Bacterial vaginosis is the most common vaginal infection in women of childbearing age. It happens when the normal balance of bacteria in the vagina is disrupted and replaced by an overgrowth of certain bacteria. The vagina normally contains mostly “good” bacteria, and fewer “harmful” bacteria. BV develops when there is an increase in “harmful” bacteria and fewer “good” bacteria.
The cause of BV is not understood. It can develop when something, like sexual contact, disrupts the balance between the good bacteria that protect the vagina from infection and the harmful bacteria that don't. It is not clear what role sexual activity plays in the development of BV, but BV is more common among women who have had vaginal sex. But BV is not always from sexual contact. We do know that certain things can upset the normal balance of bacteria in the vagina and put you more at risk for BV:
- Having a new sex partner or multiple sex partners
- Douching
- Using an intrauterine device (IUD) for birth control
- Not using a condom
- We also know that you do not get BV from toilet seats, bedding, swimming pools, or from touching objects around you.
Women with BV may have an abnormal vaginal discharge with an unpleasant odor. Some women report a strong fish-like odor, especially after sexual intercourse. The discharge can be white (milky) or gray and thin. Other symptoms may include burning when urinating, itching around the outside of the vagina, and irritation. However, these could be symptoms of another infection too. Some women with BV have no symptoms at all.
There is a test to find out if you have BV. Your doctor takes a sample of fluid from your vagina and has it tested. Your doctor may also be able to see signs of BV, like a grayish-white discharge, during an examination of the vagina.
BV is treated with antibiotics, which are medicines prescribed by your doctor. Your doctor may give you either metronidazole or clindamycin. Generally, male sex partners of women with BV do not need to be treated. You can get BV again even after being treated.
All pregnant women with symptoms of BV or who have had a premature delivery or low birth weight baby in the past should be tested for BV and treated if they have it. The same antibiotics that are used to treat non-pregnant women can be used safely during pregnancy. However, the amount of antibiotic a woman takes during pregnancy may be different from the amount taken if not pregnant.
In most cases, BV doesn't cause any problems. But some problems can happen if BV is untreated.
- Pregnancy problems. BV can cause premature delivery and low birth weight babies (less than five pounds).
- PID. Pelvic inflammatory disease or PID is an infection that can affect a woman's uterus, ovaries, and fallopian tubes, which carry eggs from the ovaries to the uterus. Having BV increases the risk of getting PID after a surgical procedure, such as a hysterectomy or an abortion.
- Higher risk of getting other STDs. Having BV can increase the chances of getting other STDs, such as chlamydia, gonorrhea, and HIV. Women with HIV who get BV increase the chances of passing HIV to a sexual partner.
BV is not well understood by scientists, and the best ways to prevent it are unknown. What is known is that BV is associated with having a new sex partner or having multiple sex partners. Follow these tips to lower your risk for getting BV:
- Don’t have sex! The best way to prevent any STD is to practice abstinence, or not having vaginal, oral, or anal sex.
- Be faithful. Have a sexual relationship with one partner is another way to reduce your chances of getting infected. Be faithful to each other, meaning that you only have sex with each other and no one else.
- Use condoms. Protect yourself with a condom EVERY time you have vaginal, anal, or oral sex.
- Condoms should be used for any type of sex with every partner. For vaginal sex, use a latex male condom or a female polyurethane condom. For anal sex, use a latex male condom. For oral sex, use a dental dam. A dental dam is a rubbery material that can be placed over the anus or the vagina before sexual contact.
- Don't douche. Douching removes some of the normal bacteria in the vagina that protects you from infection. This may increase your chances of getting BV. It may also increase the chances of BV coming back after treatment.
- Talk frankly with your doctor or nurse and your sex partner(s) about any STDs you or your partner have or had. Talk about any discharge in the genital area. Try not to be embarrassed.
- Have regular pelvic exams. Talk with your doctor about how often you need them. Many tests for STDs can be done during an exam.
- If you are pregnant and have symptoms of BV or had a premature delivery or low birth weight baby in the past, get tested for BV. Get tested as soon as you think you may be pregnant.
- Finish your medicine. If you have BV, finish all the medicine that you are given to treat it. Even if the symptoms go away, you still need to finish all of the medicine.
Sunday, June 24, 2007
HIV Risk Associated with Different Types of Sexual Activity
Sexual contact is the most common route of HIV transmission. By December 2001, 51% of all HIV infections among adolescents and adults reported to the U.S. Centers for Disease Control and Prevention (CDC) were sexually transmitted (35% by male homosexual contact, 11% by heterosexual contact in females, 5% by heterosexual contact in males). Worldwide, heterosexual transmission is the most common route of HIV infection. Given the importance of sexual transmission in the HIV epidemic, many HIV prevention strategies have focused on identifying and promoting safer-sex practices.
As efforts to develop even more effective treatments and preventive vaccines continue, it is critical to continue aggressive prevention efforts as a vital component of the battle against HIV. Although ART can result in dramatic reductions in HIV viral load, it is not a cure for HIV disease; thus prevention should still be the first line of defense.
Risk Associated with Specific Sexual Practices Epidemiologic investigations of HIV transmission provide substantial evidence that some sexual practices are associated with a high risk of HIV transmission, whereas others are not.
Penile-Vaginal Sex Heterosexual intercourse is presumed to be the most common mode of HIV infection worldwide. Studies of male-to-female and female-to-male transmission provide strong epidemiologic evidence that heterosexual transmission of HIV does occur via penile-vaginal intercourse. Vaginal sex during menstruation may increase the risk of transmission from an infected female to an uninfected male, but probably does not increase the risk of transmission from an infected male to an uninfected female.
The efficiency of heterosexual transmission of HIV and per-act risk of infection are the subjects of debate in the literature. Early studies on heterosexual transmission in Western countries established that male-to-female transmission in the vagina was significantly more likely than female-to-male transmission from the vagina, with estimates in three studies ranging from 1.9, 2.3, and 8.0 times greater efficiency of male-to-female transmission. Per-act infectivity in two studies was found to be low: 0.0005 and 0.0009 for male-to-female transmission, and 0.0003 and 0.0001 for female-to-male transmission. However, studies conducted in developing countries have estimated that per-act transmission probabilities are greater by a factor of 10 for both male-to-female and female-to-male transmission.
Although the greater efficiency of male-to-female versus female-to-male transmission has also been observed in developing countries, a systematic review of the literature found a greatly enhanced efficiency of female-to-male transmission in the high-prevalence epidemics of Asia and sub-Saharan Africa. The ratio of male-to-female summary mean transmission rates in the developing world compared to the rate in Western countries was 2.9, whereas for female-to-male transmission this ratio was 3.41. Women in some developing countries may be more infectious due to higher prevalence of sexually transmitted infections (STIs) and untreated HIV disease; although the authors state that evidence for the relative importance of these factors is unclear. The greater susceptibility of men in developing countries is also difficult explain, and may include a low prevalence of male circumcision, poor genital hygiene, a high prevalence of genital ulcer disease, and a high prevalence of unprotected sex with women having a high probability of being HIV infected. Penile-Anal Sex Strong evidence exists that being the receptive partner in unprotected penile-anal intercourse is associated with a high risk of HIV infection. Transmission of HIV to the receptive partner probably occurs as a result of the deposition of HIV-infected semen on traumatized rectal mucosa. More recently, studies have suggested that exposure to infected pre-ejaculate through anal intercourse may also carry a high risk of transmission. Unprotected receptive anal intercourse (URAI) has been consistently described as an independent risk factor for HIV infection among MSM (men who have sex with men). One recent study estimated the per-act risk of HIV infection from URAI with a partner who is HIV-positive at 0.82% (82 in 10,000) and with a partner of unknown serostatus at 0.27% (27 in 10,000).
Several investigators found that receptive penile-anal sex is also a risk factor for male-to-female transmission. Others failed to find this association among heterosexual couples. Of the latter studies, however, three had small sample sizes, which may have made a relationship between anal sex and HIV infection impossible to detect. It is probable that unprotected anal sex between heterosexual partners carries a similar per-act risk as it would between MSM, with greater risk incurred by the receptive female partner.
Whether being the inserting partner in unprotected penile-anal sex is an independent risk factor for HIV infection is not well understood. Most early studies did not demonstrate a statistically significant association between this practice and HIV infection among MSM. This was not taken as evidence that the behavior was free of risk. One recent study has estimated the per-act risk of unprotected insertive anal sex with an HIV-positive or unknown status partner at 0.06% (6 in 10,000). This risk, although 4-14 times less than that estimated for URAI, remains considerable. The lack of more complete information on the risk of unprotected insertive anal sex reflects the research community's attention to the riskier activity URAI, rather than any consensus that unprotected anal sex has been determined to be of low risk to the insertive partner. Rectal Douching and Rectal Fisting Studies of transmission among MSM have revealed that rectal douching increases the risk of HIV infection. A similar association between fisting (penetration of the anus with the hand) and HIV infection was observed in some studies, but not others. One presumptive mechanism for transmission via these practices is that they disrupt the mucosal barrier of the rectum and thus facilitate entry of HIV into the bloodstream during subsequent exposure to infected body fluids. In a large cohort study of MSM, the investigators devised a composite variable called "rectal trauma," composed of enema usage, receptive fisting, report of blood around the rectum, and evidence of scarring, fissure, or fistula on examination. They found that higher rectal trauma scores correlated with increased risk of HIV infection. Oral-Penile Sex Oral-penile contact (fellatio) is not an efficient route of HIV infection. Estimating precise per-act risk is difficult because so few people practice oral sex to the exclusion of other, higher-risk sexual activities. Nonetheless, the risk of infection from oral sex is believed to be extremely low. Early male-to-male transmission studies consistently failed to demonstrate an increased risk of HIV infection associated with the practice of oral-penile sex. A more recent study of MSM confirmed earlier findings, and further estimated that on a population level, the risk of HIV infection among MSM that is attributable to oral sex is extremely low. Most studies of male-to-female and female-to-male transmission also failed to show any increased risk of HIV infection associated with oral-penile sex. A cohort study among heterosexual couples at an STI clinic in Spain found no signs of infection attributable to oral sex, supporting the conclusion that HIV transmission via oral-penile sex between heterosexuals was extremely low.
Oral-penile contact is not completely risk free, however a study of per-contact risk of infection to the receptive partner found that the probability of infection was 0.06% with a known HIV-positive partner and 0.04% with partners of unknown status. Although these are low probabilities, the authors suggest that oral-penile sex may play a larger role in the epidemic among MSM as more men adopt these behaviors as risk reduction measures Several case reports have implicated oral-penile contact as a source of male-to-male transmission. In one study of heterosexual transmission, repeated oral sex was associated with transmission of HIV from men with AIDS to their spouses, although competing risks also showed significant associations in this study. Because so few people practice oral-penile sex to the exclusion of other sexual practices, it is very difficult to recruit and retain subjects for epidemiologic studies of the HIV risk associated with this practice. Only one study was able to do this; another examined monogamous couples whose only unprotected sexual activity was oral sex. No signs of infection were observed in either study. Despite the case reports, the epidemiologic evidence suggests that unprotected oral-penile sex is a low-risk activity.
Oral-genital sex, both oral-penile and oral-vaginal, can transmit STIs other than HIV with varying degrees of efficiency. Receptive oral-penile sex carries the risk of gonorrheal infection for both men and women, and insertive oral-penile sex, although carrying only extremely low, hypothetical risk of HIV infection to the insertive partner, carries a demonstrable risk of urethral gonorrheal infection. Other risks of receptive oral-genital sex include small probabilities of human papillomavirus and hepatitis C transmission. Insertive oral-penile sex is an efficient route for the transmission of herpes simplex virus (HSV). The damage that many STIs cause to mucosa can conceivably increase the likelihood of transmission of HIV through oral sex, although this risk has not been quantified. Oral-Vaginal Sex The risk of HIV transmission through oral-vaginal sex (cunnilingus) has received less attention than oral-penile sex. There have been case reports of female-to-male and female-to-female transmission of HIV infection via oral-vaginal sex. One study found an association between oral-vaginal sex and female-to-male transmission of HIV, although competing risks also showed significant associations in this study. As with oral-penile sex, conducting an epidemiologic study that can examine oral-vaginal sex in the absence of competing HIV risk behaviors is difficult, and no such studies have been reported. However, all studies that have controlled for competing risk behaviors have concluded that oral-vaginal sex is extremely low risk. Oral-Anal Sex Although oral-anal contact is not an independent risk factor for HIV infection based on data from male-to-male transmission studies, it may be a marker for other high-risk sexual practices. Analysis showed an increased risk of HIV infection associated with oral-anal sex. Oral-anal sex has been shown to be a route of transmission for hepatitis A and B, and parasitic infections such as giardiasis and amebiasis.
As efforts to develop even more effective treatments and preventive vaccines continue, it is critical to continue aggressive prevention efforts as a vital component of the battle against HIV. Although ART can result in dramatic reductions in HIV viral load, it is not a cure for HIV disease; thus prevention should still be the first line of defense.
Risk Associated with Specific Sexual Practices Epidemiologic investigations of HIV transmission provide substantial evidence that some sexual practices are associated with a high risk of HIV transmission, whereas others are not.
Penile-Vaginal Sex Heterosexual intercourse is presumed to be the most common mode of HIV infection worldwide. Studies of male-to-female and female-to-male transmission provide strong epidemiologic evidence that heterosexual transmission of HIV does occur via penile-vaginal intercourse. Vaginal sex during menstruation may increase the risk of transmission from an infected female to an uninfected male, but probably does not increase the risk of transmission from an infected male to an uninfected female.
The efficiency of heterosexual transmission of HIV and per-act risk of infection are the subjects of debate in the literature. Early studies on heterosexual transmission in Western countries established that male-to-female transmission in the vagina was significantly more likely than female-to-male transmission from the vagina, with estimates in three studies ranging from 1.9, 2.3, and 8.0 times greater efficiency of male-to-female transmission. Per-act infectivity in two studies was found to be low: 0.0005 and 0.0009 for male-to-female transmission, and 0.0003 and 0.0001 for female-to-male transmission. However, studies conducted in developing countries have estimated that per-act transmission probabilities are greater by a factor of 10 for both male-to-female and female-to-male transmission.
Although the greater efficiency of male-to-female versus female-to-male transmission has also been observed in developing countries, a systematic review of the literature found a greatly enhanced efficiency of female-to-male transmission in the high-prevalence epidemics of Asia and sub-Saharan Africa. The ratio of male-to-female summary mean transmission rates in the developing world compared to the rate in Western countries was 2.9, whereas for female-to-male transmission this ratio was 3.41. Women in some developing countries may be more infectious due to higher prevalence of sexually transmitted infections (STIs) and untreated HIV disease; although the authors state that evidence for the relative importance of these factors is unclear. The greater susceptibility of men in developing countries is also difficult explain, and may include a low prevalence of male circumcision, poor genital hygiene, a high prevalence of genital ulcer disease, and a high prevalence of unprotected sex with women having a high probability of being HIV infected. Penile-Anal Sex Strong evidence exists that being the receptive partner in unprotected penile-anal intercourse is associated with a high risk of HIV infection. Transmission of HIV to the receptive partner probably occurs as a result of the deposition of HIV-infected semen on traumatized rectal mucosa. More recently, studies have suggested that exposure to infected pre-ejaculate through anal intercourse may also carry a high risk of transmission. Unprotected receptive anal intercourse (URAI) has been consistently described as an independent risk factor for HIV infection among MSM (men who have sex with men). One recent study estimated the per-act risk of HIV infection from URAI with a partner who is HIV-positive at 0.82% (82 in 10,000) and with a partner of unknown serostatus at 0.27% (27 in 10,000).
Several investigators found that receptive penile-anal sex is also a risk factor for male-to-female transmission. Others failed to find this association among heterosexual couples. Of the latter studies, however, three had small sample sizes, which may have made a relationship between anal sex and HIV infection impossible to detect. It is probable that unprotected anal sex between heterosexual partners carries a similar per-act risk as it would between MSM, with greater risk incurred by the receptive female partner.
Whether being the inserting partner in unprotected penile-anal sex is an independent risk factor for HIV infection is not well understood. Most early studies did not demonstrate a statistically significant association between this practice and HIV infection among MSM. This was not taken as evidence that the behavior was free of risk. One recent study has estimated the per-act risk of unprotected insertive anal sex with an HIV-positive or unknown status partner at 0.06% (6 in 10,000). This risk, although 4-14 times less than that estimated for URAI, remains considerable. The lack of more complete information on the risk of unprotected insertive anal sex reflects the research community's attention to the riskier activity URAI, rather than any consensus that unprotected anal sex has been determined to be of low risk to the insertive partner. Rectal Douching and Rectal Fisting Studies of transmission among MSM have revealed that rectal douching increases the risk of HIV infection. A similar association between fisting (penetration of the anus with the hand) and HIV infection was observed in some studies, but not others. One presumptive mechanism for transmission via these practices is that they disrupt the mucosal barrier of the rectum and thus facilitate entry of HIV into the bloodstream during subsequent exposure to infected body fluids. In a large cohort study of MSM, the investigators devised a composite variable called "rectal trauma," composed of enema usage, receptive fisting, report of blood around the rectum, and evidence of scarring, fissure, or fistula on examination. They found that higher rectal trauma scores correlated with increased risk of HIV infection. Oral-Penile Sex Oral-penile contact (fellatio) is not an efficient route of HIV infection. Estimating precise per-act risk is difficult because so few people practice oral sex to the exclusion of other, higher-risk sexual activities. Nonetheless, the risk of infection from oral sex is believed to be extremely low. Early male-to-male transmission studies consistently failed to demonstrate an increased risk of HIV infection associated with the practice of oral-penile sex. A more recent study of MSM confirmed earlier findings, and further estimated that on a population level, the risk of HIV infection among MSM that is attributable to oral sex is extremely low. Most studies of male-to-female and female-to-male transmission also failed to show any increased risk of HIV infection associated with oral-penile sex. A cohort study among heterosexual couples at an STI clinic in Spain found no signs of infection attributable to oral sex, supporting the conclusion that HIV transmission via oral-penile sex between heterosexuals was extremely low.
Oral-penile contact is not completely risk free, however a study of per-contact risk of infection to the receptive partner found that the probability of infection was 0.06% with a known HIV-positive partner and 0.04% with partners of unknown status. Although these are low probabilities, the authors suggest that oral-penile sex may play a larger role in the epidemic among MSM as more men adopt these behaviors as risk reduction measures Several case reports have implicated oral-penile contact as a source of male-to-male transmission. In one study of heterosexual transmission, repeated oral sex was associated with transmission of HIV from men with AIDS to their spouses, although competing risks also showed significant associations in this study. Because so few people practice oral-penile sex to the exclusion of other sexual practices, it is very difficult to recruit and retain subjects for epidemiologic studies of the HIV risk associated with this practice. Only one study was able to do this; another examined monogamous couples whose only unprotected sexual activity was oral sex. No signs of infection were observed in either study. Despite the case reports, the epidemiologic evidence suggests that unprotected oral-penile sex is a low-risk activity.
Oral-genital sex, both oral-penile and oral-vaginal, can transmit STIs other than HIV with varying degrees of efficiency. Receptive oral-penile sex carries the risk of gonorrheal infection for both men and women, and insertive oral-penile sex, although carrying only extremely low, hypothetical risk of HIV infection to the insertive partner, carries a demonstrable risk of urethral gonorrheal infection. Other risks of receptive oral-genital sex include small probabilities of human papillomavirus and hepatitis C transmission. Insertive oral-penile sex is an efficient route for the transmission of herpes simplex virus (HSV). The damage that many STIs cause to mucosa can conceivably increase the likelihood of transmission of HIV through oral sex, although this risk has not been quantified. Oral-Vaginal Sex The risk of HIV transmission through oral-vaginal sex (cunnilingus) has received less attention than oral-penile sex. There have been case reports of female-to-male and female-to-female transmission of HIV infection via oral-vaginal sex. One study found an association between oral-vaginal sex and female-to-male transmission of HIV, although competing risks also showed significant associations in this study. As with oral-penile sex, conducting an epidemiologic study that can examine oral-vaginal sex in the absence of competing HIV risk behaviors is difficult, and no such studies have been reported. However, all studies that have controlled for competing risk behaviors have concluded that oral-vaginal sex is extremely low risk. Oral-Anal Sex Although oral-anal contact is not an independent risk factor for HIV infection based on data from male-to-male transmission studies, it may be a marker for other high-risk sexual practices. Analysis showed an increased risk of HIV infection associated with oral-anal sex. Oral-anal sex has been shown to be a route of transmission for hepatitis A and B, and parasitic infections such as giardiasis and amebiasis.
Source:Safer-Sex Methods HIV InSite Knowledge Base ChapterDecember 2003; Content reviewed January 2006 Tim Lane, PhD, MPH, University of California San Francisco Herminia Palacio, MD, MPH, Harris County Health Department, Houston, Texas http://hivinsite.ucsf.edu/InSite?page=kb-07-02-02#S3.2X
Treatment and Cure
Optimizing treatment and exploring the potential for a cure are vital to our efforts to bring an end to the suffering caused by HIV/AIDS.
One of the greatest successes in HIV/AIDS research so far has been the development of treatments that have lengthened the lives of people living with HIV. Progress made since the earliest days of antiretroviral therapy, when AZT extended lives by only a couple of months, means that today a patient can expect to survive for thirteen additional years on average, thanks to sophisticated highly active antiretroviral therapy (HAART).
Yet the benefits of HAART often come at the cost of serious side effects and toxicities that can limit the utility of the very drugs designed to improve lives. These range from inconvenient and uncomfortable symptoms to serious or even life-threatening conditions such as increased cholesterol, increased risk of heart attack and liver failure, and a diabetes-like syndrome called insulin resistance.
In addition, growing numbers of patients on treatment, as well as those newly infected with the virus, harbor strains of HIV that are resistant to one, two, or even three classes of drug treatment. Side effects such as neuropathy, nausea, diarrhea, insomnia, and fever lead to reduced adherence to therapy and thereby increase the rate at which drug resistance appears in the patient and is transmitted to others.
While today’s treatments can significantly improve both the length and quality of life for people with HIV/AIDS, they do not represent a cure. Once started, therapy is a lifelong commitment. A cure, if possible, would represent a more sustainable option than costly, complicated, and potentially toxic treatment regimens.
One of the greatest successes in HIV/AIDS research so far has been the development of treatments that have lengthened the lives of people living with HIV. Progress made since the earliest days of antiretroviral therapy, when AZT extended lives by only a couple of months, means that today a patient can expect to survive for thirteen additional years on average, thanks to sophisticated highly active antiretroviral therapy (HAART).
Yet the benefits of HAART often come at the cost of serious side effects and toxicities that can limit the utility of the very drugs designed to improve lives. These range from inconvenient and uncomfortable symptoms to serious or even life-threatening conditions such as increased cholesterol, increased risk of heart attack and liver failure, and a diabetes-like syndrome called insulin resistance.
In addition, growing numbers of patients on treatment, as well as those newly infected with the virus, harbor strains of HIV that are resistant to one, two, or even three classes of drug treatment. Side effects such as neuropathy, nausea, diarrhea, insomnia, and fever lead to reduced adherence to therapy and thereby increase the rate at which drug resistance appears in the patient and is transmitted to others.
While today’s treatments can significantly improve both the length and quality of life for people with HIV/AIDS, they do not represent a cure. Once started, therapy is a lifelong commitment. A cure, if possible, would represent a more sustainable option than costly, complicated, and potentially toxic treatment regimens.
Travel Tips for HIV+ People
Many of the more recently-approved HIV drugs have fairly easy dosing schedules. Compared to the “old days” when people took handfuls of pills three and four times a day, some people are now fortunate enough to be able to take one or two pills just once or twice a day.
Whether you are taking one pill or many, it’s still important to stick to your assigned dosing schedule at home or away. Traveling with your HIV drugs – and staying on your schedule – can seem a bit daunting at first, but HIV shouldn't "ground" anyone who needs to travel for work or wants to see old friends or new places. And once you get the hang of it, it's really quite easy to manage your meds while you're on the road.
Pack your Pills First
It's one thing if you forget your socks, or your shaving kit, or even your address book. You can replace those items when you reach you destination or you can get along without them. You cannot get along without your medications, not even for a day, so pack them first – and pack them carefully.
Count out your pills for how long you will be away and transfer them to appropriate containers. (It's wise to take a two-day backup supply of your HIV drugs with you.) At home you may use a subdivided seven-day plastic pillbox to hold all your drugs, but for travel it's often more convenient to carry your pills in something smaller, like relabeled film canisters, sturdy, resealable plastic bags, or even a pocket-sized plastic tackle box. However, if you are traveling internationally or anywhere by plane, you should carry your meds in their original bottles clearly marked with the prescribing information so that security or customs will not give you too much trouble.
Pack your pills in a carry-on bag – and nowhere else. There's no guarantee that your flight will depart on time or arrive on time or that checked baggage will be waiting for you at your destination.
If you carry your pills on board, you can take any doses you need while on the plane and you will be prepared to take additional doses later if there is any sort of travel delay. The airline may not be able to keep to its posted schedule, but you will be able to keep to your dosing schedule and that's the important thing.
Food and Water
The HIV drug regimen you are on may impose dietary restrictions: certain pills should be taken on an empty stomach, others must be taken with a meal or snack, and all of them should be taken on schedule.
Not all airlines offer food on flights these days, and even if they do, there is no way of knowing when you will get fed on an airplane, or whether the meal will be anything you want to eat. It’s best to carry food with you if you need to eat when you take your medicine.
The same is true for water. If you are driving or taking a bus or train, you should bring your own. However, with some of the latest airport restrictions you may have to ask for water rather than take it on board with you. Most of the time the flight attendants will help you out by bringing a glass of water right away if you mention that you need to take medicine.
Asking for water as soon as you board the plane is a good plan. If you have ever flown across the country, you may have marveled at the time it takes a pack of flight attendants to get down the aisles of a 747 with a three-ounce beverage for each passenger. By the time your mouth turns to dust and all 32 of your pearly whites have put on their wool socks, you may as well forget trying to swallow even a single pill, unless you've had the good sense to ask for water in advance!
Beyond that, it's good to drink plenty of fluids because flying is dehydrating. To varying degrees, dehydration affects all passengers on long flights, and HIV+ people need to be especially careful that they do not allow themselves to get dehydrated. So take every opportunity to get a beverage and make a point of drinking throughout the flight, not simply when you feel thirsty.
Adjust your Dosing Schedule
Adjust your dosing schedule according to the number of time zones you cross. This sounds tricky, but it's actually quite simple.
West to East
As you travel from west to east, take each successive dose of your HIV drugs one hour earlier than you usually do. If you fly from Los Angeles to New York, for example, you cross three time zones and after three slightly shorter dosing cycles you will be back on your normal schedule.
East to West
When you travel from east to west, you reverse this process – adding an hour between dosing cycles. If you fly from London to Boston, for example, you cross five time zones and after five slightly longer dosing cycles you will be back on your normal schedule.
Taking your doses an hour earlier, or an hour later than usual falls well within the approved range for adherence to any dosing regimen.
North to South or South to North
When you travel north-south (or vice versa), there's no need to make any adjustments. Just stick to your regular dosing schedule, even on an 11-hour flight from the U.S. to Buenos Aires.
Traveling Outside the Country
Do a little research about your destination. If you are going to another country, check if there are restrictions about HIV+ visitors or traveling with medications. You may also want to take a set of written prescriptions.
If you travel to developing countries, you may be at a greater risk of getting cryptosporidiosis (an infection caused by a parasite). Foods and drinks, in particular, raw fruits and vegetables, tap water or ice made from tap water, unpasteurized milk or dairy products, and items purchased from street vendors may be contaminated. It’s best to drink filtered or boiled water.
Talk with your health care provider about other precautions you may want to take when you travel abroad, especially in developing countries (i.e. getting vaccines, bringing antibiotics). Check the Centers for Disease Control (CDC) website for useful information.
Reminders
It's relatively easy to stick to your daily schedule of pill-taking when you're at home. You are in your usual place, your pills are in their usual place, and your routine is a familiar one. It's not so easy to remain fully compliant with your HIV regimen when you travel, especially when you travel to an unfamiliar destination.
To guard against missing any of your doses, or leaving your medications behind, it helps to travel with fluorescent Post-It notes. Stick them on the bathroom mirror, on the dresser top, on your suitcase, on your car keys, on your hotel or motel room key. Those flashes of bright color will remind you to take every dose of every one of your medications every day and they will remind you to take your pills with you when you leave.
Taking Care of Yourself
While planning ahead how to stick to your regimen may seem like a hassle, it will make it easier when you are on the road. Even if you are on vacation, your pills still need to keep working! So, don’t leave home without them!
Whether you are taking one pill or many, it’s still important to stick to your assigned dosing schedule at home or away. Traveling with your HIV drugs – and staying on your schedule – can seem a bit daunting at first, but HIV shouldn't "ground" anyone who needs to travel for work or wants to see old friends or new places. And once you get the hang of it, it's really quite easy to manage your meds while you're on the road.
Pack your Pills First
It's one thing if you forget your socks, or your shaving kit, or even your address book. You can replace those items when you reach you destination or you can get along without them. You cannot get along without your medications, not even for a day, so pack them first – and pack them carefully.
Count out your pills for how long you will be away and transfer them to appropriate containers. (It's wise to take a two-day backup supply of your HIV drugs with you.) At home you may use a subdivided seven-day plastic pillbox to hold all your drugs, but for travel it's often more convenient to carry your pills in something smaller, like relabeled film canisters, sturdy, resealable plastic bags, or even a pocket-sized plastic tackle box. However, if you are traveling internationally or anywhere by plane, you should carry your meds in their original bottles clearly marked with the prescribing information so that security or customs will not give you too much trouble.
Pack your pills in a carry-on bag – and nowhere else. There's no guarantee that your flight will depart on time or arrive on time or that checked baggage will be waiting for you at your destination.
If you carry your pills on board, you can take any doses you need while on the plane and you will be prepared to take additional doses later if there is any sort of travel delay. The airline may not be able to keep to its posted schedule, but you will be able to keep to your dosing schedule and that's the important thing.
Food and Water
The HIV drug regimen you are on may impose dietary restrictions: certain pills should be taken on an empty stomach, others must be taken with a meal or snack, and all of them should be taken on schedule.
Not all airlines offer food on flights these days, and even if they do, there is no way of knowing when you will get fed on an airplane, or whether the meal will be anything you want to eat. It’s best to carry food with you if you need to eat when you take your medicine.
The same is true for water. If you are driving or taking a bus or train, you should bring your own. However, with some of the latest airport restrictions you may have to ask for water rather than take it on board with you. Most of the time the flight attendants will help you out by bringing a glass of water right away if you mention that you need to take medicine.
Asking for water as soon as you board the plane is a good plan. If you have ever flown across the country, you may have marveled at the time it takes a pack of flight attendants to get down the aisles of a 747 with a three-ounce beverage for each passenger. By the time your mouth turns to dust and all 32 of your pearly whites have put on their wool socks, you may as well forget trying to swallow even a single pill, unless you've had the good sense to ask for water in advance!
Beyond that, it's good to drink plenty of fluids because flying is dehydrating. To varying degrees, dehydration affects all passengers on long flights, and HIV+ people need to be especially careful that they do not allow themselves to get dehydrated. So take every opportunity to get a beverage and make a point of drinking throughout the flight, not simply when you feel thirsty.
Adjust your Dosing Schedule
Adjust your dosing schedule according to the number of time zones you cross. This sounds tricky, but it's actually quite simple.
West to East
As you travel from west to east, take each successive dose of your HIV drugs one hour earlier than you usually do. If you fly from Los Angeles to New York, for example, you cross three time zones and after three slightly shorter dosing cycles you will be back on your normal schedule.
East to West
When you travel from east to west, you reverse this process – adding an hour between dosing cycles. If you fly from London to Boston, for example, you cross five time zones and after five slightly longer dosing cycles you will be back on your normal schedule.
Taking your doses an hour earlier, or an hour later than usual falls well within the approved range for adherence to any dosing regimen.
North to South or South to North
When you travel north-south (or vice versa), there's no need to make any adjustments. Just stick to your regular dosing schedule, even on an 11-hour flight from the U.S. to Buenos Aires.
Traveling Outside the Country
Do a little research about your destination. If you are going to another country, check if there are restrictions about HIV+ visitors or traveling with medications. You may also want to take a set of written prescriptions.
If you travel to developing countries, you may be at a greater risk of getting cryptosporidiosis (an infection caused by a parasite). Foods and drinks, in particular, raw fruits and vegetables, tap water or ice made from tap water, unpasteurized milk or dairy products, and items purchased from street vendors may be contaminated. It’s best to drink filtered or boiled water.
Talk with your health care provider about other precautions you may want to take when you travel abroad, especially in developing countries (i.e. getting vaccines, bringing antibiotics). Check the Centers for Disease Control (CDC) website for useful information.
Reminders
It's relatively easy to stick to your daily schedule of pill-taking when you're at home. You are in your usual place, your pills are in their usual place, and your routine is a familiar one. It's not so easy to remain fully compliant with your HIV regimen when you travel, especially when you travel to an unfamiliar destination.
To guard against missing any of your doses, or leaving your medications behind, it helps to travel with fluorescent Post-It notes. Stick them on the bathroom mirror, on the dresser top, on your suitcase, on your car keys, on your hotel or motel room key. Those flashes of bright color will remind you to take every dose of every one of your medications every day and they will remind you to take your pills with you when you leave.
Taking Care of Yourself
While planning ahead how to stick to your regimen may seem like a hassle, it will make it easier when you are on the road. Even if you are on vacation, your pills still need to keep working! So, don’t leave home without them!
First CCR5 Blocker Gets Vote of Approval
(AIDSmeds.com) - An advisory committee to the U.S. Food and Drug Administration (FDA) has voted unanimously to recommend the approval of Pfizer's Celsentri® (maraviroc), an HIV entry inhibitor that targets the CCR5 receptor on CD4 cells. Should the FDA follow the recommendations of its Antiviral Drugs Advisory Committee (ADAC), the drug – the first member of a new class of oral HIV drugs in more than a decade – will likely be approved for treatment-experienced patients with "CCR5-tropic" HIV.
Celsentri in Development
In order for HIV to infect a T-cell, researchers have long known that the virus must first bind with a receptor called CD4 on the cell's surface (T-cells expressing the CD4 receptor are known as CD4 cells). Researchers also suspected that HIV requires the use of a second receptor on the surface of CD4 cells, but this elusive "coreceptor" remained a mystery for more than a decade of intense research.
It wasn't until 1996 that research groups in New York, Boston, and Bethesda simultaneously discovered what they were looking for: chemokine (C-C motif) receptor 5 (CCR5). In turn, a more complete picture of HIV "fusion and entry" came into view. While HIV first binds with the CD4 receptor, it must then latch on to a coreceptor, either CCR5 or CXCR4, with CCR5 being the most common of the two.
As research into CCR5 continued, a fascinating picture began to form. It turned out that people born with two defective CCR5 receptor genes (dubbed the CCR5 delta-32 mutation) – one from each parent – are highly resistant to HIV (provided that they are exposed to CCR5-tropic HIV, not CXCR4-tropic HIV). There are also people who inherit a defective CCR5 gene from one parent. While they're still able to contract HIV, studies suggest that they're more likely to experience slower disease progression than those without the genetic defect.
With these important data, along with additional research suggesting that CCR5 is not vital to health or survival, pharmaceutical and biotech companies scrambled to develop therapeutic compounds that block the CCR5 receptor. In effect, Pfizer's Celsentri – which made its research debut in 1997 as UK-427,857 – will likely end up being the first approved treatment for HIV that works by targeting a function of cells in the body, not the virus itself.
The Tests of Efficacy
With respect to effectiveness, the blue-ribbon experts sitting on the April 24 ADAC panel were most interested in the preliminary results from MOTIVATE-1 and MOTIVATE-2, two Phase III clinical trials pitting Celsentri against placebo. While the studies intend to follow patients for a total of 48 weeks, 24-week results indicated that Celsentri, combined with an optimized background regimen (OBR), is associated with greater viral load reductions and CD4 count increases compared to placebo among HIV-positive patients with limited treatment options due to drug resistance.
The ADAC panelists noted that, aside from the necessary 48-week follow-up data and the anticipated results from another Phase III study exploring Celsentri in patients new to HIV treatment, more data are needed regarding the drug's effectiveness in key HIV populations. Approximately 90% of the patients in the MOTIVATE studies were men and 83% were white. If approved, the FDA will likely request additional data involving women and African-Americans, to allow for a more complete evaluation of Celsentri's efficacy and safety in these groups.
Safety Issues
As for maraviroc's safety, clinical trial data reviewed by the ADAC panelists suggest that the addition of Celsentri to a combination of other antiretroviral drugs is generally well tolerated. In the MOTIVATE studies, toxicities were similar among the treatment groups, with 84% to 89% of the study participants experiencing at least one mild adverse effect. While discontinuation rates due to side effects were slightly higher in the maraviroc groups compared to the placebo groups, the differences were not statistically significant.
The most common side effects, during the first 24 weeks of the MOTIVATE studies, were diarrhea, nausea, headache, fatigue, cough, fevers, Fuzeon-related injection site reactions, decreased hemoglobin and neutrophil levels, and elevated liver enzymes and bilirubin levels.
The ADAC panelists noted that rates of upper respiratory infections, herpes simplex virus infections, and cardiac problems were slightly more common among patients taking Celsentri compared to placebo. However, these events were consistent with rates observed in the general population of treatment-experienced HIV-positive people.
ADAC panelists representing the FDA noted that additional short- and long-term safety data regarding cancer rates and liver toxicity will likely be needed. This is due to concerns raised in clinical trials of other CCR5 inhibitors, notably Schering-Plough's vicriviroc and GlaxoSmithKline's aplaviroc.
In one Phase II study, four cases of lymphoma – all of them among patients receiving vicriviroc – were reported in March 2006 by Schering-Plough. However, a causal relationship between the vicriviroc use and the lymphoma occurrences has not been confirmed. And while lymphomas have been documented in the ongoing and completed Celsentri studies, they do not appear to be any more common among those receiving the CCR5 inhibitor.
In October 2005, GlaxoSmithKline reported that approximately 4% of patients receiving its CCR5 inhibitor aplaviroc experienced a phenomenon called Hy's law – a sharp increase in three liver function test parameters (ALT, AST, and bilirubin) – that can potentially damage the liver permanently. In turn, the aplaviroc's development was discontinued. Rates of Hy's law have been significantly lower in the Celsentri Phase II/III studies.
The Trouble with Tropism
Celsentri will only be effective against CCR5-tropic HIV. It will not be effective against virus targeting CXCR4 (and will have a limited effect against HIV with the ability to target both receptors). Because "CXCR4-tropic" and "dual-tropic" HIV is more common in people who have been infected with HIV for several years – the people who are most likely going to be using Celsentri – a new laboratory test, Monogram Bioscience's Trofile® tropism assay, will be necessary before Celsentri is used, to determine if treatment with the drug will be useful.
Even among patients who begin Celsentri treatment with CCR5-tropic HIV, there is the possibility that their virus will switch to the CXCR4 receptor during therapy, meaning that the addition of Celsentri will no longer have any significant benefit. Much like drug-resistance testing, tropism testing can be ordered by a healthcare provider if Celsentri treatment failure is suspected.
What's more, because CXCR4-tropic HIV is usually seen in people who have advanced infection, experts have speculated that the emergence of CXCR4-tropic virus during entry inhibitor therapy would result in more rapid disease progression. In another Phase III study, however, patients who experienced a "switch" to CXCR4-tropic virus while taking Celsentri actually ended up with significantly greater CD4 cell counts. In other words, while therapy with a CCR5 inhibitor may not be virologically effective in patients who experience a switch to CXCR4-tropic HIV, it does not appear to be harmful.
Pfizer is committed to providing the FDA with long-term follow-up data from its ongoing clinical trials, as well as pediatric research and a patient registry, to help settle lingering questions and concerns. For its part, the FDA did not specify when it would issue an agency decision regarding the approval of Celsentri, but official word is expected in the coming weeks.
Celsentri in Development
In order for HIV to infect a T-cell, researchers have long known that the virus must first bind with a receptor called CD4 on the cell's surface (T-cells expressing the CD4 receptor are known as CD4 cells). Researchers also suspected that HIV requires the use of a second receptor on the surface of CD4 cells, but this elusive "coreceptor" remained a mystery for more than a decade of intense research.
It wasn't until 1996 that research groups in New York, Boston, and Bethesda simultaneously discovered what they were looking for: chemokine (C-C motif) receptor 5 (CCR5). In turn, a more complete picture of HIV "fusion and entry" came into view. While HIV first binds with the CD4 receptor, it must then latch on to a coreceptor, either CCR5 or CXCR4, with CCR5 being the most common of the two.
As research into CCR5 continued, a fascinating picture began to form. It turned out that people born with two defective CCR5 receptor genes (dubbed the CCR5 delta-32 mutation) – one from each parent – are highly resistant to HIV (provided that they are exposed to CCR5-tropic HIV, not CXCR4-tropic HIV). There are also people who inherit a defective CCR5 gene from one parent. While they're still able to contract HIV, studies suggest that they're more likely to experience slower disease progression than those without the genetic defect.
With these important data, along with additional research suggesting that CCR5 is not vital to health or survival, pharmaceutical and biotech companies scrambled to develop therapeutic compounds that block the CCR5 receptor. In effect, Pfizer's Celsentri – which made its research debut in 1997 as UK-427,857 – will likely end up being the first approved treatment for HIV that works by targeting a function of cells in the body, not the virus itself.
The Tests of Efficacy
With respect to effectiveness, the blue-ribbon experts sitting on the April 24 ADAC panel were most interested in the preliminary results from MOTIVATE-1 and MOTIVATE-2, two Phase III clinical trials pitting Celsentri against placebo. While the studies intend to follow patients for a total of 48 weeks, 24-week results indicated that Celsentri, combined with an optimized background regimen (OBR), is associated with greater viral load reductions and CD4 count increases compared to placebo among HIV-positive patients with limited treatment options due to drug resistance.
The ADAC panelists noted that, aside from the necessary 48-week follow-up data and the anticipated results from another Phase III study exploring Celsentri in patients new to HIV treatment, more data are needed regarding the drug's effectiveness in key HIV populations. Approximately 90% of the patients in the MOTIVATE studies were men and 83% were white. If approved, the FDA will likely request additional data involving women and African-Americans, to allow for a more complete evaluation of Celsentri's efficacy and safety in these groups.
Safety Issues
As for maraviroc's safety, clinical trial data reviewed by the ADAC panelists suggest that the addition of Celsentri to a combination of other antiretroviral drugs is generally well tolerated. In the MOTIVATE studies, toxicities were similar among the treatment groups, with 84% to 89% of the study participants experiencing at least one mild adverse effect. While discontinuation rates due to side effects were slightly higher in the maraviroc groups compared to the placebo groups, the differences were not statistically significant.
The most common side effects, during the first 24 weeks of the MOTIVATE studies, were diarrhea, nausea, headache, fatigue, cough, fevers, Fuzeon-related injection site reactions, decreased hemoglobin and neutrophil levels, and elevated liver enzymes and bilirubin levels.
The ADAC panelists noted that rates of upper respiratory infections, herpes simplex virus infections, and cardiac problems were slightly more common among patients taking Celsentri compared to placebo. However, these events were consistent with rates observed in the general population of treatment-experienced HIV-positive people.
ADAC panelists representing the FDA noted that additional short- and long-term safety data regarding cancer rates and liver toxicity will likely be needed. This is due to concerns raised in clinical trials of other CCR5 inhibitors, notably Schering-Plough's vicriviroc and GlaxoSmithKline's aplaviroc.
In one Phase II study, four cases of lymphoma – all of them among patients receiving vicriviroc – were reported in March 2006 by Schering-Plough. However, a causal relationship between the vicriviroc use and the lymphoma occurrences has not been confirmed. And while lymphomas have been documented in the ongoing and completed Celsentri studies, they do not appear to be any more common among those receiving the CCR5 inhibitor.
In October 2005, GlaxoSmithKline reported that approximately 4% of patients receiving its CCR5 inhibitor aplaviroc experienced a phenomenon called Hy's law – a sharp increase in three liver function test parameters (ALT, AST, and bilirubin) – that can potentially damage the liver permanently. In turn, the aplaviroc's development was discontinued. Rates of Hy's law have been significantly lower in the Celsentri Phase II/III studies.
The Trouble with Tropism
Celsentri will only be effective against CCR5-tropic HIV. It will not be effective against virus targeting CXCR4 (and will have a limited effect against HIV with the ability to target both receptors). Because "CXCR4-tropic" and "dual-tropic" HIV is more common in people who have been infected with HIV for several years – the people who are most likely going to be using Celsentri – a new laboratory test, Monogram Bioscience's Trofile® tropism assay, will be necessary before Celsentri is used, to determine if treatment with the drug will be useful.
Even among patients who begin Celsentri treatment with CCR5-tropic HIV, there is the possibility that their virus will switch to the CXCR4 receptor during therapy, meaning that the addition of Celsentri will no longer have any significant benefit. Much like drug-resistance testing, tropism testing can be ordered by a healthcare provider if Celsentri treatment failure is suspected.
What's more, because CXCR4-tropic HIV is usually seen in people who have advanced infection, experts have speculated that the emergence of CXCR4-tropic virus during entry inhibitor therapy would result in more rapid disease progression. In another Phase III study, however, patients who experienced a "switch" to CXCR4-tropic virus while taking Celsentri actually ended up with significantly greater CD4 cell counts. In other words, while therapy with a CCR5 inhibitor may not be virologically effective in patients who experience a switch to CXCR4-tropic HIV, it does not appear to be harmful.
Pfizer is committed to providing the FDA with long-term follow-up data from its ongoing clinical trials, as well as pediatric research and a patient registry, to help settle lingering questions and concerns. For its part, the FDA did not specify when it would issue an agency decision regarding the approval of Celsentri, but official word is expected in the coming weeks.
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