education in both patient and provider communities.

All programs shown on the Blog site www.IFARABLOG.org will appear with past conferences within a month on the IFARA Website: https://IFARA.info . The IFARA website contains further information about this year’s project including disclosure statements, Host site information and evaluation forms.
 

FDA Advises Serious Liver Disorder Associated with the Use of Videx/Videx EC (Didanosine)
AIDSinfo At-A-Glance Volume 6 Issue 4 (1.29.10)
"The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals and patients about a rare, but serious, complication in the liver known as non-cirrhotic portal hypertension in patients using Videx or Videx EC (didanosine). Didanosine is a medication used to treat human immunodeficiency virus (HIV) infection. Videx was the first approved didanosine medication. Videx EC is a delayed-release version of Videx.

"Non-cirrhotic portal hypertension (portal hypertension that is not caused by cirrhosis of the liver) is rare in the United States. It occurs when blood flow in the major vein in the liver (the portal vein) slows down. This slowed blood flow can lead to the development of severely enlarged esophageal veins (varices) in the gastrointestinal system. Because esophageal varices are thin and portal hypertension increases the pressure of blood flow in these veins, esophageal varices can break open. This can result in serious bleeding and, in some cases, death.

"FDA became aware of cases of non-cirrhotic portal hypertension through adverse event reports submitted to FDA's Adverse Event Reporting System (AERS). Based on these reports, FDA has revised the didanosine drug label to include information about non-cirrhotic portal hypertension to help ensure the safe use of this drug.

"FDA believes the clinical benefits of didanosine for certain patients with HIV continue to outweigh its potential risks. The decision to use this drug, however, must be made on an individual basis between the treating physician and the patient."

Additional safety information regarding Videx/Videx EC (didanosine) can be found in the FDA press release.