Treatment Review #21 - March 1996 Contents New Treatments Approved: New AIDS and HIV treatments, and combinations of existing treatments have recently been approved. One treatment has been shown to greatly reduce the amount of HIV virus in the body, and to help people stay healthy and live longer. This issue of Treatment Review provides basic information about existing HIV treatments and the new drugs that are available. We've also included fact sheets about all three approved protease inhibitors, and the newly approved combination treatment of 3TC and AZT. Combination Therapy: Good, unexpected news about an entirely new class of drugs called protease inhibitors. A new protease inhibitor has been clearly shown to help prevent disease progression and death in people with low T4 cells. A new combination treatment reduces the amount of HIV virus in the body, and also raises T4 cells even in people who are already taking AZT. Another protease inhibitor, when taken together with other anti-HIV drugs, dramatically reduces the amount of HIV in the blood. Epivir (3TC or lamivudine) is a new treatment, approved by the FDA for combination therapy with AZT. Ongoing studies are testing 3TC in combination with other anti-HIV drugs, including protease inhibitors. Saquinavir Fact Sheet: The first protease inhibitor approved by the FDA. Ritonavir Fact Sheet: This protease inhibitor was recommended for approval by the FDA, then fully approved within 24 hours. It's a potent drug that has been shown to prolong life and decrease the amount of HIV virus in the blood. A drug that people with less than 100 T4 cells should consider taking. Indinavir Fact Sheet: Although this protease inhibitor has not been tested in a large number of people or for a long period of time, the study results were promising enough that the FDA recommended the drug for approval. Viral Load Testing: A new type of test is being studied as a way to better measure whether or not a treatment is actually working. Researchers hope these tests will help show if an HIV treatment is working. They also hope the amount of virus in the blood may indicate if someone should start or change to a different HIV treatment. Treatment Briefs Resources About the Network Network Publications Combination therapy advances Studies of anti-HIV treatment have been done, for the most part, in people with between 200 and 500 T4 cells. In the absence of any symptoms, this is thought to be a good time to start thinking about anti-HIV treatment. The drugs most widely tested in this group of people are called nucleoside analogues. AZT, ddC, ddI, d4T and 3TC are drugs of this type. The body breaks down these drugs into chemicals that stop HIV from infecting uninfected cells in the body, but it does not help cells that have already been infected with the virus. As people with AIDS lose T4 cells - one of the immune systems main defenses - they become more likely to get infections and illnesses. In the past, people took one of these types of drugs at a time. Now, however, it is known that a combination of these drugs work better, even in people who have under 200 T4 cells. There are several new drugs that can be used as part of combination treatment. 3TC, also known as Epivir or lamivudine, is in the same class of drugs as AZT, ddI, ddC and d4T. The combination of AZT and 3TC was recently approved by the Food and Drug Administration (FDA) for people with less than 500 T4 cells. Several studies showed that people who took this combination, even if they were already taking AZT, had increases in their T4 cells, as well as a reduction in the amount of HIV virus in their blood. Studies are being done to find out if 3TC works as well with other anti-HIV drugs. In addition, the combination of AZT and ddC (HIVID) was also recently recommended for full approval as combination therapy. Results of several studies showed that this drug combination slowed progression of HIV disease and improved survival, primarily in people who had never taken AZT before. A new class of drugs: Protease inhibitors are a long awaited, new class of anti-HIV drugs that block a part of the HIV virus called protease. Protease inhibitors force the HIV virus to make copies of itself that can't infect new cells. This is the first new class of anti-HIV drugs approved since nucleoside analogues (AZT, etc.). It seems likely that combination anti-HIV therapy will also include a protease inhibitor, although the decision to start taking a protease inhibitor should be well thought out. Each recently approved protease inhibitor is described in this issue of Treatment Review. Protease inhibitors appear to cause less side effects than AZT type drugs, but each individual protease inhibitor is different. Like any other drugs, they all have potential side effects and may effect the way other drugs work in the body. The newly approved protease inhibitor, ritonavir, for example, can not be taken with the drug mycobutin. It is important to discuss potential side effects and interactions with a health care provider before starting to take any new treatment. Whether or not someone is able to take a protease inhibitor may also be determined by the kind of health insurance or assistance program a person uses to get medications. (Contact The Access Project at The Network if you need a referral to an ADAP in your state, or assistance accessing any treatment). The first protease inhibitor to be approved by the FDA is saquinavir (Invirase). Although this drug is not very well absorbed by the body - a new version of saquinavir that is better absorbed is being studied - studies show that the drug lowers the amount of HIV virus in the body, and increases T4 cells. People who are already on combination therapy might consider adding this drug to their treatment regimen, especially if the benefits of combination therapy seem to be wearing off. According to the makers of the drug, Hoffman-La Roche, taking saquinavir is not likely to spoil the benefits of taking other protease inhibitors in the future. This has not yet been proven, however. The protease inhibitor ritonavir (Norvir) was recently approved by the FDA. It is made by Abbott Laboratories. Studies show that ritonavir reduces the amount of HIV in the blood better than saquinavir. Ritonavir is the only protease inhibitor, so far, that has been shown to actually help people live longer. The study that demonstrated these benefits was conducted in people with less than 100 T4 cells. This is very good news for people already diagnosed with AIDS. It is not yet proven that the same effects will be seen in people with higher T4 cell counts. The third protease inhibitor, recommended for approval by the FDA, is called indinavir (Crixivan). Like ritonavir, this protease inhibitor appears to be more potent than saquinavir. All of the study results of indinavir have shown increases in T4 cell counts and a reduction of HIV virus. Although the studies of this drug have been very small, the results have been very encouraging. Hopefully, further studies will show that the benefits of indinavir are seen for a longer period of time in a greater number of people. Deciding which treatment to take The decision about which combination to take should be based on several factors, such as which combination has the best chance of reducing the amount of HIV in the body for the longest time, and which combination will best increase or keep the T4 cell count at its current number and hopefully prevent disease progression. Possible side effects of the drug combination, the number of pills that would need to be taken, and the kind of symptoms someone is experiencing, if any, should also be part of the decision making process. It is also important to think about what the other options would be if one combination stops working. Those who are currently benefitting from combination nucleoside analog therapy, and those who have not yet started combination therapy, may want to wait for more information before starting to take any protease inhibitor. Different combinations of protease inhibitors and nucleoside analog drugs are being tested in clinical trials. The Network has a current information on all combination therapy trials in our area, and a free handbook about the potential risks and benefits of clinical trials called "Should I Join An AIDS Drug Trial?" Protease inhibitors can have side effects. These seem to be seen less often than with the nucleoside analog drugs, but some side effects can be serious. Ritonavir, for example, blocks a pathway in the liver that is often used to clear drugs from the body. This effects the way other medications are processed in the body, causing drugs to get backed up in the liver. It is important to be carefully monitored when taking any new treatment. Protease inhibitors may also be rare side effects that have not yet been seen. Resistance is a big concern with protease inhibitors. It seems that the best way to avoid resistance is to take the drug on time, and not to skip doses. Taking protease inhibitors in combination with other anti-HIV drugs has also been shown to slow down resistance. Researchers have been very clear about one thing: It is a very bad idea to stop taking a protease inhibitor once started. Be well informed about the possible risks and benefits of any treatments. If you have questions, ask your doctor or a health care provider, or call our national, toll-free phone number at (800)734-7104. AZT & 3TC Studies have shown that 3TC can raise T4-cell levels, and lower levels of HIV. More importantly, studies show that 3TC treatment may make AZT work better, even in people who have already taken AZT for a long time. 3TC has been approved by the government for use in combination with AZT in people with less than 500 T4 cells. The recommended dosage of 3TC is 150 mg twice a day. Trial results: One trial compared AZT plus 3TC to AZT alone. Participants started with T4 cell counts of 100-400 and had taken AZT for less than 4 weeks at any time. After the first 24 weeks all participants switched to 3TC plus AZT for 24 more weeks. Increases in T4 cell counts were seen in those taking both drugs together. T4 cell counts rose an average of 85 cells by week 8 and 80 cells by week 24. Smaller increases were seen in those taking AZT alone. During the second phase of the study, T4 cell counts for those who had started on AZT alone and added 3TC increased by 40 cells. Participants who took both drugs from the beginning had an average of 49 more T4 cells by week 48. Levels of HIV measured in the blood were reduced by more than 90% by the combination treatment. Only 5 people withdrew from the study because of side effects. Another trial compared AZT plus 3TC to AZT plus ddC in people who had taken AZT for an average of two years and had average T4 cell counts of 211. Participants taking AZT plus 3TC were divided into two more groups. One group took low-dose 3TC with the AZT, the other group took high-dose 3TC with the AZT. The participants in this trial had more advanced disease than those in the first trial. After 6 months of treatment, levels of virus measured in the blood were nearly the same in both groups on this trial. T4 cell counts rose an average of 32 for the low dose 3TC combination, 15 for the high dose 3TC combination, and went down 15 for those taking AZT and ddC. Studies have also shown that 3TC reduces the amount of hepatitis B virus to where it can't be found anymore in all participants. Lasting results at the same dosage level were found in 6 of 22 patients over six months. Side effects: In studies, the side effects of headache, nausea and fatigue were all seen in more than a quarter of the people taking the combination of 3TC and AZT. Other side effects seen were nasal signs and symptoms, diarrhea, neuropathy (burning pain in the hands or feet), low white blood cells and anemia (low red blood cells). These side effects are sometimes seen when AZT is taken by itself. 3TC alone has few side-effects, mainly nausea, vomiting and headaches, and rare cases of hair loss. In children, 3TC can cause a side effect called pancreatitis. Pancreatitis is a dangerous swelling of an organ in the body called the pancreas. Children taking 3TC should be carefully monitored for this side effect. Resistance: HIV can mutate to try and resist the effects of 3TC within a few weeks after treatment starts. But lab tests have shown that when the virus becomes resistant to 3TC, it is no longer resistant to AZT. It seems to take a long time for HIV to become resistant to both drugs. Virus that is resistant to 3TC may also reproduce less well than normal virus. Access: Glaxo Wellcome Inc. has a patient assistance program for people having problems getting the drug. The number to call is (800) 722-9294. People that have been receiving the drug through the expanded access program and who now need help with reimbursement should call (800) 513-3028. Studies of 3TC in combination with other anti-HIV drugs are enrolling. Call The Network at (800) 734-7104 for a referral. saquinavir (Invirase) Saquinavir (trade name Invirase) is the first protease inhibitor to be approved for the treatment of HIV infection. Protease inhibitors are a new class of anti-HIV drugs. They work by blocking a part of HIV called protease. When protease is blocked, HIV makes copies of itself that can't infect new cells. Saquinavir has been approved for use by people with under 300 T4 cells, in combination with one or more of the approved nucleoside analog drugs (AZT, ddI, ddC, d4T and 3TC). The current recommended dosage is 600 mg, three times a day. Trial results: In the largest clinical trial of saquinavir, the combinations tested were saquinavir/AZT, saquinavir/AZT/ddC, and AZT/ddC. After 48 weeks of treatment, people taking saquinavir/AZT/ddC had an average increase of 111 T4 cells. People taking saquinavir/AZT had an average increase of 74 T4 cells. People taking AZT and ddC had an average increase of 72 T4 cells. Resistance: Studies have shown that HIV can become resistant to the effects of saquinavir. This happens because HlV makes more of itself all the time, and each new HIV virus that gets made can be slightly different. The type of protease that the HIV virus creates may be slightly different than the one it made before. The new protease that the virus has made may not be affected by saquinavir. If HIV becomes resistant to saquinavir, it may also be resistant to the effects of other protease inhibitors. There are two changes, called mutations, in HIV protease that saquinavir commonly causes. One of the mutations may make it easier for HIV to resist the effects of some other protease inhibitors. In one study, after a year of taking saquinavir, less than half the participants had any resistant virus. Saquinavir, in the current formulation, is not very well absorbed by the body. A small study done in California showed that the drug could have more anti-HIV effect when taken in higher doses. However, the doses used in this study would be very expensive and involve taking many pills every day. A new version of the drug is being tested that will hopefully be better absorbed. This new version of saquinavir will replace the current pill when the testing is completed. Studies have looked at ways to help the body better absorb saquinavir. Taking the drug after a full meal is strongly recommended. A small study found that ordinary reconstituted frozen grapefruit juice could help increase the levels of saquinavir in the body. People in the study drank a small (150ml) glass of the grapefruit juice with their saquinavir, followed by another glass an hour later. Drug levels were increased by about 50 percent. When people made the grapefruit juice stronger by mixing it with half the amount of water, the levels of saquinavir in their bodies doubled. There may be problems with using this method to try and increase the absorption of saquinavir. The grapefruit juice may affect other drugs you are taking, and this could be dangerous. The acidity of grapefruit juice may also irritate the stomach. If you are thinking of using grapefruit juice to boost the levels of saquinavir in your body, talk about it with your healthcare provider. Side effects: Compared to nucleoside analog drugs, saquinavir seems to have few side effects. In studies, the most common side effects, occurring in very few people, were diarrhea, stomach discomfort and nausea. Drug interactions: The antibiotics rifampin and rifabutin (Mycobutin) can greatly reduce the amount of saquinavir in the body. It is recommended that alternatives to these drugs are used if someone needs to take saquinavir. The anti-fungal drug ketaconazole slightly increases the amount of saquinavir in the body. Hoffman-La Roche, the company that makes saquinavir, has set up an assistance program for people that need help getting the drug. The number to call is (800) 282-7780. The hours are Monday to Friday, 9:00 AM to 8:00 PM EST. Studies are ongoing of the new version of saquinavir. Call The Network if you would like more information about these studies. ritonavir (Norvir) Ritonavir (trade name Norvir, also known as ABT-538) is also one of the new group of anti-HIV drugs called protease inhibitors. Ritonavir is made by a company called Abbott Pharmaceuticals. Trial results: In a study in people with less than 100 T4 cells, ritonavir was found to help people live longer, and delay progression of disease. There were 1090 people in this study. The average T4 cell count was around 30. People were allowed to take any approved anti-HIV drugs while on the study. One group of people added ritonavir to the medications they were taking, the second group got a placebo or dummy pill. After an average of six months of follow-up, 46 people taking the placebo had died compared to 26 people taking ritonavir. This means that for people taking ritonavir, the risk of death was greatly reduced - almost halved - compared to people taking the placebo. The researchers also looked at the study results after just one month. At this point in time, 149 people taking the placebo had experienced a new opportunistic infection or died, compared to 69 people taking ritonavir. This seems to show that the drug can have an effect very soon after someone starts taking it. Other studies of ritonavir in combination with other anti-HIV drugs are ongoing. The full results of these studies are not yet known, although early reports are encouraging. The current recommended dosage of ritonavir is 600mg, twice a day. The drug should be taken with meals, if possible. Side effects: The major side effects seen in this study were nausea, vomiting, weakness and diarrhea. 91 people stopped taking ritonavir because of side effects, compared to 32 people taking placebo. Other side effects that have been associated with the drug are numbing sensations around the mouth and elevated liver enzymes. Some of these side effects are thought to be caused by the bad taste of the current syrup formulation of the drug. This has now been replaced by a gelatin capsule. Drug interactions: Ritonavir can effect the way other drugs are absorbed by the body. There is a long list of drugs that may be affected on the package insert that comes with ritonavir. It is very important that anyone about to start taking ritonavir goes over this list thoroughly with their healthcare provider. Some of the potential drug interactions are potentially life-threatening. If you need help working out which drugs are on the interaction list (some drugs have several different names) call The Network. Not all protease inhibitors interact with as many other drugs. You may also be able to switch a problem drug so that you can take ritonavir. Availability: Ritonavir is now approved for the treatment of HIV disease and AIDS in adults. A study of ritonavir for people recently infected with HIV, and a study for children are enrolling. Call the Network for a referral. indinavir (Crixivan) Indinavir (trade name Crixivan, also known as MK-639) is another of the new group of anti-HIV drugs called protease inhibitors. Indinavir is made by a company called Merck Pharmaceuticals. Trial results: There is only limited information from trials of indinavir. All of the study results so far have been limited to changes in T4 cell counts and viral load (the amount of virus in the blood). The information that has been presented has also been from a small number of people. A study of the combination of indinavir, AZT and 3TC is ongoing. People in this study had been taking AZT for at least six months before they joined the trial. Participants were randomly assigned to indinavir/AZT/3TC, indinavir alone, or AZT and 3TC. After 16 weeks, 24 of the 26 people taking the triple combination of indinavir, AZT and 3TC had so little virus in their blood that it could not be found using the standard viral load test. This test cannot find less than 500 copies of HIV in a milliliter of blood. 13 out of 26 people taking indinavir alone also had less than 500 copies of HIV in their blood samples. No-one taking AZT and 3TC had the amount of HIV in their blood reduced below 500 copies. Some people in this study have now been followed for 24 weeks. 6 out of 7 people on indinavir/AZT/3TC still have less virus in their blood than the viral load test can find. 4 out of 9 people on indinavir alone also have less virus in their blood than can be detected. No-one in the AZT/3TC group has undetectable virus. The median increases in T4 cells after 24 weeks were 146 in the indinavir/AZT/3TC group, 77 for the people taking indinavir alone, and 22 for people taking AZT/3TC. Other studies of indinavir seem to confirm that it has a strong anti-HIV effect. A small study combining indinavir/AZT/ddI found that people had a median increase of 90 T4 cells after 24 weeks. It's important to remember that these results are from only a few people, and it isn't known yet whether they will be confirmed by larger studies. It is not yet proven that the drug will help people live longer or stay healthy longer. However, recent studies have found that reducing the amount of virus in the blood can also reduce the risk of disease progression and death. This leads scientists to hope that drugs like indinavir will help people stay healthy and live longer. Resistance: HIV can become resistant to the effects of indinavir. This has been seen in people in early studies where the indinavir dose was lower than the one now recommended. In these people, after 24 weeks on the study, levels of HIV in the blood returned to where they were before the study began. However, T4 cell increases averaging 80 to 100 were sustained for at least 52 weeks. This may mean that indinavir-resistant HIV is less harmful to the immune system than normal HIV. Further studies are being done to investigate this. Resistance seems to occur much more slowly at the dose now being used. Using indinavir in combination with nucleoside analog anti-HIV drugs also seems to significantly delay HIV resistance to the drugs. Combinations of protease inhibitors are being studied, and should not be tried until results are known. Protease inhibitors could interact in ways that may be harmful to the body. Drug interactions: The antibiotic drug rifabutin (Mycobutin) can be affected by indinavir. It is recommended that people halve their dose of rifabutin when taking it with indinavir. Side effects: The most common side effects of indinavir are kidney stones and the temporary elevation of a liver enzyme called bilirubin. These have been seen in about 2-3% of people taking the drug so far. Bilirubin usually returns to normal levels on it's own. Kidney stones can be avoided by drinking plenty of water. It is currently recommended that people taking indinavir drink a quart of water a day. Viral load testing There are two kinds of viral load tests. The two tests measure what's called HIV RNA. RNA is the part of HIV that knows how to make more virus. One test, called the branched DNA test (bDNA), is made by a company called Chiron. The other is the polymerase chain reaction or PCR test made by Hoffman-LaRoche. Scientists have a good idea what some parts of HIV RNA look like. By creating a mirror image and matching it against what they find in someone's blood, they can find HIV RNA. The PCR test encourages the HIV RNA to make more of itself in a laboratory test tube. This makes it easier to measure the amount of HIV RNA that was in the blood sample. The bDNA test sets off a chemical reaction with the HIV RNA so it gives out light. Then the amount of light is measured in order to show how much RNA was found. The results of these tests are usually given per milliliter (ml) of blood, like the T4 cell count. The PCR test may give the amount per 0.05/ml, so you need to multiply the number by 20 to get the standard result. Each virus carries two copies of RNA. If there are 100,000 copies of HIV RNA, that means 50,000 viruses (often called particles or virions) are present. Currently, the bDNA test can't find less than 10,000 copies of HIV RNA, but a recent improvement means it will soon be able to find anything down to 500 copies. Test results can be different, or variable, when repeated on the same blood sample. Any test results should say how variable the test might be. For example if the result was 20,000 copies and the variability of the test was 5,000, you'd know that the result was somewhere between 15,000 and 25,000 copies. There is still concern that there is a lot of virus in other places in the body, not just the blood. Only 2% of HIV is in circulating blood. The rest is in your lymph system and other body tissue. Also, measuring the good effect an HIV treatment has on the viral load doesn't take into account any bad side-effects the treatment might have on the body. Using the Test to Study a New Drug. Early viral load results from a large study of a drug called delavirdine have recently been released. This study found that the viral load test was a very good marker of disease progression. In this study of around 1,900 people, viral load was better than T4 cell counts at showing whether someone might be at risk for getting sicker. The study also found that if a treatment reduced the amount of virus in the blood by half, for as little as 8 weeks, the risk of disease progression was also halved. Scientists hope that this means that the kind of reductions in virus seen with newer treatments such as protease inhibitors will help people stay healthy and live much longer. With some protease inhibitors the viral load test has shown a 99.99% reduction in the amount of HIV virus. A Test of the Viral Load Test. A study of the viral load test is currently enrolling. People in the study will be divided into two groups. One group will make decisions about HIV treatments based on their viral load. The second group will make treatment decisions using their T4 cell counts and symptoms. In the guidelines for this study, it says that a viral load test result of over 100,000 copies may mean that someone is at a higher risk for disease progression. A result of less than 10,000 copies is associated with a lower risk for disease progression. The guidelines also state that only a large change in viral load can be considered important. Anything less than a threefold change may be due to unimportant changes that occur with all kinds of tests. In addition, other infections such as a cold or the flu can cause a temporary increase in viral load. If you are interested in taking part in the viral load testing study, call The Network for a referral. Currently, viral load testing is still experimental. Doctors can order them at a cost of about $200. However, it's hard to get an insurance company to pay for them. Medicaid will not cover them. It is likely that the tests will be approved for general use during 1996, once more results from ongoing research are available. More information on the Hoffman-LaRoche PCR test is available by calling (800) 533-0567. The number to call for information on the Chiron bDNA test is (800) 642-4657 x2909. Reimbursement assistance for the Chiron bDNA test is available by calling (800) 775-7533. Treatment briefs Agouron protease inhibitor: A new protease inhibitor called nelfinavir (trade name Viracept) is in clinical trials. One study is investigating nelfinavir in combination with d4T, compared to d4T alone. A second study will investigate nelfinavir in combination with AZT and 3TC, compared to AZT and 3TC treatment. Call the Network for a referral to the trial sites. Oxandrolone: The anabolic steroid oxandrolone (trade name Oxandrin) is available by prescription for the treatment of weight loss. This drug was approved in the 1960's for the treatment of weight loss due to chronic infection or trauma. In one study of oxandrolone as a treatment for AIDS-related wasting, weight gain was seen in people taking 15 mg a day for 16 weeks. In people taking 5 mg a day, weight remained stable. People taking a placebo (a fake pill used in clinical trials) experienced weight loss. Oxandralone is a pill. This drug is not usually toxic to the liver, which can be a problem with other oral anabolic steroids. The drug also seems less likely to have a masculinizing effect on women than other anabolic steroids. The drug must be obtained direct from the distributor, Quantum Express. The number to call is (800) 741-2698. Quantum Express can deal directly with your health insurance to help obtain reimbursement, and also has a compassionate access program for those that cannot afford to pay for the drug. The Access Project: If you're having trouble affording a treatment, the Network's Access Project has a database of federal, state and pharmaceutical industry programs that may be able to help. Call (800) 734-7104 for more information and referrals. DOXIL: DOXIL is a newly approved treatment for Kaposi's sarcoma, or KS. DOXIL is a liposomal drug. Liposomal drugs are standard chemotherapy drugs used to treat KS that are put inside microscopic bubbles of fat called liposomes. When the drugs are used this way, it is hoped they will have fewer side effects and be more effective. DOXIL is a liposomal version of the anti-cancer drug doxorubicin. The drug is given intravenously, which means via a tube placed into your arm or chest. The procedure takes 30 minutes, and is done once every three weeks. DOXIL has been approved for the treatment of advanced KS in people that have not responded to the standard treatment. DOXIL is also recommended for people who can't take the standard treatments for KS because of side effects. Very few people in DOXIL studies have had to stop treatment because of side effects. The main side effect is neutropenia, which is low white blood cells. Treatment with G-CSF, also known as Neupogen, can help lessen this side effect. Other side effects can be hot flushes, tight chest, difficulty breathing or swallowing and back pain. DOXIL can also cause heart problems, although this has not been seen as often as with standard chemotherapy. Sequus Pharmaceuticals, the makers of DOXIL, have set up a patient assistance program. Patient assistance programs help people having difficulty paying for a treatment. Call (800) 375-1658 for more information. The FDA recently approved a new kind of CMV retinitis treatment called Vitrasert. This is the anti-CMV drug ganciclovir, which is usually given by intravenous infusion, put into small plastic pellets. The pellets are placed into the eye during minor surgery that can cause distorted vision for two to four weeks. The pellets dissolve and deliver the anti-CMV drug directly into the eye for five to eight months, after which they can be replaced with new pellets. People with CMV retinitis who use the pellets will most likely still need other CMV treatments to prevent CMV in other parts of the body. For full information about the drug cytovene in pellet, intravenous or capsule form contact Joy Schmitt at Hoffman-LaRoche at (201) 562-2202. For information about the pellets contact Missy Lowery at Chiron Vision at (800) 352-1891. Network Resources The Network now has Simple Fact Sheets available on the following subjects: AZT, ddI, ddC, d4T, 3TC, protease inhibitors, saquinavir, indinavir, ritonavir, combination therapy, non-nucleoside reverse transcriptase inhibitors (NNRTI's), IL-2, oral ganciclovir, ganciclovir implants, anabolic steroids, thalidomide, HIV, MAC, Kaposi's sarcoma, cryptosporidiosis, fungal infections, and viral load tests. Call to order any fact sheet. The Network now has a home page on the World Wide Web called The InterNetwork. Expanded access programs and clinical trials are listed according to condition and are updated the minute we get any new information. Treatment updates and announcements, as well as all The Network's publications are stored here, ready to be read or printed out. Our InterNetwork is part of being a Network member, so send in your annual $25.00 membership contribution now! Our home page address is: http://www.aidsnyc.org/network About The Network The information in this review is not meant to replace the advice or care of a medical professional. Always discuss your treatment options with a trained health care provider. We don't manufacture, test or sell any of these drugs or therapies. We do not endorse them, nor do we guarantee their safety or efficacy. Treatment Review is published 8 times a year. A $16.00 a year contribution is requested, but not required. A $25.00 a year membership contribution is requested from all Network members and users. This donation greatly helps our run our day to day operations. Treatment Review is written and edited by Ken Fornataro and Richard Jefferys, with the assistance of Stephen Rehberg, Eddy Gordon Berroa, Lizzie Nevarez, Maximo Sepulveda , Felix Cruz, Nancy Fornataro, Bill Valenti, MD, Paul E. Cothran, Marlene Diaz, Rick Loftus, and many friends and colleagues. If you want to copy, reproduce or excerpt this information, please give us a call at (800) 734-7104. This helps us to keep track of where and how this information is being used. Treatment Review and other Network resources are available by E-mail, and are on the Internet. Drop us a line at AIDSTreatD@AOL.com. The AIDS Treatment Data Network (The Network) is a not-for-profit, independent organization. We receive support for our work from individuals, foundations, government, and corporations. We appreciate and encourage contributions for our work. In honor and memory of Robert D. Farber, our friend, colleague, artist, teacher, brother, and sponsor. Special thanks also go to the Farber Family, Fund for the City of New York, Hoffman-LaRoche, and The Ryan White Emergency Care Act of 1990, Title I. Network publications The Experimental Treatment Guide The Experimental Treatment Guide is a quarterly directory of experimental treatments in clinical trials, as well as other treatment programs in New York State and surrounding states. Includes a short version of the handbook, Should I Join an AIDS Drug Trial? . These publications are supported by The New York State Department of Health AIDS Institute. They are free of charge. A donation of $10 is requested if you are from out-of-state, or if you can afford it. Now available entirely in Spanish as La Gu’a de Tratamientos Experimentales! Treatment Review Treatment Review is the newsletter of the AIDS Treatment Data Network. Each issue includes descriptions of approved, alternative, and experimental treatments, as well as announcements of seminars and forums on treatments and clinical trials. Published eight or more times a year. $16.00. Publicado en Espa–ol como Rese–a de Tratamientos. Network Membership There is no charge to become a Network member, although many people support our work by making a yearly contribution. Individuals, service providers and clinicians, and organizations are asked to make a yearly contribution of $25.00. Members receive information about approved and experimental treatments, treatment counseling, referrals, and case management support. Professional members receive the same services and support for their clients and patients. You can contact us by phone, by mail, or by computer. We're interested in hearing your comments, and suggestions of treatments you would like to see written about in Treatment Review. Send us a request and we will do the research and put together a summary of that treatment. Our nationwide toll-free number is (800) 734-7104. Our New York City number is (212) 260-8868. If you have a computer and modem, our e-mail address is AIDSTreatD@aol.com. Copyright (c) 1996 - AIDS Treatment Data Network. 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