“We are delighted to be able to open these two important clinical studies ahead of schedule,” said Geoff Nichol, executive vice president of research and development at Sangamo, in a press release.

Both trials are testing gene therapy approaches to curing HIV. In the field of HIV/AIDs, gene therapy involves modifying a person’s DNA (the genetic information in cells) so that it becomes, for example, resistant to HIV infection (see related AIDS Beacon news).

In both trials, cells will be taken from the patient’s body, genetically modified in the laboratory, and then injected back into the patient.

Altogether, Sangamo anticipates recruiting around 29 people with HIV for both clinical trials.

Gene therapy as a cure for HIV is a somewhat controversial approach. Some researchers believe the technique is too risky and expensive for widespread use. Others, however, think that gene therapy may be the only way to cure HIV, and that the science behind it is developing rapidly enough to make it a viable treatment option (see related AIDS Beacon news).

The gene therapy approach being tested by Sangamo is an attempt to mimic the success of “The Berlin Patient,” a man who received a bone marrow transplant from a carefully selected donor with a mutated form of the CCR5 gene.

HIV requires the CCR5 protein, which is located on the surface of white blood cells, in order to attach to and infect the cell. People naturally born with an alternate form of the CCR5 gene are almost entirely immune to HIV. Since his transplant, no sign of HIV has been detected in The Berlin Patient.

In the Sangamo trials, investigators will genetically modify immune cells, called T-cells, to remove CCR5. The researchers hope that the genetically modified T-cells will be immune to the virus and thus able to block viral entry and replication. They also hope the cells will multiply to make other HIV-resistant T-cells. The goal is to eventually attain a “functional cure” for HIV: a remission state with long-term control of HIV, including low viral loads (amount of HIV in the blood) in the absence of antiretroviral therapy.

Results from a Phase 1 trial showed that the technique successfully reduced viral loads in patients with HIV. One study participant, who already naturally had one copy of the HIV-resistant CCR5 gene form, achieved undetectable viral loads with the treatment.

“Both of these new Phase 2 clinical trials are specifically designed to confirm and further investigate these findings,” said Nichol.

In the Phase 2 trials, Sangamo will test two approaches to improve the efficacy of their technique.

In the first trial, the researchers will further explore the gene therapy’s effects on people who naturally have one copy of the HIV-resistant CCR5 gene. Up to 20 HIV-positive adults on antiretroviral therapy who have the alternate gene will be enrolled.

Study participants will receive one course of the gene therapy treatment. After two months, they will then stop antiretroviral therapy for 16 weeks while the researchers monitor their CD4 (white blood cell) counts and viral loads.

Participants whose CD4 counts drop below 350 or whose viral loads rise above 100,000 copies per milliliter will restart therapy, as will participants with detectable viral loads after 16 weeks. However, participants who retain undetectable viral loads will remain off therapy until their viral loads become detectable or their CD4 counts drop below 350.

In the second trial, researchers will test whether an initial preparative regimen of cyclophosphamide (Cytoxan) prior to the gene therapy treatment improves its efficacy.

Cyclophosphamide is used in cancer patients to improve the outcome of stem cell transplants by killing a patient’s existing T-cells. The goal of the trial is to determine if depleting these cells will allow the gene therapy-modified T-cells to better take hold and multiply.

The trial will enroll at least nine participants and will test three different dosages of cyclophosphamide a day prior to the gene therapy treatment. After the gene therapy treatment, study participants will then undergo a 16 week antiretroviral treatment interruption with the same guidelines as in the first trial, but with a more stringent CD4 count cutoff of 500 cells per microliter.

For more information, please see the Sangamo BioSciences press release.

Gilead Sciences And Janssen Therapeutics Agree To Lower AIDS Drug Prices For ADAPs – Gilead Sciences and Janssen Therapeutics (a division of Johnson & Johnson) have reached agreements with the ADAP Crisis Task Force (ACTF) to further reduce the prices for antiretrovirals purchased by state AIDS Drug Assistance Programs (ADAPs), which provide free antiretrovirals to low-income people with HIV. Due to state budget crises and an increase in the number of people requesting assistance, many states have tightened eligibility requirements or implemented waiting lists for ADAPs. According to ACTF, there were 6,595 people on ADAP waiting lists nationwide as of November 17. For more information, please see the press releases from ACTF (pdf) and the AIDS Healthcare Foundation.

GeoVax Begins Phase 1/2 Trial Of Therapeutic AIDS Vaccine; Still Recruiting Participants – Biotechnology company GeoVax Labs announced today that the first patient has received a dose of its investigational therapeutic HIV vaccine as part of a Phase 1/2 trial. The company is testing the safety and efficacy of the vaccine in controlling HIV replication in people already infected with the virus; participants will stop taking antiretrovirals for 12 weeks as part of the trial. The company also noted that it is still recruiting participants for the trial. Eligible participants must be HIV-positive and have started antiretrovirals within 18 months of their last negative HIV test; or have had a negative HIV test within the past 18 months and not yet started antiretrovirals. For more information, please see the GeoVax press release (pdf) or the U.S. Clinical Trials Registry.

Governors Push For Legalization Of Medical Marijuana – The governors of Rhode Island and Washington states have petitioned the federal government to legalize use of marijuana for medicinal purposes. Both states have legalized medical marijuana, and the governors argue that the change in federal law is necessary so that state employees are not prosecuted for distributing the drug. The U.S. Justice Department had previously sent letters to state governments warning of prosecution if they continued to distribute medical marijuana (see related AIDS Beacon news). The federal Drug Enforcement Agency rejected a request to reclassify the drug as acceptable for medicinal use in June; however, the governors argued that the evidence used for that rejection is several years old and that the medical community has since changed its stance on marijuana. For more information, please see the article in the New York Times.

“These positive two-year data indicate that elvitegravir has the potential to be an important new once-daily treatment option for people living with HIV who have developed resistance to other therapies,” said Norbert Bischofberger, executive vice president of Research and Development and chief scientific officer of Gilead Sciences, which is developing elvitegravir, in a press release.

“In addition, we are very excited about elvitegravir’s role as part of our new Quad single-tablet regimen, which is currently in U.S. regulatory review,” he added.

Gilead stated that based on the results, the company plans to file for approval of elvitegravir from the United States Food and Drug Administration (FDA) in the second quarter of 2012.

Gilead also submitted a new drug application for its investigational Quad pill (cobicistat/elvitegravir/emtricitabine/tenofovir) to the FDA in October (see related AIDS Beacon news).

Elvitegravir belongs to a relatively new class of antiretroviral called integrase inhibitors. Currently, Isentress (raltegravir) is the only approved integrase inhibitor. It is approved both as a first-line treatment for HIV and for people who are treatment-experienced.

Gilead previously presented 48-week results from the Phase 3 clinical trial showing that elvitegravir was comparable in safety and efficacy to Isentress (see related AIDS Beacon news). On Friday the company released the full 96-week results.

The study included 702 participants, a majority of whom (63 percent) were resistant to two or more classes of antiretrovirals at the start of the trial.

Participants were randomly assigned to receive once-daily elvitegravir (150 mg or 85 mg) or twice-daily Isentress (400 mg). In addition, participants took a Norvir (ritonavir)-boosted protease inhibitor plus another antiretroviral.

The most common background regimen was Norvir-boosted Prezista (darunavir) plus Viread (tenofovir). Participants who took Reyataz (atazanavir) or Kaletra (lopinavir/ritonavir) received a lower dose of elvitegravir, 85 mg daily instead of 150 mg.

After 96 weeks, 48 percent of patients in the elvitegravir group achieved and maintained viral loads (amount of HIV in the blood) of less than 50 copies per milliliter, compared to 45 percent of patients in the Isentress group.

Gilead reported that the rates and types of side effects were also comparable, and that discontinuation rates due to side effects were similar between the two groups.

The company had previously reported that, after 48 weeks, the most common side effects in participants taking elvitegravir were diarrhea (12 percent of participants), upper respiratory tract infection (6 percent), bronchitis (5 percent), back pain (5 percent), depression (5 percent), sinus infection (4 percent), joint pain (4 percent), nausea (4 percent), and urinary tract infection (3 percent).

Gilead stated that it would present the full clinical trial results at a scientific conference in 2012.

For more information, please see the Gilead Sciences press release.

AIDS Patients Sue Ohio Department Of Health Over New ADAP Regulations – Three HIV-positive patients and advocates have sued the Ohio Department of Health over new restrictions to the state’s AIDS Drug Assistance Program (ADAP), which provides free antiretrovirals to low-income people with HIV. According to the lawsuit, Department of Health officials failed to follow state laws on adopting new regulations, making them illegal. The plaintiffs also argue that the regulations would arbitrarily deny treatment to people with HIV. The new regulations would allow the Department to tighten restrictions on patient income for ADAP eligibility; they also include medical guidelines to determine waitlist priority if a waitlist is needed. A judge granted an injunction last week delaying implementation of the new regulations until the lawsuit has been resolved. For more information, please see the article on the New England Cable News website or the AIDS Healthcare Foundation press release.

Vertex Pharmaceuticals To Initiate Phase 3 Trial Of 12-Week Hepatitis C Regimen – Vertex Pharmaceuticals, the developer of Incivek (telaprevir), announced last week that it will initiate a Phase 3 trial of a 12-week hepatitis C treatment regimen consisting of Incivek, peginterferon-alfa, ribavirin, and its investigational hepatitis C virus polymerase inhibitor VX-222. The trial will test the regimen in both previously untreated and relapsed hepatitis C patients. The announcement of the new trial is based on results from a Phase 2 clinical trial that showed that 93 percent of patients treated with the four-drug regimen were cured of hepatitis C after 12 weeks. For more information, please see the Vertex Pharmaceuticals press release.

Bristol-Myers Squibb Investigates 12-Week, Interferon-Free Hepatitis C Treatment Regimen – Bristol-Myers Squibb is also independently investigating a 12-week, interferon-free treatment regimen for the treatment of hepatitis C. Bristol-Myers Squibb announced that it is adding the new 12-week treatment protocol to an existing Phase 2 clinical trial that is testing the same regimen as a 24-week treatment program. Patients will receive the investigational polymerase inhibitor PSI-7977 (developed by Pharmasett) plus Bristol-Myers Squibb’s investigational NS5A replication complex inhibitor daclatasvir (BMS-790052). Some patients will also receive ribavirin. The trial will test the regimens in both previously untreated patients and patients who have failed treatment with Incivek or Victrelis. For more information, please see the Bristol-Myers Squibb press release.

The response rate is similar to that reported last month for Victrelis (boceprevir) in a Phase 2 clinical trial in people with HIV (see related AIDS Beacon news).

“As HIV treatments have improved, liver disease associated with hepatitis C has become a leading cause of death among people who are co-infected, so offering patients a better chance at a cure for hepatitis C while maintaining their suppression of HIV would be a major advance in treatment,” said Dr. Kenneth Sherman, a professor of medicine at the University of Cincinnati College of Medicine and lead investigator of the trial, in a press release.

The results were presented today at the 62nd Annual Meeting of the American Association for the Study of Liver Diseases in San Francisco.

Based on the results, Vertex Pharmaceuticals, which developed Incivek (telaprevir), stated that it will initiate a Phase 3 trial of the drug in people with HIV by the end of the year. The trial will evaluate both a 24-week and 48-week treatment course for hepatitis C.

“As we prepare for our new Phase 3 study to evaluate Incivek combination therapy in a much larger group of people who are co-infected, data from this study give us hope that in the future we’ll be able to help more co-infected patients clear the virus,” said Dr. Robert Kauffman, senior vice president and chief medical officer at Vertex.

HIV and hepatitis C virus co-infection is very common; researchers estimate that a quarter to a third of people with HIV also have hepatitis C. People who are infected with both viruses are less likely to spontaneously clear the hepatitis C virus from their systems than people with hepatitis C only. Co-infected patients are also less likely to respond to hepatitis C treatment, which currently consists of Pegasys (peginterferon-alfa-2a) or PegIntron (peginterferon-alfa-2b) plus ribavirin (Rebetol, Copegus) for 48 weeks.

Incivek, which was approved by the United States Food and Drug Administration in May of this year for the treatment of hepatitis C (in combination with peginterferon-alfa and ribavirin), has been shown to improve hepatitis C cure rates compared to peginterferon-alfa and ribavirin alone.

However, it was not approved at the time for people with both HIV and hepatitis C, due to lack of information on efficacy in people who are co-infected.

In this ongoing Phase 2 study, researchers are comparing the efficacy of Incivek plus Pegasys and ribavirin to Pegasys and ribavirin alone in adult patients with both hepatitis C and HIV.

The trial includes 60 HIV-positive adults with genotype-1 hepatitis C. Twenty-two percent of participants are not on antiretroviral therapy, 40 percent are taking Atripla (efavirenz/emtricitabine/tenofovir), and 38 percent are taking Norvir (ritonavir)-boosted Reyataz (atazanavir) plus Viread (tenofovir) and Emtriva (emtricitabine) or Epivir (lamivudine).

The average participant age at the start of the study was 46 years old. Most (88 percent) are male; 27 percent are African-American. None of the participants have previously been treated for hepatitis C.

Study participants were randomly assigned to receive 12 weeks of Incivek or a placebo, both in combination with Pegasys and ribavirin, followed by 36 weeks of Pegasys and ribavirin alone.

Patients taking Atripla took a larger dose of Incivek (1,125 mg every eight hours) than patients taking a Reyataz-based regimen or no antiretrovirals (750 mg every eight hours).

Results showed that after 24 weeks, 74 percent of participants taking Incivek had undetectable levels of hepatitis C virus, compared to 55 percent of participants taking only Pegasys and ribavirin.

CD4 (white blood cell) counts dropped in both the Incivek and placebo groups during the course of the study, although there was no difference in the magnitude of the change between the two groups. All participants successfully maintained undetectable HIV viral loads throughout the 24 weeks.

The most common side effects in participants taking Incivek were abdominal pain, vomiting, nausea, fever, dizziness, depression, and itchiness. No participants contracted the severe rash that is a known possible side effect of Incivek (see related AIDS Beacon news).

Overall, 27 percent of participants discontinued treatment during the first 24 weeks; 2 percent discontinued due to side effects, 7 percent due to non-adherence to the drug regimen, and the rest for other reasons.

For more information, please see the press release from Vertex Pharmaceuticals.

“The most important message from the study is that dolutegravir is a safe and highly potent drug which can be given at low doses without a pharmacologic booster once daily,”  said Dr. Jan van Lunzen, a professor at the University Medical Center Hamburg-Eppendorf, in Hamburg, Germany and lead author of the study.

“Thus it has the potential to be a very attractive future component of combination antiretroviral therapy, both in antiretroviral-naïve as well as experienced patients,” he added.

Patients receiving dolutegravir also showed a more rapid decrease in viral load (amount of HIV in the blood) compared to patients receiving Sustiva. The decrease was maintained through week 48 of the study, and the rate of decrease was similar to that reported for the integrase inhibitor Isentress.

The investigators noted that this might have important implications for people with HIV who require an especially rapid reduction in viral load, for example, late-presenting pregnant women with HIV.

The investigators stated that based on their results, they selected the once-daily 50 mg dose of dolutegravir, the highest well-tolerated dose studied, for further testing in Phase 3 trials.

“Currently there are three Phase 3 studies underway in treatment-naïve populations comparing dolutegravir with either efavirenz [Sustiva], darunavir/r [Norvir-boosted Prezista], or raltegravir [Isentress]. Another Phase 3 trial is currently ongoing in experienced patients with previous treatment failure,” said Dr. van Lunzen.

The interim results after 48 weeks were first presented at the 6^th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention (see related AIDS Beacon news),

Dolutegravir (S/GSK1349572) is a potential new integrase inhibitor being developed by ViiV Healthcare, a joint venture by GlaxoSmithKline and Pfizer.

Currently, the only approved integrase inhibitor is Isentress (raltegravir), which is marketed by the United States pharmaceutical company Merck. Isentress must be taken twice-daily in combination with other antiretrovirals as part of highly active antiretroviral therapy.

In recent years, the U.S. Food and Drug Administration has approved once-daily rather than twice-daily dosages of several antiretrovirals. Previous research has shown that once-daily dosing is more convenient and promotes better adherence to drug regimens. Better adherence allows for slower disease progression and helps prevent the development of drug-resistant HIV strains.

However, results from a recent study showed that Isentress once daily is not as effective as twice daily (see related AIDS Beacon news). Elvitegravir, which is another investigational integrase inhibitor that is currently in Phase 3 clinical trials, is given once daily but must be taken with a booster such as Norvir (ritonavir) or cobicistat.

According to the study authors, previous studies of dolutegravir in people have shown it to be long lasting without the need for a booster. Results of another ongoing study also indicate that dolutegravir is effective against viral strains resistant to both Isentress and elvitegravir.

The 96 week-long Phase 2 trial was designed to test the safety and efficacy of several once-daily dolutegravir dosages relative to Sustiva (efavirenz). Sustiva, when combined with Truvada (emtricitabine/tenofovir) in the form of Atripla (efavirenz/emtricitabine/tenofovir), is the most commonly prescribed first-line regimen to treat HIV.

A total of 205 previously untreated HIV-positive adults were randomly assigned to receive 10 mg, 25 mg, or 50 mg dolutegravir, or 600 mg Sustiva. Patients in each group also took either Truvada or Epzicom (abacavir/lamivudine).

Results showed that after 16 weeks, about 93 percent of patients in all dosage groups of dolutegravir had undetectable viral loads, with little difference between the dose groups. Sixty percent of participants taking Sustiva had undetectable viral loads.

After 48 weeks, 91 percent, 88 percent, and 90 percent of participants in the dolutegravir groups, respectively, and 82 percent of the participants in the Sustiva group had successfully achieved undetectable viral loads.

In addition, CD4 (white blood cell) counts increased in all three dolutegravir groups and in the Sustiva group through week 48. Average increases were larger in the dolutegravir group, 231 cells per microliter versus 174 cells per microliter in the Sustiva group.

Nearly half of participants (46 percent) experienced one or more drug-related side effects during the first 48 weeks of the study, but investigators concluded that no serious side effects were related to dolutegravir. More participants in the Sustiva group had moderate or severe drug-related side effects (20 percent, compared with 8 percent in the dolutegravir groups).

The most common side effects in participants taking dolutegravir were nausea (12 percent of participants), diarrhea (8 percent), headache (6 percent), dizziness (3 percent), fatigue (3 percent), and weakness (3 percent).

Six participants withdrew from the study: one each in the 25 mg and 50 mg dolutegravir groups due to upset stomach/indigestion and lymphatic cancer, respectively, and four in the Sustiva group due to drug intolerance, drug sensitivity, abnormal dreams, and suicide attempt.

Investigators did not identify any HIV integrase mutations in patients in the study.

For more information, please see the study in The Lancet Infectious Diseases (abstract).

“[Patients] could use elvitegravir [once daily] instead of Isentress [twice daily] in combination with a boosted protease inhibitor with the same efficacy and safety,” said Dr. Jean-Michel Molina, a researcher at the Hôpital Saint Louis and University of Paris and lead author of the study.

The study authors noted that once daily dosing as opposed to twice daily dosing might improve patients’ adherence to treatment.

Investigators previously presented the results of the study in July at the International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention (see related AIDS Beacon news).

Elvitegravir, which is being developed by Gilead Sciences, and Isentress (raltegravir) are both integrase inhibitors, a relatively new class of antiretroviral. Currently, Isentress is the only approved integrase inhibitor.

In this clinical trial, researchers compared the safety and efficacy of elvitegravir to that of Isentress in 702 HIV-positive adults who had previously been treated for HIV. Two-thirds of the participants had resistance to two or more classes of antiretroviral drugs.

Half of the participants were randomly assigned to receive elvitegravir once daily and the other half Isentress twice daily. Placebo pills were used to ensure that all participants received the same number of pills daily.

All patients also took a Norvir (ritonavir)-boosted protease inhibitor and a third antiretroviral, which was either a nucleoside reverse transcriptase inhibitor, Intelence (etravirine), Selzentry (maraviroc), or Fuzeon (enfuvirtide). The most commonly used protease inhibitor was Prezista (darunavir).

Results showed that after 48 weeks, 59 percent of patients in the elvitegravir group achieved and maintained undetectable viral loads (amount of HIV in the blood), compared to 58 percent of patients in the Isentress group.

Increases in CD4 (white blood cell) counts were also similar between the two groups: an average increase of 119 of cells per microliter in participants taking elvitegravir versus 127 cells per microliter in participants taking Isentress.

Drug adherence up to week 48 of the study was determined by pill counts at every visit during the study. Adherence was similar (95 percent) in both groups.

Rates and types of side effects were similar between the two groups. The most common side effects in participants taking elvitegravir were diarrhea (12 percent of participants), upper respiratory tract infection (6 percent), bronchitis (5 percent), back pain (5 percent), depression (5 percent), sinus infection (4 percent), joint pain (4 percent), nausea (4 percent), and urinary tract infection (3 percent).

Although diarrhea was equally common in both treatment groups in the first month of treatment, diarrhea was reported more often after the first month by patients receiving elvitegravir.

One percent of patients assigned to elvitegravir experienced serious side effects, compared to two percent of patients assigned to Isentress. Two patients (0.5 percent) and eight patients (2 percent) died in each group, respectively, during the study period.

The trial will continue for an additional 48 weeks. In addition, studies are ongoing of elvitegravir as a component of the investigational single-tablet combination “Quad” (cobicistat/elvitegravir/emtricitabine/tenofovir) regimen in previously untreated HIV-positive adults.

Gilead stated in July that it plans to apply for approval of elvitegravir in the U.S. and Europe in 2012.

For more information, please see the study in The Lancet Infectious Diseases (abstract).

“We are encouraged by these interim results with Victrelis in combination therapy in this difficult-to-treat patient population,” said Dr. Roger Pomerantz, senior vice president of Infectious Diseases at U.S. pharmaceutical company Merck, in a press release.

Based on the results, Dr. Pomerantz said that Merck is planning to initiate a Phase 3 study of Victrelis in people with both HIV and hepatitis C later this year.

The results were presented last week at the Infectious Diseases Society of America 2011 Annual Meeting in Boston.

Hepatitis C is a liver disease caused by the hepatitis C virus. If untreated, infection with the hepatitis C virus can cause damage and scarring to the liver, liver cancer, and eventually liver failure. Once the liver fails, a liver transplant is necessary for a patient to survive. Some people who are infected can spontaneously clear the virus themselves; the rest need treatment with antiviral drugs.

HIV patients with hepatitis C are less likely to clear the infection compared to patients with hepatitis C only. Once the infection develops and becomes chronic, HIV patients are less likely to respond to hepatitis C treatment, which currently consists of peginterferon-alfa  (PegIntron, Pegasys) plus ribavirin (Rebetol, Copegus) for 48 weeks.

Victrelis (boceprevir) was approved by the United States Food and Drug Administration in May of this year for the treatment of hepatitis C, in combination with peginterferon-alfa and ribavirin. However, it was not approved at the time for people with both HIV and hepatitis C, due to lack of information on efficacy in people who are co-infected.

In this ongoing Phase 2 study, researchers are comparing the efficacy of Victrelis plus PegIntron (peginterferon alfa-2b) and ribavirin to PegIntron and ribavirin alone in adult patients with both hepatitis C and HIV.

The study includes 98 participants who were randomly assigned to receive one of the two above mentioned treatments. All participants had stable HIV infections, were receiving an optimized antiretroviral regimen, and had not previously been treated for hepatitis C.

Since studies have shown that certain HIV antiretrovirals may potentially interact with Victrelis, non-nucleoside reverse transcriptase inhibitors, zidovudine (Retrovir), stavudine (Zerit), and didanosine (Videx) were not allowed during the study.

Most participants were Caucasian (82 percent), and a majority were male (69 percent). The median participant age was 43 years old.

Participants in each of the two treatment groups received four weeks of treatment with PegIntron plus ribavirin. Two-thirds of the participants then initiated treatment with Victrelis three times daily in addition to PegIntron and ribavirin; the remaining participants continued treatment with just PegIntron plus ribavirin.

Results showed that after 24 weeks, 70 percent of participants taking Victrelis had undetectable hepatitis C virus levels, compared to 34 percent of participants taking PegIntron and ribavirin alone.

The most common side effects in the group receiving Victrelis versus the group receiving PegIntron and ribavirin alone were: low white blood cell levels (neutropenia), 13 percent versus 3 percent; bad taste in the mouth, 25 percent versus 15 percent; vomiting, 25 percent versus 15 percent; fever, 34 percent versus 21 percent; headache, 28 percent versus 12 percent; and decreased appetite, 30 percent versus 18 percent.

Serious side effects occurred in 8 percent of the patients receiving Victrelis in combination with PegIntron and ribavirin, compared with 21 percent of patients receiving PegIntron plus ribavirin alone.

Overall, 14 percent of participants receiving Victrelis discontinued treatment due to side effects, compared to 9 percent of participants receiving PegIntron and ribavirin alone.

The trial will continue for an additional 24 weeks. Merck stated that final results are expected in 2012.

For more information, please see the study (abstract) or the Merck press release.

People With HIV And Tuberculosis Should Not Wait To Start Antiretroviral Therapy – Results from three large studies indicate that starting antiretroviral therapy two to four weeks after starting tuberculosis treatment reduces the number of AIDS-related illnesses and deaths in people with both HIV and tuberculosis who have low CD4 (white blood cell) counts, 50 to 200 cells per microliter or less. Earlier guidelines recommended that people wait to start antiretroviral therapy for at least eight weeks to reduce the rate of immune reconstitution inflammatory syndrome (IRIS), a potentially serious condition in which the recovering immune system overreacts to other illnesses in the body. The studies found that the benefits of starting therapy sooner outweighed the risks from IRIS. For more information, please see the article in the San Francisco Chronicle or the first, second, and third studies in the New England Journal of Medicine.

Theratechnologies Applies For Approval Of Egrifta In Mexico – Theratechnologies, via an affiliate of its partner Sanofi, has applied for marketing approval of Egrifta (tesamorelin) in Mexico. If approved, Egrifta will be the first drug in Mexico to treat lipodystrophy, a condition of abnormal fat distribution that is a side effect of certain anti-HIV medications. Based on targeted approval times, a decision would be expected in late 2011 or early 2012. Egrifta was approved in the U.S. in November of last year, and Theratechnologies’ partners have since applied for approval in Europe, Israel, Canada, Brazil, and Argentina. For more information, please see the Theratechnologies press release.

Vertex Pharmaceuticals Initiates Phase 3 Trial Of 12-Week Treatment Course For Hepatitis C – Vertex Pharmaceuticals is initiating a Phase 3 clinical trial to test the efficacy of a 12-week course of the hepatitis C drug Incivek (telaprevir) in people with a certain genetic variant, IL28B CC, that makes them respond particularly well to treatment. Currently, Incivek must be taken for at least 24 weeks. Participants who respond well to Incivek will also take a shortened course of peginterferon-alfa (Pegasys) plus ribavirin (Copegus), either 12 or 24 weeks total. All other patients will receive the standard 48 weeks of peginterferon-alfa plus ribavirin. For more information, please see the Vertex Pharmaceuticals press release.

In addition, participants taking Isentress (raltegravir) reported fewer side effects than participants taking Sustiva (efavirenz).

“These results offer further insight into the virologic and immunologic response seen with Isentress in combination therapy when compared to [Sustiva] at 192 weeks in treatment-naïve adult patients with HIV-1,” said Dr. Jürgen Rockstroh, a professor of medicine at the University of Bonn in Bonn-Venusberg, Germany, in a press release. Dr. Rockstroh presented the results yesterday at the European AIDS Conference (EACS) in Belgrade, Serbia.

U.S. pharmaceutical company Merck, which sponsored the trial, released results in July from a Phase 2 clinical trial that also showed similar long-term safety and efficacy of Isentress compared to Sustiva (see related AIDS Beacon news).

The antiretroviral Isentress is approved both for treatment-experienced adults with HIV and as a first-line treatment for people who have not previously taken antiretrovirals. Isentress is currently the only approved integrase inhibitor, although two other investigational integrase inhibitors – dolutegravir and elvitegravir – are in Phase 3 clinical trials.

Sustiva, which is a non-nucleoside reverse transcriptase inhibitor, is often combined with Truvada (emtricitabine/tenofovir)  in the form of Atripla (efavirenz/emtricitabine/tenofovir). Atripla is the most commonly prescribed first-line regimen for people with HIV.

Both Sustiva and Isentress, in combination with Truvada, are listed in HIV treatment guidelines as “preferred” regimens for people starting antiretroviral therapy for the first time.

In this study, researchers are comparing the long-term safety and efficacy of Isentress and Sustiva.

The study includes 563 previously untreated HIV-positive adults. Participants were randomly assigned to take either Sustiva once daily or Isentress twice daily, both in combination with Truvada.

Results after 192 weeks (about three and a half years) show that 76 percent of participants taking Isentress have successfully achieved and maintained undetectable viral loads (amount of HIV in the blood), compared to 67 percent of participants taking Sustiva.

In addition, participants taking Isentress have had an average increase in CD4 (white blood cell) counts of 361 cells per microliter over this period, versus an average increase of 301 cells per microliter in participants taking Sustiva.

Fewer patients taking Isentress reported side effects (50 percent) than those taking Sustiva (80 percent), although the rate of serious side effects was similar for the two groups (18 percent).

Overall, 5 percent of participants taking Isentress and 8 percent of participants taking Sustiva discontinued the drugs due to side effects.

For more information, please see the Merck press release.